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A flop in PhIII, spurned by the FDA, but NICE recommends PTC’s Duchenne drug

Trendfiercebiotech2016-04-18 09:56 Read   59

PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna (ataluren) failed a pivotal Phase III and recently was spurned by the FDA, which refused to even consider the biotech’s application after regulators concluded that the company couldn’t make a case on efficacy. 

Q1 '16: Venture cash is still pouring into U.S. biotechs

Trendfiercebiotech2016-04-18 09:13 Read   59

Even as share prices and biotech valuations wilted under the glare of a savage bear market during the first quarter of the year, venture capital groups showed no signs of slowing down from last year’s torrid pace.

April 12, 2016 03:05 AM Eastern Daylight Time

Trendbusinesswire2016-04-18 08:56 Read   67

Symphogen, announced today dosing of the first patient in its Sym015 program.

Merck Provides Update on Filing Plans for Omarigliptin, an Investigational DPP-4 Inhibitor for Type 2 Diabetes

Trendmercknewsroom2016-04-15 09:47 Read   380

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company will not proceed with submitting marketing applications for omarigliptin, an investigational, once-weekly DPP-4 inhibitor, in the United States or Europe.

Synta and Madrigal Announce Merger Agreement to Create Leading Cardiovascular-Metabolic Diseases and NASH Company

Trendbusinesswire2016-04-15 09:32 Read   77

“Following an extensive review of strategic alternatives, Synta’s Board of Directors believes that a merger with Madrigal Pharmaceuticals offers shareholders the most compelling opportunity for enhancing long-term value”

Nabriva Initiates Second Phase 3 Clinical Trial of Lefamulin (“LEAP 2”) in Patients with Community-Acquired Bacterial Pneumonia (CABP)

Trendnabriva2016-04-15 09:15 Read   102

Nabriva Therapeutics AG today announced the initiation of the second of two Phase 3 multinational pivotal trials evaluating the safety and efficacy of Nabriva’s lead product candidate, lefamulin, for the treatment of adults with community-acquired bacterial pneumonia (CABP).

Cantabio Pharmaceuticals Announces the Development of Small Molecule Chaperones of the Abeta Peptide for the Treatment of Alzheimer's Disease in Collaboration with NovAliX

Trendglobenewswire2016-04-14 15:23 Read   142

Cantabio Pharmaceuticals Inc. (OTCQB:CTBO) announced today a new preclinical therapeutic program for Alzheimer’s Disease which it is pursuing through its drug discovery partnership with NovAliX.

Boehringer's Giotrif beats AZ' Iressa in lung cancer trial

Trendpharmatimes2016-04-14 13:55 Read   81

Boehringer Ingelheim’s Giotrif has beaten AstraZeneca’s Iressa on a number of clinical measures investigated in a head-to-head study involving patients with EGFR mutation-positive advanced non-small cell lung cancer.

FDA finds Epigenomics appealing

TrendEP WANTAGE2016-04-14 13:48 Read   70

In pulling off the almost unheard-of feat of successfully appealing against an FDA rejection, Epigenomics today got full approval for its twice-denied colon cancer blood test, saw its share price rise 24%, and shone a light on some rather odd behaviour from the US regulator.

UCSD targets dendritic spines in promising Alzheimer's approach

Trendfiercebiotech2016-04-14 09:51 Read   72

Current Alzheimer’s treatments control symptoms without tackling the underlying disease or delaying its progression. Scientists from the University of California, San Diego have created molecules that may be able to protect neuronal function in people with neurodegenerative disease, a potential new take on Alzheimer's disease.

KENILWORTH, N.J. – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet. The BLA for Merck's investigational house dust mite SLIT-tablet is supported by a comprehensive clinical program involving more than 4,000 patients, including two Phase III in-field trials that ev

Trendmerck2016-04-14 09:48 Read   72

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet.

AstraZeneca and Eli Lilly and Company announce continuation of pivotal clinical trial for people with early Alzheimer’s disease

Trendastrazeneca2016-04-14 08:53 Read   188

AstraZeneca and Eli Lilly and Company today announced that AMARANTH, a Phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue into Phase III of the Phase II/III seamless trial.