The first big breakthrough in 30 years of Alzheimer’s research is providing momentum for clinical trials of “cocktail” treatments targeting the two hallmark proteins associated with the mind-robbing disease.
The FDA has accepted Roche and Sarepta’s Biologic License Application for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec), an investigational gene therapy for Duchenne muscular dystrophy (DMD).
Kintara Therapeutics Inc., a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC).
Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”). The clinical-stage biopharma was originally set to unveil the Phase II data for its lead breast cancer medication, ARV-471, on Dec. 8, 2022. But Arvinas’ and Pfizer’s joint abstract was inadvertently published early for conference participants by SABCS. Arvinas’ stock price has since fallen by 18% over the first two days of the holiday-shortened week.
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its Biologics License Application (BLA) for Roctavian (valoctocogene roxaparvovec), an AAV gene therapy for adults with severe hemophilia A.
Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.
An experimental vaccine provided broad protection against all 20 known influenza A and B virus subtypes in initial tests in mice and ferrets, potentially opening a pathway to a universal flu shot that might help prevent future pandemics, according to a U.S. study published on Thursday.
There is now an imminent threat of measles spreading in various regions globally, as COVID-19 led to a steady decline in vaccination coverage and weakened surveillance of the disease, the World Health Organization (WHO) and the U.S. public health agency said on Wednesday.
The investment would add capacity in research and development for manufacturing of active pharmaceutical ingredients (API), the main biologically active components of medicines, to supply its global clinical trials.