8:43 PM Dec 14, 2018

O’Day’s expansive task at Gilead

A fresh executive team and a track record of building deep portfolios could allow incoming Gilead Sciences Inc. chairman and CEO Daniel O’Day do what his predecessors couldn’t -- make Gilead a...

8:19 PM Dec 14, 2018

Extending Immunocore’s runway

The $100 million upfront payment from Immunocore Ltd.’s most recent deal with Roche's Genentech Inc. unit gives it enough cash to read out pivotal data from lead program IMCgp100, a catalyst...

5:34 PM Dec 14, 2018

FDA to facilitate access to unapproved drugs

FDA plans to launch a new program in 2019 that will help patients gain access to unapproved therapies. The agency will field telephone requests from physicians and patients, streamline the...

7:55 PM Dec 13, 2018

Gene therapy’s make or buy choice

Whether or not to bring manufacturing in house for gene therapy companies is becoming a critical choice, as contract manufacturers struggle to keep up with demand. The trade-off for the upfront...

6:02 PM Dec 13, 2018

Bigger sandbox for in silico tox

A consortium of companies and regulators could trigger a step change in how industry uses in silico toxicology to evaluate drug impurities and reduce the list of wet experiments required for...

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Latest News

4:06 PM Dec 14, 2018

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Friday to list on the Hong...

4:04 PM Dec 14, 2018

Firdapse re-catalyzes pricing debate

A decision by Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) to charge $375,000 a year for Firdapse...

4:04 PM Dec 14, 2018

J&J shares plummet following asbestos report

Johnson & Johnson (NYSE:JNJ) fell $14.84 (10%) to $133 on Friday, wiping out nearly $40 billion in...

4:02 PM Dec 14, 2018

BIO, PhRMA look to U.S.-Japan trade talks to shape pricing reforms

Forthcoming U.S-Japan trade negotiations could provide industry trade groups BIO and PhRMA a mechanism to...

3:39 PM Dec 14, 2018

FDA approves Celltrion's Herceptin biosimilar

FDA approved a BLA for Herceptin biosimilar Herzuma trastuzumab-pkrb from Celltrion Inc. (KOSDAQ:068270)...

3:37 PM Dec 14, 2018

Amgen pulls out of Advaxis immunotherapy deal

Advaxis Inc. (NASDAQ:ADXS) will continue to enroll patients in a Phase I trial of its ADXS-NEO program...

3:22 PM Dec 14, 2018

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi...

2:38 PM Dec 14, 2018

Idera down on melanoma response data

Idera Pharmaceuticals Inc. (NASDAQ:IDRA) lost $2.62 (40%) to $3.98 on Friday after reporting updated data...

1:36 PM Dec 14, 2018

FDA approves Shire's constipation drug

FDA approved Motegrity prucalopride from Shire plc (LSE:SHP; NASDAQ:SHPG) to treat chronic idiopathic...

1:30 PM Dec 14, 2018

More aboard for Amsterdam as EMA staffing outlook improves

More EMA staff may make the move to Amsterdam than the agency forecast this summer, but staff losses will...

1:28 PM Dec 14, 2018

Carter to fill Decicco's role until BMS finds new discovery head

With former head of discovery Carl Decicco gone, Bristol-Myers Squibb Co. (NYSE:BMY) will turn to Head of...

7:40 AM Dec 14, 2018

Kurma announces first close of €150 million Biofund III

Kurma Partners S.A. completed the first close of its third fund, Kurma Biofund III, which is targeting a...

3:44 PM Dec 13, 2018

NIH finds 'systematic' foreign theft of U.S. research due to lax disclosure rules

NIH's Foreign Influences on Research Integrity Working Group has identified specific instances of foreign...

3:34 PM Dec 13, 2018

Biogen returns gene therapies to AGTC on lack of clinical activity

Applied Genetic Technologies Corp. (NASDAQ:AGTC) said late Wednesday that Biogen Inc. (NASDAQ:BIIB)...

3:28 PM Dec 13, 2018

Senate bill could give HHS teeth to stop excessive drug price hikes

Democrat senators introduced a bill Thursday that would give HHS power to force drugmakers to pay back...

2:24 PM Dec 13, 2018

Management tracks: Ambys, Foghorn

Liver regenerative medicine company Ambys Medicines (Redwood City, Calif.) hired Jeff Jonker as president,...

11:58 AM Dec 13, 2018

U.S., Chinese academies planning meeting to set strict germline gene editing standards

The U.S. National Academy of Sciences, U.S. National Academy of Medicine and Chinese Academy of Sciences...

10:37 AM Dec 13, 2018

Biohaven nets $125M ahead of NDA submissions

Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHNV) raised $125 million late Wednesday through the sale...

9:47 AM Dec 13, 2018

Junshi IPO on deck in Hong Kong as WuXi AppTec shares debut

Shares of WuXi AppTec Co. Ltd. (Shanghai:603259; HKSE:2359) were unchanged in their first day of trading...

9:00 AM Dec 13, 2018

Mission Bio raises $30M series B to expand Tapestri’s reach

Precision genomics company Mission Bio Inc. (South San Francisco, Calif.) raised $30 million in an...

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