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The Pulse of the Pharmaceutical Industry

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More than a third of US adults prescribed opioids in 2015

The United States needs to curb excessive opioid prescribing and improve access to pain management techniques, suggests a new government study.

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New Research Shows 99 Percent of Life Science Companies Still Need to Unify Clinical Applications

It’s no longer a question of if, but when. The life sciences industry has begun its journey to unify applications with the aim of driving greater efficiency across the end-to-end clinical landscape.

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Express Scripts to cover Mylan’s EpiPen, exclude rivals

Pharmacy benefit manager Express Scripts Holding Co. said it would favor drugmaker Mylan Inc.’s versions of the EpiPen lifesaving allergy treatment over the allergy auto-injectors of other companies.

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U.S. FDA to review Teva and Celltrion’s cancer biosimilar drug

Teva Pharmaceutical Industries and South Korea’s Celltrion said the U.S. Food and Drug Administration has accepted for review a biologics application for a biosimilar drug to treat breast cancer.

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J&J RA drug sirukumab raises safety concerns

There were more deaths in patients taking J&J’s experimental rheumatoid arthritis drug sirukumab than among those taking a placebo, FDA staff reviewers said.

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LabCorp Scoops Up CRO for $1.2 Billion

Clinical diagnostics company LabCorp announced it is buying private contract research organization Chiltern for $1.2 billion.

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FDA Panel Votes to Recommend Dynavax’s Hepatitis B Vaccine; Hepsilav Can Compete With GlaxoSmithKline’s Engerix-B

A U.S. Food and Drug Administration advisory committee gave a thumb’s-up recommendation for Dynavax Technologies Corporation’s Heplisav-B hepatitis B vaccine.

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Abilify Maintena Approved by FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder

Otsuka Pharmaceutical and H. Lundbeck’s Abilify Maintena (aripiprazole) was approved by the U.S. FDA for the maintenance monotherapy treatment of bipolar I disorder in adults.

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AbbVie’s profit beats analysts’ expectations

U.S. drugmaker AbbVie Inc. reported Q2 2017 earnings that edged past analysts’ expectations, helped by robust demand for the company’s flagship RA drug Humira.

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Merck cyber attack will hurt profits

The international cyber attack Merck & Co. suffered in June halted some of the company’s manufacturing and other operations and cut its profit forecast for 2017.

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CMOs Cringe as GlaxoSmithKline Will be Cutting Its Use by 25%

GlaxoSmithKline provided information about its second-quarter financials this week. The attention focused on plans to kill more than 30 preclinical and clinical programs and allocate 80 percent of its research-and-development budget to respiratory and HIV/infectious diseases. But a closer look at new CEO Emma Walmsley’s plans point to big changes in the company’s manufacturing network as well.

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Boston Scientific Warns of Fluke Death Involving Its S-ICD Pacemaker

Boston Scientific called a single pacemaker-related death for its S-ICD implant a “fluke” that was the result of radiation corruption that negatively impacted the device’s memory.

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U.S. House panel spotlights use of FDA rules to slow generic drugs

Republican and Democratic lawmakers discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines.

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Amgen gets fast FDA review for adding heart benefits to cholesterol drug label

Amgen Inc. said the U.S. FDA granted priority review to the company’s request to add important heart safety data to the label of its expensive injectable cholesterol drug Repatha.

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U.S. Senator expands opioid probe to distributors, drugmakers

U.S. Democratic Senator Claire McCaskill expanded an investigation into the causes of the opioid crisis plaguing the country, seeking information from four more drugmakers and three drug distributors.

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Bristol-Myers shares slump after rival’s failed study

Bristol-Myers Squibb shares fell as a failed cancer-drug trial at AstraZeneca could have negative implications for its similar immunotherapy treatment regimen.

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Scientists find sunscreen potential in Antarctic plants

Scientists in Chile have discovered molecules in two species of Antarctic flowers that protect the plants from solar radiation and could potentially be used in products such as sunscreen for humans and protection for vulnerable crops.

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Not-Yet Sold Tesaro Bags $340 Million Cancer Deal With Pharma Giant Takeda

There is a ray of sunshine for beleaguered Tesaro as Japanese pharma giant Takeda Pharmaceutical struck a deal worth up to $340 million for Asian development and marketing rights for recently approved PARP inhibitor Zejula (niraparib).

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Astellas Takes a $387 Million+ Loss as It Shuts Down SoCal’s Agensys

Astellas Pharma announced that the company is wrapping up its research operations with Santa Monica, Calif.-based Agenus.

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Alexion Redefines R&D Strategy, Discontinues Programs and Kills Deals With Moderna, Blueprint and Arbutus Biopharma

While reporting strong earnings, New Haven, Conn.-based Alexion Pharmaceuticals also indicated the company plans to retool its research-and-development strategy.

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