Regulatory

President Biden has instructed FDA to develop a plan to import prescription drugs from Canada while asking federal officials to create a “comprehensive plan” to cut drug prices within 45 days. Biden has also recommended that FTC block “pay for delay” agreements from pharma companies paying generic drug makers to hold off on introducing competitive…

The U.K. is laying the groundwork for a COVID-19 vaccine booster program starting in the fall, making it one of the first nations to do so. The interim initiative would prioritize providing boosters to those 70 and older, other high-risk patients and frontline health workers starting in September. Officials at the Joint Committee on Vaccination…

Nestlé Health Science (SWX:NESN) plans on taking a leading role in commercializing Seres Therapeutics’ (NSDQ:MCRB) experimental oral microbiome drug SER-109 for recurrent Clostridioides difficile infection (CDI). The infection from the bacteria can lead to diarrhea and, in severe cases, severe colon damage and life-threatening inflammation. More than 20,000 Americans die each year from CDI, according…

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 Two of the documents are final, while another two are draft guidance.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…