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Home » Newsletters » BioWorld

BioWorld

April 25, 2019

View Archived Issues

Can market forces correct the course? Or is it time to explore a new approach?

In a race against time, Congress is determined to do something this year to counter the gravitational forces at work in the U.S. prescription drug market. Leaders from both parties and in both the House and the Senate have vowed to heed their constituents' call to do something about high drug prices – before the nation is thrust into the abyss of the 2020 presidential election season.  Read More

Abbvie psoriasis drug Skyrizi wins FDA approval

Abbvie Inc.'s Skyrizi (risankizumab), a medicine for adults with moderate to severe plaque psoriasis, won FDA approval and is expected to be available in the U.S. in early May, the company said. Abbvie paid Boehringer Ingelheim GmbH (BI) $595 million up front for rights to the anti-IL-23 therapy and another asset in 2016 while promising further significant milestone and royalty payments to come for the German company. Read More

Post-Alzheimer's trial fallout puts damper on Biogen's solid first-quarter earnings report

Despite a better than expected first-quarter earnings report, Biogen Inc.'s stock (NASDAQ:BIIB) continued its drift downward Wednesday as shares traded 2.5% lower at the close, ending the day at $224.40. Read More

Satsuma peels out, raising $62M in migraine series B; phase III plan takes shape

Satsuma Pharmaceuticals Inc. CEO John Kollins told BioWorld the migraine space may be in a stage of development similar to the depression therapeutic area before the advent of selective serotonin reuptake inhibitors, and his firm's dry-powder inhaled STS-101 (dihydroergotamine [DHE]) could help turn the corner in acute treatment of headaches. Read More

Chi-Med opts for 'home market' for third listing, files HKEX IPO

HONG KONG – Hong Kong-based cancer drugmaker Hutchison China Meditech Ltd. (Chi-Med) filed its third IPO, seeking a listing on the Hong Kong Exchange (HKEX) after getting listed on the AIM market of the London Stock Exchange and on Nasdaq. The HK IPO follows a major milestone for the company, which won regulatory approval in China for innovative cancer drug Elunate (fruquintinib) last year. Read More

Researchers develop reliable method to identify off-target effects of CRISPR gene editing

Therapeutics based on CRISPR genome editing started making their way into human trials about a year ago. However, until recently, scientists still had a limited ability to assess which unintended genome edits accompany the precision genomic cuts characteristic of CRISPR. Read More

Golden Meditech, HKBU to treat neurodegenerative diseases with stem cells

HONG KONG – Chinese integrated health care group Golden Meditech Holding Ltd. has partnered up with Hong Kong Baptist University (HKBU)'s biology department to conduct research in the area of cell therapy with an aim to treat neurodegenerative diseases with stem cells. Read More

Appointments and advancements

Logicbio Therapeutics Inc., of Cambridge, Mass., appointed Matthias Hebben vice president, technology development, Marie Payton vice president, clinical operations, Carol Sherako senior director, program management, Sven Loebrich director of process development and Lauren Drouin associate director, analytical development. Read More

Other news to note

Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., earned a $25 million milestone payment from Janssen Pharmaceuticals Inc., part of New Brunswick, N.J.-based Johnson & Johnson, upon the start of dosing in a triple-combination cohort that includes JNJ-3989 (formerly ARO-HBV) in patients with chronic hepatitis B virus. The companies inked the collaboration agreement last year. Read More

Financings

Nervgen Pharma Corp., of Vancouver, British Columbia, increased the amount of its nonbrokered private placement disclosed on March 14 from $500,000 to $740,000. The company now intends to issue 350,000 shares at $1 each (as before) and 300,000 shares at $1.30 each (new).  Read More

Regulatory front

The U.S. FDA Wednesday finalized its 2017 guidance on extending the expiration dates for doxycycline tablets and capsules held in state and local strategic stockpiles for use as a post-exposure prophylaxis or treatment of inhalational anthrax. The guidance applies to both doxycycline monohydrate and doxycycline hyclate tablets and capsules equivalent to 50 mg and 100 mg of doxycycline, the FDA said.  Read More

Clinical data for April 24, 2019

Read More

Regulatory actions for April 24, 2019

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