New Drug Application News and Research

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FDA grants Fast Track designation for ARCA biopharma's Gencaro

ARCA biopharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM, the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.

23 Nov 2009

A.P. Pharma regains compliance with shareholders’ equity requirement for continued listing on Nasdaq Capital Market

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that, on November 19, 2009, the Company received notice from the Nasdaq Listing Qualifications Panel that it has regained compliance with the shareholders’ equity requirement for continued listing on the Nasdaq Capital Market.

23 Nov 2009

New Drug Application for ticagrelor submitted to the FDA

AstraZeneca today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

23 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

FDA extends Exalgo NDA review by three months

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.

20 Nov 2009

Significant increases in IT use have not reduced drug review process

Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval intervals from 1997 to 2006, published in the International Journal of Electronic Healthcare.

20 Nov 2009

Data from second positive pivotal study of PSD502 for treatment of PE presented

At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora")., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).

20 Nov 2009

Positive results from Sciele Pharma's second pivotal study of PSD502 for the treatment of PE

At the annual meeting of the Sexual Medicine Society of North America, Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company, and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC, today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).

19 Nov 2009

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

19 Nov 2009

New Drug Application for NicOx's naproxcinod accepted for filing

NicOx S.A. today announced that it has received a filing communication from the U.S. Food and Drug Administration (FDA) stating that the New Drug Application (NDA) for naproxcinod is accepted for filing. NicOx submitted the NDA on September 24th, seeking approval for the relief of the signs and symptoms of osteoarthritis.

18 Nov 2009

On-going Phase 2b study conducted by Roche of ITMN-191 modified

InterMune, Inc. today announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified.

18 Nov 2009

FDA provides feedback on the pending NDA for EXALGO tablets

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA).

17 Nov 2009

BioSante Pharmaceuticals applauds Boehringer Ingelheim for developing a therapy to treat HSDD

BioSante Pharmaceuticals, Inc., a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for the treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need.

17 Nov 2009

FDA approves Par Pharmaceutical's new painkiller drug

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER.

17 Nov 2009

ARCA biopharma provides financial and Gencaro NDA update

ARCA biopharma, Inc. today announced its planned next steps in response to the May 29, 2009 Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ARCA’s New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. Following receipt of the CRL, the Company and the FDA have held a series of meetings to discuss how best to address the requirements identified in the CRL.

17 Nov 2009

Addrenex Pharmaceuticals to be acquired by Sciele Pharma

Sciele Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd. and Addrenex Pharmaceuticals, Inc., a privately-held U.S. pharmaceutical company specializing in developing drugs that regulate the adrenergic system, today announced that Sciele has agreed to acquire Addrenex.

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Inovio Biomedical reports financial results for the three and nine months ended September 30, 2009

Inovio Biomedical Corporation today reported financial results for the three and nine months ended September 30, 2009.

16 Nov 2009

A.P. Pharma announces financial results for its third quarter ended September 30, 2009

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2009.

16 Nov 2009

Priority Review of the NDA for intravenous acetaminophen extended by three months

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months.

15 Nov 2009