Ampio Pharmaceuticals Inc., of Englewood, Colo., received a notification letter from the New York Stock Exchange confirming that the company is now in full compliance with the exchange's listing requirements. Read More
PTC Therapeutics Inc., of South Plainfield, N.J., said the underwriters of its public offering of 4 million shares of its common stock have exercised in full their option to purchase an additional 600,000 shares at the public offering price less underwriting discounts and commissions. Read More
The FDA finalized the May 4, 2016, draft guidance for special protocol assessments (SPAs), a document that will overwrite a 2002 guidance by the same name. The guidance is intended to facilitate assessments of the design of pivotal studies of drugs and biologics, and the FDA said the final represents edits to the draft in order to "improve clarity and readability." Read More
HONG KONG – The Central Drugs Standard Control Organization (CDSCO) of India is setting up a national database, known as Sugam, of pharmaceutical manufacturers and their medicines to help address drug shortages and quality issues. Read More
In findings that could improve both risk prediction and treatment of anaphylactic shock, researchers at the Institute Pasteur have discovered that IgG antibodies could activate platelets, exacerbating the severity of anaphylactic episodes. Read More
Kineta Inc.'s immuno-oncology (I-O) efforts have tended to grab the spotlight, but it's the push with alpha9/alpha10 nicotinic acetylcholine receptor (nAChR) antagonists in pain that drew a deal potentially worth more than $359 million with Genentech, a unit of Roche Holding AG. Read More
Despite the fact that the industry inked more than 1,000 deals last year, it appears that biopharma companies are not losing their appetite for dealmaking. According to data from BioWorld and Cortellis Deals Intelligence, there were 271 deals signed in the first quarter of 2018, on par with 2017 first quarter transactions. However, the total value of those deals topped $30 billion, which is 33 percent higher than last year's total, reflecting that it has become a seller's market with competition for biotech assets driving up their price. Read More
PARIS – Alnylam Pharmaceuticals Inc. used the International Liver Congress (ILC) as the forum to report solid success in the phase I and I/II open-label extension (OLE) studies of givosiran to treat acute hepatic porphyrias (AHPs), a family of ultra-rare inherited disorders. Read More
PARIS – Biopsy data from a subgroup of patients enrolled in Intercept Pharmaceuticals Inc.'s phase III POISE study of Ocaliva (obeticholic acid, or OCA) for the treatment of primary biliary cirrhosis (PBC) confirmed stabilization or regression of fibrosis/cirrhosis in 85 percent of the cohort following three years of treatment. The findings provided the first evidence that improvements in biochemical markers of PBC observed in previous studies are accompanied by antifibrotic effects suggested in preclinical trials of Ocaliva, which gained accelerated approval in 2016 to treat individuals with PBC who had an incomplete response to ursodeoxycholic acid (UDCA). Read More
Mitochondria are the only cellular organelle with their own genome, but that genome encodes only a minority of the proteins that mitochondria need to function, with the remainder being produced in the cell and imported into the mitochondrion. That process can go awry in at least three places: the mitochondrial genome, the cellular genome, and the protein import machinery. Now, researchers from the Massachusetts Institute of Technology have identified a surveillance system that prevented glitches in protein import into mitochondria from damaging mitochondria. Read More
