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BioWorld - Monday, February 23, 2026
Home » Newsletters » BioWorld

BioWorld

June 25, 2019

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Vyleesi does it: Sales risk tempers HSDD drug hoopla, Amag launch due this fall

With the FDA go-ahead for Vyleesi (bremelanotide) in generalized hypoactive sexual desire disorder (HSDD), Amag Pharmaceuticals Inc.'s comparison of prospects for the compound to those of depression drugs in an earlier time gained more scrutiny, as Wall Street continued trying to guess revenues due from the auto-injectable melanocortin receptor agonist. Read More

Minerva's phase IIb MIN-202 data for insomnia wakes company stock

Minerva Neurosciences Inc.'s phase IIb trial of seltorexant (MIN-202) for insomnia disorder hit its primary endpoint and a secondary endpoint, giving the company stock (NASDAQ:NERV) a 40.2% lift Monday, helping to heal the damage from the past year. Read More

Krystal RDEB gene therapy shines in midstage GEM-2 study

New clinical data on Krystal Biotech Inc.'s investigational gene therapy for dystrophic epidermolysis bullosa (DEB), KB-103, found five of six wounds treated with the topical candidate closed completely during a phase II trial and, along with wounds investigators treated in phase I, have stayed closed so far.  Read More

Post Keytruda royalty sale, Lifearc commits $30M to U.K. antibody firm Kymab

LONDON – Fresh from the $1.3 billion sale of its royalty stake in Keytruda (pembrolizumab), the research charity Lifearc is starting to put the money to work, announcing it will invest $30 million in antibody specialist Kymab Group Ltd.  Read More

China's new stock market to boost investment in domestic biotech firms

HONG KONG – Aiming to accelerate investment in China's science and technology ventures, Shanghai Stock Exchange officially opened a new market earlier this month. The Science and Technology Innovation Board (STIB) launched the Sci-Tech Innovation Board (STAR) to list Chinese companies with high potential, namely tech unicorns from emerging sectors such as biomedicine, AI, IT, advanced equipment, new materials and energy. Read More

CBD-based antibiotic vanquishes gram-positive bugs in early test

SAN FRANCISCO – New research presented at the annual meeting of the American Society of Microbiology has shown that pure cannabidiol (CBD), the main nonpsychoactive chemical compound of cannabis and hemp, can rapidly kill gram-positive bacteria.  Read More

For lower drug prices, something better than outrage

Cutting pills in half is currently an act of desperation by those who can't afford the full amount their doctor has prescribed. But for some of the most expensive drugs on the market – cancer drugs – there are a number of drugs where cutting the dose by half, or by more, can result in treatment that is just as effective, and cuts financial toxicity and, possibly, other toxicity risks as well. Read More

IPI model for Medicare Part B drugs advances as critics pile on

A controversial Trump administration proposal aimed at lowering Medicare Part B drug prices by tying them to an international pricing index (IPI) took another step forward in the U.S. rulemaking process late last week as it advanced to the White House Office of Management and Budget for review. Read More

Other news to note

Noxxon Pharma NV, of Berlin, said an unnamed top 10 international pharmaceutical company has signed an agreement with Noxxon for the purpose of evaluating NOX-A12 (olaptesed pegol) in a new indication, which will remain undisclosed for competitive reasons.  Read More

Regulatory front

The FDA finalized its 2015 draft guidance outlining the requirements and recommendations for various types of submissions of promotional materials for prescription drugs and biological products.  Read More

Financings

Bioeclipse Therapeutics Inc., of South San Francisco, said it raised $7.7 million in its series A-1 financing round, which was led by Revelis Capital Group LLC, with participation from Tsingyuan Ventures, DEFTA Partners, TSVC (TEEC Angel Fund) and Plum Alley. Read More

Clinical data for June 24, 2019

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Regulatory actions for June 24, 2019

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