Phase 2
Corvidia Therapeutics, headquartered in Waltham, Massachusetts, closed on a Series B funding round worth $60 million.
On April 16, Celldex Therapeutics reported that its Phase IIb trial of glembatumumab vedotin (glemba) failed in a trial of metastatic triple-negative breast cancer. Now the company has filed with the U.S. Securities and Exchange Commission (SEC) that it is cutting about 20 percent of staff.
Biogen saw a strong first quarter with 11 percent growth in revenues to $3.1 billion, which were spurred by gains in spinal muscular atrophy (SMA) treatment Spinraza and multiple sclerosis treatment Tecfidera.
Safety Concerns Force Loss of Breakthrough Therapy Designation for Synthetic Biologic’s C. Diff Drug
Shares of Synthetic Biologics are down more than 14 percent this morning after the company announced that SYN-004 (ribaxamase), the company’s treatment for the Clostridium difficile infection (CDI), lost the Breakthrough Therapy Designation awarded by U.S. Food and Drug Administration last year.
The FDA granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation and declined to approve its biosimilar of Roche’s Herceptin for breast cancer.
Prothena Corporation announced it had shuttered its NEOD001 program for AL amyloidosis after the failure of its Phase IIb PRONTO study and Phase III VITAL study. Shares dropped 60 percent in premarket trading at the news.
Sage Therapeutics has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for brexanolone (SAGE-547) to treat postpartum depression (PPD).
Bluebird bio announced interim data from two different two-year clinical trials of LentiGlobin gene therapy for transfusion-dependent beta-thalassemia (TDT).
With growing concerns about the rise of drug resistant bacteria, multiple companies are developing new forms of antimicrobials to take on serious health concerns.
Janssen Pharmaceuticals has teamed up with Bristol-Myers Squibb to drive BMS-986177, a Factor XIa (FXIa) inhibitor, into Phase II development for the study of secondary stroke prevention and major thrombotic conditions.
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