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Cempra’s bacterial skin infection drug clears study

Cempra Inc. said its experimental oral drug to treat acute bacterial skin infections cleared a late-stage study.

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Scientists test deep brain stimulation as potential anorexia therapy

A small study in 16 people with severe anorexia has found that implanting stimulation electrodes into the brains of patients could ease their anxiety and help them gain weight.

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Merck drug prevents serious infection after marrow transplant: study

An experimental Merck drug succeeded in preventing clinically serious cytomegalovirus following bone marrow transplant and was associated with a lower death rate compared with placebo.

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Cyclacel’s leukemia drug fails in key study

Cyclacel Pharmaceuticals Inc. said its lead experimental drug did not help elderly patients with acute myeloid leukemia live longer in a late-stage study.

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Roche Reports Death in Phase III Hemophilia Study

Swiss-based Roche reported a death in its ACE910 study of emicizumab in patients with hemophilia A and factor VIII inhibitors.

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Massachusetts’ Agenus Quietly Discloses Failure of Cancer Vaccine Trial

Lexington, Mass.-based Agenus quietly filed with the U.S. Securities and Exchange Commission (SEC) that it was halting the company’s clinical trial of its cancer vaccine Prophage.

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Data on Trevena’s opioid painkiller irks investors

Only some doses of Trevena’s experimental opioid painkiller were found as effective as morphine in two late-stage studies, though the drug met its main study goals.

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Phase II Study Supports Potential for Genentech’s Tecentriq Plus Avastin for People With Locally Advanced or Metastatic Renal Cell Carcinoma

Proof-of-concept study in first-line mRCC (a type of kidney cancer) shows that Tecentriq and Avastin can be combined with a manageable safety profile.

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Celgene Announces Positive Results from Phase III SUNBEAM Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis

Celgene Corporation announced that its phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod – an investigational oral, selective S1P 1 and 5 receptor modulator – in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex).

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LYNPARZA Meets Primary Endpoint in Phase III Trial in BRCA-Mutated Metastatic Breast Cancer

AstraZeneca announced positive results from its Phase III OlympiAD trial comparing LYNPARZA (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations.

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U.S. FDA Accepts BLA for Mylan and Biocon’s Proposed Biosimilar Pegfilgrastim for Review

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

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Bay Area Biotech Ardelyx Rejoices as Lead Drug Hits Phase III Goals

Fremont, Calif.-based Ardelyx announced that its Phase III clinical trial of tenapanor for hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis met its primary endpoint.

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Another Drug Bites the Dust: Merck & Co. Stops Late-Stage Alzheimer’s Study

Another experimental amyloid-targeting Alzheimer’s treatment has failed. Merck & Co. pulled the plug on its Phase II/III study of verubecestat for use in patients with mild-to-moderate Alzheimer’s disease.

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Gilead challenges GSK with strong HIV drug data

Gilead Sciences has thrown down a challenge to GlaxoSmithKline with good clinical trial results for an experimental HIV drug.

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Special Report: Top 10 Pipelines 2017

There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.

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New Jersey Rare Disease Alliance Commemorates Global Rare Disease Day 2017

The New Jersey Rare Disease Alliance will hold its annual Rare Disease Day commemoration on February 27 at the New Jersey Business and Industry Association (NJBIA).

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Acorda Rockets After Parkinson’s Drug Hits Late-Stage Goals

Shares of Acorda Therapeutics were up more than 14 percent after the company announced its Phase III drug CVT-301 hit its endpoints in treating patients with Parkinson’s disease experiencing OFF periods.

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AstraZeneca Quietly Kills Some Programs

AstraZeneca canceled its combination of PD-L1 durvalumab and CTLA-4 medication tremelimumab in pancreatic ductal carcinoma.

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Repatha successful in heart problems study

Amgen Inc. said its potent cholesterol fighter Repatha significantly reduced the risk of heart attacks, strokes and death in patients with heart disease.

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Eli Lilly Ends Another Solanezumab Phase 3 Study

Lilly has closed off another avenue for solanezumab, its once-promising experimental therapy for Alzheimer’s disease, after scrapping another Phase III study.

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