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  • At least one killed in KP’s Bajaur blast during cricket match: police – Pakistan

    At least one killed in KP’s Bajaur blast during cricket match: police – Pakistan

    At least one person was killed in a bomb blast while a cricket match was being played in Khyber Pakhtunkhwa’s Bajaur district on Saturday, according to the police.

    Bajaur District Police Officer Waqas Rafique confirmed the incident to Dawn.com in Khar tehsil’s Kausar Cricket Ground and said the blast was carried out through an improvised explosive device.

    “It appears to be a targeted attack,” he added.

    Last Saturday, two people, including a police official, were wounded after terrorists attacked a police station in the district’s Laghari area of Lowi Mamund tehsil through a quadcopter.

    Sources said police constable Mohammad Habib and civilian Najeeb Khan were injured in the attack, which also damaged a vehicle parked on the premises.

    Israr Khan, a public relations officer of the district police, had told Dawn that the injured were immediately shifted to the district headquarters hospital in Khar.

    He also said terrorists launched another attack on the police station through a quadcopter but it missed the target.

    No group claimed responsibility for the attack. However, police officials blamed it on terrorists in light of Operation Sarbakaf launched by security forces against them a couple of weeks ago.

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  • Ultra-Processed Foods May Harm Male Fertility, Study Finds

    Ultra-Processed Foods May Harm Male Fertility, Study Finds

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    Ultra-processed foods may contain endocrine disrupters that negatively impact male fertility. New Saetiew/Getty Images
    • Ultra-processed foods can increase the risk of multiple chronic health conditions, such as heart disease and type 2 diabetes.
    • A new study found that a diet heavy in ultra-processed foods can harm male reproductive health and reduce sperm quality.
    • The researchers say that ultra-processed foods may contain molecules found in plastics that are known to disrupt hormonal systems in the body.

    A new study reports that ultra-processed foods may be linked to a decline in male reproductive health, including sperm quality.

    The research, published on August 28 in Cell Metabolism, states that regular consumption of ultra-processed foods has several effects on a person’s health.

    These include higher cholesterol levels and increased body weight. They noted that participants in their study gained more than a kilogram of weight when they ate ultra-processed foods. The amount of fat mass in their bodies also increased.

    The researchers added that “sperm quality trended toward impairment” when participants were on an ultra-processed diet.

    The researchers pointed out that these health effects occurred even when a person on an ultra-processed diet consumed the same number of calories as a person on another type of diet.

    “This study provides evidence that consumption of ultra-processed food is detrimental for cardiometabolic and reproductive outcomes, regardless of excessive caloric intake,” the study authors wrote.

    Philip Werthman, MD, a urologist and director of the Center for Male Reproductive Medicine and Vasectomy Reversal in Los Angeles, says the study is proof that what you eat can be more important than how much you eat.

    “It’s not the calories you’re getting. It’s the type of calories you’re getting,” Werthman told Healthline.

    For their study, researchers recruited 43 males ages 20–35. Each participant spent three weeks on both a diet primarily of ultra-processed foods and a diet of unprocessed foods, with a 3-month “washing out” period between the two diets.

    Half of the participants started on the unprocessed diet while the other half began with the ultra-processed diet. Half of the men from each group were also put on a diet that included 500 extra calories per day.

    Researchers noted that subjects on the ultra-processed diet experienced an increase in the phthalate cxMINP, a substance found in plastics that can disrupt hormones.

    Those on the ultra-processed diet also saw decreases in their testosterone levels and follicle-stimulating hormones, which are crucial for sperm production.

    The researchers said some of the endocrine-disrupting substances may come from the plastic packaging used for ultra-processed foods.

    They note that the introduction of ultra-processed foods in the 1970s seems to fall in line with a 60% decline worldwide in sperm count.

    Kristin Kirkpatrick, president of KAK Consulting and a dietitian at Cleveland Clinic’s Department of Wellness & Preventive Medicine, said the research sends a clear message.

    “The study found that endocrine disrupters and other components altered hormone levels in men, even if the men were healthy,” she told Healthline. “This means, even if you’re healthy based on other parameters, yet consume a diet higher in ultra-processed foods, you still are at risk for increases in chronic conditions.”

    Werthman added that a man’s general health can also affect their reproductive system. For example, a person who has gained weight, developed type 2 diabetes, or experienced a rise in cholesterol levels may see a decline in reproductive health measures such as sperm quality.

    “The reproductive system is a function of your overall health,” Werthman explained. “The reproductive system is quite sensitive.”

    Michael Eisenberg, MD, a professor of urology at Stanford University, had one caution about the study’s conclusions.

    “While none reached statistical significance, there does appear to be a decline in semen quality when examining the summative data,” he told Healthline. “However, it’s important to note that the intervention was for three weeks, and a cycle of sperm production typically takes between two to three months.”

    The Centers for Disease Control and Prevention (CDC) reports that ultra-processed foods account for an average of 55% of total calories consumed by people in the United States.

    It notes that people under 19 years of age tend to eat slightly more ultra-processed foods than adults 19 years and older. The agency states there is little difference in ultra-processed food consumption between men and women.

    The CDC says ultra-processed foods tend to be “hyperpalatable, energy-dense, low in dietary fiber, and contain little or no whole foods, while having high amounts of salt, sweeteners, and unhealthy fats.”

    It states that sandwiches (including burgers), sweet bakery products, sweetened beverages, and savory snacks are among the top sources of calories from ultra-processed foods.

    An April 2025 study estimated that ultra-processed foods were linked to 124,000 preventable deaths in the United States during a two-year period.

    Kirkpatrick said there are a number of reasons for these impacts, including what a person is not eating.

    “Consuming ultra-processed foods means that other foods, which are found to help in the prevention of heart disease (like fresh fruit and vegetables, healthy fats, and fiber) are not being consumed,” she said.

    “Further, excess sugar and sodium consumption has been found in multiple studies to pose a significant risk to heart health. Sugar and sodium are common ingredients in ultra-processed foods.”

    Werthman said the pattern is clear. “This study is another confirmation that the food industry has been poisoning us for the past 20 to 30 years,” he noted. “We see the effects of that now.”

    Experts say there are lifestyle habits that can help improve and maintain male reproductive health.

    “In general, good diet (whole grains, fruits, vegetables), exercise, and maintaining a good body weight will help overall and reproductive health,” said Eisenberg.

    Werthman says a healthy diet is “a big component” of that equation, but noted that men, especially those in the process of trying to have children, should exercise regularly as well as avoid alcohol and tobacco.

    Werthman noted that heat sources such as saunas and hot tubs can temporarily impact sperm quality and quantity.

    “All these things affect the reproductive system,” he said. “The body is an integrated system.”

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  • India vs Japan ends in 2-2 draw

    India vs Japan ends in 2-2 draw

    The Indian hockey team fought back from a goal down twice to draw their second Women’s Asia Cup 2025 match 2-2 with Japan at the Gongshu Canal Sports Park Hockey Field in Hangzhou, the People’s Republic of China, on Saturday.

    For India, 10th in the women’s hockey rankings, both the goals were equalising goals and were scored by Rutuja Dadaso Pisal (30’) and Navneet Kaur (60’). Defending champions and world No. 12, Japan’s goals were scored by Hiroka Murayama (10’) and Chiko Fujibayashi (58’).

    The result means India are unbeaten so far in the tournament, having won their first game against Thailand 11-0 on Friday. After the round-robin phase, the top two from each pool will progress to the Super 4s, which will decide the finalists. India are drawn in Pool B with Japan, Thailand and Singapore.

    It was a quick start from India as Japan did their best to thwart their attacks. However, Japan’s resistance eventually paid off as they drew first blood when Hiroka Murayama found the back of the net to round off a sweeping move. Japan led 1-0 and kept India at bay for the remainder of the first quarter.

    After the breather, India went on the attack in the hunt for the equaliser, although Japan were not giving anything away. However, in the final minutes of the first half, India found a way through as Rutuja Dadaso Pisal scored and made it 1-1 at half-time.

    The second half started with both sides taking a watchful approach in their bid not to concede momentum. India were looking to get their noses out in front, having finished the first half strongly, while Japan’s disciplined defensive unit held on. The third quarter saw both teams trade punches and go into the break with the scores at 1-1.

    In the final quarter, both teams upped the ante in attack as they were looking for the crucial winner. However, it was Japan’s pressure that paid off initially as they got the goal a few minutes before the final hooter.

    A penalty stroke fell to Chiko Fujibayashi and she smashed home to make it 2-1 with barely any time left. However, India gave it their all as they went in search of a late equaliser and it came in the form of Navneet Kaur from a penalty corner in the dying moments of the game.

    Eventually, both teams shared the spoils with the scores at 2-2 at the hooter. India will face Singapore next in the women’s Asia Cup hockey tournament on Monday.

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  • BioMarin Announces Positive Pivotal Phase 3 Data for PALYNZIQ® (pegvaliase-pqpz) in Adolescents with Phenylketonuria at 15th International Congress of Inborn Errors of Metabolism

    BioMarin Announces Positive Pivotal Phase 3 Data for PALYNZIQ® (pegvaliase-pqpz) in Adolescents with Phenylketonuria at 15th International Congress of Inborn Errors of Metabolism

    New data from Phase 3 PEGASUS study demonstrates a 49.7% decrease in mean blood Phe levels in adolescents aged 12-17 treated with PALYNZIQ

    BioMarin’s planned submission to global health authorities on track for second half of 2025

    SAN RAFAEL, Calif., Sept. 6, 2025 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced new data characterizing the efficacy and safety of PALYNZIQ® (pegvaliase-pqpz) for the treatment of adolescents with phenylketonuria (PKU), which were presented at the 15th International Congress of Inborn Errors of Metabolism (ICIEM) in Kyoto, Japan, Sept. 2-6, 2025.

    The Phase 3 PEGASUS study evaluating the efficacy and safety of PALYNZIQ in adolescents aged 12-17 demonstrated statistically significant blood phenylalanine (Phe) lowering compared to diet alone. The study enrolled 55 adolescents, randomized to receive PALYNZIQ (n=36) or diet alone (n=19). At baseline, the mean age was 14.3 years, mean blood Phe was 1026.4 µmol/L, and nearly half (49.1%) of participants had blood Phe levels above 1000 µmol/L. Notably, after the 72-week primary treatment phase, almost half of participants in the PALYNZIQ arm (n=14; 45.2%) achieved reductions in blood Phe concentrations of 50% or more from baseline, with many reaching guideline-recommended and even normal Phe target levels.

    Table 1. Primary and Secondary Efficacy Results After 72 Weeks

    PALYNZIQ

    (n=31)

    Diet only

    (n=17)

    Mean % change in blood Phe
    concentration from baseline

    -49.7 %

    -0.3 %

    # of participants achieving blood Phe
    levels ≤600 µmol/L

    16 (51.6 %)

    1 (5.9 %)

    # of participants achieving blood Phe
    levels ≤360 µmol/L

    12 (38.7 %)

    0 (0 %)

    # of participants achieving blood Phe
    levels ≤120 µmol/L

    6 (19.4 %)

    0 (0 %)

    Change from baseline in intact food
    protein intake (g/kg/day)

    0.21 (107 %)

    -0.02 (-10 %)

    Change from baseline in medical food
    protein intake (g/kg/day)

    -0.20 (-29 %)

    0.03 (22 %)

    The safety profile and overall efficacy trends in adolescents were consistent with the known profile of the medicine in adults. The vast majority of adverse events (AEs) in the study were manageable, with 5.6% representing serious AEs (anaphylaxis) leading to study discontinuation. The ongoing extension phase of the PEGASUS trial will continue to evaluate long-term results of PALYNZIQ treatment for adolescents.

    “These data from the PEGASUS study underscore the impact PALYNZIQ can have in enabling adolescents to experience more freedom from the burden of their condition, particularly during this pivotal period of transition to adulthood,” said Greg Friberg, M.D., Executive Vice President and Chief Research & Development Officer at BioMarin. “BioMarin has been deeply committed to advancing scientific progress for people living with PKU over the past two decades, and we look forward to sharing these results with global regulators with the aim of bringing the unequaled efficacy observed with PALYNZIQ to an even younger group of people.”

    PALYNZIQ is the first and only enzyme substitution therapy approved to treat adults with PKU. The company is on track with its planned submission of the PEGASUS study data to global health authorities to expand the approved indication for PALYNZIQ to include the treatment of adolescents.

    Below are key presentations for BioMarin and PALYNZIQ at ICIEM (all times Japan Standard Time):

    Neuropsychiatric Comorbidities in Adults with PKU in Sweden
    Oral #3
    Wednesday, Sept. 3, 2025, 11 a.m. – 12:30 p.m.

    Safety and Efficacy of Pegvaliase in Adolescents with Phenylketonuria: Primary Results from PEGASUS, a Phase 3, Open-Label Randomized Controlled Study 
    Oral #21
    Friday, Sept. 5, 2025, 10:15 – 11:45 a.m.

    Lifetime Monitoring of Phe Levels in PKU from Birth to Adulthood in the Swedish Registry for Inherited Metabolic Diseases
    Poster #P-593 
    Wednesday, Sept. 3, 2025, 6 – 7 p.m.

    Work Ability in Adults with PKU in Sweden in 2020
    Poster #P-594
    Wednesday, Sept. 3, 2025, 6 – 7 p.m.

    Neuropsychiatric Comorbidities in Adolescents with PKU in the United States
    Poster #P-595
    Wednesday, Sept. 3, 2025, 6 – 7 p.m.

    PALLADIUM: A Phase 4 Study to Evaluate a Rapid Drug Desensitization Protocol for Adults with Phenylketonuria Experiencing Hypersensitivity Reactions to Pegvaliase
    Poster #P-586
    Thursday, Sept. 4, 2025, 5:30 – 6:30 p.m.

    Real-World Safety and Tolerability of Pegvaliase: A Non-Interventional Surveillance Study in Japan
    Poster #P-584 
    Thursday, Sept. 4, 2025, 5:30 – 6:30 p.m.

    About PEGASUS

    PEGASUS is a Phase 3 multi-center open-label randomized controlled study evaluating the efficacy and safety of PALYNZIQ compared to diet alone in 55 adolescents aged 12-17 with phenylketonuria. The primary endpoints are change in blood Phe concentration and characterization of the safety profile in adolescents. Secondary endpoints include change in total dietary protein intake and pharmacokinetics. 

    The study is being conducted in two parts: the primary treatment phase ranging from weeks 1-73 (Part 1), and the extension phase (Part 2), which lasts for up to an additional 80 weeks of monitoring for the PALYNZIQ arm and allows for crossover for those in the diet-only arm.

    For more information, please visit clinicaltrials.biomarin.com. 

    About PALYNZIQ

    PALYNZIQ substitutes the deficient phenylalanine hydroxylase (PAH) enzyme in PKU with a PEGylated version of the enzyme phenylalanine ammonia lyase to break down Phe. PALYNZIQ is administered using a dosing regimen designed to facilitate tolerability; PALYNZIQ’s safety profile consists primarily of immune-mediated responses, which can include anaphylaxis, for which robust risk management measures effective in clinical trials are in place.

    PALYNZIQ is approved to reduce blood Phe concentrations for adults in the U.S., for people 16 and older in the EU, Canada and Brazil, and for people 15 and older in Japan with PKU who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management.

    Patient Support Accessing PALYNZIQ

    To reach a BioMarin RareConnections® Case Manager, please call, toll-free, 1-866-906-6100 or e-mail [email protected]. For more information about PALYNZIQ, please visit www.palynziq.com. For additional information regarding this product, please contact BioMarin Medical Information at [email protected].

    About Phenylketonuria

    PKU, or phenylalanine hydroxylase (PAH) deficiency, is a genetic condition affecting approximately 70,000 people in the regions of the world where BioMarin operates. This enzyme is required for the metabolism of Phe, an essential amino acid found in most protein-containing foods. If functional enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms.

    As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually all individuals with PKU born after this period in countries with newborn screening programs are diagnosed at birth and treatment is implemented soon after.

    PKU can be managed with a severe Phe-restricted diet, which is supplemented by low-protein modified foods and Phe-free medical foods; however, it is difficult for most individuals to adhere to the lifelong strict diet to the extent needed to achieve adequate control of blood Phe levels. Dietary control of Phe in childhood can prevent major developmental neurological toxicities, but poor control of Phe in adolescence and adulthood is associated with a range of neurocognitive disabilities with significant functional impact.

    PALYNZIQ U.S. Indication and Important Safety Information

    PALYNZIQ® (pegvaliase-pqpz) is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood Phe levels in adult patients with phenylketonuria who have uncontrolled blood Phe levels greater than 600 micromol/L on existing management.

    BOXED WARNING: RISK OF ANAPHYLAXIS

    • Anaphylaxis has been reported after administration of PALYNZIQ and may occur at any time during treatment
    • Administer the initial dose of PALYNZIQ under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient competency with self-administration, and patient’s and observer’s (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed
    • Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer auto-injectable epinephrine, and call for emergency medical support upon its use
    • Prescribe auto-injectable epinephrine. Prior to the first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during PALYNZIQ treatment
    • PALYNZIQ is available only through a restricted program called PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Further information, including a list of qualified pharmacies, is available at www.PALYNZIQREMS.com or by telephone at 1-855-758-REMS (1-855-758-7367)

    WARNINGS AND PRECAUTIONS

    Anaphylaxis

    • Signs and symptoms of anaphylaxis reported include syncope, hypotension, hypoxia, dyspnea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, tongue), throat tightness, skin flushing, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, diarrhea)
    • Anaphylaxis generally occurred within 1 hour after injection; however, delayed episodes occurred up to 48 hours after PALYNZIQ administration
    • Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer auto-injectable epinephrine, and call for emergency medical support upon its use
    • Anaphylaxis requires immediate treatment with auto-injectable epinephrine. Prescribe auto-injectable epinephrine to all patients receiving PALYNZIQ and instruct patients to carry auto-injectable epinephrine with them at all times during PALYNZIQ treatment. Prior to the first dose, instruct the patient and observer (if applicable) on how to recognize the signs and symptoms of anaphylaxis, how to properly administer auto-injectable epinephrine, and to seek immediate medical care upon its use. Consider the risks associated with auto-injectable epinephrine use when prescribing PALYNZIQ. Refer to the auto-injectable epinephrine prescribing information for complete information
    • Consider the risks and benefits of readministering PALYNZIQ following an episode of anaphylaxis. If the decision is made to readminister PALYNZIQ, administer the first dose under the supervision of a healthcare provider equipped to manage anaphylaxis and closely observe the patient for at least 60 minutes following the dose. Subsequent PALYNZIQ dose titration should be based on patient tolerability and therapeutic response
    • Consider premedication with an H1-receptor antagonist, H2-receptor antagonist, and/or antipyretic prior to PALYNZIQ administration based upon individual patient tolerability

    Other Hypersensitivity Reactions

    • Hypersensitivity reactions other than anaphylaxis have been reported in 204 of 285 (72%) patients treated with PALYNZIQ in clinical trials
    • Management of hypersensitivity reactions should be based on the severity of the reaction, recurrence of the reaction, and the clinical judgment of the healthcare provider, and may include dosage adjustment, temporary drug interruption, or treatment with antihistamines, antipyretics, and/or corticosteroids

    ADVERSE REACTIONS

    • The most common adverse reactions (at least 20% of patients in either treatment phase) were injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety
    • Of the 285 patients exposed to PALYNZIQ in an induction/titration/maintenance regimen in clinical trials, 44 (15%) patients discontinued treatment due to adverse reactions. The most common adverse reactions leading to treatment discontinuation were hypersensitivity reactions (6% of patients) including anaphylaxis (3% of patients), angioedema (1% of patients), arthralgia (4% of patients), generalized skin reactions lasting at least 14 days (2% of patients), and injection site reactions (1% of patients)
    • The most common adverse reactions leading to dosage reduction were arthralgia (15% of patients), hypersensitivity reactions (9% of patients), injection site reactions (4% of patients), alopecia (3% of patients), and generalized skin reactions lasting at least 14 days (2% of patients)
    • The most common adverse reactions leading to temporary drug interruption were hypersensitivity reactions (14% of patients), arthralgia (13% of patients), anaphylaxis (4% of patients), and injection site reactions (4% of patients)
    • Angioedema and serum sickness: In clinical trials, 22 out of 285 (8%) patients experienced 45 episodes of angioedema (symptoms included: pharyngeal edema, swollen tongue, lip swelling, mouth swelling, eyelid edema, and face edema) occurring independent of anaphylaxis. In clinical trials, serum sickness was reported in 7 out of 285 (2%) patients

    Blood Phenylalanine Monitoring and Diet

    • Obtain blood Phe levels every 4 weeks until a maintenance dosage is established. Periodically monitor blood Phe levels during maintenance therapy
    • Counsel patients to monitor dietary protein and Phe intake, and adjust as directed by their healthcare provider

    DRUG INTERACTIONS

    Effect of PALYNZIQ on Other PEGylated Products

    • In a single-dose study of PALYNZIQ in adult patients with PKU, two patients receiving concomitant injections of medroxyprogesterone acetate suspension (a formulation containing PEG 3350) experienced a hypersensitivity reaction. One of the two patients experienced anaphylaxis
    • The clinical effects of concomitant treatment with different PEGylated products is unknown. Monitor patients treated with PALYNZIQ and concomitantly with other PEGylated products for hypersensitivity reactions including anaphylaxis

    USE IN SPECIFIC POPULATIONS

    Pregnancy and Lactation

    • PALYNZIQ may cause fetal harm when administered to a pregnant woman
    • Advise women who are exposed to PALYNZIQ during pregnancy or who become pregnant within one month following the last dose of PALYNZIQ that there is a pregnancy surveillance program that monitors pregnancy outcomes. Healthcare providers should report PALYNZIQ exposure and encourage these patients to report their pregnancy to BioMarin (1-866-906-6100)
    • Monitor blood Phe levels in breastfeeding women treated with PALYNZIQ

    Pediatric Use

    • The safety and effectiveness of PALYNZIQ in pediatric patients have not been established

    Geriatric Use

    • Clinical studies of PALYNZIQ did not include patients aged 65 years and older

    You are encouraged to report suspected adverse reactions to BioMarin at 1-866-906-6100, or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see accompanying full Prescribing Information, including Boxed Warning.

    About BioMarin

    BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The San Rafael, California-based company, founded in 1997, has a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world. To learn more, please visit www.biomarin.com.

    Forward-Looking Statements

    This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: data from the Phase 3 PEGASUS study presented at the 15th International Congress of Inborn Errors of Metabolism, including the oral and poster presentations; the safety profile and potential benefits of PALYNZIQ for adolescents, including ability to lower blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone; the development of BioMarin’s PALYNZIQ program generally, including plans to submit PEGASUS study to global health authorities during the second half of 2025 to expand the approved indication for PALYNZIQ to include the treatment of adolescents; and the continued clinical development of PALYNZIQ, including BioMarin’s plans to continue to evaluate long-term results of PALYNZIQ treatment for adolescents through the ongoing extension phase of the PEGASUS trial. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of PALYNZIQ; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the U.S. Food and Drug Administration, the European Medicines Agency, the European Commission and other regulatory authorities; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as such factors may be updated by any subsequent reports. Investors are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

    BioMarin®, BioMarin RareConnections® and PALYNZIQ® are registered trademarks of BioMarin Pharmaceutical Inc.

    Contacts:


    Investors                                            

    Media

    Traci McCarty                                         

    Katherine Powell

    BioMarin Pharmaceutical Inc.              

    BioMarin Pharmaceutical Inc.

    (415) 455-7558                                  

    (415) 827-2968

    SOURCE BioMarin Pharmaceutical Inc.

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  • UFC Paris: The most important day for the 'Fighting Nerds' – MARCA

    UFC Paris: The most important day for the 'Fighting Nerds' – MARCA

    1. UFC Paris: The most important day for the ‘Fighting Nerds’  MARCA
    2. Caio Borralho predicts fourth-round finish to break Nassourdine Imavov’s almost decade-long durability streak  Bloody Elbow
    3. Official Scorecards | UFC Paris  UFC.com
    4. Caio Borralho Says He’d Fight Khamzat Chimaev Despite Friendship  wrestling-world.com

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  • Krishan Bhatia, Who Helped Amazon Build Presence in TV Upfronts, Exits

    Krishan Bhatia, Who Helped Amazon Build Presence in TV Upfronts, Exits

    Krishan Bhatia, who joined Amazon last year to help build its presence on Madison Avenue and in the industry’s annual “upfront” sales market, is leaving the streaming and e-commerce giant, according to an internal memo sent to staffers Friday.

    “Krishan Bhatia has made the decision to leave Amazon. We’re grateful for his contributions to the Amazon Ads organization and we wish him well in his future endeavors,” the company said in a statement. Bhatia declined to comment Saturday when reached by Variety. Ad Age previously reported on his departure.

    Bhatia, who had been a senior executive at NBCUniversal, joined Amazon to build out a sales team as the company ramped up its efforts to win sponsorships and support for its growing array of media and content properties, which include Prime Video and Twitch. During his tenure there, Amazon displayed aggressive tendencies, making an effort to set up a sales presentation on the first day of TV’s so-called “Upfront Week” — a Monday that has been reserved for pitches from NBCUniversal and Fox Corp.

    At NBCUniversal, Bhatia was deeply enmeshed with developing new systems of audience measurement, part of a growing effort by many TV companies to find alternative methods of counting viewership as audiences move to on-demand streaming. He also worked on building new revenue systems and infrastructure as NBCU grew more vocal about its efforts to strike e-commerce and data partnerships with advertisers. He was known to be a confidant of Linda Yaccarino, the former NBCU ad-sales chairman who became CEO of the social-media outlet now known as X before leaving in July.

    Bhatia was also involved with a “joint industry committee” backed by many of the biggest U.S. media companies that aims to gain industry certification of new types of audience-measuring technology. This committee, supported by Fox, NBCU, Warner Bros. Discovery, Paramount Global and TelevisaUnivsion. gave early nods to technology from Comscore and VideoAmp, two Nielsen rivals that have worked in recent years to challenge that company’s status as the media industry’s primary means of audience tabulation.

    Amazon recently said it had “exceeded our own expectations in upfront commitments” with new and exiting advertisers, citing interest from advertisers in its new NBA rights, “provided incremental volume growth for us in this upfront cycle.”

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  • PEPFAR and Gilead Partner to Deliver Twice-Yearly Lenacapavir for HIV Prevention

    PEPFAR and Gilead Partner to Deliver Twice-Yearly Lenacapavir for HIV Prevention

    Gilead logo

    Image credits: Gilead Sciences

    The US President’s Emergency Plan for AIDS Relief (PEPFAR), coordinated by the US State Department, has partnered with Gilead Sciences to deliver lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), to up to 2 million people in primarily low- and lower-middle-income countries (LLMICs) over the next three years.1

    The collaboration builds on prior agreements with the Global Fund and other multilateral organizations, aiming to accelerate equitable access in high-incidence, resource-limited settings. Gilead will provide lenacapavir at no profit until licensed generic manufacturers are able to fully meet demand.1

    Lenacapavir, the first long-acting twice-yearly PrEP option, is currently approved in the United States and European Union, with regulatory submissions in 18 priority countries expected by the end of 2025. The World Health Organization (WHO) prequalification process is underway, supported by the European Medicines Agency’s EU-M4all opinion, which expedites evaluations in resource-limited settings.1

    The therapy is administered as a subcutaneous injection every six months following an oral lead-in dose. As a capsid inhibitor, lenacapavir targets multiple stages of the HIV replication cycle. Clinical trials have demonstrated its efficacy for both HIV prevention and the treatment of multidrug-resistant HIV.1

    US government officials underscored the partnership as part of broader efforts to accelerate epidemic control, while Global Fund leadership emphasized the importance of rapid and affordable deployment of long-acting prevention options in high-burden populations.1

    What You Need To Know

    PEPFAR and Gilead will supply lenacapavir at no profit until generic manufacturers meet demand, targeting high-incidence, resource-limited countries.

    Lenacapavir is the first long-acting, twice-yearly injectable PrEP option, approved in the US and EU, with WHO prequalification and regulatory submissions in 18 priority countries underway.

    Experts emphasize the importance of rapid, affordable deployment to reduce HIV incidence and advance epidemic control in high-burden populations.

    Background News

    June 18, 2025 – FDA Approval
    The FDA approved lenacapavir (Yeztugo), the first and only twice-yearly injectable PrEP option, supported by the phase 3 PURPOSE 1 and PURPOSE 2 trials. These trials demonstrated 96% to 100% efficacy in preventing HIV across diverse populations. In an interview with Contagion, Jared Baeten, MD, PhD, senior vice president of clinical development and virology at Gilead Sciences, highlighted lenacapavir’s potential to overcome adherence and stigma barriers associated with daily oral PrEP.2

    Listen to our full interview from the approval: FDA Approves Gilead’s Twice-Yearly Injectable Lenacapavir (Yeztugo) for HIV Prevention

    July 9, 2025 – Global Fund Partnership
    Gilead announced a three-year partnership with the Global Fund to provide up to 2 million doses of lenacapavir at no profit in LLMICs. This agreement was designed to bridge access until generic manufacturers under voluntary licensing arrangements could meet demand across 120 high-incidence countries. Distribution will be prioritized according to national HIV prevention strategies, while Gilead has contracted at-risk manufacturing capacity to ensure supply.3

    July 25, 2025 – EMA Positive Opinion
    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending lenacapavir (Yeztugo) for PrEP in adults and adolescents at increased risk of HIV-1. The accelerated review positions the drug for European Commission approval later this year, extending market exclusivity and enabling rollout across all 27 EU member states plus Norway, Iceland, and Liechtenstein. PURPOSE trials demonstrated 99.9–100% efficacy, and the CHMP also endorsed the EU-M4all pathway to streamline WHO prequalification and access in resource-limited countries.4

    References
    1.Gilead Sciences. Gilead announces partnership with PEPFAR to deliver twice-yearly lenacapavir for HIV prevention. Business Wire. Published September 4, 2025. Accessed September 6, 2025. https://www.gilead.com/news/news-details/2025/gilead-announces-partnership-with-pepfar-to-deliver-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low–and-lower-middle-income-countries
    2. Gilead. Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. June 18, 2025. Accessed June 18, 2025. https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection
    3.Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low and Lower Middle Income Countries. Gilead.com. Published 2025. Accessed July 9, 2025. https://www.gilead.com/news/news-details/2025/gilead-finalizes-agreement-with-the-global-fund-to-accelerate-access-to-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low–and-lower-middle-income-countries
    4.Gilead. Gilead receives positive CHMP opinions under accelerated review from European Medicines Agency for twice-yearly lenacapavir for HIV prevention [news release]. Gilead Sciences. July 25, 2025. Accessed September 6, 2025. https://www.gilead.com/news/news-details/2025/gilead-receives-positive-chmp-opinions-under-accelerated-review-from-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention

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  • Strong starting position for Porsche Junior Ghiretti in title showdown

    Strong starting position for Porsche Junior Ghiretti in title showdown




    The Porsche Mobil 1 Supercup 2025 heads into a nail-biting finale. In a thrilling qualifying session at the Autodromo Nazionale Monza, France’s Marvin Klein secured pole position in BWT Lechner Racing’s Porsche 911 GT3 Cup. The three contenders for the Supercup title experienced mixed fortunes in the hunt for top times: While Porsche Junior Alessandro Ghiretti planted his 911 on the front row, Robert de Haan and Flynt Schuring face the challenge of battling their way up the order from P10 and P16 in tomorrow’s race. The second Porsche Junior, Theo Oeverhaus, lines up seventh.


    Alessandro Ghiretti edges closer to his big goal – the Porsche Mobil 1 Supercup 2025 title. In qualifying for the season finale, the Porsche Junior from France set the second-fastest lap. On the 5.793-kilometre Grand Prix circuit at Monza, only his compatriot Marvin Klein outpaced him. The Spielberg race winner stormed to pole position for BWT Lechner Racing with a best time of 1:47.697 minutes – shattering the previous pole record of his teammate Robert de Haan from last year by almost nine-tenths of a second.

    ‟I can’t put into words how delighted I am about this pole,” said Klein. ‟It means a lot to me to finish this challenging season on a high. At the same time, I want to support my teammate Robert de Haan and the BWT Lechner Racing squad in the fight for the drivers’ and teams’ championships. Given the situation, the best way I can help is by winning tomorrow’s race, so it’s a fantastic feeling to start from the front.”

    For Ghiretti, the qualifying result is especially significant: his title rivals de Haan and Flynt Schuring (Schumacher CLRT) will only line up from the fifth and eighth rows of the grid. That puts the three-time race winner, who sits nine points ahead of de Haan in the standings, in an excellent position for the showdown. ‟Unfortunately, it wasn’t quite enough for pole, but P2 is a strong foundation,” commented Ghiretti, who won at Monza last year. ‟I don’t want to waste time on calculations, my focus is on trying to win. As always, I’ll give it everything.”

    Porsche 911 GT3 Cup, Porsche Junior Alessandro Ghiretti (ITA), Schumacher CLRT (#11), Porsche Mobil 1 Supercup, Monza, Qualifying, 2025, Porsche AG





    Regardless of how his two title rivals perform, the 23-year-old from Montauban will be crowned Supercup champion if he finishes on the podium at the ‟Temple of Speed” just outside Milan.

    Ghiretti’s main rivals expressed their disappointment after qualifying. ‟We had a car capable of pole, as my teammate demonstrated,” emphasised de Haan. ‟Unfortunately, I experienced bad luck again. On my fastest lap with the first set of tyres, yellow flags came out in the final sector and I was forced to lift. Then, on the second set, I was on pace for the fastest time when the red flags appeared.” The session was interrupted when Luciano Facundo Martinez crashed his Ombra Racing Porsche into the tyre barriers at the Parabolica.

    After the restart, the drivers had just three minutes left to attempt a flying lap. ‟And by then my tyres already had four laps on them,” complained de Haan. To make matters worse, the Monaco winner was handed a two-place grid penalty for not slowing sufficiently under yellow.

    Porsche 911 GT3 Cup, Robert de Haan (NLD), BWT Lechner Racing (#1), Porsche Mobil 1 Supercup, Monza, Qualifying, 2025, Porsche AG





    Schuring, who had already secured the rookie title at the previous round in Zandvoort and trails Ghiretti by 14 points in the drivers’ standings, was also disappointed with 16th on the grid. The Dutchman expressed frustration with his performance: ‟I failed to put together a clean lap, and on my final attempt, the red flags came out. My goal for tomorrow: overtaking. Lots of overtaking…”

    Third place in qualifying went to Wouter Boerekamps in the Team GP Elite Porsche, ahead of Hungarian race winner Mathys Jaubert (Martinet by Alméras). ‟That was a good qualifying, even though pole would’ve been possible,” said the Dutchman. ‟On my fastest lap, I locked a wheel braking for the first chicane and lost about three tenths. The rest of the lap was flawless and could have been enough.” In fact, Boerekamps missed Klein’s best time by just over a tenth of a second.

    Another standout performance came from 20-year-old Frenchman Paul Cauhaupé, who posted the fifth-fastest time in his second Supercup guest outing this season with Martinet by Alméras. Porsche Junior Theo Oeverhaus also turned heads: the Imola season-opener winner was just 0.15 seconds off pole and will start from seventh. Once again, the level of competition in the 28-strong Porsche 911 GT3 Cup field was extraordinary, with 22 of the ca. 375 kW (510 PS) cars separated by less than a second.

    Porsche 911 GT3 Cup, Paul Cauhaupe (FRA), Martinet by Almeras (#17), Porsche Mobil 1 Supercup, Monza, Qualifying, 2025, Porsche AG





    Fans at Europe’s oldest active racetrack (built in 1922), as well as motorsport enthusiasts watching on TV, can look forward to a thrilling finale. This race will also mark the final appearance of the 992.1 generation Porsche 911 GT3 Cup in the Supercup. The eighth and final round of the Porsche Mobil 1 Supercup will get underway on Sunday at 11:45 am CEST, with 15 laps covering a distance of 86.895 kilometres or a maximum race duration of 30 minutes plus one lap.

    TV and online coverage of the Porsche Mobil 1 Supercup

    TV channels Eurosport und Sky Sport as well as streaming service f1tv.formula1.com broadcast live. On the Porsche Motorsport Hub, also a live timing is available.

    Porsche provides comprehensive information about the Porsche Mobil 1 Supercup on the social networks @porschesupercup (Instagram), @porschesupercup (Facebook) and @PorscheSupercup (X, formerly Twitter) as well as the new WhatsApp channel Porsche Motorsport.

    Qualifying result, round 8, Porsche Mobil 1 Supercup, Monza (Italy)

    1. Marvin Klein (FRA/BWT Lechner Racing), 1:47.697 minutes
    2. Alessandro Ghiretti (FRA/Schumacher CLRT), 0.100 seconds behind
    3. Wouter Boerekamps (NLD/Team GP Elite), 0.107 seconds behind
    4. Mathys Jaubert (FRA/Martinet by Alméras), 0.119 seconds behind
    5. Paul Cauhaupé (FRA/Martinet by Alméras), 0.151 seconds behind
    6. Huub van Eijndhoven (NLD/Team GP Elite), 0.152 seconds behind

    Full qualifying result on the Porsche Motorsport Hub:
    https://racing.porsche.com/mobil-1-supercup/results-season-2025


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  • What Parents Need To Know About Measles As Kids Head Back To School

    What Parents Need To Know About Measles As Kids Head Back To School

    As children head back to school this year, parents are hearing conflicting advice, particularly about immunizations. Florida’s Surgeon General, Joseph Ladapo, created a stir this week suggesting the state eliminate all school vaccine requirements. Mehmet Oz, the celebrity doctor who oversees Medicaid and Medicare, echoed that desire. And Robert F. Kennedy, Jr. has been steadily attacking vaccines with unscientific and debunked statements about them causing harm. He has also fired 17 expert members of the Vaccine Advisory Committee and replaced them with people with questionable credentials. And despite his promises of continued access, he has just declared new rules for who can receive COVID-19 vaccines, excluding healthy people under the age of 65, even if they want them.

    Dropping school vaccine requirements flies in the face of decades of public health recommendations and specific evidence-based guidance from the Centers for Disease Control and the American Academy of Pediatrics.

    Measles Is Spreading And Is Dangerous

    As of Sept. 2, 2025, there have been a total of 1,431 confirmed measles cases reported in the U.S., with three deaths, two of them in unvaccinated children.

    Note that because of good vaccination levels, measles had been eliminated from the U.S. in 2000, and now we have a resurgence, centered in Texas.

    Measles is the most highly contagious infection. It is spread through tiny droplets in the air and lingers for up to two hours. If exposed to an infected person, 90% of unvaccinated people will become infected. Transmission can readily happen in a school or a pediatrician’s office.

    Children with measles often become sick with high fevers, cough, runny nose and conjunctivitis, and about 1 in 5 need to be hospitalized. Pneumonia occurs in 1 in 20, encephalitis (brain swelling) in 1/1000, and deaths in 1-3/1000. A late complication, occurring in 1 in 600, is subacute sclerosing panencephalitis, a fatal brain inflammation.

    Measles also wipes out immune memory, making children more susceptible to other infections because the affected B cells “forget” how to fight infections. The kids may also have to be revaccinated against different diseases. This immunosuppression may last from months to three years.

    I can’t imagine anyone who wants children to die or be permanently disabled from an infection that is so easily preventable with an immunization.

    What Happens If An Unvaccinated Person Is Exposed To Measles? A Warning To Parents

    The incubation period—time from exposure to symptoms—is 7 to 14 days. Another 3-5 days go by before a rash develops. The person is infectious for another 4 days.

    If an unvaccinated person is exposed to measles, they have to quarantine for 21 days after exposure. That means no school for the child and no work for an unvaccinated adult.

    How many parents can afford to take 3 weeks off work to care for an ill child?

    How many unvaccinated adults can afford to take 3 weeks off work if they been exposed to measles?

    Besides the personal cost of stress and lost wages, there is a societal cost for any infectious outbreak.

    Costs Of Measles Outbreaks

    A review of measles outbreaks showed that the median cost per case was $32,805, with an additional $4000 per day of investigation. The cost of lost productivity (due to illness, home isolation, quarantine, or informal caregiving) was $47,479 per case or $814 per contact.

    There are billions of dollars in savings to society for routine childhood vaccinations, in addition to the millions of hospitalizations and deaths averted.

    There is also a huge strain on public health departments, which are already overburdened and short-staffed from budget cuts. Measles outbreaks have necessitated providing post-exposure prophylaxis, public outreach, setting up a “toll-free measles information hotline, subpoenaing flight records, and daily screening of all hospital staff for rash and fever.” The added personnel time is reallocated from other programs, resulting in holes in those services.

    With 20% of children infected with measles requiring hospitalization, how will medical centers maintain adequate staffing? Many healthcare workers are young adults with school-aged children. A previous study earlier in the COVID-19/influenza pandemic found higher absenteeism due to caring for sick children and dealing with school closures.

    Further Dividing The Country

    There are striking differences in vaccine acceptance and approaches between Red and Blue states, with Florida and Texas leaning toward “medical freedom” to be free from mandates. [That inherently goes against another person’s desire to be free from unnecessary infection, disability, or death from unvaccinated people. Vaccines are not 100% effective—you need herd immunity to protect you and the community). More liberal states are considering forming compacts and creating their own regulations that require vaccines to protect their communities.

    Ladapo’s proposal is raising other questions. Kathy Browning, former president of the Florida Association of School Nurses, asked, “If the state decides they’re no longer going to require mandatory vaccinations, are they no longer going to require the mandatory reporting of diagnoses?”

    Will Florida eliminate quarantine for such a highly infectious disease? Last year, Ladapo did that, saying, the state’s Department of Health “is deferring to parents or guardians to make decisions about school attendance” because of the “burden on families and the educational cost of healthy children missing school” and the “high immunity rate in the community.”

    Another question arises whether private schools can have different rules, requiring vaccination for their students, while public schools won’t have that option.

    The Texas measles outbreak served as a warning shot in the new vaccine wars, pitting different parts of the country against each other, with a focus on maximizing individual freedoms versus the common good. With all of these unintended consequences, wouldn’t it be better if we all were vaccinated?

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  • Dusan Vlahovic hit a first-half winner to send Dragan Stojkovic's men into second in Group K. – FIFA

    1. Dusan Vlahovic hit a first-half winner to send Dragan Stojkovic’s men into second in Group K.  FIFA
    2. Watch: Juventus forward Vlahovic keeps up good form with goal for Serbia  Football Italia
    3. Saturday’s World Cup qualifying predictions, betting odds and tips: Serbia should stand firm in Riga  Racing Post
    4. Preview: Latvia vs Serbia – prediction, team news, lineups  Sports Mole
    5. Latvia vs Serbia: UEFA World Cup Qualifiers stats & head-to-head  BBC

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