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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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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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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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Kmart settles hard-fought whistleblower case

Kmart Corp. agreed to pay $35.3 million to the federal government and a number of states to settle a whistleblower lawsuit.

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Novartis drug Tasigna is approved by FDA as first CML therapy with Treatment-free Remission data in its label

Novartis announced that the FDA approved the inclusion of Treatment-free Remission data in the Tasigna (nilotinib) U. S. product label.

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Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy

Janssen Biotech Inc. entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen.

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FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with Inlyta in Advanced Renal Cell Carcinoma

Merck KGaA and Pfizer Inc. announced that the U.S. FDA granted Breakthrough Therapy Designation for avelumab in combination with Inlyta (axitinib) treatment-naïve patients with advanced renal cell carcinoma.

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FDA approves NDA for Prexxartan

Carmel Biosciences Inc. received final approval of its New Drug Application from the U.S. Food and Drug Administration for Prexxartan (valsartan) oral solution.

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Regeneron and ISA Pharmaceuticals Announce Strategic Immuno-Oncology Collaboration

Regeneron Pharmaceuticals Inc. and ISA Pharmaceuticals B.V. announced a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16-induced cancer, in combination with the PD-1 antibody cemiplimab (REGN2810).

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Lilly Announces 2018 Financial Guidance and Enhances Outlook Through 2020

Eli Lilly and Company today announced its 2018 financial guidance, including low-single-digit revenue growth driven by volume from recently launched pharmaceutical products. The company also highlighted key events for 2018, including continued progress on Lilly’s pipeline.

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Smart Hospitals to Invest over $11 billion in Cloud Computing and Data Analytics, Says Frost & Sullivan

By 2025, 10 percent of hospitals across the globe will become or will have started implementations to become smart hospitals.

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Sanofi’s Toujeo met main objective in study

Sanofi’s Toujeo met the primary study objective in the first large head-to-head clinical trial, called BRIGHT study, comparing Toujeo with insulin degludec.

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Lilly’s Taltz Receives U.S. FDA Approval for Treating Active Psoriatic Arthritis

Eli Lilly and Company announced that the U.S. FDA approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).

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FDA Approves Sublocade, the First Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder

Indivior PLC announced that the U.S. FDA approved Sublocade (buprenorphine extended-release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

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ArmaGen’s AGT-181 Granted Fast Track Designation for the Treatment of Hurler Syndrome

ArmaGen Inc. today reported that the U.S. FDA granted Fast Track designation to AGT-181. The novel, investigational enzyme replacement therapy is being developed for the treatment of somatic and cognitive symptoms in patients with Hurler syndrome (also known as mucopolysaccharidosis type I, or MPS I).

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FDA Clears First Medical Device Accessory for Apple Watch

AliveCor today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime and anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.

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Cochlear obtains FDA approval for first remote programming option for cochlear implants

Cochlear Limited received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

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FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

The U.S. Food and Drug Administration approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

“As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. …”

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