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MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Biodel Inc. today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine).

13 Jul 2010

Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market sevelamer carbonate for oral suspension, 0.8g and 2.4g per packet. Watson's sevelamer carbonate for oral suspension product is the generic version of Genzyme's Renvela for Oral Suspension.

13 Jul 2010

Stanford University, OHSU receive grants to study VIAject for treating patients with diabetes

Biodel Inc. announced today the award of two research grants by the Juvenile Diabetes Research Foundation to Stanford University and Oregon Health & Science University to evaluate the use of VIAject (ultra-rapid-acting injectable human insulin) in the treatment of diabetes.

12 Jul 2010

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Protalix BioTherapeutics, Inc., announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

12 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus Conference in Montreal, July 3 - 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile.

9 Jul 2010

FDA approves Roxane's Naratriptan Tablets ANDA

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Naratriptan Tablets USP, 1mg and 2.5mg by the U.S. Food and Drug Administration. The product is available in bottles of 9 for immediate shipment to wholesalers and pharmacies nationwide.

9 Jul 2010

Roxane announces FDA approval for Anastrozole Tablets ANDA

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the U.S. Food and Drug Administration. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies nationwide.

9 Jul 2010

Shire files patent infringement lawsuit against Zydus

Shire plc, the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals, Inc. for the infringement of U.S. Patent No. 6,773,720.

8 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

Winston submits NDA for CIVANEX to U.S. FDA

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee.

7 Jul 2010

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that a third multi-center Phase 3 clinical study of Lymphoseek (NEO3-09) has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma.

7 Jul 2010

Caraco Pharmaceutical Laboratories commences shipping azelastine ophthalmic solution

Caraco Pharmaceutical Laboratories, Ltd. has started shipping azelastine ophthalmic solution, 0.05%. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA).

7 Jul 2010

Impax confirms challenge of patent relating to RENVELA

Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Genzyme Corporation in connection with RENVELA® (sevelamer carbonate for suspension), 2.4 g and 0.8 g.

3 Jul 2010

Watson Laboratories receives FDA approval for Tacrolimus ANDA

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Tacrolimus 5 mg capsules, the generic equivalent to Astellas' Prograf® capsules.

2 Jul 2010

Teva launches antidepressant Venlafaxine HCl ER Capsules

Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial launch of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®. The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.

2 Jul 2010

Caraco Pharmaceutical Laboratories commences marketing of rivastigmine tartrate capsules

Caraco Pharmaceutical Laboratories, Ltd. has started shipping rivastigmine tartrate capsules. These products, approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA), are therapeutically equivalent to Exelon® capsules from Novartis.

2 Jul 2010

Watson commences shipment of generic Exelon

Watson Pharmaceuticals, Inc. announced today that, under a settlement with Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively "Novartis"), Watson has commenced shipment of a generic version of Exelon® (rivastigmine tartrate) 1.5mg, 3mg, 4.5mg and 6mg capsules. Exelon® is used to treat dementia in people with Alzheimer's disease.

1 Jul 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

New Drug Application News and Research

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

Stanford University, OHSU receive grants to study VIAject for treating patients with diabetes

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

FDA approves Roxane's Naratriptan Tablets ANDA

Roxane announces FDA approval for Anastrozole Tablets ANDA

Shire files patent infringement lawsuit against Zydus

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

Winston submits NDA for CIVANEX to U.S. FDA

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Caraco Pharmaceutical Laboratories commences shipping azelastine ophthalmic solution

Impax confirms challenge of patent relating to RENVELA

Watson Laboratories receives FDA approval for Tacrolimus ANDA

Teva launches antidepressant Venlafaxine HCl ER Capsules

Caraco Pharmaceutical Laboratories commences marketing of rivastigmine tartrate capsules

Watson commences shipment of generic Exelon

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

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