After the approval last week of Dynavax Technologies Corp.'s Heplisav-B hepatitis B virus (HBV) vaccine, backers are looking forward to the launch in the first quarter of next year and the meeting of the Advisory Committee on Immunization Practices (ACIP), which can vote to add the vaccine to its "preferred" list for easier coverage by payers. Read More

While there are important similarities, the U.S. Senate and the House of Representatives have taken different approaches to several matters in their respective tax reform proposals, including the tax credit for clinical studies of orphan drugs, which the Senate bill would cut substantially while the House bill would eliminate that tax credit altogether. Read More

Entera Bio Ltd., established in June 2010 as a joint venture of fellow Israeli firms DNA Biomedical Solutions and Oramed Pharmaceuticals Inc., is seeking to raise up to $50 million, including overallotments, in an IPO, with a listing on Nasdaq under the ticker ENTX. The Jerusalem-based firm is developing oral formulations of teriparatide (parathyroid hormone, or PTH, 1-34) to treat hypoparathyroidism (EB-612) and osteoporosis (EB-613). Oppenheimer & Co. is the sole bookrunner on the deal, which was not priced. Read More

The creation of a new microdevice that allows generation of three-dimensional (3-D) axonal structures from human stem cell-derived neurons should facilitate future studies on axon development and allow drug screening for diseases including amyotrophic lateral sclerosis (ALS), a new study has found. Read More

A nanotech-based brain implant with probes that are thinner than a human hair has been developed and tested by a coalition of scientists. Those researchers recently published in Nature about their work monitoring the brains of live rats and mice via the novel device, with silicon probes so tiny that insertion into a living brain causes very little damage. Read More

Sarepta Therapeutics Inc., of Cambridge, Mass., said the initial purchasers of its convertible senior unsecured notes that will mature on Nov. 15, 2024, have exercised their option to purchase an additional $95 million in notes, which is expected to close on Nov. 14, 2017. Read More

Amgen Inc., of Thousand Oaks, Calif., and Allergan plc, of Dublin, said the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of ABP-215, a biosimilar to Avastin (bevacizumab, Roche Holding AG). Read More

Topas Therapeutics GmbH, of Hamburg, Germany, named Rupert Sandbrink chief development officer and chief medical officer. Read More

Intelgenx Corp., of Saint-Laurent, Quebec, submitted a clinical trial application to Health Canada for approval to initiate its phase IIa proof-of-concept study with montelukast in mild to moderate Alzheimer's disease (AD). Read More

Fibroblasts are the major cell type that is responsible for wound healing, as they migrate to the sites of injuries and secrete extracellular matrix molecules that physically allow repair of damaged tissue. Read More