New Drug Application News and Research

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TapImmune announces successful conveyance of Investigational New Drug Application from Mayo Clinic

TapImmune, Inc., a clinical stage immunotherapy company, specializing in the development of innovative technologies for the treatment of metastatic cancer, announced today the successful conveyance of the Mayo Clinic IND (Investigational New Drug Application) to TapImmune as part of the recently completed licensing agreement.

18 Aug 2015

Mylan sued in connection with ANDA filing for generic version of Zytiga

Mylan N.V. today confirmed that the company has been sued by BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Abiraterone Acetate Tablets, 250 mg.

18 Aug 2015

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD

17 Aug 2015

Omeros plans to file patent infringement lawsuit against Par

Omeros Corporation today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

17 Aug 2015

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Chiasma, Inc., a U.S. late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application (NDA) for the marketing and sale of octreotide capsules, an oral drug proposed for the maintenance therapy of adult patients with acromegaly.

17 Aug 2015

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

Neurocrine Biosciences, Inc. announced today that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Mono-Amine Transporter 2 (VMAT2) compound NBI-98854 in tardive dyskinesia patients.

13 Aug 2015

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

ImmunoCellular Therapeutics, Ltd. announced today that it has reached agreement with the US Food and Drug Administration on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma.

13 Aug 2015

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

Sinovac Biotech releases results of 2015 Annual General Meeting of Shareholders held in Beijing, PRC

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced the results of the Company's 2015 Annual General Meeting of Shareholders held on Tuesday, August 11, 2015 in Beijing, PRC.

11 Aug 2015

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label.

11 Aug 2015

Mylan announces launch of Lidocaine Patch 5% in the U.S.

Mylan N.V. today announced the U.S. launch of its Lidocaine Patch 5%, which is the generic version of Endo Pharmaceutical's Lidoderm. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for relief of pain associated with post-herpetic neuralgia.

10 Aug 2015

GenVec reports net loss of $1.9 million for second quarter 2015

GenVec, Inc. today reported financial results for the second quarter ended June 30, 2015. For the three months ended June 30, 2015, GenVec reported a net loss of $1.9 million, or $0.11 per share, on revenues of $0.1 million, compared with a net loss of $1.7 million, or $0.10 per share, on revenues of $0.1 million, for the same period in the prior year.

7 Aug 2015

Lexicon Pharmaceuticals' revenues decrease to $0.4 million in second quarter 2015

Lexicon Pharmaceuticals, Inc., today reported financial results for the second quarter ended June 30, 2015 and provided an overview of key milestones for the company's lead drug candidates.

7 Aug 2015

Mylan announces launch of Esomeprazole Magnesium Delayed-release Capsules USP in U.S.

Mylan N.V. today announced the U.S. launch of Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg and 40 mg, which is the generic version of AstraZeneca's Nexium.

6 Aug 2015

Par Pharmaceutical starts shipment of generic version of Sodium Edecrin

Par Pharmaceutical today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ethacrynate sodium for injection USP, equivalent to ethacrynic acid 50 mg.

4 Aug 2015

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.

31 Jul 2015

TWi releases generic version of MEGACE ES (megestrol acetate oral suspension) 625mg/5ml

TWi Pharmaceuticals, Inc. today announced that it launched its generic version of Par Pharmaceutical's MEGACE ES (megestrol acetate oral suspension) 625mg/5ml after the United States District Court for the District of Maryland reinstated its finding that United States Patent No. 7,101,576 (the '576 Patent) is invalid.

29 Jul 2015

Regeneron, Sanofi to jointly advance new immuno-oncology treatment options for cancer patients

Regeneron Pharmaceuticals, Inc. and Sanofi have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology.

28 Jul 2015

CHMP recommends Zalviso for management of acute post-operative pain in adult patients

AcelRx Pharmaceuticals, Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency, has adopted a positive opinion for Zalviso (sufentanil sublingual tablets).

25 Jul 2015

Groundbreaking experimental therapy has ability to suppress ulcerative colitis

UCLA scientists have discovered a groundbreaking experimental therapy that has the ability to suppress the development of ulcerative colitis (UC), a disease which causes inflammation in the digestive tract and colon cancer. The treatment utilizes a chemical inhibitor able to block an RNA molecule (microRNA-214) involved in the transmission of genetic information.

24 Jul 2015

New Drug Application News and Research

TapImmune announces successful conveyance of Investigational New Drug Application from Mayo Clinic

Mylan sued in connection with ANDA filing for generic version of Zytiga

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Omeros plans to file patent infringement lawsuit against Par

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

Sinovac Biotech releases results of 2015 Annual General Meeting of Shareholders held in Beijing, PRC

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Mylan announces launch of Lidocaine Patch 5% in the U.S.

GenVec reports net loss of $1.9 million for second quarter 2015

Lexicon Pharmaceuticals' revenues decrease to $0.4 million in second quarter 2015

Mylan announces launch of Esomeprazole Magnesium Delayed-release Capsules USP in U.S.

Par Pharmaceutical starts shipment of generic version of Sodium Edecrin

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

TWi releases generic version of MEGACE ES (megestrol acetate oral suspension) 625mg/5ml

Regeneron, Sanofi to jointly advance new immuno-oncology treatment options for cancer patients

CHMP recommends Zalviso for management of acute post-operative pain in adult patients

Groundbreaking experimental therapy has ability to suppress ulcerative colitis

Drug Discovery - Second Edition eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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