An FDA advisory committee made history Thursday with its unconditional support for Spark Therapeutics Inc.’s Luxturna, which is on track to become the first gene therapy to be approved in the U.S. to treat an inherited disease.

DUBLIN – Virionhealth Ltd., a newly funded U.K. startup, raised up to £13 million (US$17 million) in series A funding to take forward a novel approach for preventing and treating respiratory viral infections, which relies on a long-recognized quirk of viral replication that has long been overlooked by the biotechnology industry.

LONDON – The U.K. is to move ahead with the creation of an advanced research program that will put in place large-scale infrastructures and carry out high-risk science needed to support development of entirely new industries in health care. The Health Advanced Research Programme (HARP) will form a central pillar of a new industrial strategy, designed to help life sciences prosper post-Brexit.

Spruce Biosciences Inc. landed a $20 million series A last year but kept the financing under wraps, waiting for its only asset, SPR-001, to achieve its first clinical milestone. With a phase II study now testing the small molecule in adults with congenital adrenal hyperplasia (CAH), the San Francisco-based company opted to shed a bit of light on its strategy.

Acelrx Pharmaceuticals Inc. CEO Vincent Angotti said he was “hesitant to put a timeline on this until we get further clarification from the FDA” regarding what’s required to satisfy the agency’s issues raised in a complete response letter (CRL) related to its NDA for 30-mg sublingual tablet Dsuvia (sufentanil), an opioid therapy that’s intended to reduce moderate to severe acute pain as well as dosing errors that can happen with intravenous administration.

The NIH and 11 big biopharma companies have agreed to contribute $215 million to fund a new five-year effort to facilitate systematic and uniform clinical testing of biomarkers to understanding mechanisms of response and resistance to cancer immunotherapy.

The FDA released a draft guidance on developing antiviral drugs for prophylaxis and treatment of respiratory syncytial virus (RSV) infection. The draft discusses nonclinical development, early phases of clinical development and phase III trial designs.

Vidac Pharma Ltd., of Jerusalem, reported data from a phase IIa trial testing VDA-1102 in patients with actinic keratosis (AK), an early form of cutaneous squamous cell carcinoma.

American Gene Technologies International Inc., of Rockville, Md., presented its approach for developing a functional cure for HIV infection at the Cell & Gene Meeting on the Mesa in La Jolla, Calif.

Immunogen Inc., of Waltham, Mass., closed its public offering of about 16.7 million shares, including 2.2 million shares sold to cover the underwriters’ full overallotment option, priced at $6.50 per share.