DUBLIN – With the clock ticking on the April 30 PDUFA date for its Contepo (fosfomycin) NDA, Nabriva Therapeutics plc disclosed late Tuesday that the FDA had slapped a complete response letter (CRL) on the file, citing manufacturing deficiencies at one of its contract manufacturers. The Dublin-based antibiotic developer stressed that the agency was not seeking any additional clinical data and had not raised any new safety concerns about fosfomycin, but investors were less than impressed with the inevitable delay to a U.S. launch of the drug, which is in development for treating complicated urinary tract infection (cUTI). Shares in Nabriva (NASDAQ:NBRV) plunged by as much as 42.5% during premarket trading Wednesday before closing down 27.4% at $2.17. Read More
Saying he was "extraordinarily disappointed" by the complete response letter (CRL) from the FDA regarding HTX-011, Heron Therapeutics Inc. CEO Barry Quart called it "very discouraging" that the agency's objections could have been raised earlier during talks but were not. Read More
Vertex Pharmaceutical Inc. stood tall Tuesday as it announced first-quarter numbers that vaulted the company from a strong 2018 to an even more powerful new year as the top-line grew and the pipeline firmed up. Read More
LONDON – The clamp-down on Chinese investment in U.S. technology companies is prompting investors to look elsewhere, with European biotech startups emerging as one of the beneficiaries. Read More
The U.S. Trade Representative's (USTR) 2019 Special 301 Report shows some progress is being made, but a lot of work remains to be done to end the global free-loading as the U.S. continues to pick up the lion's share of the cost of innovation in the drug and device sectors. Read More
HONG KONG – The Korean government plans to invest KRW2.93 trillion (US$2.52 billion) this year to give the biomedical and pharmaceutical industries, as well as medical technologies a boost, according to the Ministry of Science and ICT (Information & Communications Technology). The most significant investments are likely to go toward bioscience and medicine, which will account for 54% and 18% of the budget, respectively. Read More
PERTH, Australia – Drug safety advisories around the globe are often inconsistent, and Australia's Therapeutic Goods Administration (TGA) is one of the most inconsistent compared to its peers, according to a review of drug regulators in Australia, Canada, the U.K. and the U.S. over the last decade. Read More
United Therapeutics Corp., of Silver Spring, Md., reported that first-quarter revenues decreased by $26.6 million, or 7%, to $362.6 million compared to the same period in 2018. Read More
Brink Biologics Inc., of San Diego, an affiliate of Nantkwest Inc., nonexclusively licensed its bioanalytical testing solution that uses Nantkwest's NK-92 natural killer cells to Worcester Polytechnic Institute. Terms of the deal weren't disclosed. Read More
US Worldmeds LLC, of Louisville, Ky., agreed to pay $17.5 million to resolve U.S. Department of Justice (DoJ) allegations that it violated the False Claims Act by paying kickbacks to patients and doctors to induce prescriptions of its drugs, Apokyn (apomorphine) and Myobloc (rimabotulinumtoxin B). Read More
Translate Bio Inc., of Lexington, Mass., said it agreed to a private placement by institutional accredited investors of approximately 5.6 million common shares priced at $8.50 apiece for expected gross proceeds of $47.5 million. Read More
Repare Therapeutics Inc., of Montreal, appointed Maria Koehler executive vice president and chief medical officer, Katina Dorton executive vice president and chief financial officer and Carol Schafer to its board. Read More
