New Drug Application News and Research

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Mylan enters into agreement to resolve patent litigation related to Bexarotene Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. and Valeant Pharmaceuticals Luxembourg S.a.r.l that will resolve patent litigation related to Bexarotene Capsules, 75 mg.

17 Dec 2013

Alnylam initiates Phase II study with ALN-TTRsc for treatment of ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated a pilot Phase II study with ALN-TTRsc, a subcutaneously delivered RNAi therapeutic targeting the transthyretin gene in development for the treatment of TTR-mediated amyloidosis.

17 Dec 2013

Janssen receives complete response letter for canagliflozin/metformin FDC therapy for type 2 diabetes

Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.

16 Dec 2013

GW Pharmaceuticals receives U.S. patent for treating glioma

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 12/996,124, a patent which covers the use of cannabinoids for treating glioma.

11 Dec 2013

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.

11 Dec 2013

Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

Population Council partners with USAID to introduce new line of contraceptive rings

The Population Council was awarded a cooperative agreement from the U.S. Agency for International Development's Office of Population and Reproductive Health, "Delivering a Family of Contraceptive Vaginal Rings." Included in this agreement is support for two innovative, Population Council-developed contraceptive vaginal rings: a one-year contraceptive vaginal ring that can be used by women to plan their pregnancies and a three-month vaginal ring that can be used by breastfeeding women.

10 Dec 2013

Alnylam presents new pre-clinical data with ALN-AT3 for treatment of hemophilia and RBD

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data with ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders (RBD), at the 55th Annual Meeting of the American Society of Hematology (ASH) held December 7 - 10, 2013 in New Orleans.

10 Dec 2013

Soligenix initiates SGX942 Phase 2 study for treatment of oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating SGX942, a first-in-class innate defense regulator, as a treatment for oral mucositis in patients undergoing chemoradiation therapy for head and neck cancer.

5 Dec 2013

Mylan Pharmaceuticals introduces Cabergoline Tablets USP, 0.5 mg

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Cabergoline Tablets USP, 0.5 mg. Cabergoline Tablets USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product.

5 Dec 2013

New studies offer hope to women who want to get sexual mojo back

For women, passing midlife can deal a blow to their sex drive. But two new studies just published online in Menopause, the journal of The North American Menopause Society, offer hope to women who want to get their sexual mojo back.

5 Dec 2013

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Teva Pharmaceutical Industries Ltd. and Takeda Pharmaceutical Company Limited (Takeda) today announced the signing earlier this year of an agreement in which Teva licensed to Takeda the right to commercialize Teva's innovative glatiramer acetate ( active ingredient) formulation for the treatment of multiple sclerosis, in Japan.

4 Dec 2013

FDA accepts Purdue Pharma's Targiniq ER Tablets CII NDA for review

Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration has accepted for review a New Drug Application for Targiniq ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain.

27 Nov 2013

QRxPharma refiles MOXDUO New Drug Application with US FDA

QRxPharma Limited announced today that the Company resubmitted its MOXDUO New Drug Application. At a meeting in early October, the United States Food and Drug Administration provided QRxPharma with guidance on its requirements for the NDA refiling as well as data validation documentation.

26 Nov 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

23 Nov 2013

Omeros’ OMS302 reduces incidence of miosis during intraocular lens replacement in Phase 3 clinical trial

Omeros Corporation today reported analyses of Phase 3 clinical data showing the impact of OMS302 on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement. OMS302 is the company's proprietary Pharmacosurgery product being developed for all ILR, including cataract surgery and refractive lens exchange.

20 Nov 2013

Generex Biotechnology provides update on Phase II trial of AE37 breast cancer vaccine

Generex Biotechnology Corporation today announced that it has reached a pre-specified point in the ongoing Phase II trial of its AE37 breast cancer vaccine to initiate its primary efficacy analysis. The drug is a novel immunotherapeutic cancer vaccine being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. A previously released positive interim analysis showed a strong trend toward reduced relapse in breast cancer patients receiving the AE37 vaccine.

18 Nov 2013

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration.

18 Nov 2013

Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.

18 Nov 2013

New Drug Application News and Research

Mylan enters into agreement to resolve patent litigation related to Bexarotene Capsules

Alnylam initiates Phase II study with ALN-TTRsc for treatment of ATTR

Janssen receives complete response letter for canagliflozin/metformin FDC therapy for type 2 diabetes

GW Pharmaceuticals receives U.S. patent for treating glioma

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Navidea receives Fast Track designation for Lymphoseek injection

Population Council partners with USAID to introduce new line of contraceptive rings

Alnylam presents new pre-clinical data with ALN-AT3 for treatment of hemophilia and RBD

Soligenix initiates SGX942 Phase 2 study for treatment of oral mucositis

Mylan Pharmaceuticals introduces Cabergoline Tablets USP, 0.5 mg

New studies offer hope to women who want to get sexual mojo back

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

FDA accepts Purdue Pharma's Targiniq ER Tablets CII NDA for review

QRxPharma refiles MOXDUO New Drug Application with US FDA

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

Omeros’ OMS302 reduces incidence of miosis during intraocular lens replacement in Phase 3 clinical trial

Generex Biotechnology provides update on Phase II trial of AE37 breast cancer vaccine

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

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