New Drug Application News and Research

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FDA accepts filing of Jazz Pharmaceuticals' NDA for sodium oxybate

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

19 Feb 2010

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Incyte Corporation today reported fourth quarter and full year 2009 financial results, provided an update on key fourth quarter accomplishments and 2010 objectives, and announced its 2010 financial guidance.

18 Feb 2010

FDA issues Complete Response Letter for Horizant in treatment of RLS

GlaxoSmithKline and XenoPort, Inc. Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

18 Feb 2010

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults.

18 Feb 2010

Covidien's Exalgo NDA: FDA sets new PDUFA action date

Covidien today announced that the U.S. Food and Drug Administration has set a new action date of March 1, 2010, under the Prescription Drug User Fee Act (PDUFA) for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) Extended-Release Tablets, (CII).

17 Feb 2010

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.

16 Feb 2010

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2009.

16 Feb 2010

MAP Pharmaceuticals initiates LEVADEX-intravenous DHE comparative trial

MAP Pharmaceuticals, Inc. today announced that the Company initiated a trial to compare the pharmacokinetics (PK), safety and metabolic profiles of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

16 Feb 2010

Delcath Systems to initiate Expanded Access Program for melphalan in patients with metastatic melanoma to the liver

Delcath Systems, Inc., which is testing its proprietary treatment system for metastatic cancers to the liver, announced today that the U.S. Food and Drug Administration ("FDA") will allow the Company to initiate an Expanded Use – Intermediate Size Population protocol for the hepatic arterial infusion of melphalan with venous filtration via the Delcath PHP System™ for patients with ocular and cutaneous melanoma metastatic to the liver.

16 Feb 2010

Meda publishes 2009 year-end report

“The Meda Group expects to achieve sales of about SEK 13,000 million and an EBITDA of about SEK 4,200 million for full-year 2009.”

16 Feb 2010

U.S. Court rules in favor of Perrigo over Mucinex patent litigation

Perrigo Company announced today that a federal court has granted summary judgment in its favor in patent litigation involving Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex® tablets. Perrigo had been sued by Adams Respiratory Therapeutics, Inc., (a subsidiary of Reckitt Benckiser Group plc.) the New Drug Application holder and patent owner. The United States District Court for the Western District of Michigan ruled today that Perrigo does not infringe the patent in the suit. Perrigo's ANDA is awaiting FDA approval.

12 Feb 2010

Positive results from Shire's velaglucerase alfa Phase III study for Type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, today presented positive results from its first Phase III study (TKT 032) evaluating safety and efficacy of velaglucerase alfa, its investigational enzyme replacement therapy for the treatment of Type 1 Gaucher disease. The data were presented in an oral presentation at the Lysosomal Disease Network (LDN) World Symposium in Miami, Florida.

12 Feb 2010

Cadence Pharmaceuticals' IV acetaminophen NDA receives FDA Complete Response letter

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for intravenous (IV) acetaminophen.

11 Feb 2010

CTI reports financial results for fourth-quarter and year ended December 31, 2009

Cell Therapeutics, Inc. (CTI) today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2009.

11 Feb 2010

QRxPharma announces the initiation of second pivotal Phase 3 registration trial of MoxDuo IR

QRxPharma Limited announced today initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo™IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone.

11 Feb 2010

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Celsion Corporation announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

10 Feb 2010

sanofi-aventis reports 2009 fourth-quarter and full-year net earnings

Commenting on the Group's 2009 performance, sanofi-aventis Chief Executive Officer Christopher A. Viehbacher said, "2009 was the first year of implementation of our new strategy. Major steps have already been achieved in strengthening our growth platforms and reinforcing our R&D pipeline while delivering a double-digit EPS(1) growth".

10 Feb 2010

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

10 Feb 2010

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc.

10 Feb 2010

Elan announces fourth-quarter and full-year financial results ended December 31, 2009

Elan Corporation, plc today reported its fourth quarter and full-year 2009 financial results and provides financial guidance for 2010.

10 Feb 2010

New Drug Application News and Research

FDA accepts filing of Jazz Pharmaceuticals' NDA for sodium oxybate

Incyte announces 2009 financial results and key fourth-quarter accomplishments

FDA issues Complete Response Letter for Horizant in treatment of RLS

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Covidien's Exalgo NDA: FDA sets new PDUFA action date

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

MAP Pharmaceuticals initiates LEVADEX-intravenous DHE comparative trial

Delcath Systems to initiate Expanded Access Program for melphalan in patients with metastatic melanoma to the liver

Meda publishes 2009 year-end report

U.S. Court rules in favor of Perrigo over Mucinex patent litigation

Positive results from Shire's velaglucerase alfa Phase III study for Type 1 Gaucher disease

Cadence Pharmaceuticals' IV acetaminophen NDA receives FDA Complete Response letter

CTI reports financial results for fourth-quarter and year ended December 31, 2009

QRxPharma announces the initiation of second pivotal Phase 3 registration trial of MoxDuo IR

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

sanofi-aventis reports 2009 fourth-quarter and full-year net earnings

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

Elan announces fourth-quarter and full-year financial results ended December 31, 2009

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