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Mylan Wins FDA Approval of First Generic for Estrace Cream

The FDA approved Mylan’s Estradiol Vaginal Cream USP 0.01%, the first generic version of Allergan’s Estrace.

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China: U.S. should do more to cut opioid demand

The United States should take action to reduce demand for the drugs fueling its deadly opioid crisis, a top Chinese drug control official said.

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Obamacare enrollment figure dips to 8.7 million

About 8.7 million people enrolled in healthcare plans for 2018 using the federal Obamacare marketplace, according to updated government figures.

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Germany’s Vetter Begins Construction on $350M 500-Job U.S. HQ

Vetter Pharma – a Germany-based contract company specializing in aseptic filling and packaging of drugs into syringes, vials and cartridges – broke ground on its U.S. headquarters in Des Plaines, Illinois.

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Four Top-Performing S&P 500 Biotech Stocks of 2017

Todd Campbell, writing for The Motley Fool, notes four biopharma stocks that topped out in the S&P 500 in 2017.

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Fresenius Allegedly Ignored Hundreds of Bad Quality Tests at Plant in India

The U.S. Food and Drug Administration issued a warning letter to Fresenius Kabi AG of Germany for its plant in India.

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Five Biotechs Awaiting FDA Decisions in January 2018

Here are five companies looking at possible drug approvals in January 2018.

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NDA Filing Accepted for GW’s Epidiolex

GW Pharmaceuticals plc announced that the U.S. FDA accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex (cannabidiol or CBD) as an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

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Male doctors make a lot more in industry payments than female peers

Male physicians in the U.S. – across almost every specialty – took in more money from the biomedical industry in 2015 than their female peers, a new study suggests.

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Theranos Avoids Bankruptcy by Snagging $100M Lifeline From Fortress

The Wall Street Journal reported that Theranos Inc. secured a loan from Fortress Investment Group.

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Array BioPharma Spins Off Heart Drug R&D Into New Subsidiary Yarra Therapeutics

Array BioPharma spun off some intellectual property and equipment into a new company, Yarra Therapeutics.

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Putting the Patient at the Center of Patient-Centric Support Programs

Are marketers just paying lip service to the idea that the patient is in charge when it comes to developing patient acquisition and support programs?

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Odonate Therapeutics Announces Initiation of Phase 3 Study for Metastatic Breast Cancer

Odonate Therapeutics Inc. announced that it has initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer.

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Teva Announces Exclusive U.S. Launch of Generic Version of Reyataz

Teva Pharmaceutical Industries Ltd. announced the exclusive launch of a generic version of Reyataz (atazanavir) capsules in the U.S.

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Anika Announces FDA 510(k) Clearance for Injectable HA-Based Bone Repair Treatment

Anika Therapeutics Inc. announced that its HA-based bone void filler received 510(k) clearance from the U.S. FDA and is indicated for filling bone voids or defects of the skeletal system, which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.

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GenScript Biotech Acquires CustomArray to Expand Synthetic Biology Product Portfolio

GenScript Biotech Corp. – a leading global provider of gene synthesis services – announced an agreement to acquire 100 percent of the issued shares of CustomArray Inc., a privately held DNA microarray company.

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FDA Accepts Sun Pharma’s NDA for OTX-101

Sun Pharmaceutical Industries Ltd. announced the U.S. FDA accepted a New Drug Application (NDA) for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%.

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Supplements may not lower fracture risk

Older adults who take vitamin D and calcium are no less likely to break their hips or other bones than peers who do not use these supplements per a research review.

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Mallinckrodt To Acquire Sucampo Pharmaceuticals For Approximately $1.2 Billion

Mallinckrodt plc will acquire Sucampo Pharmaceuticals Inc., including its commercial and development assets.

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Soliris Receives Approval in Japan for gMG

Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.

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