Former JHL Biotech Inc. CEO Racho Jordanov and former Chief Operating Officer Rose Lin were sentenced for their respective roles in conspiring to commit trade secret theft and wire fraud exceeding $101 million.
Despite global drops in COVID-19 infections and because variants never rest, Eiger Biopharmaceuticals Inc. is taking its strong top-line phase III data of pegylated interferon lambda to global regulatory agencies for approval. The type III interferon that stimulates immune responses significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits longer than six hours by 50% and death by 60%. The results prompted Eiger to say it would submit the data to the FDA for an emergency use authorization – and also to the EMA and Asian agencies – as soon as it could.
Alnylam Pharmaceuticals Inc. has filed suits against both Pfizer Inc. and Moderna Inc. over alleged infringements of its patent on biodegradable cationic lipids that it said "are foundational to the success of the mRNA COVID-19 vaccines."
With global COVID-19 cases on the rise once again, the World Trade Organization (WTO) said it reached consensus among four WTO members – the U.S., European Union, India and South Africa – for an IP waiver regarding vaccines, a proposal to which biopharma reiterated its objections. Meanwhile, in the U.S., the White House appealed to Congress to provide adequate funding to continue the country’s pandemic response, and Pfizer Inc. and Biontech SE submitted an application to the FDA seeking emergency use authorization for a fourth shot of its COVID-19 vaccine.
When it comes to lowering U.S. drug prices, Congress has a lot of options among the several bills that have been introduced in both the House and Senate over the years. But a deadlock between bipartisan measures and partisan proposals has reduced legislative action to mere talk. The deadlock, and the at times hyperbolic debate, continued in yet another congressional hearing March 16 on “the urgent need to lower drug prices in Medicare,” as the Senate Finance Committee billed it.
The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone March 15, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote.
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
Disagreement over offsets for an additional $15.6 billion in COVID-19 funding forced the supplemental pandemic funds recently requested by the White House to be cut from the fiscal 2022 spending bill, so the U.S. House would have the votes to pass the $1.5 trillion omnibus spending package late March 9.
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