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HHS announced that it will restrict distribution of Eli Lilly’s COVID-19 antibody therapy, bamlanivimab, in three states because of concerns about its effectiveness against a variant strain of the virus first identified in California. Read More
A study by researchers at the University of Utah and other universities found that payments for neurology drugs under Medicare Part D saw a substantial hike over five years despite only a small bump in the number of claims. Read More
The U.S. Senate has unanimously passed two bipartisan bills aimed at lowering prescription drug prices by elevating generics and biosimilars that are now awaiting consideration in the House. Read More
India’s and South Africa’s proposal to temporarily waive intellectual property rights for COVID-19 vaccines and medicines was stopped once again by opposition from wealthy Western nations, including the U.S., during the World Trade Organization (WTO)’s meeting last week, in a victory for the pharma industry. Read More
As part of an industry-wide FDA review, the agency’s Oncologic Drugs Advisory Committee will convene next month to discuss six cancer indication approvals given under the agency’s Accelerated Approval program that haven’t verified their clinical benefit in confirmatory trials as required. Read More
The European Commission (EC) granted Johnson & Johnson (J&J)’s COVID-19 vaccine a conditional marketing authorization yesterday, giving the 27-member bloc a desperately needed alternative as the region faces serious supply delays for previously authorized shots. Read More
Nearly two months into the Biden administration, the president has still not nominated a permanent FDA commissioner or spoken publicly on who he’s considering, and a group of six former agency heads are imploring him to prioritize the task. Read More
Moderna has announced that it has begun dosing trial participants with a modified COVID-19 vaccine meant to target the variant SARS-Cov-2 strain first identified in South Africa. Read More
House Democrats passed the $1.9 trillion COVID-19 relief bill yesterday in an 220-211 vote along party lines, sending the legislation to President Biden’s desk for signing on Thursday. Read More
EU member states increasingly frustrated with the speed of vaccine rollouts are going it alone through separate authorizations and side deals for vaccines from Russia and China. Read More
Novartis subsidiary Sandoz is suing the FDA over the new chemical entity (NCE) exclusivity it granted Sanofi’s multiple sclerosis drug Aubagio (teriflunomide), alleging the five-year protection it gave was unlawful and wrongly kept Sandoz’s generic teriflunomide from being reviewed by the agency. Read More
San Diego, Calif.-based Acadia Pharmaceuticals has received a notification of deficiencies from the FDA regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin), an anti-psychosis drug being reviewed for treating dementia-related hallucinations and delusions. Read More