Shares of Israel-based Mediwound Ltd. (Nasdaq:MDWD) rose 11.6 percent to $4.89 Tuesday on news that Nexobrid, its EMA-approved enzyme for removing dead and damaged tissue, or eschar, in adults with thermal burns met the primary and secondary endpoints of a U.S.-based pivotal phase III trial. Jeremy Goverman, a Harvard Medical School professor and principal investigator for the study, said that, among other benefits, the product might help him and other doctors forgo use of the foot-long razor blade sometimes used to remove burnt skin layer by layer in surgical excision. Read More
LONDON - The U.K. Bioindustry Association (BIA) has joined with industry leaders across other sectors to call on the government to rule out a no-deal Brexit, after the withdrawal agreement that Prime Minister Theresa May spent two years negotiating with the EU was voted down last week. Read More
HONG KONG – Founded only last year, Boston-Shanghai clinical-stage biotech startup Anji Pharmaceuticals Inc. is using its team's ties to big pharma to bring in valuable assets to be developed for indications suffered by Chinese patients, especially metabolic diseases. Most recently, it in-licensed Novartis AG's pradigastat, an inhibitor of acyl coA: diacylglycerol acyl transferase, or DGAT1, which has progressed to phase III testing in familial chylomicronemia syndrome (FCS). Read More
Wren Therapeutics Ltd. chirped about its £18 million (US$23.3 million) series A round, raised from an international syndicate led by the Baupost Group with participation from Lifeforce Capital and high net worth individuals. The Cambridge, U.K.-based company, a 2016 spinout from the University of Cambridge and Sweden's Lund University, declined to warble about the details, but Wren is known to be focused on protein misfolding diseases – a broad development area where it has its pick of some four dozen indications. Read More
It didn't take long for the U.S. Supreme Court to sort out a grammar issue and decide that the America Invents Act (AIA) did not disrupt nearly 200 years of precedent with its addition of five words to the "on-sale" bar for patents. Read More
NEW DELHI, India - Princeton, N.J.-based Vyome Therapeutics Inc., which specializes in medicines for treating skin diseases caused by resistant microbes, has announced a $22 million financing for the phase IIb trial of its lead molecule, VB-1953, for treatment of moderate to severe acne. Read More
LONDON - Achilles Therapeutics Ltd. has won approval for a clinical trial of a new form of autologous T-cell therapy that does not require any genetic manipulation of a patient's cells in order for them to induce an immune response against a tumor. Read More
PERTH, Australia – Like many Aussie companies, Invion Ltd. started out with some assets that it had a difficult time progressing forward, and it ended up remaking itself into a completely different company with new assets. Now, Melbourne-headquartered Invion plans to enter the clinic early this year with a photosensitizer therapy to treat melanoma. Read More
The FDA issued a final guidance Tuesday on labeling for drugs and biologics approved on the accelerated approval path. The guidance is intended to help sponsors develop the Indications and Usage section of labeling for products that were approved on the basis of a surrogate endpoint or a clinical endpoint other than survival or irreversible morbidity. Read More
Outlook Therapeutics Inc., of Cranbury, N.J., lowered the exercise price of its series A warrants from $6.60 per share to $1.50 per share and extended the maturity from Feb. 18, 2019, to Feb. 18, 2022. Read More
Gamida Cell Ltd., of Boston, and Minneapolis-based Be The Match Biotherapies, a subsidiary of the National Marrow Donor Program/Be The Match, are collaborating on the ongoing development of Gamida's cell therapy, Nicord. Be The Match Biotherapies will provide research assets and services, including access to its Be The Match Registry. Read More
