Regulatory

Senate finance Committee members Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) are pushing to have a hearing to discuss the Medicare coverage of Aduhelm (aducanumab), Biogen’s controversial Alzheimer’s treatment, which recently won FDA approval. In a letter addressed to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), Warren and Cassidy express…

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB). The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand…

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.…

FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final, while another two are draft guidance.  “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of…

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md. FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and…

This week, bipartisan lawmakers in the House and Senate introduced legislation known as the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. The bill would make changes to fees tied to direct and indirect remuneration, or DIR, under Medicare Part D. The National Association of Specialty Pharmacy (NASP) released a statement applauding the proposed…

In an SEC filing, Eli Lilly (NYSE:LLY.N) revealed that it had received a subpoena from the U.S. Department of Justice connected to a manufacturing site in New Jersey that produces bamlanivimab, one of two COVID-19 monoclonal antibodies it produces. The plant also produces the blockbuster Trulicity and cancer drugs. Lilly did not state which types…

A recent report from the House Oversight and Reform Committee concluded that AbbVie (NYSE:ABBV) aggressively increased prices of popular drugs, including the bestseller Humira (adalimumab), which brought in close to $20 billion last year. Approximately $16 billion of those sales were in the U.S. In recent years, the company also repeatedly increased the price of…

Aurobindo Pharma has received approval from FDA for its abbreviated new drug application for the glaucoma medication dorzolamide hydrochloride (HCl) and timolol maleate ophthalmic solution in 2% and 0.5% concentrations.  The product is a generic equivalent to the reference listed drug Cosopt ophthalmic solution, from Akorn Operating Company. FDA indicates the drug to reduce intraocular…

Canada’s National Advisory Council on Immunization (NACI) has recommended that Canadians wait to receive the messenger RNA (mRNA) vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) when feasible. The advice stands in contrast to prior guidance that Canadians seek the first-available vaccines. “What we’re saying and what we’ve said all along is that mRNA vaccines are the…