4:08 PM Aug 10, 2018

Takeda gets Ambys-tious

After a two-year search, Takeda Pharmaceutical Co. Ltd.’s equity investment and option deal with newco Ambys Medicines finally gets the ball rolling on the pharma’s goal of building a liver...

3:29 PM Aug 10, 2018

A new diagnosis

FDA has given up on the idea that diagnostic tests can be shoehorned into the medical device regulatory paradigm, and has asked Congress to create a new framework for oversight.

8:00 PM Aug 09, 2018

Getting to function

A new target for sarcopenia that increases muscle function directly, in addition to adding muscle mass, could help address calls from patients and regulators to make functional recovery central to...

6:37 PM Aug 09, 2018

Super-sized ambitions

A trend toward super-sized initial financings is attracting a new set of deep-pocketed investors to the early stage space. These new players are making earlier commitments with hopes of...

2:59 PM Aug 07, 2018

Navigating the Hot Topics landscape

Investors are making aggressive bets on the ability of early stage companies to deliver on the next generation of therapeutics and technologies. But advances in biology and novel technologies come...

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Latest News

3:35 PM Aug 14, 2018

CVS to launch ICER-restricted formulary

CVS Health Corp. (NYSE:CVS) plans to offer a new formulary restricted to drugs deemed cost-effective by...

3:04 PM Aug 14, 2018

Management tracks: Cheng departing Gilead as CMO

Gilead Sciences Inc. (NASDAQ:GILD) said CMO Andrew Cheng will leave the company, effective Sept. 7, after...

2:05 PM Aug 14, 2018

Loncar's China biopharma fund to list on NASDAQ Wednesday

The Loncar China BioPharma ETF (NASDAQ:CHNA) is scheduled to begin trading on NASDAQ on Wednesday.

10:32 AM Aug 14, 2018

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for...

7:02 AM Aug 14, 2018

Juvenescence, partners form anti-aging biotech

Juvenescence Ltd. (Douglas, Isle of Man), Insilico Medicine Inc. (Baltimore, Md.) and the Buck Institute...

4:04 PM Aug 13, 2018

Trump signs expanded CFIUS jurisdiction into law

President Donald Trump signed into law Monday the Foreign Investment Risk Review Modernization Act (...

2:03 PM Aug 13, 2018

Management tracks: FDA, Allergan

Patrick Frey will depart as chief of staff in FDA’s Office of New Drugs (OND) on Aug. 24 to become...

1:50 PM Aug 13, 2018

Mustang licenses immunodeficiency gene therapy from St. Jude

Mustang Bio Inc. (NASDAQ:MBIO) gained exclusive, worldwide rights to develop and commercialize an ex vivo...

1:46 PM Aug 13, 2018

Polygenic scores increase disease risk prediction

Two studies in Nature Genetics suggest that aggregating SNPs, instead of assessing single SNPs, to...

12:53 PM Aug 13, 2018

Amicus prices Galafold at $315k per year

Amicus Therapeutics Inc. (NASDAQ:FOLD) said Monday that it will price Galafold migalastat at $315,000 per...

12:22 PM Aug 13, 2018

Crossover investors join Orchard's syndicate in $150M series C

Gene therapy company Orchard Therapeutics Ltd. (London, U.K.) raised $150 million in a series C round led...

11:22 AM Aug 13, 2018

NICE draft guidance recommends against Spinraza for SMA

U.K.’s NICE published draft guidance recommending against the use of Spinraza nusinersen from Biogen...

9:46 AM Aug 13, 2018

Priority Review for Stemline's blood cancer therapy

Stemline Therapeutics Inc. (NASDAQ:STML) said FDA accepted and granted Priority Review to its BLA for...

9:45 AM Aug 13, 2018

Delay for Regeneron’s 12-week Eylea regimen

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA issued a complete response letter to an sBLA for an...

3:03 AM Aug 13, 2018

MD Anderson launches neuroscience newco with $31M series A

The University of Texas MD Anderson Cancer Center and Accelerator Life Science Partners (Seattle, Wash.)...

3:49 PM Aug 10, 2018

New approach could identify Ras-blocking small molecules

With an eye on historically undruggable cancer target Ras, a University of Oxford team and colleagues...

2:27 PM Aug 10, 2018

Astellas acquires ophthalmic company Quethera

Astellas Pharma Inc. (Tokyo:4503) acquired ophthalmic gene therapy company Quethera Ltd. (Cambridge, U.K.)...

1:35 PM Aug 10, 2018

Amicus' Galafold wins accelerated approval from FDA

FDA granted accelerated approval to Galafold migalastat from Amicus Therapeutics Inc. (NASDAQ:FOLD) to...

12:56 PM Aug 10, 2018

Management tracks: Oncopeptides, Merz

Cancer company Oncopeptides AB (SSE:ONCO) said CFO Birgitta Ståhl has stepped down. She is succeeded by...

11:37 AM Aug 10, 2018

RegenxBio raises $175.5M follow-on

RegenxBio Inc. (NASDAQ:RGNX) raised $175.5 million through the sale of 2.7 million shares at $65 in a...

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