The FDA issued a warning letter to Hubei Kangzheng Pharmaceutical detailing significant violations observed during an inspection of the company’s facility in Hubei Province, China. Source: Drug Industry Daily
CMS’ proposal to only cover Aduhelm in clinical trials has put a big hole in Biogen’s plan to create a global Alzheimer’s disease therapy franchise. Source: Drug Industry Daily
Amgen and Arrakis Therapeutics have teamed up to develop targeted RNA degraders, an entirely new class of therapeutic molecules designed to destroy disease-causing RNA. Source: Drug Industry Daily
It’s been a banner year for the financial side of the pharmaceutical industry. Source: Drug Industry Daily
Medicare will only cover Aduhelm, the controversial Alzheimer’s disease antibody, for people who are enrolled in qualifying clinical trials, the Centers for Medicare and Medicaid Services (CMS) proposed today. Source:…
The FDA has lifted its clinical hold on Allogene Therapeutics’ five early-stage clinical trials of its chimeric antigen receptor T (CAR-T) therapy. Source: Drug Industry Daily
Pfizer is eying March as a potential roll-out date for a hybrid COVID-19 vaccine that would cover both the original Wuhan strain and the highly vaccine-resistant Omicron strain. Source: Drug…
Drugmakers are not pleased with the FDA’s draft guidance on microbiological contamination, published in September to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Source: Drug Industry Daily
Pfizer has partnered with Beam Therapeutics to develop messenger RNA (mRNA)-based therapies for rare genetic diseases — a move to expand its portfolio of mRNA technology used to produce its…
After flopping a phase 3 trial in hospitalized COVID-19 patients, Molecular Partners’ antiviral ensovibep has scored in a new phase 2 study, reducing viral load and cutting the risk of…