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Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.

31 Aug 2010

FDA grants Priority Review status to Alimera Sciences' Iluvien for diabetic macular edema

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that the Company's New Drug Application (NDA) for Iluvien® (fluocinolone acetonide intravitreal insert) has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration (FDA).

31 Aug 2010

FDA extends Prescription Drug User Fee Act date for ezogabine

GlaxoSmithKline and Valeant Pharmaceuticals International announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine to 30 November 2010.

31 Aug 2010

BioMarin's BMN-701 receives FDA orphan drug designation for treatment of Pompe disease

BioMarin Pharmaceutical Inc. announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease. An investigational new drug application (IND) for BMN-701 has been submitted, investigational material has been manufactured and a Phase I/II study is expected to start in the first quarter of 2011.

30 Aug 2010

Eisai receives new action date for FDA priority review of eribulin mesylate NDA for metastatic breast cancer

Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010.

30 Aug 2010

Protalix common stock receives approval for Tel Aviv Stock Exchange listing

Protalix BioTherapeutics, Inc.,a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, today announced that the Company's common stock has been approved for listing on the Tel Aviv Stock Exchange in addition to its current listing on the NYSE Amex.

30 Aug 2010

KemPharm broadens protection for LAT prodrug technology platform for ADHD with second patent

KemPharm, Inc. announced today that it has received a Notice of Issuance from the United States Patent and Trademark Office (USPTO) for its patent application entitled "Non-Standard Amino Acid Conjugates of Amphetamine and Processes for Making and Using the Same", U.S. Patent No. 7,776,917 B2. This patent, combined with KemPharm's recently issued U.S. Patent No. 7,772,222, provides broad protection of the Company's Ligand Activated Therapy (LAT) prodrug technology platform and its application to the treatment of Attention Deficit – Hyperactivity Disorder.

27 Aug 2010

Alexza Pharmaceuticals licenses Staccato nicotine technology to Cypress Bioscience

Alexza Pharmaceuticals, Inc. announced today that it has licensed its Staccato nicotine technology to Cypress Bioscience, Inc. The Staccato nicotine technology is a novel electronic multidose delivery system designed to help people stop smoking. The Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation, mimicking the nicotine effects of smoking without the harmful side effects associated with cigarettes.

26 Aug 2010

Momenta Pharmaceuticals provides update on generic Lovenox litigation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that on August 25, 2010, the United States District Court for the District of Columbia denied sanofi-aventis U.S. LLC's request for a preliminary injunction directing the FDA to suspend and withdraw its approval of the Abbreviated New Drug Application (ANDA) filed by the Company's collaboration partner, Sandoz, for enoxaparin sodium injection USP, a generic version of Lovenox®. The decision is subject to appeal.

26 Aug 2010

FDA notification confirms acyclovir Lauriad for oro-facial herpes labialis

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, today announces that the US Food and Drug Administration (FDA) considers the positive results of the pivotal phase III study with acyclovir Lauriad acceptable to submit a 505(b)(2) New Drug Application of the product in the United States.

26 Aug 2010

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

26 Aug 2010

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

CHX Technologies Inc., a private Canadian pharmaceutical company that is developing new treatments for the prevention of dental diseases, today announced successful results in its final controlled pivotal trial of Prevora, its proprietary antibacterial tooth coating for the prevention of cavities. The trial surpassed objectives set by the Food and Drug Administration (FDA) protocol, clearing the way for CHX to start the process of seeking FDA approval for use in the United States.

25 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

FDA grants Fast Track Designation to Celsion's ThermoDox for liver cancer treamtment

Celsion Corporation, a leading oncology drug development company, today announced that the U.S. Food and Drug Administration has designated the HEAT Study of its investigational drug, ThermoDox, in combination with radiofrequency ablation, as a Fast Track Development Program.

25 Aug 2010

Epicept receives refusal to file letter on new drug application

EpiCept Corporation today announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene(histamine dihydrochloride).

23 Aug 2010

Jazz Pharmaceuticals disappointed with FDA Advisory Committee recommendation for JZP-6 in fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

21 Aug 2010

Impax confirms initiation of challenge of patents listed by MSP Singapore for VYTORIN

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by MSP Singapore Co. LLC in connection with VYTORIN® (ezetimibe/simvastatin), 10 mg/80 mg.

21 Aug 2010

FDA extends review on Acetadote for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure.

21 Aug 2010

Gilead receives Notice Letter of Sigmapharm's ANDA submission for generic Hepsera

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Sigmapharm Laboratories, LLC submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Hepsera® (adefovir dipivoxil).

20 Aug 2010

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Sun Pharma announced that USFDA has granted an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Venlafaxine Hydrochloride Extended Release tablets.

19 Aug 2010

New Drug Application News and Research

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

FDA grants Priority Review status to Alimera Sciences' Iluvien for diabetic macular edema

FDA extends Prescription Drug User Fee Act date for ezogabine

BioMarin's BMN-701 receives FDA orphan drug designation for treatment of Pompe disease

Eisai receives new action date for FDA priority review of eribulin mesylate NDA for metastatic breast cancer

Protalix common stock receives approval for Tel Aviv Stock Exchange listing

KemPharm broadens protection for LAT prodrug technology platform for ADHD with second patent

Alexza Pharmaceuticals licenses Staccato nicotine technology to Cypress Bioscience

Momenta Pharmaceuticals provides update on generic Lovenox litigation

FDA notification confirms acyclovir Lauriad for oro-facial herpes labialis

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

FDA grants Fast Track Designation to Celsion's ThermoDox for liver cancer treamtment

Epicept receives refusal to file letter on new drug application

Jazz Pharmaceuticals disappointed with FDA Advisory Committee recommendation for JZP-6 in fibromyalgia

Impax confirms initiation of challenge of patents listed by MSP Singapore for VYTORIN

FDA extends review on Acetadote for non-acetaminophen acute liver failure

Gilead receives Notice Letter of Sigmapharm's ANDA submission for generic Hepsera

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

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