Pharmaceutical Processing

BioNTech has won approval from the European Medicines Agency (EMA) to manufacture its COVID-19 vaccine Marburg, Germany–based facility. BioNTech will produce mRNA at the site, an instrumental component of the Comirnaty (BNT162b2) vaccine it jointly developed with Pfizer. The manufacturing for the vaccine process requires approximately 50,000 steps, which spans mRNA synthesis and manufacture of…

Democratic lawmakers joined by Sen. Bernie Sanders (I-Vt.) are preparing drug pricing controls that could help bankroll a planned $3 trillion infrastructure bill they will attempt to pass in the summer. If Democrats add the drug-pricing proposal to their next budget reconciliation bill, they could pass it with a simple majority in both the House…

In a complaint filed in Illinois federal court, AbbVie alleges that the Icelandic biopharma company Alvotech sought to copy its rheumatoid arthritis blockbuster biologic Humira (adalimumab).  The lawsuit accuses Alvotech of hiring a former AbbVie employee, Rongzan Ho, to help it develop a copycat version of Humira.  Ho, a team leader of upstream manufacturing for…

Over the past several months, AstraZeneca has struggled to win broad support for its vaccine, which it jointly developed with Oxford University. In the past several months, a series of bruising headlines have put the company on the defensive, forcing the company to issue a series of statements answering questions over its vaccine data.  The…

Nanotechnology-enabled mRNA vaccines are having a banner year in 2021. That much is clear. But making sense of the long-term prospects of the nascent market for mRNA therapeutics remains challenging.  Global Data projected that sales of leading nanotechnology-enabled mRNA vaccines could hit $17 billion this year in its January “The State of the Biopharmaceutical Industry”…

Pfizer CFO & EVP of supply chain Frank D’Amelio has said there could be an opportunity to potentially hike up prices on its COVID-19 vaccine in a post-pandemic state. Speaking last week at the Barclays Global Healthcare Conference, D’Amelio revealed that the company is considering what will become of the vaccine situation, especially involving pricing,…

Purdue Pharma has proposed paying an additional approximately $500 million in cash to settle hundreds of thousands of opioid lawsuits. As part of a proposed bankruptcy settlement, the payments would be spaced out over the next decade. The Sackler family that owns the company has earlier agreed to pay an additional $4.2 billion to settle…

Sotera Health (NASDAQ:SHC) recently announced that it has acquired Bozeman, Mont.–based BioScience Laboratories in a deal that will expand the U.S.-based antimicrobial and antiviral testing capabilities of Sotera Health’s Nelson Labs business. The financial terms of the deal were not disclosed in the March 10 announcement. BioScience Laboratories provides topical antimicrobial product testing in the…

The European Commission has announced that it has secured four million more COVID-19 vaccine doses than it had expected to be delivered over the next two weeks. The vaccines will help E.U. “tackle coronavirus hotspots,” “facilitate free border movement” and fight COVID-19 variants. The E.U. has been involved in a recent vaccine-related tussle with the…

Baxter announced that its Baxter BioPharma Solutions business will make Moderna‘s COVID-19 vaccine at its fill/finish sterile manufacturing facilities in Bloomington, Ind. The plan — announced yesterday — is for Baxter to make 60–90 million doses of the Moderna vaccine in 2021. “We have seen a remarkable demonstration of scientific and health care expertise in…