9:17 PM Oct 12, 2018

Trevena goes for MOR than morphine

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee meeting on pain candidate oliceridine from Trevena Inc. gave the agency little reason to reverse its skepticism about the...

8:01 PM Oct 12, 2018

COI failure fallout

Jose Baselga resigned as CMO of Memorial Sloan Kettering Cancer Center after being accused of failing to disclose conflicts of interest, upsetting a hornet’s nest on his way out the door that is...

6:55 PM Oct 12, 2018

Bourla’s breadcrumbs to value

Incoming CEO Albert Bourla has spent only a few of his 25 years at Pfizer Inc. in the pharma’s innovative drugs business, but there are signs he already has laid the groundwork for innovating...

6:51 PM Oct 11, 2018

Adult path for mitochondrial gene editing

Two parallel studies show gene editing can target mutant mitochondria in adult mice, providing an alternative path for drug developers to the controversial approach of modifying embryos.

3:14 PM Oct 11, 2018

Border security for China’s genomes

China’s policies on sharing genomic data have so far produced cumbersome but manageable hurdles for cross-border clinical trials and translational research. But the explosive growth of its...

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Latest News

10:31 PM Oct 15, 2018

Pharnext planning U.S., EU submissions for Charcot-Marie-Tooth therapy on Phase III data

Pharnext S.A. (Euronext:ALPHA) plans to submit regulatory applications to FDA and EMA in 2H19 for PXT3003...

4:48 PM Oct 15, 2018

Management Tracks: Rhythm, Redpin

Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) hired Murray Stewart as CMO of the metabolic disorder company....

4:20 PM Oct 15, 2018

ICER weighing issuing advice on trial design

The Institute for Clinical and Economic Review is evaluating whether to collaborate earlier than it now...

3:10 PM Oct 15, 2018

FDA guides on minimal residual disease endpoint in hematologic cancer trials

FDA Commissioner Scott Gottlieb highlighted minimal residual disease (MRD)'s potential as a surrogate...

2:19 PM Oct 15, 2018

mAb blocks fibrin's inflammation without clotting interference to treat MS, Alzheimer's

Gladstone Institutes researchers developed a mAb that could help treat neurodegenerative and autoimmune...

1:49 PM Oct 15, 2018

Krystal gains on early data for topical gene therapy in skin blistering disease

Krystal Biotech Inc. (NASDAQ:KRYS) added $4.32 (28%) to $20 on Monday when it reported interim data from...

12:33 PM Oct 15, 2018

CMS, PhRMA release dueling plans on price disclosures in ads

The Trump administration released a proposed regulation that would mandate disclosure of prices in DTC...

10:34 AM Oct 15, 2018

New CEO Forster eyes capital raise for F-star

Immuno-oncology company F-star Biotechnology Ltd. (Cambridge, U.K.) named Eliot Forster as CEO, replacing...

7:41 AM Oct 15, 2018

SQZ, Roche expand deal to jointly develop cancer cell therapies

SQZ Biotechnologies Co. (Watertown, Mass.) and Roche (SIX:ROG; OTCQX:RHHBY) expanded a 2015 deal to co-...

3:26 PM Oct 12, 2018

Biotech stocks ride tech rally

Biotech indexes ended the week on a positive note but it wasn’t enough to salvage the week.

3:20 PM Oct 12, 2018

FDA panel votes in favor of AcelRx's pain candidate

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile...

3:04 PM Oct 12, 2018

Opdivo misses survival endpoint in Phase III for SCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Opdivo nivolumab missed the primary endpoint of improving overall...

2:00 PM Oct 12, 2018

Gene editing creates offspring from same-sex parents

Chinese researchers showed it may be possible to create viable offspring from same-sex parents, pushing...

1:53 PM Oct 12, 2018

iPS cell-derived models offer new opportunities for drug screening

New models for Down syndrome and amyotrophic lateral sclerosis harness patient-derived induced pluripotent...

1:47 PM Oct 12, 2018

Iovance raises $219M for Phase II trials

Iovance Biotherapeutics (NASDAQ:IOVA) raised $219.3 million in a follow-on Friday to fund five ongoing...

5:15 AM Oct 12, 2018

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis...

3:05 PM Oct 11, 2018

Advisory panel narrowly rejects oliceridine for acute pain

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval...

2:53 PM Oct 11, 2018

Inter Partes Review to be more favorable to biotech

The U.S. Patent and Trademark Office (PTO) finalized a rule requiring higher standards for invalidating...

1:07 PM Oct 11, 2018

Management tracks: Former Baxalta exec joins VisionGate; Carrick names Golumbeski chair

Cancer company VisionGate Inc. (Phoenix, Ariz.) hired John Glasspool as chief operating and strategy...

11:15 AM Oct 11, 2018

FDA lifts hold on IND for CRISPR's sickle cell trial

CRISPR Therapeutics AG (NASDAQ:CRSP) and partner Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said late...

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