02:23 , May 18, 2019 |  BioCentury  |  Product Development

AAVs on the brink: Charting the clinical landscape of in vivo gene therapies

Gene therapy is finally teetering on the edge of becoming a drug development mainstay, with at least nine AAV-based therapies in Phase III or II/III testing. An analysis of the AAV therapies in the clinic...
19:24 , May 17, 2019 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
17:12 , May 17, 2019 |  BC Extra  |  Financial News

Tools4Patient raises €4M to refine, expand placebo response analytics

As it seeks to apply its placebo response measurement tool to new therapeutic areas beyond pain, Tools4Patient has tapped investors for a €4 million ($4.5 million) series B round. The company's Placebell technology uses an...
21:13 , May 16, 2019 |  BC Extra  |  Company News

May 16 Company Quick Takes: Iconic oncology deals; plus Zymeworks-GSK, Aimmune and more

Iconic in pair of deals to develop lead oncology program  Iconic Therapeutics Inc. (South San Francisco, Calif.) granted Exelixis Inc. (NASDAQ:EXEL) an option to license ICON-2 for $7.5 million up front and funding for preclinical...
17:34 , May 3, 2019 |  BC Extra  |  Financial News

With potential launches nearing, Zai taps investors for $200M

Eight months after raising $150 million in a follow-on, Zai has returned to the well to raise $200 million in an upsized offering as it prepares for a pair of potential launches in mainland China....
23:05 , May 2, 2019 |  BC Innovations  |  Translation in Brief

Public funding highlights

Public funding highlights Selected developments and initiatives in 1Q19 from major sources of public funding including National Institutes of Health (NIH), the U.K.’s Medical Research Council (MRC), the Innovative Medicines Initiative (IMI), the Canadian Institutes...
22:52 , May 2, 2019 |  BC Extra  |  Clinical News

May 2 Clinical Quick Takes: Biogen, GSK, Celgene/bluebird, Genkyotex

Biogen's ALS candidate reduces SOD1 protein levels in CSF  Biogen Inc. (NASDAQ:BIIB) will present on May 7 at the American Academy of Neurology meeting the interim Phase I/II data of tofersen that had prompted it...
21:52 , May 1, 2019 |  BC Extra  |  Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
23:07 , Apr 29, 2019 |  BC Extra  |  Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

Takeda considering value-based pricing in EU  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) is mulling employing a value-based pricing model in Europe for Alofisel darvadstrocel, a stem cell therapy to treat complex perianal fistulas in patients...
22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...