TAKEDA PHARMACEUTICAL COMPANY: TRINTELLIX® (vortioxetine) Prescribing Information Now Includes New Data Showing Improvement in Processing Speed, an Important Aspect of Cognitive Function in Acute Major Depressive Disorder (MDD)

Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine). Read More »

PORTOLA PHARMACEUTICALS: U.S. FDA Approves Portola Pharmaceuticals’ Andexxa®, First and Only Antidote for the Reversal of Factor Xa Inhibitors

Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Read More »

VALEANT PHARMACEUTICALS: Bausch + Lomb Launches LUMIFY, The First And Only OTC Redness Relieving Eye Drop With Low-Dose Brimonidine

Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International (NYSE/TSX: VRX), today announced the launch of LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%), the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of eye redness. Read More »

GENENTECH, INC:Genentech Provides Update on Phase III Study Of TECENTRIQ (Atezolizumab) and COTELLIC (Cobimetinib) in People With Heavily Pre-Treated Locally Advanced or Metastatic Colorectal Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC ® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. Read More »

MYLAN INC: Mylan Statement on Supply of EpiPen® (epinephrine injection, USP) Auto-Injectors from Meridian Medical Technologies, a Pfizer company

The U.S. Food and Drug Administration (FDA) posted a supply notification about EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, on its website to provide greater transparency and confirm that the product remains available. Read More »

NOVARTIS CORPORATION: Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis

Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy indicated for these patients2. Read More »

VALERITAS, INC:Valeritas’ V-Go® Wearable Insulin Delivery Device Results in Clinical Benefits Sustained Over Time in Patients with Diabetes

Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, announced today the publication last week of a manuscript titled “Clinical Benefits Over Time Associated with Use of V-Go Wearable Insulin Delivery Device in Adult Patients with Diabetes: a Retrospective Analysis” in Advances in Therapy, an international, peer-reviewed journal. Read More »

TEVA PHARMACEUTICAL INDUSTRIES LTD.: Teva Announces Publication of Phase III Trial Data of Fremanezumab for the Preventive Treatment of Episodic Migraine in the Journal of the American Medical Association

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the publication of data from the Phase III HALO study evaluating the efficacy, safety, and tolerability of both quarterly (every three months) and monthly subcutaneous dosing regimens of fremanezumab for the prevention of episodic migraine (EM). Read More »

GILEAD SCIENCES, INC: U.S. Food and Drug Administration Approves Expanded Indication for Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. Read More »