A lack of 12-month endometrial safety data led to the FDA's rejection of an NDA filed by Therapeuticsmd Inc. for Yuvvexy, an investigational treatment of moderate to severe vaginal pain during sex. The complete response letter (CRL) for the 505(b)(2) application arrived on the heels of the regulator alerting the company to an unspecified deficiency in its application last month. Read More

LONDON – Exscientia Ltd. has moved its artificial intelligence-based drug discovery to a new level with a $275 million-per-compound deal to generate bispecific small molecules against metabolic diseases for Sanofi SA. Read More

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., reported net U.S. sales of constipation drug Linzess (linaclotide), as provided by partner Dublin-based Allergan plc, totaling $147.6 million for the first quarter, up 8 percent over the same period in 2016. Read More

Aptose Biosciences Inc., of Toronto, reported preclinical data demonstrating that CG-806, a highly potent pan-FLT3/BTK inhibitor, exerts compelling activity against acute myeloid leukemia (AML) cells harboring mutant forms of FLT3 and eradicates AML tumors in a murine xenograft model. Read More

Norgine BV, of Amsterdam, presented post-hoc analyses from the phase III DAYB and MORA studies that demonstrate the high-quality cleansing efficacy of Plenvu, a low-volume, 1-liter PEG and ascorbate bowel preparation, when compared to sodium picosulfate with magnesium citrate and 2-liter PEG with ascorbate (Moviprep), respectively, when using site colonoscopist assessments. Read More

The EMA and the European Commission published a biosimilars information guide to give health care professionals reference information on the science and regulation underpinning the follow-ons. Read More

The FDA has joined Japanese and South Korean regulators in approving edaravone, an intravenously administered antioxidant free radical scavenger, for treating amyotrophic lateral sclerosis (ALS), with its late Friday approval coming more than a month ahead of the PDUFA date. Read More

HONG KONG – Novartis AG's South Korean branch faces a double whammy of hefty fines and suspension of state insurance reimbursement on its products. Read More

WASHINGTON – Combination products have proved nettlesome for the FDA. Despite that recent legislation seemed to tackle several major headaches, two speakers at the Food and Drug Law Institute annual meeting said questions persist, including the issue of how a combo product's primary mode of action will be determined by the FDA. Read More

Durect Corp., of Cupertino, Calif., said it entered a development and commercialization agreement with Sandoz AG, a division of Novartis AG, of Basel, Switzerland, to develop and market in the U.S. Read More

Australian scientists at the University of Queensland (UQ) have discovered a new type of lymphatic brain "scavenger" cell in zebrafish, which may provide protection from stroke and dementias such as Alzheimer's disease and have important implications for drug development. Read More

CHICAGO – Drug-induced liver injury, or DILI, doesn't affect a large number of patients on drug therapy, but in clinical practice it disproportionately impedes patient care. When elevated liver enzymes are detected, treating physicians must consider whether DILI is implicated and, if so, which drug is involved, often forcing them to discontinue multiple medications while they investigate the cause. Read More

Lamellar Biomedical, of Bellshill, Scotland, raised £5.75 million (US$7.4 million) in a series C equity funding round. The financing was led by Invesco Asset Management Ltd. acting as agent for its clients and supported by the Scottish Investment Bank, the investment arm of Scottish Enterprise, both current investors in Lamellar. Read More