News
Pfizer announces the first data from its Metsera-acquired pipeline just ahead of its earnings call, where analysts pressed execs for more details; Merck and Roche also released Q4 and full year earnings, with Eli Lilly, Novo Nordisk and others reporting Wednesday; REGENXBIO hits a regulatory snag ahead of its upcoming PDUFA; more.
FEATURED STORIES
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
THE LATEST
A thorough reassessment of the confounders between FibroGen’s trials is necessary to salvage the company’s Duchenne Muscular Dystrophy program and regain investor confidence.
The RNAi therapy, which the companies are co-developing and commercializing, reduced blood pressure in hypertensive patients with high cardiovascular risk by 15 mmHg over placebo.
At the recommendation of an independent data monitoring committee, J&J decided to stop the MACiTEPH trial in chronic thromboembolic pulmonary hypertension due to futility.
Blue Cross and Blue Shield of Louisiana has filed a case against Bristol Myers Squibb alleging the company conducted patent fraud to extend protections for its multiple myeloma drug Pomalyst.
The company has withdrawn a suit against the Department of Health and Human Services after its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list.
Interim data from the company’s late-stage clinical trial suggests its cell therapy treatment for heart failure likely won’t meet the primary efficacy endpoint, BioCardia announced on Tuesday.
The vaccine maker reported new trial data confirming an 8.7 to 11-fold increase in neutralizing antibodies against circulating strains, including the highly watched BA.2.86, EG.5 and FL.1.5.1 variants.
Citing the need to improve its Risk Evaluation and Mitigation Strategy, the regulator has declined AstraZeneca’s bid to get its C5 complement inhibitor approved in neuromyelitis optica spectrum disorder.
Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.