New Drug Application News and Research

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InterMune seeks FDA marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.

5 Nov 2009

Shionogi files New Drug Application in Japan

BioCryst Pharmaceuticals, Inc. today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. As a consequence of this filing, BioCryst will receive a regulatory milestone payment of $7 million under its agreement with Shionogi.

4 Nov 2009

Shire receives FDA Priority Review for velaglucerase alfa NDA

Shire plc, the global specialty biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

4 Nov 2009

USPTO issues Notice of Allowance for Transcept Pharmaceuticals' Intermezzo

Transcept Pharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/833,323, which covers the use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate. Once issued, this patent will expire in February 2025.

4 Nov 2009

Takeda Pharmaceuticals strengthens its North American market

Takeda Pharmaceuticals North America, Inc., today announced the incorporation of Takeda Pharmaceuticals Mexico, S.A. de C.V. This expansion strengthens the company's North American presence, bolstering existing operations in the United States and Canada. Takeda Pharmaceuticals Mexico will be headquartered in Mexico City.

4 Nov 2009

Pfizer and Medivation initiate dimebon trials in patients with Alzheimer’s disease

Pfizer Inc and Medivation, Inc. today announced the initiation of CONTACT and CONSTELLATION, two Phase 3 trials of the investigational drug dimebon (latrepirdine)* in patients with moderate-to-severe Alzheimer’s disease (AD).

4 Nov 2009

Financial results for third-quarter 2009 announced by Combinatorx

CombinatoRx, Incorporated today reported financial results for the third quarter ended September 30, 2009.

3 Nov 2009

Acorda Therapeutics' financial results for the third quarter of 2009 and update on Fampridine-SR

Acorda Therapeutics, Inc. today announced its financial results for the third quarter of 2009.

3 Nov 2009

NUVIGIL improves wakefulness in patients with excessive sleepiness associated with shift work disorder

Cephalon, Inc. today announced that the November issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial demonstrating that NUVIGIL® (armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD).

3 Nov 2009

Cipher Pharmaceuticals to defend alleged patent infringement of CIP-TRAMADOL ER

Cipher Pharmaceuticals Inc. today announced that Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. have filed a complaint against Cipher in the United States District Court for the Eastern District of Virginia, for alleged infringement of two U.S. patents. The action relates to Cipher's New Drug Application ("NDA") filed with the U.S. Food and Drug Administration ("FDA") for CIP TRAMADOL ER, the Company's extended-release tramadol product.

3 Nov 2009

EnzymeRx commences patient enrollment in Uricase-PEG 20 phase 1 study

EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, announced that it has launched its first clinical study of Uricase-PEG 20. Subjects have begun enrolling in a phase 1 safety, pharmacokinetic and pharmacodynamic study of single intravenous doses of Uricase-PEG 20.

2 Nov 2009

FDA issues a Complete Response Letter for GTx' toremifene NDA

GTx, Inc. today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

2 Nov 2009

Valeant Pharmaceuticals announces financial results for the third quarter of 2009

Valeant Pharmaceuticals International today announced third quarter financial results for 2009.

2 Nov 2009

Perrigo announces financial results for the first quarter of fiscal 2010

Perrigo Company today announced results for its first quarter ended September 26, 2009.

2 Nov 2009

Shire announces third quarter 2009 financial results

Shire plc, the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

31 Oct 2009

FDA approves Covidien's Abbreviated New Drug Application for CII

Covidien, a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

31 Oct 2009

Impax Laboratories initiates patent challenge for TRICOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg.

30 Oct 2009

Isotechnika Pharma develops portfolio of NICAMs with potent cyclophilin inhibition

Isotechnika Pharma Inc. today announced that it has developed a portfolio of non-immunosuppressive cyclosporine analogue molecules (NICAMs) with potent cyclophilin inhibition. Cyclophilin inhibition has garnered considerable attention as a novel therapy in the treatment of a wide range of diseases including hepatitis C, stroke, and chronic neurological disorders such as Parkinson's, Lou Gehrig's, and Alzheimer's.

30 Oct 2009

Allergan reports operating results for the third quarter of 2009

Allergan, Inc. today announced operating results for the quarter ended September 30, 2009. Allergan also announced that its Board of Directors has declared a third quarter dividend of $0.05 per share, payable on November 30, 2009 to stockholders of record on November 9, 2009.

29 Oct 2009

Third-quarter fiscal 2009 results announced by Adolor

Adolor Corporation today reported a net loss of approximately $11.1 million, or ($0.24) per basic and diluted share, for the three months ended September 30, 2009 compared to a net loss of $13.3 million, or ($0.29) per basic and diluted share, for the three months ended September 30, 2008.

29 Oct 2009