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Home » Newsletters » BioWorld

BioWorld

May 2, 2019

View Archived Issues

Delay for fosfomycin; Nabriva slips on CRL as FDA cites manufacturing issues

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

FDA hits Heron with great blue CRL in surprise last-hour move

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 flexes Symdeko to produce strong first-quarter 2019 numbers

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

European industry raking in benefits as U.S./China trade skirmish continues

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

USTR calls out 36 trade partners, but what about Malaysia?

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

Building on 2018 successes, Korea's $2.52B investment to boost biomed, pharma sectors

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

Australia's TGA appears lax when it comes to drug warnings compared to regulatory peers

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

Earnings

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

Other news to note

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

Regulatory front

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

Financings

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

Appointments and advancements

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

Clinical data for May 1, 2019

Read More

Regulatory actions for May 1, 2019

Read More

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