The U.K.'s Medicines and Health Care Products Regulatory Agency (MHRA) has posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K. However, the agency has also floated a regulation for the production of pharmaceuticals at the point of care, a proposal MHRA said is the first of its kind.
For once, the U.K.’s health technology assessment body, the National Institute of Health and Care Excellence (NICE), has no reservations about the cost effectiveness of a new drug and is recommending Eli Lilly and Co.’s obesity therapy, Mounjaro (tirzepatide), for use in the National Health Service (NHS).
Cureverse Inc. and Angelini Pharma SpA signed a potential $360 million deal for CV-01, an oral small-molecule candidate for Alzheimer’s disease and neurological disorders like epilepsy. As a novel candidate, CV-01 suppresses neuroinflammatory reactions through the Kelch-like ECH-associated protein 1 and nuclear factor erythroid 2-related factor signaling pathway.
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17.
Inventiva SA is back on course to complete phase III development of its metabolic dysfunction-associated steatohepatitis (MASH) drug, lanifibranor, after putting in place new financing of up to €348 million (US$379.4 million), including an immediate cash injection of €94.1 million.
H. Lundbeck A/S is to acquire Longboard Pharmaceuticals Inc. in an all-cash deal valuing the epilepsy specialist at $2.6 billion. The agreed price of $60 per share is a 54% premium to the closing price of Longboard stock (NASDAQ:LBPH) on Oct. 11 and represents the biggest deal in Lundbeck’s 110-year history. The acquisition will give the Copenhagen, Denmark-based pharma company ownership of bexicaserin, which in September entered phase III development in Dravet syndrome. The 5-HT2C agonist has the potential to treat this and other rare developmental and epileptic encephalopathies, for most of which there are no approved therapies.
Booster Therapeutics is ready to open up a new arm of the proteasome after raising $15 million in seed funding to advance small molecules it says can degrade multiple types of harmful proteins. Rather than tagging single disease proteins with a ubiquitin marker for degrading via 26S proteasomes, these compounds directly activate 20S proteasomes that naturally recognize disordered proteins without the need for ubiquitin tagging.
Purespring Therapeutics Ltd. has raised £80 million (US$104.6 million) in a series B, putting it on course to be the first to take a gene therapy for a kidney disease into the clinic. The money enables the company to move the lead program, PS-002, for the treatment of IgA nephropathy to clinical proof of concept and advance programs in other complement-mediated kidney diseases, and in an undisclosed glomerular kidney disease.
It’s hard to know where to start in describing the biopharma applications of the 2024 Nobel Prize in Physics. It was awarded to John Hopfield and Geoffrey Hinton “for foundational discoveries and inventions that enable machine learning with artificial neural networks.”
Aviadobio Ltd. has entered a potential $2.18 billion license and commercialization agreement for its frontotemporal dementia gene therapy, AVB-101, with Astellas Pharma Inc. Astellas is making a $20 million equity investment in London-based Aviadobio and will pay up to $30 million up front in advance of deciding whether or not to exercise the exclusive option to worldwide rights.
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