Pharmaceuticals
Drugmakers, approvals, recalls, pricing, and medicine pipelines.
AstraZeneca and Ionis shares fall after Wainua misses heart-disease trial endpoint
AstraZeneca said Wainua failed a Phase 3 cardiomyopathy trial, sending AstraZeneca and Ionis shares lower and clouding expansion plans for the partnered drug.
AstraZeneca and Ionis Stocks Sink on Wainua Trial Miss, but Analysts See an Overreaction
AstraZeneca and Ionis shares fell after Wainua missed its phase 3 heart-disease trial target, but analysts said the selloff may overstate the damage because the drug still has an approved indication.
AstraZeneca, Ionis stocks tumble after heart drug fails key trial
AstraZeneca and Ionis said Wainua failed its primary endpoint in a Phase 3 trial in ATTR-CM, sending both stocks sharply lower. The companies will keep analyzing the data and plan to present results at a cardiology meeting in August.
Torrent Pharma recalls select batches of Semalix injection
Torrent Pharmaceuticals said it is voluntarily recalling select batches of its Semalix injection disposable pens as a precaution after a Dr. Reddy's notice tied to semaglutide batch quality issues.
AstraZeneca Shares Slide After Wainua Misses Target in Heart Disease Trial
AstraZeneca shares fell after Wainua failed to meet its primary goal in a Phase 3 ATTR-CM trial, a setback for the drug’s expansion into heart disease. The company said it will review the data with regulators, while Wainua remains approved for hereditary transthyretin amyloidosis-related polyneuropathy.
AstraZeneca shares fall after Wainua misses late-stage heart trial target
AstraZeneca said Wainua failed to meet its primary endpoint in a phase 3 trial for transthyretin-mediated amyloid cardiomyopathy, sending shares down about 9% and clouding the drug's expansion prospects.
Galderma says FDA rejected U.S. application for Relfydess antiwrinkle injection
Galderma said the FDA declined its U.S. application for Relfydess after manufacturing-site inspection observations and analytical-method comments, marking a second setback in three years for the Botox rival.
FDA’s new peptide panel includes industry-linked proponents, AP reports
The FDA has released the participant list for its July 23-24 advisory meeting on seven controversial peptides, and AP reports the panel includes several people with financial ties to the market. The roster disclosure comes as Health Secretary Robert F. Kennedy Jr. pushes for broader access despite safety concerns and limited evidence.
31,400 bottles of seizure drug recalled over possible mix-up with blood-pressure medicine
Annora Pharma has voluntarily recalled about 31,400 bottles of 100mg lacosamide after an FDA notice said some bottles may have been filled with selexipag instead. The Class II recall involves two lots of 60-count bottles with a September 30, 2027 expiration date.
European regulator calls for Amgen’s Tavneos to lose its marketing authorization
The European Medicines Agency’s human medicines committee recommended revoking Tavneos’s EU marketing authorization after concluding the study supporting approval could not be relied upon and that the drug’s benefits no longer outweigh its risks.
Amgen recalls more than 900,000 bottles of Corlanor and Sensipar after foreign matter found on some tablets
Amgen has voluntarily recalled about 944,142 bottles of Corlanor and Sensipar after finding unexpected foreign matter on some tablets during reserve-sample inspection. The company said the issue was precautionary and posed a low potential health risk.
Pharma boss warns UK risks squandering Trump trade deal
Bristol Myers Squibb chief Chris Boerner warned the UK risks wasting the value of its pharma trade deal with the Trump administration if promised reforms are not delivered quickly, saying future investment and launches will depend on how competitive Britain becomes.
FDA to reverse Regenxbio rejection of Hunter syndrome gene therapy, WSJ reports
Regenxbio says the FDA has agreed to reverse its earlier rejection of Navsunli, a Hunter syndrome gene therapy, and may review the filing within about two months after a July meeting.
AbbVie to buy Apogee Therapeutics for $10.9 billion
AbbVie has agreed to buy Apogee Therapeutics for about $10.9 billion in cash, giving the drugmaker control of zumilokibart, a late-stage immunology candidate being studied for atopic dermatitis and other inflammatory diseases. The deal, announced June 22, is expected to close in the third quarter pending approvals.
Cancer drugmaker Revolution Medicines says sale not a priority
Revolution Medicines said it is not prioritizing a sale, even as late-stage daraxonrasib data, expanded FDA access and reported buyer interest keep the biotech in focus.
FDA advisory committee backs Moderna's seasonal flu vaccine
An FDA advisory committee unanimously backed Moderna’s mRNA flu vaccine for adults 50 and older, marking a major step toward what would be the first U.S. flu shot made with mRNA technology. The FDA still has to issue a final decision, which is expected by early August 2026.
uniQure Shares Surge After FDA Reverses Course on Huntington's Gene Therapy Filing
uniQure shares jumped after the company said the FDA reversed its earlier stance on AMT-130, its Huntington's disease gene therapy, and will now allow a filing using limited clinical data. The change could accelerate the program's regulatory timeline, though questions remain about a confirmatory study and the exact data package.
Australian court refuses bail to woman with alleged Islamic State links
A Melbourne magistrate has refused bail to Zeinab Ahmad, who faces Commonwealth crimes-against-humanity charges over allegations linked to a Yazidi teenager in Syria. Chief Magistrate Lisa Hannan said there was no compelling evidence Ahmad had renounced Islamic State and found she remained an unacceptable risk to the community.
New TGA crackdown targets illegal peptides
The Therapeutic Goods Administration has made unlawful peptide products a priority enforcement target, warning that many are unapproved and may pose consumer-safety risks. The regulator says it will use seizures, infringement notices, import interventions and legal penalties against importers, sellers and advertisers.
Apotex shares rally after C$1.3 billion IPO pricing
Apotex Health priced its Canadian IPO at C$24 a share, raising about C$1.3 billion and sending the stock to an opening gain of 17% on debut. The offering, one of the largest Canadian IPOs in years, was upsized amid strong demand.
Australia’s TGA cracks down on unregulated peptide products
Australia’s medicines regulator has made illegal peptide importation, supply and advertising a priority enforcement area, warning that many online products are unapproved and may pose serious safety risks.
Wegovy pill tops 3 million prescriptions as Novo Nordisk touts ADA 2026 data
Novo Nordisk said Wegovy pill has surpassed 3 million U.S. prescriptions since launching on January 5, 2026, and tied the milestone to ADA 2026 presentations and an investor event on June 7.
Ionis to present new analyses from CORE and CORE2 supporting olezarsen
Ionis said it will present four oral analyses from the Phase 3 CORE and CORE2 studies of olezarsen for severe hypertriglyceridemia at upcoming ADA, NLA and ENDO 2026 meetings, while the drug’s U.S. review continues under FDA Priority Review.
Pharming says FDA accepted resubmission of Joenja pediatric sNDA
Pharming said the U.S. FDA accepted its resubmitted pediatric sNDA for Joenja and set a PDUFA target action date of October 24, 2026.