After five years and 350,000 hours of DNA sequencing, the UK Biobank has opened up access Nov. 30 to the whole genome sequences of half a million people who volunteered to give samples 15 years ago.
For biopharma, the 2023 post-pandemic reality check has been harsh, replete with sagging stock prices, bankruptcy filings and restructurings, as well as IPOs at their lowest levels in a decade. The good news, according to a handful of industry experts, is that it could be coming to an end, possibly as early as 2024.
Johnson & Johnson completed the previously unheralded acquisition of privately held Laminar Inc. for $400 million upfront, with undisclosed contingent payments depending on achievement of clinical and regulatory milestones starting in 2024. The deal provides the med-tech giant a potentially game-changing entree into the lucrative left atrial appendage (LAA) market.
With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in the high list prices facing American patients.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
Johnson & Johnson will excise less profitable lines and markets within its Depuy Synthes orthopedics business over the next two years, management revealed in its quarterly investor call on Oct. 16. Paring its products and related pursuits could cost as much as $800 million by the end of 2025, J&J Chief Financial Officer Joe Wolk said.
Qyuns Therapeutics Co. Ltd. has filed to list on the Hong Kong Exchange to fund its autoimmune and allergic disease therapy pipeline, including lead assets QX-002N for ankylosing spondylitis and QX-005N for multiple indications including atopic dermatitis.
Orthofix Medical Inc. terminated its CEO, chief financial officer and chief legal officer in a move that plunged the stock from $18.63 at Monday’s close to $13.01 by the end of Tuesday. The clean sweep of the executive suite followed the “unanimous decision by the board’s independent directors to terminate for cause Keith Valentine, John Bostjancic and Patrick Keran,” the company said in a statement that named their interim replacements. Valentine was also asked to resign from the board.
