A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
Bloomsbury Genetic Therapies Ltd. has raised £5 million (US$5.5 million) in a seed round, to take four gene therapy programs based on research carried out by the scientific founders at University College London into clinical development.
Claiming it would be impossible to carve out a so-called skinny label that would comply with generic drug “same labeling” rules, Novartis AG is petitioning the U.S. FDA, for the second time, not to approve generic versions of its blockbuster heart drug, Entresto (sacubitril + valsartan), that attempt to carve around a cardiovascular indication that has exclusivity until Feb. 16, 2024.
Novartis AG rolled out positive phase III data Sept. 13 with Cosentyx (secukinumab), its interleukin-17A (IL-17A) inhibitor for hidradenitis suppurativa, offering more evidence for the approach taken up by a handful of biopharma firms.
Proto-oncogene tyrosine-protein kinase receptor Ret is a widely expressed oncogene and chromosomal rearrangements involving RET lead to fusion genes and RET kinase activation, which occur in lung cancer in about in 2% of cases of non-small cell lung cancer.
Novartis AG and Les Laboratoires Servier SAS have identified proteolysis targeting chimeras (PROTACs) compounds comprising E3 ubiquitin ligase-binding moiety covalently bonded to Bcl-2-like protein 1 (BCL2L1)-targeting moiety through a linker reported to be useful for the treatment of cancer.
As Novartis AG works to streamline the company and finalized a long-considered plan to separate its Sandoz Inc. business by creating a standalone company, it temporarily stopped dosing in a study of branaplam for treating Huntington’s disease. Several findings from the phase IIb study suggested the presence of peripheral neuropathy in some participants. An independent data monitoring committee recommended the dosing halt but fell short of recommending the study be terminated. The VIBRANT-HD steering committee agreed with the committee’s recommendation.
Ophthalmic therapy and device developer Alcon SA, of Geneva, further strengthened its portfolio by buying Aerie Pharmaceuticals Inc. for about $770 million in equity. Aerie’s financial guidance for its glaucoma franchise puts net product revenue at $130 million to $140 million for all of 2022.
Alain Bouaziz, a French citizen and resident of the United Arab Emirates, pleaded guilty Aug. 12 to one count of lying to the U.S. FDA in an attempt to steal a discontinued Novartis AG weight loss drug. The charge carries a maximum prison term of five years and a fine of up to $250,000, or twice the gain or loss caused by the offense, whichever is greatest.
