All articles tagged with #pharmaceuticals
The FDA issued a Class II recall of about 2.5 million bottles of prednisolone acetate ophthalmic suspension 1% eye drops by Lupin Pharmaceuticals due to a potential foreign-substance contamination. The products—available in 5 mL, 10 mL, and 15 mL sizes—were initially recalled on June 4 and reclassified on June 30; the drops treat non-infectious eye allergies and inflammation.
Medicare has started covering certain GLP-1 weight-loss medications with a $50 copay, outlining which drugs are included and the eligibility criteria for beneficiaries. The policy aims to expand access to obesity treatments from manufacturers like Novo Nordisk and Eli Lilly, though coverage may depend on clinical indications and program details.
Pharma firms are racing to bring pill-form GLP-1 weight-loss drugs to market, with aleniglipron and elecoglipron delivering about 11–12% weight loss over 36 weeks in Phase II, thanks to absorption-enhancers or small-molecule designs, while other candidates like Roche CT-996, Ascletis ASC30, and Viking VK2735 are in development. Even if approved, competition could lower prices and expand options beyond injections like Ozempic/Wegovy.
Healthcare stocks outperformed the broader market as Eli Lilly (LLY), Johnson & Johnson (JNJ) and AbbVie (ABBV) hit fresh 52-week highs (with Merck near highs), while biotech names like Moderna led rallies; the Health Care Select Sector SPDR ETF XLV has climbed about 3% year-to-date, signaling renewed investor interest in defensive healthcare plays amid ongoing M&A activity.
Sangamo Therapeutics has filed for bankruptcy and will pursue a sale of substantially all its assets. Eli Lilly and Astellas are named as stalking-horse bidders, with Lilly set to acquire Sangamo’s capsid delivery platform, zinc finger platform, Modular Integrase (MINT) platform, and the ST-506 prion disease program, while Astellas aims to buy the Fabry disease asset isaralgagene civaparvovec. Other assets, including ST-503 for chronic neuropathic pain, giroctocogene fitelparvovec for hemophilia A, and the cell therapy/Treg assets, are not included in these initial bids. Sangamo has faced years of cash strain, Pfizer exiting a key collaboration, and its stock has fallen dramatically, prompting the asset-sale process to maximize value for creditors and stakeholders.
The Supreme Court unanimously ruled Hikma Pharmaceuticals did not infringe Amarin's patents in a skinny-label case, shielding generic manufacturers from certain patent lawsuits and paving the way for more affordable generics while overturning a lower court ruling.
Regenxbio announced its experimental Duchenne muscular dystrophy gene therapy produced sufficient levels of a miniaturized muscle protein in a clinical trial, paving the way for an FDA submission and aiming to improve on Sarepta’s Elevidys in both efficacy and safety, amid ongoing safety concerns surrounding the competitor.
Private space startup Varda Space Industries is expanding commercial drug production in orbit, partnering with United Therapeutics to use microgravity to improve drug crystallization and stability. The approach combines Earth‑based screening in a new 10,000‑sq‑ft lab with a plan to launch multiple autonomous satellites to test and manufacture therapies in space, aiming to shorten development times and create products valuable enough to justify reentry to Earth. This marks a notable milestone in the evolving orbital biotech economy as the cadence of launches increases and long‑term goals shift toward building a space‑based pharmaceutical business.
Sun Pharmaceutical Industries will acquire Organon & Co in an all-cash deal valued at $11.75 billion (including debt) at $14 per share, boosting Sun Pharma’s revenue to about $12.4 billion and expanding its footprint in the U.S. and global markets with Organon’s women’s health and biosimilars portfolio, aligning with Sun Pharma’s move into innovative medicines.
STAT’s First Opinion interview with Thomas Goetz explains Drug Story, a podcast that uses a three‑act framework—diagnosis, prescription, side effects—to explore how individual drugs illuminate broader social, economic, and policy forces shaping health, from obesity and insomnia to ivermectin repurposing. Goetz, who holds an MPH, argues medicines reflect not just biology but systemic determinants and the common good, and he plans a second season of about 30 more drugs, produced independently to broaden public understanding of health and medicine.
The Iran conflict is disrupting far more than oil: helium supplies are tightening due to LNG-linked production in Qatar, with prices possibly rising as storage and demand pressure increase; pharmaceutical shipments—especially vaccines, insulin, biologics, and cancer therapies—face delays that could raise costs for consumers; and fertilizer flows through the Strait of Hormuz have slowed, heightening farmer costs and the risk of food-price inflation, underscoring that Hormuz is a chokepoint for multiple essential trades beyond energy.
The FDA announced a recall of about 89,592 bottles of Strides Pharma’s Children’s Ibuprofen Oral Suspension sold in the U.S. after reports of a gel-like mass and black particles. The Class II recall affects lot numbers 7261973A and 7261974A with an expiration date of Jan. 31, 2027, manufactured for Taro Pharmaceuticals USA Inc. and distributed nationwide. No serious adverse health effects have been reported, but consumers should stop using the recalled product immediately.
A dog named Rose reportedly received a personalized cancer vaccine designed with ChatGPT and Google’s DeepFold and manufactured by a university; while not cured, the cancer was greatly reduced and the dog’s quality of life improved. Tech investor Eric Jackson says this exemplifies “programmable medicine,” where AI-driven genomics and molecule design turn medicine into software, a shift that could boost biotech and AI-enabled stocks such as Moderna (MRNA) and platforms from Nvidia (NVDA), Alphabet (GOOGL), and Microsoft (MSFT), among others. The piece underscores the investment and regulatory implications of moving toward individualized therapies.
Horizons examines GLP-1 obesity drugs, highlighting their potential to significantly aid millions with obesity while raising questions about long-term safety, side effects, access, and broader societal implications, with insights from multiple medical experts.
A Johns Hopkins study shows crops irrigated with treated wastewater accumulate psychoactive drug residues mainly in leaves rather than edible parts, with leaf concentrations in tomatoes far higher than in fruit and carrot leaves higher than roots; drug behavior varies by compound, informing risk assessment and future monitoring/regulation.