BridgeBio's oral achondroplasia drug shows growth and body proportionality gains in late-stage trial
BridgeBio Pharma (BBIO) said its experimental oral drug for achondroplasia improved not only growth but also body proportionality in children with the condition, a secondary benefit that analysts believe could distinguish the treatment from rival therapies for the most common form of dwarfism.
Merck's anti-TL1A drug hits main goal in ulcerative colitis trial, though data gaps temper analyst enthusiasm
Merck & Co (MRK) said that its experimental drug tulisokibart met the main goal and key secondary goals in a late-stage trial of patients with ulcerative colitis, a chronic inflammatory bowel disease.
UK antitrust watchdog secures reversal in Pfizer epilepsy drug pricing case
Britain's Competition and Markets Authority has welcomed a Court of Appeal ruling that overturned an earlier decision finding the regulator had relied on flawed reasoning when it fined Pfizer (PFE) and Flynn Pharma £70mn for excessive pricing of the epilepsy drug phenytoin.
South Africa court blocks compounded Ozempic copies in Novo Nordisk case
A South African court has granted an interim order blocking a local pharmacy group from manufacturing and selling weight-loss medicines containing semaglutide, the active ingredient in Novo Nordisk's (NOVO) Ozempic and Wegovy drugs.
AbbVie deepens immunology push with $10.9bn Apogee swoop
AbbVie (ABBV) has agreed to buy Apogee Therapeutics (APGE) for $10.9bn, its largest acquisition in more than five years, as the pharmaceutical group looks to strengthen its pipeline of treatments for inflammatory diseases such as atopic dermatitis and asthma.
Kardigan surges in Nasdaq debut after upsized $400mn IPO
Kardigan (KARD) shares surged 31 per cent above their initial public offering price after the heart drug developer raised $400mn in an upsized US initial public offering, in a sign of strong investor appetite for new biotech listings.
FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval path
Regenxbio (RGNX) shares jumped 16 per cent after the company said the US Food and Drug Administration had indicated that existing data for its rare-disease gene therapy could support an accelerated approval application, reversing course months after declining to approve the treatment.
Pfizer's experimental lung cancer drug fails to extend survival in late-stage trial
Pfizer (PFE) has said that an experimental cancer drug acquired through its $43bn takeover of Seagen in 2023 failed to extend survival compared with chemotherapy in a late-stage trial of previously treated lung cancer patients, denting hopes for one of the assets underpinning the group's oncology pivot.
Alnylam reprimanded over Amvuttra promotion after Pfizer complaint to UK watchdog
Alnylam Pharmaceuticals (ALNY) has been reprimanded by the UK's Prescription Medicines Code of Practice Authority after a complaint from Pfizer (PFE), though the industry watchdog softened its harshest criticism on appeal.
Nara Organics recalls US infant formula after botulism cases linked to product
Nara Organics is voluntarily recalling all of its infant formula sold in the United States after the Food and Drug Administration and the Centers for Disease Control and Prevention flagged three cases of infant botulism in babies who had consumed the product.
Novo Nordisk to seek Wegovy pill approval in China within months
Novo Nordisk (NOVO) plans to submit its oral Wegovy weight-loss pill for Chinese regulatory approval within a few months, Chief Executive Mike Doustdar said, as the Danish drugmaker seeks to close the gap with rival Eli Lilly (LLY) in the world's second-largest pharmaceutical market.
Sixth Street and KKR to provide BridgeBio with $1bn in financing
Sixth Street Partners and KKR & Co (KKR) have agreed to provide $1 billion in preferred equity financing to BridgeBio Pharma (BBIO), according to people familiar with the matter, in one of the largest biotech deals so far this year.
Activist investor builds stake in Bio-Techne, pushes for sale
Ananym Capital Management has built a stake in Bio-Techne Corp (TECH) and is pressing the company's board to launch a strategic review that would include weighing a potential sale, according to a letter reviewed by Bloomberg News.
Jazz Pharmaceuticals lung cancer drug fails phase 3 trial in fresh setback for accelerated approval
Zepzelca, the small-cell lung cancer treatment sold by Jazz Pharmaceuticals (JAZZ) and developed with Spain's PharmaMar (PHM), has failed a phase 3 trial on its primary endpoint of overall survival, threatening the drug's original accelerated approval for the second time in its history.
Alnylam Pharmaceuticals shares hit fresh low as stock slides 27% this year
Alnylam Pharmaceuticals (ALNY) shares fell to a 52-week low of $282.71 in mid June, just above the yearly trough of $283.10, extending a slide that has knocked more than a quarter off the drugmaker's valuation in 2026.
FDA clears first over-the-counter glucose monitor for children
The US Food and Drug Administration has expanded approval of Dexcom's (DXCM) Stelo Glucose Biosensor System to include children with diabetes, making it the first over-the-counter continuous glucose monitor cleared for pediatric use.
FDA approves wider use of Sanofi's Tzield in newly diagnosed type 1 diabetes patients
The US Food and Drug Administration has approved an expanded label for Sanofi's (SNY) type 1 diabetes treatment Tzield, allowing its use in children aged 8 to 17 who have recently been diagnosed with stage 3 of the disease.
Spyre's bowel disease drug meets goals in mid-stage trial
Spyre Therapeutics (SYRE) said its experimental ulcerative colitis treatment significantly reduced disease severity in a mid-stage clinical trial, marking a key milestone for the biotech's inflammation pipeline.
Elicio Therapeutics Shares Plunge 72% After Pancreatic Cancer Vaccine Misses Mid-Stage Trial Goal
Shares in Elicio Therapeutics (ELTX) fell roughly 72% after the biotech company's experimental pancreatic cancer vaccine failed to meaningfully extend the time patients lived without disease recurrence, missing the primary endpoint of a mid-stage clinical study.
mRNA Cancer Vaccines Show Durable Results in Melanoma, Early Promise in Harder-to-Treat Tumors
Treatments based on the messenger RNA technology behind Covid-19 vaccines are demonstrating lasting efficacy against melanoma and showing early promise in pancreatic and brain cancers long considered beyond the reach of immunotherapy, researchers reported at a major oncology conference this week.