The U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for a vaccine candidate from Johnson & Johnson (NYSE:JNJ). HHS and DoD announced the agreement with Janssen Pharmaceutical, as the J&J subsidiary is set to offer large-scale manufacturing and the delivery of its COVID-19 vaccine candidate, with the federal…
U.S. paying Novavax $1.6b to ramp up COVID-19 vaccine manufacturing
The U.S. Health and Human Services Dept. and Defense Dept. announced a joint agreement with Novavax (NSDQ:NVAX) worth $1.6 billion to scale the manufacturing of its COVID-19 vaccine candidate. Gaithersburg, Md.-based Novavax’s commercial-scale manufacturing is expected to produce 100 million doses of the investigational vaccine that would become available for use in clinical trials or,…
Most Americans concerned about rising drugs costs amid COVID-19, Gallup says
A new study by West Health and Gallup revealed that Americans are concerned with potential negative developments resulting from the COVID-19 pandemic. Nearly 90% of the 1,016 U.S. adults surveyed between May 11, 2020, and May 22, 2020, said they are “very” (55%) or “somewhat” (33%) concerned that the pharmaceutical industry will leverage the ongoing…
AbbVie gains U.S. nod for $63B Allergan takeover
Pharmaceutical giant AbbVie (NYSE:ABBV) has won U.S. antitrust approval for its purchase of Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. North Chicago-based AbbVie announced the deal in June 2019, but ran up against U.S. Federal Trade Commission…
Next COVID-19 device shortage? ‘Smart’ infusion pumps
Severely ill COVID-19 patients may need multiple medications delivered by infusion pumps. Manufacturers and hospitals are planning on how to avoid shortages of these pumps and the associated tubing. You’ve likely seen the videos of ICU hallways lined with medical devices that would normally be in patient rooms. Among them are machines that are ubiquitous…
Drug deactivation system helps N.J. pharmacies comply with new anti-overdose law
Verde Environmental Technologies announced that it launched four new retail products with its Deterra system in compliance with New Jersey’s “Charlie’s Law” that requires every pharmacy practice site in the state to provide effective options for consumers to dispose of unused, unwanted or expired medications. The law requires pharmacies to carry effective drug disposal methods…
Hurry Up and Wait: Brexit from a Regulatory Point of View
You Brexit, You Buy It – Europe and the New Regulatory – Part 1 of 2 By Lynn Hansen, Director of Clinical and Regulatory Affairs, Pharmatech Associates With Brexit looming, questions and concerns hover like a grey cloud over the UK pharmaceutical industry. Industry insiders and colleagues in London found that the confusion surrounding what…
Hurry Up and Wait: Brexit from a Regulatory Point of View – Part 2
You Brexit, You Buy It – Europe and the New Regulatory – Part 2 By Lynn Hansen, Director of Clinical and Regulatory Affairs, Pharmatech Associates In Brexit Part 1, I expressed my Brexit thoughts as Theresa May was providing a tearful resignation and now the United Kingdom has the return of an energetic Boris Johnson,…
Jump into cGMP: An FDA Roadmap to Manufacturing Tissue-based Products
Companies currently in the tissue-based regenerative medicine business need to understand and comply with the FDA’s expectations for human cells, tissues and cellular and tissue-based product (HCT/P) under development in the next two years. HCT/P pertains to products containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If we are to jump…
Regulatory Experience Plays into New Regulatory Affairs Certifications for 2019
With new exams introduced this year, the Regulatory Affairs Certification (RAC) program has seen major changes since the beginning of 2019, as announced at the Regulatory Affairs Professional Society (RAPS) Regulatory Annual Convergence meeting in October 2018. There are two new Regulatory Affairs Certifications with the associated exams for RAC (Drugs) and RAC (Devices). These…