Pfizer Inc. entered into a conciliation agreement with the U.S. Department of Labor’s Office of Federal Contract Compliance Programs to resolve alleged compensation discrimination affecting female employees at its New York headquarters.
To resolve a U.S. SEC insider trading charge related to Pfizer Inc.’s $11.4 billion acquisition of Array Biopharma Inc. in 2019, Brian Rubin consented Oct. 17 to a judgment ordering him to disgorge $90,458, plus prejudgment interest of $16,914, and to pay a civil penalty to be determined by the court.
The official end of the COVID-19 public health emergency in the U.S. in May did not mark the end of interest and investment in the area. In the shifting landscape, attention has pivoted to new markets, emerging strains, boosters, and the commercialization and distribution of COVID-19 vaccines and therapies.
The vagaries of the COVID-19 market and the uncertainties of pandemic fatigue are hitting some biopharma companies in the pocketbook, at least for now. Due to lower-than-expected revenues from its COVID-19 Comirnaty vaccine and antiviral Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. reduced its 2023 revenue guidance by $9 billion after hours Oct. 13, saying it now anticipates full-year 2023 revenues to range from $58 billion to $61 billion – down from its previous guidance range of $67 billion to $70 billion.
Pfizer Inc. may have a blockbuster on its hands with the U.S. FDA’s approval of Velsipity (etrasimod), a selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).
Following an unexpected FDA complete response letter (CRL), Alnylam Pharmaceuticals Inc. said it will no longer pursue an expanded indication for Onpattro (patisiran) in the U.S. The RNAi therapeutic was approved in 2018 to treat polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis and seemed well on its way to snagging a second U.S. indication after the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in September that the drug’s benefits outweighed its risks as a treatment for cardiomyopathy of ATTR amyloidosis. The FDA disagreed with the committee, saying in the CRL that patisiran’s clinical meaningfulness had not been established in the proposed indication.
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over.
Despite China’s near-frozen startup scene and increasingly cautious foreign investors following the COVID-19 pandemic, multinational pharmaceutical firms continued to scout for innovative up-and-coming Chinese biotechs in Shanghai at Chinabio Partnering Forum 2023 over its two-day run.
Despite China’s near-frozen startup scene and increasingly cautious foreign investors following the COVID-19 pandemic, multinational pharmaceutical firms continued to scout for innovative up-and-coming Chinese biotechs in Shanghai at Chinabio Partnering Forum 2023 over its two-day run.
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
