Da Volterra SA, of Paris, said results from a clinical study of 44 healthy volunteers testing DAV-132, which is designed to capture residual antibiotics in the colon, were published in the Journal of Infectious Diseases. Read More
Centrexion Therapeutics Corp., of Boston, which is focused on developing non-opioid, nonsteroidal therapeutics for the treatment of chronic pain, said the FDA has granted fast track designation to CNTX-4975 for the treatment of pain associated with knee osteoarthritis. Read More
Biofrontera AG, of Leverkusen, Germany, filed with the SEC to raise up to $22 million in an IPO. The dermatology-focused firm plans to list on Nasdaq under the symbol BFRA. Read More
HONG KONG – Singapore isn't just becoming a biotech hub. The island nation's biotech ecosystem is at "an inflection point," said Benjamin Seet, executive director of the biomedical research council at A*STAR (The Agency for Science, Technology and Research), a statutory board under the Ministry of Trade and Industry. Read More
A new study by an international team of researchers led by Sweden's Karolinska Institute has for the first time pinpointed a mechanism for the conversion of energy-storing white fat into energy-expending brown fat, a key finding that may lead to the discovery of new diabetes and obesity treatments. Read More
LONDON – Pherecydes Pharma SA has raised $10.3 million in a series B round, which it said will enable it to get approval for its bacteriophage manufacturing system and to make products available for treating serious antibiotic-resistant infections on a compassionate use basis. Read More
The FDA has penciled-in a meeting for this quarter with Sarepta Therapeutics Inc. regarding phase I/II champ golodirsen (SRP-4053) for Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 53. Investors will be watching eagerly for word from the discussion, which should take the measure of relations between U.S. gatekeepers' neurology division and the Cambridge, Mass.-based company, after what H.C. Wainwright analyst Debjit Chattopadhyay noted was a "thorny," patient-driven approval process for Exondys 51 (eteplirsen). Read More
As U.S. courts and states clear the way for drug and device companies to speak more about their products, "the FDA can't afford to sit still and silent," Peter Lurie, president of the Center for Science in the Public Interest, said Tuesday at a symposium on transparency at the agency. Read More
A Japanese cancer drug that Eiger Biopharmaceuticals Inc. hoped would help key subgroups of people with pulmonary arterial hypertension (PAH) failed to do so, missing both the primary and a key secondary endpoint of the phase II study, Liberty. The trial's failure marks the end of Eiger's pursuit of PAH with the drug, ubenimex, though it continues to test it in lymphedema. Read More