LONDON – The biotech and pharma industry across Europe has put its combined firepower behind a new lobbying offensive to keep Europe's medicines regulatory system intact after the U.K. leaves the EU. Read More

Congress rarely scores a bipartisan win these days, so it was with some relish that the House of Representatives gaveled down on a voice vote on H.R. 2430, the bill that reauthorizes the FDA user fee programs for the next five years. Read More

Topping off a series A round that began in the summer of 2015 with $55 million, E-Scape Bio Inc. raised $63 million in total that CEO Leon Chen told BioWorld should carry the firm into proof-of-concept work that takes aim at the apolipoprotein E4 (ApoE4) protein structure in Alzheimer's disease (AD). Read More

As promised last year during its merger with Scivac Therapeutics Inc., VBI Vaccines Inc. is seeking to move Sci-B-Vac, a third-generation hepatitis B virus (HBV) vaccine licensed in Israel and 14 other countries, onto the world stage. After gathering input from the FDA, EMA and Health Canada, the Cambridge, Mass.-based company is preparing to conduct a 15-month phase III program that will include two concurrent studies – the safety and immunogenicity PROTECT study and lot-to-lot consistency CONSTANT study – with combined enrollment of approximately 4,800 participants across some 40 sites in the U.S., Europe and Canada. Read More

A hearing in the U.S. House of Representatives dealing with FDA regulation of commercial speech highlighted the partisan nature of this issue, but the Republican majority in the House and the FDA's inability to come to terms with the First Amendment suggest that support for the two bills in question will continue to build, particularly given that patient advocates at the hearing had few kind words for the legal and regulatory status quo. Read More

A new way of analyzing computerized tomography (CT) angiography, the standard method for imaging blood vessels to look for potential blockages, could help find future trouble spots before they are causing trouble. Read More

Egalet Corp., of Wayne, Pa., said it closed its underwritten public offering of 16.66 million shares of its common stock and accompanying warrants to purchase up to 16.66 million shares, at a combined public offering price of $1.80 per share and accompanying warrant. The gross proceeds are expected to be approximately $30 million. The company anticipates using the net proceeds to support its commercial sales and marketing efforts for Arymo ER (morphine sulfate) extended-release tablets for oral use - CII, Sprix (ketorolac tromethamine) nasal spray and Oxaydo (oxycodone HCI, USP) tablets for oral use only CII, and for general corporate purposes. Cantor Fitzgerald & Co. acted as the sole book-running manager. Read More

Applied Immunotherapeutics Inc., of Morris, Conn., and The Feinstein Institute for Medical Research at Northwell Health inked a deal in which Applied licensed discoveries in treating inflammation, as well as specific antibodies and drug candidates. Included in the agreement are patent rights covering the use of antibody and small-molecule therapeutics against HMGB1, an established target in inflammatory and autoimmune diseases. Terms were not disclosed. Read More

The Human Capital Management Coalition petitioned the U.S. SEC to adopt new rules or amend existing ones to require public companies to disclose information about their human capital management policies, practices and performance. The global coalition, which is composed of institutional investors with $2.8 trillion in assets, said effective human capital management is "essential to long-term value creation and therefore material to evaluating a company's prospects." The group cited several categories of information it considers fundamental to improving investors' understanding of how well a company is managing its human capital. The categories include workforce demographics, stability, composition, skills and capabilities, culture and empowerment, health and safety, productivity, and compensation and incentives. Read More

Asterias Biotherapeutics Inc., of Fremont, Calif., said it completed dosing of the third cohort in its ongoing SCiStar phase I/IIa trial testing the dose of 10 million AST-OPC1 cells in five patients with AIS-B grade spinal cord injury. Asterias expects to report top-line six-month data from that cohort in January 2018. A cohort of AIS-A patients dosed with the 20 million cells is currently being enrolled and the final cohort of AIS-B patients to receive 20 million AST-OPC1 cells will begin enrollment later this quarter. Read More