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Deals:
Pfizer said it would acquire weight loss biotech Metsera in a deal valued at up to $7.3 billion.
Jiangsu Hengrui Pharmaceuticals agreed to a potential $1.1 billion transaction with Glenmark Pharmaceuticals.
Merck and Siemens signed a memorandum of understanding to enhance their strategic partnership.
Bristol Myers Squibb committed to Veeva’s Vault CRM.
InterCure bought ISHI.
Little Penguin PR, a boutique public relations company, and Digital Elevator, an SEO agency, announced a strategic partnership.
The Gates Foundation, the Clinton Health Access Initiative and several health organizations including backing for two generic manufacturers to produce and distribute a low-cost version of Gilead Sciences‘ HIV prevention drug in dozens of low-income countries.
LifeStance Health Foundation teamed with the American Foundation for Suicide Prevention to advance mental health research.
Numab Therapeutics achieved a milestone in its collaboration with Boehringer Ingelheim.
FDA:
The FDA re-approved Wellcovorin, a drug from GSK, that the company stopped selling more than 25 years ago, as part of a push from the Trump administration to identify the causes of and potential treatments for autism.
The agency granted accelerated approval to Stealth BioTherapeutics’ treatment for Barth syndrome, an ultra-rare mitochondrial disorder.
The FDA granted priority review for Chiesi’s idebenone to treat leber hereditary optic neuropathy.
The agency approved Eli Lilly’s Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.
The FDA extended by three months the target action date of its review of Sanofi’s new drug application of tolebrutinib.
The agency removed the Risk Evaluation and Mitigation Strategies for Sanofi’s Caprelsa (vandetanib).
The FDA announced it will allow innovative clinical trials to help streamline reviews of cell and gene therapies for rare diseases that affect small numbers of patients.
Scholar Rock said the FDA rejected its treatment for the muscle-wasting disease spinal muscular atrophy due to long-unresolved problems at a contract manufacturing facility where the drug is packaged.
Artios Pharma received Fast Track Designation for alnodesertib in ATM-negative metastatic colorectal cancer.
The FDA declined to approve a higher-dose version of Biogen‘s drug for a rare genetic disorder that causes progressive muscle weakness
Following a meeting with FDA officials, Capricor Therapeutics said improvement in upper limb muscle function will remain the primary efficacy goal of a Phase 3 clinical trial for its cell therapy in Duchenne muscular dystrophy.
Funding rounds:
Sanofi committed an additional $625 million to Sanofi Ventures.
Capital Rx announced a $400 million funding round and a rebranding to Judi Health.
Sparrow Pharmaceuticals announced the close of a $95 Series B financing round.
Sevaro Health closed a $39 million oversubscribed Series B funding round.
Gilead granted $6.5 million in funding to STEM education.
MAIA Biotechnology was awarded a $2.3 million grant by the National Institutes of Health.
Trethera received a $1.8 million NIH grant to advance TRE-515 development for Crohn’s disease.
MapLight Therapeutics filed for an initial public offering
Persista Bio secured two NIH grants to advance its O2Line oxygenated cell therapy platform.
Layoffs:
ARCH Venture-backed startup Rome Therapeutics is laying off staff and “exploring strategic options.”
Heidelberg Pharma is reducing its workforce by 75%.
Seres Therapeutics is firing 25% of its workforce.
Industry news:
Bluebird Bio rebranded as Genetix Biotherapeutics.
Roche’s estrogen receptor-targeting pill beat the standard of care in a Phase 3 breast cancer trial.
Lilly plans to build a new $6.5 billion facility to manufacture active pharmaceutical ingredients in Texas.
Lilly sold its New Jersey site to Celltrion for $330 million
Johnson & Johnson will withdraw a device to treat acid reflux disease from markets outside the U.S.
AstraZeneca wants the Supreme Court to review an appeals court order that rejected its challenge to Medicare drug price negotiations.
The White House is considering a website where patients could purchase discounted prescription drugs.
An experimental gene therapy from Uniqure slowed the progression of Huntington’s disease by 75% after three years.
Nazaré, an Inizio Engage learning and capability brand, announced the launch of Access Academy.
Hansa Biopharma’s kidney transplant drug succeeded in a Phase 3 trial.
Planned Parenthood of Wisconsin will halt abortion services.
The Commerce Department said it has opened new national security investigations into the import of personal protective equipment, medical items, robotics and industrial machinery.
TNF Pharma rebranded as Q/C Technologies.
Ionis Pharmaceuticals announced positive topline results from a pivotal study of zilganersen in Alexander disease.
The BMJ Group retracted a study published last spring in its nutrition and preventative health journal that found apple cider vinegar could help people with BMIs classified as overweight or obese to lose weight.
Over-the-counter sales of the overdose reversal drug naloxone didn’t widely expand access to the life-saving treatment, a recent RAND study suggests.
A French court ordered Sanofi to pay $177 million for anti-competitive behavior.
Molecular science startup Evolv launched an oral GLP-1 pill: Evolv GLP-1.
Ipsen’s LANTIC Phase II in aesthetics delivers a first-in-class, differentiated long-acting clinical profile for IPN10200, enabling the initiation of Phase III
STEM, part of Inizio Advisory, launched STEM AI, a next-generation platform
Acadia Pharmaceuticals’ experimental drug ACP-101 failed in a pivotal study of Prader-Willi syndrome.
Infection rates from drug-resistant “nightmare bacteria” rose almost 70% between 2019 and 2023, according to a recent report from the Centers for Disease Control and Prevention.
Alphabet announced YouTube will offer creators a way to rejoin the streaming platform if they were banned for violating COVID-19 and election misinformation policies that are no longer in effect.