Viatris Recalls Extended-Release Xanax over Dissolution Test Failure
Viatris has issued a Class II recall of a single batch of its extended‑release Xanax (Xanax XR) after dissolution testing showed the tablets did not meet release specifications. The affected bottles, each containing 60 3‑mg tablets, were manufactured in Ireland and are being withdrawn from the U.S. market. This recall is one of 30 drug recalls listed in the FDA’s latest weekly enforcement report and follows a 2022 recall of 110 bottles for the same product. Viatris reported Xanax XR sales of $145 million in 2024, down from $154.8 million in 2023.
Biotech Has Become a Good News Story. Let the Sun Shine
Biotech is back in the spotlight as Revolution Medicines reported a Phase 3 trial that doubled survival for patients with advanced pancreatic cancer, a disease with a historically low five‑year survival rate. In March, Denali Therapeutics earned the first FDA approval...
Lilly Adds Gene Delivery Technology to CAR T in up to $7B Kelonia Deal
Eli Lilly announced an up‑to $7 billion acquisition of Kelonia Therapeutics, securing its Phase 1 lentiviral in‑vivo CAR‑T candidate KLN‑1010 and the iGPS gene‑delivery platform. iGPS uses lentiviral particles to program a patient’s own T‑cells, potentially eliminating ex‑vivo manufacturing and pre‑treatment chemotherapy. The deal...
Agenus Cancer Cocktail Records 0% Response Rate, Missing Midstage Goal
Agenus and its spin‑out MiNK Therapeutics reported a zero percent overall response rate in a Phase 2 trial of a three‑drug cocktail for advanced gastroesophageal adenocarcinoma. The regimen combined two experimental immunotherapies, botensilimab and balstilimab, with MiNK’s allogeneic iNKT cell therapy...
Novo’s Late-Stage Sickle Cell Win Piles Pressure on Competitors
Novo Nordisk reported that its oral pyruvate kinase‑R activator etavopivat reduced vaso‑occlusive crises by 27% in the Phase 3 HIBISCUS trial and more than doubled hemoglobin response rates versus placebo. The data support a regulatory filing slated for the second half...
Merck’s Early PD-1/VEGF Data Competitive in Lung Cancer, but Summit ‘Looms Large’
Merck’s anti‑PD‑1/VEGF bispecific MK‑2010 posted a 55% overall response rate in treatment‑naïve non‑small cell lung cancer (NSCLC) and a 44% response in later‑line patients, figures that rival the current leader, Summit/Akeso’s ivonescimab. The data were presented at the AACR meeting,...
From Product to Patient in Nuclear Medicine: Why Vertical Integration Is Essential for a Competitive Advantage
Nuclear medicine’s ultra‑short radiopharmaceutical half‑lives make delivery inseparable from production, forcing a single, time‑bound operational system. Curium has built a globally integrated model that combines isotope manufacturing, quality release, and distribution into one coordinated network. The approach proved its resilience...
Lilly’s Foundayo Reaches 1,390 Patients in First Week, Trailing Novo’s Oral Wegovy Launch
Eli Lilly’s newly approved oral obesity drug Foundayo recorded 1,390 prescriptions in its first two days, a modest start compared with Novo Nordisk’s oral Wegovy, which logged over 3,000 patients in its inaugural week. RBC Capital Markets noted the timing difference—Foundayo launched...
RFK Jr. Defends Makary, Claims Pharma ‘Owns’ Congress and Media
Health Secretary Robert F. Kennedy Jr. defended FDA Commissioner Marty Makary during a Ways and Means Committee hearing, praising the agency’s recent drug‑approval record and rejecting criticism from the pharmaceutical industry. He highlighted the FDA’s decision to reject Replimune’s oncolytic...
Novo May Have Muscle Advantage over Lilly in Weight-Loss Race: Preprint
A new medRxiv pre‑print analyzing nearly 8,000 GLP‑1 patients finds Novo Nordisk’s semaglutide preserves lean body mass better than Eli Lilly’s tirzepatide, despite the latter delivering greater overall weight loss. In the first year, 6.7% of semaglutide users fell into a...
Replimune Cries Foul on Regulatory Flexibility. But Many Americans Want a Stricter FDA
The FDA rejected Replimune’s RP1 melanoma combination therapy twice, citing patient‑population heterogeneity that it says undermines efficacy interpretation. The biotech’s CEO decried the agency’s lack of regulatory flexibility, while a Politico poll revealed most Americans prefer a slower, more rigorous...
Merck’s PD-1/VEGF Data Star in Stacked Lineup of AACR ‘26 Data Reveals
Merck will unveil early clinical data on MK‑2010, a PD‑1/VEGF bispecific antibody it licensed from LaNova for $588 million, at the AACR 2026 meeting. The readout will test Merck’s ability to compete with ivonescimab and other emerging bispecifics from Pfizer/BioNTech and BMS....
Funding the Future of European Biotech
In a BioSpace Insights “Denatured” podcast, host Jennifer C. Smith‑Parker talks with Edoardo Negroni of AurorA‑TT and Naveed Siddiqi of Novo Holdings about Europe’s world‑class biotech science and the venture ecosystem needed to commercialize it. The guests argue that Europe’s research...
MeiraGTx, Spying Hope in a Failed Trial, Buys Back Eye Disease Gene Therapy From J&J
MeiraGTx announced it will reacquire the rights to its X‑linked retinitis pigmentosa gene‑therapy candidate bota‑vec from Johnson & Johnson for an upfront $25 million. Although the Phase 3 LUMEOS trial missed its primary visual‑guided mobility endpoint, the study demonstrated improvements in visual...
Biopharmas Pull Back on Layoffs in Q1
Biopharma layoff activity slowed in Q1 2026, with only 35 companies announcing cuts versus 74 a year earlier. Despite fewer firms cutting staff, the total number of workers affected rose to 6,593, driven largely by Viatris’ plan to shed up...