Following new positive top-line results from its pivotal phase III study of IPX-203, Amneal Pharmaceuticals Inc. said an NDA submission for the Parkinson’s disease therapy (PD) is now planned for the middle of 2022.
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.”
In one of the biggest collaboration deals of the year, Shape Therapeutics Inc. entered a collaboration and license agreement with Roche Holding AG to develop gene therapies for targets in areas that include Alzheimer’s disease, Parkinson’s disease and rare diseases. Seattle-based Shape is eligible to receive an initial payment, development, regulatory and sales milestone payments that could exceed $3 billion in aggregate value.
The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs.
The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis, a disease that’s not endemic to the U.S. but increasingly is found in Europe and Asia. Ticovac, developed with a master seed virus, was first approved outside the U.S. 45 years ago. Before the FDA approval, the CDC had recommended that travelers on their way to high-risk areas be vaccinated in Europe though the process could take up to six months.
The FDA has made allowances for a third COVID-19 vaccine dose to protect certain adults with compromised immune systems. The amended emergency use authorization amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc.
According to the White House, the FDA is poised to allow COVID-19 booster shots from Pfizer Inc. and Moderna Inc., the two mRNA vaccines, but only for those people with compromised immune systems. The FDA announcement was anticipated to be as early as today, Aug. 12, and the boosters could be available as quickly as this coming weekend.
Fibrogen Inc. was braced for receiving a complete response letter (CRL) and it got one. The FDA suggested it would not approve roxadustat’s NDA for treating anemia of chronic kidney disease until more clinical work is conducted. In July, the FDA’s Cardiovascular and Renal Drugs Advisory Committee said basically the same thing as it voted 13-1 against approval for the nondialysis population and 12-2 against approval for patients on dialysis unless more trial data are submitted.
Seagen Inc. and Remegen Co. Ltd. will collaborate to exclusively develop and commercialize disitamab vedotin, a humanized antibody-drug conjugate (ADC) targeting HER2, giving Remegen the chance to earn up to $2.4 billion in total milestone payments.
