As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally.
In its first big pharma deal since it was founded around a cell programming technology in 2009, Immusoft Corp. signed Takeda Pharmaceutical Co. Ltd. to a research collaboration and license option targeting rare inherited metabolic disorders. The agreement brings an undisclosed up-front fee and research funding to Immusoft, which is also eligible to earn more than $900 million if all options are exercised and all milestones hit.
In its first big pharma deal since it was founded around a cell programming technology in 2009, Immusoft Corp. signed Takeda Pharmaceutical Co. Ltd. to a research collaboration and license option targeting rare inherited metabolic disorders. The agreement brings an undisclosed up-front fee and research funding to Immusoft, which is also eligible to earn more than $900 million if all options are exercised and all milestones hit.
Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.
Voyager Therapeutics Inc. is getting $30 million up front in a potential $630 million gene therapy deal with Pfizer Inc., the company’s first such agreement since a strategic refocusing effort earlier this year and a much-needed endorsement of a next-generation AAV capsid platform that has shown promising though early stage data.
Verrica Pharmaceuticals Inc.’s launch plans for drug-device candidate, VP-102 (cantharidin 0.7% topical solution), in the viral skin infection molluscum contagiosum were hit with another delay, as the FDA issued a complete response letter (CRL) in response to the NDA, just two days ahead of its Sept. 23 PDUFA date.
An unexpected complete response letter (CRL) from the FDA has thrown a wrench into Sesen Bio Inc.’s commercial launch plans for Vicineum (oportuzumab monatox) in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company, which has spent the past few months completing its commercial build phase and hiring sales reps ahead of the Aug. 18 PDUFA date, instead must now address outstanding clinical and statistical data and analyses, in addition to CMC issues, cited in the CRL.
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease.
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia.
