The development program for Sage Therapeutics Inc.'s brexanolone for the treatment of postpartum depression (PPD) received a ringing endorsement during a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM). Voting 18-0 with no abstentions, members indicated that Sage presented "substantial evidence" to support effectiveness of the type A gamma-aminobutyric acid (GABAA) receptor modulator in the indication, which has no approved medications. Read More
DUBLIN – Shares in Bioarctic AB rose 15 percent Friday following Abbvie Inc.'s decision to exercise an option on its preclinical alpha-synuclein antibody program, triggering a $50 million payment to the Stockholm-based biotech firm. Read More
Researchers at the Dana-Farber Cancer Institute and the Swiss Friedrich Miescher Institute have developed a method to find compounds that will induce the degradation of zinc fingers, which collectively are thought to comprise the single largest group of transcription factors in the human proteome. Read More
Tesaro Inc., of Waltham, Mass., reported net product revenue of $63.6 million for the third quarter, compared to a total of $41.8 million for the third quarter of 2017. Net revenue from PARP inhibitor Zejula (niraparib) increased 61 percent to $63.2 million, compared to $39.4 million for the third quarter of 2017. Read More
Adverum Biotechnologies Inc. is quitting development of a phase I/II gene therapy for alpha-1 antitrypsin deficiency (A1ATD) and abandoning plans to submit an investigational new drug application for another candidate employing the same capsid after the A1AT trial failed to show clinically meaningful protein expression. Company shares (NASDAQ:ADVM) fell $1.21, or 26.6 percent, to $3.34 on Friday. Read More
Hawaii Biotech Inc., of Honolulu, was awarded a contract from the National Institute of Allergy and Infectious Diseases to develop an anti-toxin drug for anthrax. The five-year contract is worth $38.5 million if all options are awarded. Read More
On the regulatory front Friday, one pain drug company, Trevena Inc., lost and another, Acelrx Pharmaceuticals Inc., won, as the FDA – just for good measure – also cleared a biosimilar product from Coherus Biosciences Inc. in a busy afternoon of notifications. Read More
Regardless of the outcome of the U.S. midterm elections Tuesday, the biggest change for the congressional committees dealing with health care issues could well be the retirement of Sen. Orrin Hatch (R-Utah). Read More
The FDA has issued a draft guidance to help sponsors involved in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from initial IND through to NDA/BLA and subsequent postmarketing phases. Read More
Curetis AG, Holzgerlingen, Germany, said it plans to offer up to 7.42 million newly issued ordinary shares in the range of €2 to €2.60 ($2.28 to $2.96). The offer price and the exact number of shares will be determined after the end of the offer period on the basis of the results of the book-building process. The company expects to raise gross proceeds in the range of approximately €14.2 million to €18.4 million. Read More
LONDON – Omeicos Therapeutics GmbH is making plans for the first patient trial of its small-molecule therapy for atrial fibrillation (AF), after closing a €17 million (US$19.4 million) series C round. Read More
Market corrections are always scary when they happen but, fortunately, they don't come around too often. The previous meltdown for biopharmaceutical equities was back in February 2016. This time around, the BioWorld Biopharmaceutical index experienced a dramatic drop of 10 percent in October, with the BioWorld Drug Developers index suffering an almost 19 percent swoon. A late market rally did help stop the bleeding but by then the damage had been done, leaving investors to lick their wounds and the sector to face an uphill battle to recover its losses before the close of the year. Read More
