Amicus Therapeutics set an average price of $315,000 per year for the company’s newly approved Fabry disease treatment.
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.
The U.S. FDA approved Alkermes plc’s Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.
Adamis Pharmaceuticals is selling U.S. commercial rights to Symjepi, a competitor to Mylan’s EpiPen, to Novartis.
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.
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.
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.
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.
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.
Britain’s healthcare watchdog NICE recommended Roche’s medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the medicine in 2017.
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.
A European Medicines Agency (EMA) panel recommended granting marketing approval to the diabetes drug Steglatro developed by Merck & Co. Inc. and Pfizer Inc.
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.
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.
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.
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.
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.
La Jolla Pharmaceutical said the U.S. Food and Drug Administration approved its drug Giapreza to treat dangerously low blood pressure.
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.
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.