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Amicus sets $315,000 price for new Fabry disease treatment

Amicus Therapeutics set an average price of $315,000 per year for the company’s newly approved Fabry disease treatment.

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DEA Moving Forward With Reclassification of CBD Ahead of GW’s Launch of Epidiolex

The U.S. Drug Enforcement Agency is readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.

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Alkermes Scores FDA Approval for Potential Game-Changing Schizophrenia Treatment

The U.S. FDA approved Alkermes plc’s Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.

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Adamis Pharma Sells Epinephrine Injector Rights to Novartis

Adamis Pharmaceuticals is selling U.S. commercial rights to Symjepi, a competitor to Mylan’s EpiPen, to Novartis.

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U.S. Food and Drug Administration Clears Wearable Device to Treat Opioid Addiction

DyAnsys Inc. announced that the U.S. Food and Drug Administration cleared the company’s auricular neurostimulation device, Drug Relief, to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics.

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FDA approves lower dose of Lilly-Incyte arthritis drug

The U.S. Food and Drug Administration approved the lower dose of a rheumatoid arthritis drug developed by Eli Lilly and Incyte, but declined to approve its higher and more lucrative dose.

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Newest Generation Of Leading Heart Stent Approved In U.S. For People With Coronary Artery Disease

Abbott received approval from the U.S. Food and Drug Administration for XIENCE Sierra, the newest generation of the gold-standard XIENCE everolimus-eluting coronary stent system.

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Lilly’s Taltz Receives First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving Genital Area

Eli Lilly and Company announced that the U.S. Food and Drug Administration approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area.

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FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

The U.S. Food and Drug Administration permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.

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Roche wins UK watchdog’s nod for lymphoma drug

Britain’s healthcare watchdog NICE recommended Roche’s medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the medicine in 2017.

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Novartis Receives FDA Approval for Cosentyx Label Update to Include Moderate to Severe Scalp Psoriasis

Novartis announced that the U.S. Food and Drug Administration approved a label update for Cosentyx (secukinumab), the first interleukin-17A antagonist cleared to treat moderate to severe plaque psoriasis, to include data in moderate to severe scalp psoriasis.

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EMA panel recommends Merck, Pfizer’s diabetes drug

A European Medicines Agency (EMA) panel recommended granting marketing approval to the diabetes drug Steglatro developed by Merck & Co. Inc. and Pfizer Inc.

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GSK receives FDA approval for expanded indication for Fludriarix Quavalent for persons 6 months and older

GSK announced it received approval from the U.S. FDA’s Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older.

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CMS to cover Abbott’s glucose monitoring device

Abbott Laboratories said its newly launched glucose monitoring device would be covered by the Centers for Medicare & Medicaid Services, expanding its usage to millions of diabetes patients in the United States.

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New drug approvals hit 21-year high in 2017

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the EU.

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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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Celgene’s Follicular Lymphoma Regimen Fails Phase III

Shares of Celgene plunged after the company announced Revlimid combined with Biogen’s Rituxan failed in a late-stage study of previously untreated patients with follicular lymphoma.

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FDA approves La Jolla’s low blood pressure drug

La Jolla Pharmaceutical said the U.S. Food and Drug Administration approved its drug Giapreza to treat dangerously low blood pressure.

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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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Three Hottest Areas of Drug Development to Keep an Eye on in 2018

The last several years has shown a particular focus on immuno-oncology therapies, probably as close to miracle cures as anything seen in recent years. Arpita Dutt, writing for Zacks, predicts what the three hot areas for approvals are likely to be in 2018.

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