While the medical product supply chain has always been subject to vulnerabilities, those weaknesses were laid bare early in the COVID-19 pandemic. Drug and medical device supply chains have historically been susceptible to factors such as a lack of supplier redundancy, components, active pharmaceutical ingredient (API) or finished product manufacturers. But pandemic-driven sourcing and workplace…
FDA fully approves Moderna’s COVID-19 vaccine
Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine. FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second…
American College of Clinical Pharmacology cautions against widespread off-label use of ketamine
Interest in the dissociative anesthetic ketamine is surging, given its potential to treat treatment-resistant depression and other mental health disorders. Against that backdrop, the American College of Clinical Pharmacology (ACCP) have released two policy statements advocating for stricter use of the drug. In addition, ACCP is arguing against its use in non-medical settings such as…
FDA postpones some inspectional activities amid omicron surge
The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19. With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates,…
US buys 10 million additional courses of Pfizer’s COVID-19 pill Paxlovid
As COVID-19 infections in the U.S. hit new highs, President Joe Biden announced that the country would buy at least 20 million courses of Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid. The government had planned on purchasing half as much of the drug, which won regulatory authorization in late December for certain patients with a high risk of developing…
FDA authorizes abortion drug distribution by mail
The FDA has decided to allow dispensing of mifepristone from Danco Laboratories by mail using certified prescribers of pharmacies. The move also allows dispensing of the drug via telemedicine. The agency had previously required that individuals obtain the abortion drug mifepristone (Mifeprex) in person. FDA notes that the mail-order distribution model became popular during the pandemic, leading…
A future beyond distance: How remote collaboration technologies are changing how we work
Site meetings are an integral part of business for life sciences companies — whether supplier audits, internal quality assurance inspections, process reviews, or FDA inspections. Often, these site visits involve traveling long distances to bring auditors, experts, or global teams together. Pre-COVID, the pharmaceutical and biotechnology industries spent enormous budgets on travel costs. Direct expenses…
Pfizer bolsters COVID-19 antiviral manufacturing capacity
Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame. An interim analysis of the Phase 2/3 EPIC-HR…
What to consider before renewing your serialization contract
As we kickstart the last quarter of 2021, the federal deadline for full interoperability in pharmaceutical serialization, as dictated by the DSCSA (Drug Supply Chain Security Act), will soon reach its two-year countdown on November 27. Since November 2018, all manufacturers, including virtual manufacturers and brand owners, have been required to serialize products at the…
Gottlieb: Delta wave could burn out by Thanksgiving
Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic. “This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019. In an interview with CNN, Gottlieb predicted that the pandemic in the U.S.…