22:35 , Aug 14, 2019 |  BC Extra  |  Company News

Patient access, antisense oligo key to Angelman deal for Ultragenyx

Ultragenyx's partnership and option deal with Angelman syndrome company GeneTX delivers two components key to success in the rare disease: a candidate that targets the root cause of the disease, and a direct link to...
23:45 , Jul 24, 2019 |  BC Extra  |  Company News

July 24 Company Quick Takes: Samsung's Humira biosimilar gets FDA approval; plus Intra-Cellular, Sage and more

FDA approves Samsung's Humira biosimilar  Samsung Bioepis Co. Ltd. (Incheon, South Korea) said FDA approved Hadlima adalimumab-bwwd, a biosimilar of autoimmune drug Humira from AbbVie Inc. (NYSE:ABBV). Samsung's partner Merck & Co. Inc. (NYSE:MRK) will...
22:53 , Jul 23, 2019 |  BC Extra  |  Clinical News

July 23 Clinical Quick Takes: Achillion plans U.S. IND; plus Chiasma, Myovant, Marinus and Merck

Achillion plans U.S. IND after latest readout for ACH-5228  Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) rose $1.19 (50%) to $3.57 since announcing early Monday that multiple ascending doses of its CFD inhibitor ACH-5228 led to 95% complement...
22:02 , Jun 28, 2019 |  BioCentury  |  Product Development

How small companies can leverage big changes in rare diseases

Small companies bring to the table a range of advantages over large ones when it comes to rare diseases, according to Ovid CEO Jeremy Levin. But he’s learned the hard way that it doesn’t help...
21:56 , Jun 28, 2019 |  BC Extra  |  Clinical News

June 28 Clinical Quick Takes: Imfinzi extends survival in Phase III SCLC study; plus LSK, Pfizer, FibroGen, Aclaris and more

AZ's Imfinzi shows survival benefit in Phase III for SCLC  AstraZeneca plc (LSE:AZN; NYSE:AZN) said an interim analysis of the Phase III CASPIAN trial showed Imfinzi plus etoposide and platinum-based chemotherapy met the primary endpoint...
20:49 , Apr 11, 2019 |  BC Week In Review  |  Clinical News

Cerevel's GABA A modulator reduces photosensitivity in epilepsy patients

After spinning out of Pfizer in October to develop the pharma's discontinued neuroscience pipeline, Cerevel plans to begin by year end another Phase II trial of CVL-865 in broader epilepsy populations. Cerevel Therapeutics LLC (Boston,...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
01:01 , Mar 30, 2019 |  BioCentury  |  Product Development

Sage broadens the spotlight on postpartum depression

Sage is parlaying the launch of the first drug for postpartum depression into improved awareness and diagnosis, setting up its next therapy to launch into a larger, better prepared market. On March 19, FDA approved...
22:00 , Mar 19, 2019 |  BC Extra  |  Company News

FDA approves Sage's postpartum depression therapy

Sage gained FDA approval for Zulresso brexanolone Tuesday, making it the first drug specifically indicated to treat postpartum depression. Sage Therapeutics Inc. (NASDAQ:SAGE) told BioCentury the average course of therapy will cost $34,000 per patient....
20:09 , Mar 1, 2019 |  BC Week In Review  |  Financial News

Sage raises $575M in follow-on

Weeks ahead of the PDUFA date for its antidepressant Zulresso brexanolone, Sage Therapeutics Inc. (NASDAQ:SAGE) raised $575 million in a follow-on. Including an overallotment priced Wednesday, the company sold 3.8 million shares at $150, a...