New Drug Application News and Research

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Lessons on the journey to commercialisation

One of the Asia Pacific region’s best known biotech leaders, Dr Greg Collier, says successful commercialisation of a new drug or therapy takes, “discipline, a strong set of nerves and a stroke of luck.”

28 Sep 2012

ARIAD Pharmaceuticals completes rolling submission of ponatinib NDA with FDA

ARIAD Pharmaceuticals, Inc. today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA).

28 Sep 2012

Aeterna Zentari expects to file AEZS-130 NDA with FDA for adult growth hormone deficiency

Aeterna Zentaris Inc. today announced that it continues to expect to file a New Drug Application (NDA) early next year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD), after receiving notification from the United States Food and Drug Administration (FDA) that Fast Track designation had not been granted.

27 Sep 2012

Amakem commences AMA0076 Phase 2a study in glaucoma and ocular hypertension

Amakem NV, a kinase platform company focusing on ophthalmology, today announces that it has initiated a Phase 2a proof of concept study of its novel Rho Kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension.

27 Sep 2012

Forest submits levomilnacipran NDA with FDA for treatment of major depressive disorder

Forest Laboratories, Inc. and Pierre Fabre Laboratories todayannounced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of Major Depressive Disorder (MDD) in adults.

27 Sep 2012

Pfizer, Bristol-Myers Squibb report FDA acknowledgement of ELIQUIS NDA resubmission

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for ELIQUIS (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).

27 Sep 2012

Positive results from Antares Pharma’s VIBEX MTX clinical study on rheumatoid arthritis

Antares Pharma, Inc. today announced positive results from an Actual Human Use (AHU) study for VIBEX Methotrexate (MTX).

25 Sep 2012

EPO grants patent to Aeterna Zentaris’ AEZS-130 for diagnosis of growth hormone deficiency

Aeterna Zentaris Inc. today announced that the European Patent Office has granted a patent for the use of the ghrelin agonist, AEZS-130, related to methods and kits for use in relation to the diagnosis of growth hormone deficiency in a human or animal subject.

25 Sep 2012

New clinical trial to evaluate DEX-M74 against hereditary inclusion body myopathy

Researchers have launched a clinical trial to evaluate the drug candidate DEX-M74 as a treatment for a rare degenerative muscle disease, hereditary inclusion body myopathy (HIBM). National Institutes of Health scientists from the National Center for Advancing Translational Sciences (NCATS) and the National Human Genome Research Institute (NHGRI) will conduct the clinical trial at the NIH Clinical Center.

25 Sep 2012

pSivida reports revenues of $699,000 for fourth quarter 2012

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced financial results for its fourth quarter and fiscal year ended June 30, 2012.

25 Sep 2012

Astellas seeks FDA approval for tacrolimus NDA for prophylaxis of organ rejection

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for tacrolimus extended release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

24 Sep 2012

Sleep medicine and research: an interview with James K. Walsh

There are a variety of sleep medicines. I am going to refer to what are commonly described as hypnotics or sleeping pills. Sleeping pills have been around for a long time.

24 Sep 2012

FDA approves Mylan's ANDA for generic Antivert

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Meclizine Hydrochloride Tablets USP, 12.5 mg, 25 mg and 50 mg.

21 Sep 2012

FDA approves Acton’s AEROSPAN sNDA to treat asthma

Acton Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the sNDA (Supplemental New Drug Application) for AEROSPAN (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older.

21 Sep 2012

FDA Oncologic Drugs Advisory Committee to review Celgene’s pomalidomide NDA on Nov. 8

Celgene Corporation today announced the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee will hold a review of the Company's new drug application (NDA) for pomalidomide at its meeting on November 8, 2012.

20 Sep 2012

Hemerus Medical’s SOLX red blood cell additive receives world's first CE Marking

Hemerus Medical, LLC, a Minnesota-based company that develops innovative technologies for the collection, processing, preservation, and storage of blood products announced that it has received the world's first CE Marking for a 56 day red blood cell storage solution – the SOLX red blood cell additive (AS-7).

18 Sep 2012

FDA approves Lannett’s ANDA for Butalbital, Acetaminophen and Caffeine Tablets

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg.

15 Sep 2012

Durata Therapeutics completes dalbavancin Phase 3 trials on ABSSSI

Durata Therapeutics today announced results from its QT study of the company's lead product candidate, dalbavancin. Dalbavancin is currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

11 Sep 2012

Atox Bio AB103 for Necrotizing Soft Tissue Infections granted FDA Fast Track designation

Atox Bio, a clinical stage biotechnology company engaged in the development of novel immunemodulators for severe infections in critically ill patients, announced today that the U.S. Food and Drug Administration has granted Fast Track designation to AB103, its lead product, currently in development for the treatment of Necrotizing Soft Tissue Infections (NSTI).

10 Sep 2012

Phase III data for Suvorexant, an investigational insomnia medicine, announced

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia. The new data are from one of the longest, continuously-dosed, placebo-controlled trials of a sleep medication ever conducted.

10 Sep 2012

New Drug Application News and Research

Lessons on the journey to commercialisation

ARIAD Pharmaceuticals completes rolling submission of ponatinib NDA with FDA

Aeterna Zentari expects to file AEZS-130 NDA with FDA for adult growth hormone deficiency

Amakem commences AMA0076 Phase 2a study in glaucoma and ocular hypertension

Forest submits levomilnacipran NDA with FDA for treatment of major depressive disorder

Pfizer, Bristol-Myers Squibb report FDA acknowledgement of ELIQUIS NDA resubmission

Positive results from Antares Pharma’s VIBEX MTX clinical study on rheumatoid arthritis

EPO grants patent to Aeterna Zentaris’ AEZS-130 for diagnosis of growth hormone deficiency

New clinical trial to evaluate DEX-M74 against hereditary inclusion body myopathy

pSivida reports revenues of $699,000 for fourth quarter 2012

Astellas seeks FDA approval for tacrolimus NDA for prophylaxis of organ rejection

Sleep medicine and research: an interview with James K. Walsh

FDA approves Mylan's ANDA for generic Antivert

FDA approves Acton’s AEROSPAN sNDA to treat asthma

FDA Oncologic Drugs Advisory Committee to review Celgene’s pomalidomide NDA on Nov. 8

Hemerus Medical’s SOLX red blood cell additive receives world's first CE Marking

FDA approves Lannett’s ANDA for Butalbital, Acetaminophen and Caffeine Tablets

Durata Therapeutics completes dalbavancin Phase 3 trials on ABSSSI

Atox Bio AB103 for Necrotizing Soft Tissue Infections granted FDA Fast Track designation

Phase III data for Suvorexant, an investigational insomnia medicine, announced

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