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During a virtual hearing, opioid maker Purdue Pharma told New York bankruptcy judge Robert Drain that the Sackler family, Purdue’s owners, are no longer seeking releases for non-opioid liability as part of their settlement, but are still seeking liability immunity related to opioid claims. Read More
AstraZeneca (AZ) said that its once-daily oral investigational drug, ALXN1840, performed well in phase 3 clinical trial for patients with Wilson disease, a rare, genetic condition, removing excess copper from tissues approximately three times more effectively than standard of care treatments. Read More
The number of new drugs expected to come into the marketplace will drop by 60 over the next 30 years due to effects of the Medicare drug price negotiations bill H.R. 3, the Congressional Budget Office (CBO) said in a new report. Read More
The FDA referred manufacturers to the International Council for Harmonisation’s guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. Read More
The domination of the U.S. active pharmaceutical ingredient (API) supply chain by manufacturers based in China, India and other countries cannot be addressed without the federal government’s long-term intervention, an analysis from the Olin Business School at Washington University in St. Louis concludes. Read More
At least seven U.S. states have rejected a proposed $26 billion settlement with the three largest drug distributors and drugmaker Johnson & Johnson (J&J), possibly putting the proposal in jeopardy as the refusals could cause the companies to leave the negotiating table. Read More
A federal judge pushed back his expected ruling today on Purdue Pharma’s request to approve its controversial opioid settlement in the company’s bankruptcy case, pressing those who stand against the plan to swiftly settle with the company’s owners, the Sackler family, to avoid spending money on appeals efforts later. Read More
The FDA has posted suggestions for ways to filter out viral contamination during continuous manufacturing of therapeutic proteins, based on studies conducted within the Center for Drug Evaluation and Research. Read More
Johnson & Johnson (J&J) has announced that it will submit data to the FDA showing that its booster shot dramatically raises the levels of antibodies against COVID-19 in people vaccinated six months prior. Read More
More than one-third of consumers and a quarter of physicians exposed to websites with five deceptive claims and tactics “indicated that no inaccuracies were present,” the OPDP found. Read More
In addition, the European regulator has approved a new finished product manufacturing site for the Moderna vaccine in Indiana, owned by Catalent. Read More
Purdue Pharma has released an updated bankruptcy plan that more narrowly defines the legal protections members of the Sackler family would receive in a settlement in a significant shift aimed at addressing the concerns of the federal judge presiding over the company’s bankruptcy case. Read More