Pfizer (NYSE: PFE) announced today that it will invest $120 million into its Kalamazoo, Michigan facility to support U.S.-based production of its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir). The investment is expected to create more than 250 additional, high-skilled jobs at the Kalamazoo site. The money will expand the production of active pharmaceutical ingredient (API) and registered…
Entegris opens Life Sciences Technology Center in Massachusetts
Entegris (Nasdaq:ENTG) announced today that it opened a new Life Sciences Technology Center in Billerica, Massachusetts. The new facility was built to offer life sciences customers the opportunity to leverage Entegris’ cold-chain supply expertise to optimize processes, reduce costs and increase speed to market, according to a news release. Entegris’ tools and technologies will be…
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children. Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial in young children evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong…
FDA denies EUA for COVID-19 indication of SSRI fluvoxamine
The infectious disease physician-scientist Dr. David R Boulware filed for the emergency use authorization (EUA) of fluvoxamine, an established selective serotonin reuptake inhibitor (SSRI) whose brand name is Luvox. The FDA has rejected the application, explaining the COVID-19 treatment benefit of the drug was “not persuasive” in the TOGETHER study that was the basis of the…
Emergent hid quality problems from FDA, House report concludes
A new congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated. Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in…
Fast Company 2022 World-Changing Ideas Awards highlight multiple pharma innovations
The pharmaceutical industry had an excellent showing in the Fast Company 2022 World-Changing Ideas Awards series, focusing on organizations dedicated to ‘social good.’ This year, the publication awarded three drug-delivery applications with awards, and Siemens took home a prize for its work in accelerating COVID-19 vaccine development. A 3D printed vaccine patch could deliver vaccine doses…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic
Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus. The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after…
Moderna names former Merck exec as new chief commercial officer
COVID-19 vaccine developer Moderna (Nasdaq:MRNA) has named Arpa Garay as its chief commercial officer starting May 31, 2022. Garay spent more than 15 years at Merck & Co. (NYSE:MRK). In February, she was promoted to the post of chief marketing officer for Merck’s human health division. Garay also was a member of the company’s executive…
Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between…