At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
The COVID-19 pandemic reset expectations of Medicare telehealth coverage, prompting a letter from dozens of members of Congress to Capitol Hill leadership asking for legislation that will memorialize telehealth benefits. But concerns over spending, fraud and abuse still hang over the discussion.
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
The Biosecure Act missed its expected ride through the U.S. Congress via the National Defense Authorization Act, but it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed “biotechnology companies of concern.”
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to halt its phase II trial testing oral obesity candidate azelaprag. The Strides study, launched in July, had been testing azelaprag, an oral apelin receptor agonist licensed from Amgen Inc., as a monotherapy and in combination with GLP-1/GIP therapy Zepbound (tirzepatide, Eli Lilly and Co.) in obesity.
Agios Pharmaceuticals Inc. is learning the hard way the downside of having a pipeline in a product. When a side effect crops up, investors are likely to worry that it may affect the potential of the drug in the numerous diseases the drug could potentially treat.
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.
The European Commission approved Novo Holding A/S’ acquisition of Catalent Inc., a global contract development and manufacturing organization expected to help Novo Nordisk A/S keep up with increasing demand for its GLP-1 drug, Wegovy (semaglutide).
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
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