Researchers from the University of California at Los Angeles and Duke University have developed an implantable gel that could stimulate first blood vessel formation, and then brain regeneration, after stroke. Read More
May's IPO parade marched onward Friday, with anti-infectives specialist Iterum Therapeutics plc raising about $80 million in an offering that started below-range and inched downward from there. The company's 6.15 million-share (NASDAQ:ITRM) offering priced at $13 per share instead of the planned $14 to $16. Shares closed at $12.85 on Friday. Read More
BioWorld has reported on numerous advances in digital health, which are tantalizing examples of how digitization could transform health care, but it has long been clear lip service repetition of the term "digital health" is not enough to deliver its potential: the first FDA approval of an artificial intelligence system for diagnosing diabetic retinopathy without requiring a clinician to assess an image; the launch of NIH's All of Us program, which aims to propel the development of personalized medicine by making a repository of health data from 1 million Americans available for research; and the arrival of the first true digital therapeutic judged by the FDA to the same clinical evidence standards as are applied to drug approvals. Read More
Excitement ran high last week – at the company, anyway – when Montreal-based Clementia Pharmaceuticals Inc. rolled out positive data from part B of its ongoing phase II trial testing palovarotene, a retinoic acid receptor gamma agonist, to treat the rare, life-threatening genetic bone disease called fibrodysplasia ossificans progressiva (FOP). Read More
In medicine, too, there is no free lunch – effective therapies come with side effects. But two new studies could make lunch cheaper for patients treated with chimeric antigen receptor (CAR) T cells. Researchers at the San Raffaele Hospital in Milan, Italy, and the Memorial Sloan Kettering Cancer Center (MSKCC) have gained new insights into the causes of cytokine release syndrome (CRS) and neurotoxicity, the two most serious forms of toxicity that are associated with CAR T cells. Read More
HONG KONG – China's contract drugmaking giant, Wuxi Biologics Inc., of Wuxi city, is actively expanding its global footprint, announcing plans to work with its Canadian partner on a brain cancer drug and opening its 10th global manufacturing facility in Singapore. Read More
Stellar Biotechnologies Inc., of Los Angeles, said certain holders of its common share purchase warrants have agreed to exercise and purchase 1.12 million shares of its common shares at $2.65 each. Read More
Contravir Pharmaceuticals Inc., of Edison, N.J., disclosed a reverse split of its common stock, $0.0001 par value, at a ratio of 1-for-8, effective Friday. Read More
Biomarin Pharmaceutical Inc. plans to launch Palynziq (pegvaliase-pqpz, previously Peg-Pal and BMN-165), granted full approval by the FDA late Thursday to treat adults with phenylketonuria (PKU), in late June. The San Rafael, Calif.-based company will take what Jeff Ajer, executive vice president and chief commercial officer, described on the company's conference call as a "deliberate and measured approach to titrating patients starting Palynziq to ensure that they remain on therapy and reach their effective maintenance dose." Read More
