Alkermes has announced that the FDA has accepted for review its New Drug Application (NDA) for ALKS 5461, a drug for the treatment of major depressive disorder (MDD) in patients who meet certain criteria. FDA’s acceptance of the NDA came just two weeks after the agency issued a Refusal to File letter and follows discussions […]

The BioReady Community designation from Massachusetts Biotechnology Council (MassBio) signifies that a municipality has biotech and life sciences friendly zoning, has a streamlined permitting process, and has robust infrastructure in place. The designation serves to showcase Massachusetts communities that are ready to host new life sciences research and manufacturing facilities. There are currently 84 BioReady […]

Novartis has announced that it has entered into an agreement to acquire the Illinois-based clinical stage gene therapy company AveXis, Inc. for $218 per share or a total of $8.7 billion in cash. AveXis has several clinical studies in progress for the treatment of SMA, an inherited neurodegenerative disease caused by a defect in a […]

Amgen today announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the U.S., will employ Amgen’s proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets. A next-generation biomanufacturing plant incorporates multiple innovative technologies into […]

Flagship Pioneering has unveiled Foghorn Therapeutics, a unique life science innovation enterprise that uses its proprietary Gene Traffic Control product platform to discover and develop drugs based on novel insights into the chromatin regulatory system which directs gene expression in cells. Flagship Pioneering developed and launched Foghorn Therapeutics through its innovation foundry, Flagship VentureLabs, and […]

Researchers have identified a new ALS gene called KIF5A. This important gene discovery, funded by The ALS Association through Ice Bucket Challenge donations, will help researchers understand ALS disease pathways and represents a potential new ALS therapeutic target. This was a large collaborative effort involving over 250 researchers, led by John Landers, Ph.D., Professor of […]

Biogen has announced an agreement to acquire from Pfizer a first-in-class, Phase 2b ready AMPA receptor potentiator for cognitive impairment associated with schizophrenia (CIAS). AMPA receptors mediate fast excitatory synaptic transmission in the central nervous system, a process which can be disrupted in a number of neurological and psychiatric diseases, including schizophrenia. The purchase will […]

Cambridge-based Rubius Therapeutics, a biotech company pioneering a new class of cellular therapies, today announced the successful completion of an oversubscribed $100 million crossover financing. In just under nine months, the company has now raised over $220 million. Rubius has developed the technology to grow, genetically engineer and mature long circulating Red Cell Therapeutics (RCT) […]

Vertex Pharmaceuticals has announced that the FDA approved Symdeko for treating the underlying cause of cystic fibrosis (CF) in certain patients ages 12 and older. Symdeko is Vertex’s third medicine approved to treat the underlying cause of CF. “Today is an exciting day for the CF community. The approval of Symdeko, our third disease-modifying CF […]

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the FDA has approved Imfinzi for the treatment of certain patients with non-small cell lung cancer (NSCLC), specifically those with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Stage III (locally advanced) NSCLC is […]