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Egalet submits NDA for ARYMO ER (morphine sulfate) extended-release tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced the company has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

15 Dec 2015

FDA approves Teligent's sNDA for CEFOTAN (cefotetan) for Injection

Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's supplemental new drug application (sNDA) from the U.S. Food and Drug Administration (FDA) for CEFOTAN (cefotetan) for Injection.

11 Dec 2015

FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

Cardiorentis AG, a privately held biopharmaceutical company, today announced that the U.S. Food and Drug Administration has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF).

11 Dec 2015

Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced that the Company has obtained approval to begin human clinical trials on its Sabin Inactivated Polio Vaccine (or "sIPV") candidate.

10 Dec 2015

Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

The Dompé biopharmaceutical company announced today that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has officially designated recombinant human Nerve Growth Factor (rhNGF) - the investigational biotech molecule developed by Dompé based on research by Nobel Laureate Rita Levi Montalcini - as an orphan drug for the treatment of neurotrophic keratitis.

8 Dec 2015

Can-Fite BioPharma reports financial results, provides updates on drug development programs

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today reported financial results for the nine months ended September 30, 2015 and updates on its drug development programs.

27 Nov 2015

Takeda receives FDA approval for NINLARO (ixazomib) capsules to treat patients with multiple myeloma

Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration has approved NINLARO (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a once-weekly pill.

25 Nov 2015

Mylan releases Clozapine Orally Disintegrating Tablets in U.S.

Mylan N.V. today announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo.

24 Nov 2015

Mylan announces U.S. launch of generic AXERT tablets

Mylan N.V. today announced the U.S. launch of Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT.

17 Nov 2015

Hutchison MediPharma begins sulfatinib Phase I trial in US

Hutchison China MediTech Limited today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated the Phase I clinical trial of sulfatinib (HMPL-012) in the United States.

6 Nov 2015

Braeburn, Camurus announce FDA Fast Track designation for CAM2038 to treat opioid addiction

Braeburn Pharmaceuticals and Camurus announced today that the U.S. Food and Drug Administration granted Fast Track designation for the CAM2038 weekly and monthly buprenorphine subcutaneous injection products under development for the treatment of opioid addiction.

5 Nov 2015

Alnylam presents positive ongoing phase 2 open-label extension data for Patisiran and Revusiran

Alnylam Pharmaceuticals, Inc. has announced new results from its ongoing Phase 2 open-label extension (OLE) studies with patisiran and revusiran, investigational RNAi therapeutics targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR amyloidosis).

3 Nov 2015

Mylan announces U.S. launch of generic Fusilev for Injection

Mylan N.V. today announced the U.S. launch of Levoleucovorin Calcium Injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single-use Vials, which is the generic version of Spectrum Pharmaceuticals' Fusilev for Injection.

27 Oct 2015

Mast Therapeutics begins vepoloxamer Phase 2 study in patients with chronic heart failure

Mast Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, heart failure, and stroke, announced that it has initiated its Phase 2 study of vepoloxamer for the treatment of patients with chronic heart failure.

26 Oct 2015

Sinovac Dalian receives approval to start human clinical trials of varicella vaccine candidate

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced that one of its subsidiaries, Sinovac Dalian, has received approval to begin human clinical trials on its varicella vaccine candidate. The clinical trial application for the varicella vaccine was officially accepted by the China Food and Drug Administration in January 2013.

26 Oct 2015

Breakthrough research suggests that female sex hormone may save lives on the battlefield

Breakthrough research suggests a female sex hormone may be the key to saving lives on the battlefield, where between 2001 and 2011 more than 80 percent of potentially preventable U.S. war injury deaths resulted from blood loss.

22 Oct 2015

TARSA Therapeutics' TBRIA NDA accepted by FDA for review

TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016.

19 Oct 2015

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII).

15 Oct 2015

AcelRx provides update on Zalviso (sufentanil sublingual tablet system)

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a regulatory update on Zalviso (sufentanil sublingual tablet system) intended for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

8 Oct 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial. This Phase III trial included moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.