New Drug Application News and Research

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Alkermes announces plans to advance ALKS 5461 phase 3 program for major depressive disorder

Alkermes plc today announced that it has successfully completed its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), and the company plans to advance ALKS 5461 into phase 3 development in early 2014.

9 Oct 2013

New method for improving cord blood transplant success

Starting with a discovery in zebrafish in 2007, Harvard Stem Cell Institute researchers have published initial results of a Phase Ib human clinical trial of a therapeutic that has the potential to improve the success of blood stem cell transplantation.

9 Oct 2013

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia.

9 Oct 2013

Alnylam advances Development Candidate for ALN-AS1 for treatment of hepatic porphyrias

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it is advancing its Development Candidate for ALN-AS1, an RNAi therapeutic targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of hepatic porphyrias including acute intermittent porphyria (AIP).

9 Oct 2013

FDA Approves Takeda-Lundbeck Drug For Major Depressive Disorder

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1 Oct 2013

Mylan Pharmaceuticals launches Voriconazole for Oral Suspension

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole for Oral Suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for Oral Suspension.

30 Sep 2013

AcelRx Pharmaceuticals submits Zalviso NDA to FDA

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that it submitted a New Drug Application to the U.S. Food and Drug Administration for Zalviso (sufentanil sublingual microtablet system).

30 Sep 2013

Almirall and GKV-SV reach agreement on pricing of Sativex medicine in Germany

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23 Sep 2013

Applied Integrin Sciences' drug candidate eliminates ovarian cancer tumors in pre-clinical study

Applied Integrin Sciences, Inc. announced today that its first cancer therapeutic drug candidate eliminated all intraperitoneal ovarian cancer tumors in a pre-clinical study testing a novel treatment regimen.

21 Sep 2013

GW Pharmaceuticals starts GWP42006 Phase 1 clinical trial for epilepsy treatment

GW Pharmaceuticals plc announced today it has commenced a Phase 1 clinical trial of product candidate GWP42006 for the treatment of epilepsy.

18 Sep 2013

FDA grants orphan drug designation to Soligenix’s SGX94 for treatment of Acute Radiation Syndrome

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient SGX94 for the treatment of acute radiation syndrome (ARS).

16 Sep 2013

Wistar Institute receives $1.5M grant to prepare potential new prostate cancer drug for clinical use

To prepare a potential new prostate cancer drug, called Gamitrinib, for trial in humans, The Wistar Institute has received a $1.5 million grant from the US Department of Defense's Congressionally Directed Medical Research Program.

13 Sep 2013

Biogen Idec, Amicus Launch Parkinson's Collaboration

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10 Sep 2013

Omeros seeks EMA's approval to market OMS302 for patients undergoing ILR surgery

Omeros Corporation today announced that it recently submitted a Marketing Authorization Application to the European Medicines Agency seeking approval to market OMS302 for use in patients undergoing intraocular lens replacement surgery in the European Union.

10 Sep 2013

Relmada Therapeutics reports positive results from pivotal pharmacokinetic study of LevoCap ER

Relmada Therapeutics Inc., a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced a positive outcome of its pivotal pharmacokinetic study for LevoCap ER. Based on the positive outcome of this study, Relmada is now preparing the Phase III development program and is planning to submit a request with the FDA to discuss the final pathway to the New Drug Application for this product during the fourth quarter of this year.

10 Sep 2013

Avanir Pharmaceuticals, Wockhardt settle patent litigation related to NUEDEXTA capsules

Avanir Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Wockhardt USA, LLC and Wockhardt Ltd. (collectively, "Wockhardt") to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.

7 Sep 2013

FDA schedules meeting on 3 October to discuss QRxPharma's MOXDUO NDA for acute pain

QRxPharma Limited announced today the United States Food and Drug Administration has scheduled a meeting on 3 October to discuss the Company's MOXDUO New Drug Application for the treatment of moderate to severe acute pain.

6 Sep 2013

Endo Pharmaceuticals' complete response submission to AVEED NDA accepted by FDA

Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. announced today that the U.S. Food and Drug Administration has accepted for review the complete response submission made by Endo to the new drug application for its long-acting testosterone undecanoate injection, AVEED, intended for men diagnosed with hypogonadism.

6 Sep 2013

Sanofi, POZEN ink license agreement to commercialize PA8140 and PA32540 tablets in US

Sanofi US and POZEN Inc. announced the signing of an exclusive license agreement for the commercialization of POZEN's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor, and enteric-coated aspirin in a single tablet ("PA"), PA8140 and PA32540.

5 Sep 2013

Avanir Pharmaceuticals enters into patent settlement agreement with Actavis

Avanir Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Actavis South Atlantic LLC and Actavis, Inc. (collectively, "Actavis") to resolve pending patent litigation in response to Actavis' abbreviated new drug application seeking approval to market generic versions of Avanir's NUEDEXTA (dextromethorphan hydrobromide/quinidine sulfate) capsules.

4 Sep 2013

New Drug Application News and Research

Alkermes announces plans to advance ALKS 5461 phase 3 program for major depressive disorder

New method for improving cord blood transplant success

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alnylam advances Development Candidate for ALN-AS1 for treatment of hepatic porphyrias

FDA Approves Takeda-Lundbeck Drug For Major Depressive Disorder

Mylan Pharmaceuticals launches Voriconazole for Oral Suspension

AcelRx Pharmaceuticals submits Zalviso NDA to FDA

Almirall and GKV-SV reach agreement on pricing of Sativex medicine in Germany

Applied Integrin Sciences' drug candidate eliminates ovarian cancer tumors in pre-clinical study

GW Pharmaceuticals starts GWP42006 Phase 1 clinical trial for epilepsy treatment

FDA grants orphan drug designation to Soligenix’s SGX94 for treatment of Acute Radiation Syndrome

Wistar Institute receives $1.5M grant to prepare potential new prostate cancer drug for clinical use

Biogen Idec, Amicus Launch Parkinson's Collaboration

Omeros seeks EMA's approval to market OMS302 for patients undergoing ILR surgery

Relmada Therapeutics reports positive results from pivotal pharmacokinetic study of LevoCap ER

Avanir Pharmaceuticals, Wockhardt settle patent litigation related to NUEDEXTA capsules

FDA schedules meeting on 3 October to discuss QRxPharma's MOXDUO NDA for acute pain

Endo Pharmaceuticals' complete response submission to AVEED NDA accepted by FDA

Sanofi, POZEN ink license agreement to commercialize PA8140 and PA32540 tablets in US

Avanir Pharmaceuticals enters into patent settlement agreement with Actavis

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How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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