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Sucampo receives supplement approval from FDA for AMITIZA

Sucampo Pharmaceuticals, Inc. today announced that the Company received a supplement approval from the U.S. Food and Drug Administration (FDA) that removes pregnancy "warnings and precautions" and clarifies information regarding the use of AMITIZA (lubiprostone) by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for AMITIZA.

30 Nov 2012

Eisai announces FDA acceptance of AcipHex NDA for priority review

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's New Drug Application (NDA) for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age.

30 Nov 2012

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

30 Nov 2012

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

Exelixis, Inc. today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

29 Nov 2012

InSite Vision completes enrollment in BromSite Phase 3 trial for reduction of pain, inflammation

InSite Vision Incorporated today announced that patient enrollment has been completed in the first Phase 3 clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery.

29 Nov 2012

Ponatinib thwarts T315I gene mutation in chronic myeloid leukemia

A previously invincible mutation in chronic myeloid leukemia (CML) has been thwarted by an investigational drug in a phase I clinical trial reported in the current edition of The New England Journal of Medicine.

29 Nov 2012

Suvorexant may bring help for people with insomnia

A new drug may bring help for people with insomnia, according to a study published in the November 28, 2012, online issue of Neurology, the medical journal of the American Academy of Neurology.

29 Nov 2012

FDA grants final approval to Cobrek’s generic Luxiq foam NDA for treatment of scalp psoriasis

Perrigo Company today announced that its partner, Cobrek Pharmaceuticals, Inc., received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq Foam.

28 Nov 2012

Medgenics’ EPODURE Biopump technology for EPO delivery receives U.S. patent

Medgenics, Inc., the developer of BiopumpTM a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced a patent granted by the U.S. Patent and Trademark Office (USPTO) protecting the use of Medgenics' EPODURE Biopump technology for delivery of erythropoietin (EPO).

22 Nov 2012

FDA accepts MAP Pharmaceuticals’ resubmission of NDA for LEVADEX

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) resubmission for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA).

22 Nov 2012

KemPharm announces successful Type B meeting with FDA for KP201

KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today a successful Type B meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201.

19 Nov 2012

FDA accepts Orexo’s Zubsolv NDA for review

FDA has informed Orexo that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee Act (PDUFA) action date will be July 6, 2013.

19 Nov 2012

Positive results from POZEN’s PA8140-102 Phase 1 bioavailability study

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the results from a Phase 1 study, PA8140-102, demonstrated that PA8140, POZEN's proprietary combination of aspirin (81 mg) and omeprazole (40 mg), had comparable bioavailability relative to the reference listed product, enteric-coated (EC) aspirin (81 mg).

16 Nov 2012

Feinstein seeks NDA approval for Fluorodopa F 18 PET scan to diagnose parkinsonian syndromes

The Feinstein Institute for Medical Research announced today the submission of a New Drug Application to the US Food and Drug Administration (FDA) for the Fluorodopa F 18 positron emission tomography (PET) scan used to diagnose parkinsonian syndromes.

15 Nov 2012

FDA accepts Navidea’s resubmitted NDA for Lymphoseek

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the Company's October 30, 2012 resubmission of its New Drug Application (NDA) for Lymphoseek (Technetium Tc 99m Tilmanocept) Injection.

14 Nov 2012

Omeros to present results from first pivotal Phase 3 trial of OMS302 at AAO annual meeting

Omeros Corporation today reported that it will present data from its first pivotal Phase 3 clinical trial evaluating OMS302 at the American Academy of Ophthalmology (AAO) Annual Meeting, which will take place from November 10 through November 13 in Chicago, Illinois.

9 Nov 2012

FDA accepts Merck’s suvorexant NDA for standard review

Merck, known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for suvorexant, the company's investigational insomnia medicine, has been accepted for standard review by the U.S. Food and Drug Administration (FDA).

9 Nov 2012

Mayo Clinic receives FDA approval for Choline C 11 Injection to help detect prostate cancer

Mayo Clinic has received U.S. Food and Drug Administration approval to produce and administer Choline C 11 Injection, an imaging agent used during a positron emission tomography (PET) scan to help detect sites of recurrent prostate cancer. Mayo Clinic is the first, and currently only, institution in North America approved to produce this imaging agent.

9 Nov 2012

Soligenix receives FDA Fast Track designation for SGX203 to treat pediatric Crohn's disease

Soligenix, Inc., a development stage biopharmaceutical company, announced today that its program for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate pediatric Crohn's disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA).

8 Nov 2012

Alnylam third quarter 2012 revenues decrease to $16.8 million

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter 2012, and company highlights.

6 Nov 2012

New Drug Application News and Research

Sucampo receives supplement approval from FDA for AMITIZA

Eisai announces FDA acceptance of AcipHex NDA for priority review

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

InSite Vision completes enrollment in BromSite Phase 3 trial for reduction of pain, inflammation

Ponatinib thwarts T315I gene mutation in chronic myeloid leukemia

Suvorexant may bring help for people with insomnia

FDA grants final approval to Cobrek’s generic Luxiq foam NDA for treatment of scalp psoriasis

Medgenics’ EPODURE Biopump technology for EPO delivery receives U.S. patent

FDA accepts MAP Pharmaceuticals’ resubmission of NDA for LEVADEX

KemPharm announces successful Type B meeting with FDA for KP201

FDA accepts Orexo’s Zubsolv NDA for review

Positive results from POZEN’s PA8140-102 Phase 1 bioavailability study

Feinstein seeks NDA approval for Fluorodopa F 18 PET scan to diagnose parkinsonian syndromes

FDA accepts Navidea’s resubmitted NDA for Lymphoseek

Omeros to present results from first pivotal Phase 3 trial of OMS302 at AAO annual meeting

FDA accepts Merck’s suvorexant NDA for standard review

Mayo Clinic receives FDA approval for Choline C 11 Injection to help detect prostate cancer

Soligenix receives FDA Fast Track designation for SGX203 to treat pediatric Crohn's disease

Alnylam third quarter 2012 revenues decrease to $16.8 million

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