Here are the latest stories being discussed in biopharma today:
Takeda Expands Entyvio Label to Benefit Crohn’s Patients
Healthcare company Takeda has announced the option of a subcutaneous version of Enyvio to patients using it for Crohn’s disease. This subcutaneous formulation follows a first approval from several months ago for usage in ulcerative colitis patients. The new formulation offers maintenance therapy post-induction with intravenous (IV) Entyvio and comes in a single-dose, prefilled pen which can be self-administered.
CSL Vifor Proposes Marketing Campaign to Settle Anti-competitive Allegation
Biotech company CSL Vifor plans to craft a marketing campaign to resolve an anti-competitive investigation launched by the European Commission. CSL Vifor may allegedly have unlawfully disparaged its IV iron infusion competitor, Pharmacosmos’ Monofer, to reduce competition for its own high-dose iron IV brand Ferinject. The proposed resolution includes a multimedia campaign and a decade long pledge to avoid discussions surrounding Monofer’s safety profile in promotions or medical communications.
Senators Seek Clarity on Novo’s Decision to Discontinue Levemir Insulin
Senators are demanding explanations from Novo Nordisk regarding its decision to discontinue its long-acting insulin, Levemir. Senators Jeanne Shaheen, Elizabeth Warren and Raphael Warnock are seeking information on supply constraints and whether Novo will consider producing Levemir until biosimilars are available. Novo has been given until May 1 to respond to the questions.
FDA Commissioner Discusses Drug Manufacturing and Foreign Inspections
FDA Commissioner Robert Califf spoke on the need to bring more drug manufacturing to the US and detailed the agency’s progress on increasing overseas inspections. Califf confirmed preparations to work with lawmakers to relocate overseas generic drug manufacturing back to the US. Despite challenges, the FDA has made some progress with unannounced inspections overseas.
Rare Neuro Disorder Sparks Competition Amongst Drug Developers
A competition is brewing among drug developers targeting chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder, with argenx and Sanofi releasing trial updates for their CIDP programs at a recent meeting of the American Academy of Neurology. With significant market opportunity despite CIDP’s low prevalence, firms such as Dianthus Therapeutics and Immunovant are expected to prove strong competitors.
Personnel Changes at Recursion and Sana
Dr. Najat Khan has been appointed as chief R&D and commercial officer at Recursion Pharmaceuticals, departing from her position at Johnson & Johnson. Khan’s hiring follows the departure of Recursion’s former chief business officer Shafique Virani, who left to join biotech startup Noetik. Furthermore, Doug Williams has resigned from his role as Sana’s R&D chief.
