New Drug Application News and Research

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European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.

26 Sep 2009

Investigational New Drug application for Uricase-PEG 20 approved

EnzymeRx, LLC, a clinical-stage biotechnology company, announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the U.S. Food and Drug Administration (FDA) last month, has become effective.

25 Sep 2009

NDA submitted to the FDA for new osteoarthritis drug

NicOx S.A. today announced that a New Drug Application (NDA) for naproxcinod has been submitted to the United States Food and Drug Administration (FDA), seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints. NicOx plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in Q4 2009.

25 Sep 2009

FDA grants priority review for Cephalon's sNDA

Cephalon, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year.

25 Sep 2009

Patents listed in FDA's Orange Book for Eli Lilly’s Evista invalidated

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the Southern District of Indiana has issued a decision invalidating two patents listed in the FDA’s Orange Book for Eli Lilly’s Evista® (raloxifene hydrochloride) Tablets in litigation concerning Teva’s abbreviated new drug application to market a generic version. The court found these patents to be invalid for lack of written description.

24 Sep 2009

Study reveals that AIR Inhaled Insulin is inferior to SC insulin

The commercial failure of Exubera- (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR- inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The supplement is available free online at www.liebertpub.com/dia

24 Sep 2009

FDA endorses Covidien's REMS program for EXALGO tablets

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for EXALGOTM (hydromorphone HCl extended release) tablets, an opioid formulation.

24 Sep 2009

NASDAQ halts trading in CombinatoRx's common stock

CombinatoRx, Incorporated (NASDAQ: CRXX) announced that NASDAQ has halted trading in the Company’s common stock today.

23 Sep 2009

FDA committees to review Neuromed’s NDA for Exalgo

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the September 23, 2009 joint meeting of its Anesthetics and Life Support Advisory Committee and its Drug Safety and Risk Management Advisory Committee.

23 Sep 2009

NicOx announces publication of blood pressure results from the phase 3 study of naproxcinod

NicOx S.A. (NYSE Euronext Paris: COX) today announced that an important scientific article has been published in the September issue of the American Journal of Cardiology. The publication describes the blood pressure results from the 301 phase 3 study for naproxcinod in detail. Naproxcinod is the first-in-class Cyclooxygenase-Inhibiting Nitric Oxide Donating (CINOD) anti-inflammatory agent for the relief of the signs and symptoms of osteoarthritis (OA).

22 Sep 2009

Perrigo purchases KV Pharmaceutical's ANDA for clindamycin phosphate and benzoyl peroxide gel

Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has purchased the ANDA for clindamycin phosphate (1%) and benzoyl peroxide (5%) gel from KV Pharmaceutical for $14 million in cash at closing and a $2 million milestone payment upon the completion of a successful technical transfer. This product is the AB-rated equivalent to Stiefel Laboratories' (a subsidiary of Glaxo SmithKline) Duac(R) gel, indicated for the topical treatment of inflammatory acne vulgaris.

21 Sep 2009

Impax Laboratories challenges Galderma Laboratories' patents

Impax Laboratories, Inc. confirms that it has initiated a challenge of the patents listed by Galderma Laboratories, L.P. in connection with its ORACEA® (doxycycline) delayed-release capsules, 40 mg.

21 Sep 2009

Nasdaq Stock Market issues noncompliance letter to A.P. Pharma

A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today announced that, on September 15, 2009, the Company received a letter from The Nasdaq Stock Market (Nasdaq) indicating that the minimum closing bid price of its common stock had fallen below $1.00 for 30 consecutive trading days, and therefore, A.P. Pharma was not in compliance with Marketplace Rule 5450(a)(1).

21 Sep 2009

Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

Results from the BLOSSOM trial announced by Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial.

18 Sep 2009

Phase I trial of NPC-1C to commence

Neogenix Oncology, Inc. (Neogenix) announced today that NPC-1C, the company’s first IND (Investigational New Drug Application) was granted permission by the Food and Drug Administration (FDA) for the company to begin a Phase I trial.

18 Sep 2009

NIDDK awards $1.2 million grant to Bolder BioTechnology for long-acting EPO analog program

Bolder BioTechnology, Inc. announced today that it has been awarded a $1.2 million Phase II Small Business Innovation Research (SBIR) grant, entitled "Long-Acting EPO Analog for Treating Anemia Associated with Chronic Kidney Disease," from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of The National Institutes of Health (NIH). Receipt of the entire grant award is contingent upon the achievement of certain research milestones.

18 Sep 2009

Griffin Securities' report features stem cell hypothesis of cancer

ImmunoCellular Therapeutics, Ltd., a clinical-stage biotechnology company that is developing immune based therapies for the treatment of brain and other cancers, announced today that it has been featured in an in-depth report by Griffin Securities, a New York-based brokerage firm, highlighting the importance of the role that cancer stem cell (CSCs) targeting technology such as that employed by its lead product candidate, ICT-121, may play in developing future cancer treatments.

18 Sep 2009

Results from Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 announced

GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) today announced top-line results from a Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.

17 Sep 2009

FDA issues a complete response letter for Sanofi-aventis' eplivanserin NDA

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin (Ciltyri(R)). Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.

17 Sep 2009