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Home » Newsletters » BioWorld

BioWorld

Sep. 5, 2019

View Archived Issues

Global drug supply chain jeopardized by unpredictable trade talks

BEIJING – China's position as a global power in active pharmaceutical ingredients (API) could be jeopardized by the ongoing and worsening trade war with the U.S. Perhaps more worrisome for the pharma industry, any disruption to Chinese supply chains could have a serious impact on drug manufacturing and accessibility globally. Read More

Gurnet confirms it: ADHD bid proving partner-worthy in $493M Kempharm deal

CEO Travis Mickle said prodrug-focused Kempharm Inc.'s potential $493 million deal with Gurnet Point Capital (GPC) marks "the end of a long journey to reach a very valuable point" in the story of the company, which has "ended with the same goal it started with" – gaining the best possible partner for attention deficit and hyperactivity disorder (ADHD) prospects KP-415 and KP-484. Read More

Nkarta closes oversubscribed series B financing, adds $114M for natural killer cell platform

Nkarta Therapeutics Inc.'s CEO, Paul Hastings, said while the clever spelling of the company's name puts its natural killer cell platform at the fore, he is also prompted more often than not to have to spell it out, just to make sure there's no mistake. Still, he added, the occasional hotel bill is sent to Encarta instead of Nkarta. Read More

Repare closes $83M series B round to fund clinical trials

DUBLIN – Repare Therapeutics Inc. raised $82.5 million in a series B round to progress its pipeline of precision oncology drugs that target vulnerabilities in cancer cells arising from combinations of synthetically lethal mutations. Read More

Immunotech becomes first T-cell immunotherapy specialist to seek pre-revenue listing on HKEX

BEIJING – Chinese T-cell immunotherapy specialist Immunotech Biopharm Ltd., of Beijing, has become the seventh pre-revenue biotech on the waiting list to go public on the Hong Kong Stock Exchange (HKEX). In an application filed this week, the specific amount was not disclosed, but company said much of the proceeds are expected to advance its lead candidate targeting liver cancer. Read More

With development slow, experts concerned about biosimilar pharmacovigilance

SAO PAULO, Brazil – Pharmacovigilance is emerging as a key concern for the development and distribution of biosimilars in Latin America. Experts gathered this week for the BIO Latin America conference focused on the issue and highlighted what they see as a key concern, one that is holding back the spread of that new class of drugs throughout the region. Read More

Other news to note

Applied Biomath Inc., of Concord, Mass., disclosed an agreement with Verseau Therapeutics Inc., of Bedford, Mass., for the delivery of systems pharmacology pharmacokinetic and target engagement analysis to provide early feasibility assessments for the treatment of cancer. Financial terms were not disclosed. Read More

Financings

Turning Point Therapeutics Inc., of San Diego, said it has filed a registration statement to conduct a proposed underwritten public offering of 4.5 million shares of common stock. The underwriters will be granted a 30-day option to purchase up to an additional 675,000 shares. Read More

Regulatory front

The FDA said it warned Stemell Inc., of San Juan Capistrano, Calif., and its president and CEO, Peyman Taeidi, for manufacturing and distributing the unapproved products StemL UCB-Plus and StemL UCT-Plus, derived from umbilical cord and umbilical cord blood, and for deviating from current good tissue practice and good manufacturing practice requirements, including deficient donor eligibility practices and environmental monitoring. Read More

Appointments and advancements

Reata Pharmaceuticals Inc., of Irving, Texas, appointed Manmeet S. Soni chief financial officer and executive vice president and Jason D. Wilson executive vice president of operations. Read More

Clinical data for Sept. 4, 2019

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Regulatory actions for Sept. 4, 2019

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As U.S.-China tensions curb biopharma investment, both sides could be victims

BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market. With the amount of Chinese money entering the U.S. biotech sector dropping sharply, many believe it is the U.S. that is taking the hit in this sector. Read More

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