The National Institutes of Health (NIH) will decide this month whether Pfizer’s patent on Xtandi (enzalutamide), a prostate cancer drug’s that’s five times pricier in the U.S. than it is…
It sure appears as though Robert Califf’s second confirmation as FDA commissioner could be in jeopardy. Source: Drug Industry Daily
In its latest annual report on Drug Safety Priorities released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) noted that much of its focus in 2021 remained on…
The FDA has approved Roche’s Vabysmo (faricimab-svoa) for treating the two most common forms of vision loss, paving the way for the drug to go head-to-head with Regeneron Pharmaceuticals’ blockbuster,…
Madrigal Pharmaceutical’s investigational drug resmetirom reduced liver fat by up to 48 percent over one year, raising hopes of a first-in-class approval for nonalcoholic steatohepatitis (NASH), company executives said yesterday.…
Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds.…
The FDA explains how combination products are assigned for review within the agency in a newly released final guidance. Source: Drug Industry Daily
Deadlines are approaching for drugmakers to file their CARES Act Amount Information report, detailing the amount of listed drugs and biological products they’ve produced and sold over the year. Source:…
A new consolidated, online clinical trials database that becomes active today in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with…
The European Medicines Agency’s (EMA) human medicines committee endorsed seven drugs for new indications during its monthly meeting last week, including Pfizer’s highly effective COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir).…