New Drug Application News and Research

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FDA sets new PDUFA date for AstraZeneca's ticagrelor

AstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company's reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA).

4 Feb 2011

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported results through month 36 of the completed FAME™ Study.

4 Feb 2011

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN for the treatment of Diabetic Macular Edema, today announced month 36, top-line readout results for the FAME Study prepared by its licensee, Alimera Sciences.

4 Feb 2011

ZIOPHARM prices underwritten public offering of 9,600,000 shares of common stock

ZIOPHARM Oncology, today announced the pricing of an underwritten public offering of 9,600,000 shares of its common stock at a price to the public of $5.75 per share.

3 Feb 2011

FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA

Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the status of the company's New Drug Application (NDA) for Morphine Sulfate Oral Solution as well as other pending product applications.

2 Feb 2011

FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

Eisai announced today that the company received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.

2 Feb 2011

FDA approves NCI's Sodium Fluoride F18 NDA for use in bone scans

The FDA has approved a New Drug Application from the National Cancer Institute, part of the National Institutes of Health, for a new strength of a previously approved drug, Sodium Fluoride F18, for use in bone scans.

1 Feb 2011

Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the United States Food and Drug Administration (FDA) has issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

1 Feb 2011

$FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma$

FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted fast track designation for carfilzomib, a next generation proteasome inhibitor for the potential treatment of patients with relapsed and refractory multiple myeloma.

1 Feb 2011

FDA approves ultrasmall silica inorganic nanoparticle INDA for targeted molecular imaging of cancer

Researchers at Memorial Sloan-Kettering Cancer Center's Nanotechnology Center, along with collaborators at Cornell University and Hybrid Silica Technologies, have received approval for their first Investigational New Drug Application from the US Food and Drug Administration for an ultrasmall silica inorganic nanoparticle platform for targeted molecular imaging of cancer, which may be useful for cancer treatment in the future.

31 Jan 2011

MAP Pharmaceuticals, Allergan collaborate for LEVADEX to treat acute migraine in adults

Allergan, and MAP Pharmaceuticals, today announced a collaboration within the United States for LEVADEX, a self-administered, orally inhaled therapy that has completed Phase III clinical development for the treatment of acute migraine in adults.

31 Jan 2011

Endo Pharmaceutical partners receive Paragraph IV Certification for generic version of LIDODERM

Endo Pharmaceuticals announced today that its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, have received a Paragraph IV Certification Notice from Mylan Technologies advising of the filing of an Abbreviated New Drug Application for a generic version of LIDODERM.

31 Jan 2011

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication.

29 Jan 2011

King Pharmaceuticals awards payment to Pain Therapeutics for abuse-resistant medications

Pain Therapeutics, today announced that it had received a $5,000,000 milestone payment from King Pharmaceuticals, its exclusive commercial partner for abuse-resistant prescription pain medications.

29 Jan 2011

BioTime announces acquisition of CTI assets

BioTime, today announced that it has acquired substantially all the assets of Cell Targeting, a Cleveland, Ohio-based biotechnology company conducting research in regenerative medicine.

29 Jan 2011

FDA approves Mylan's ANDA for ER Tablets

Mylan 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 Nisoldipine Extended-release Tablets, 8.5 mg, 17 mg, 25.5 mg and 34 mg.

29 Jan 2011

Arena reduces workforce by 25% and provides update on lorcaserin

Arena Pharmaceuticals, Inc. announced today a reduction of its US workforce of approximately 25%, or 66 employees. As a result of the workforce reduction, which Arena plans to complete around March 28, 2011, the company expects to incur restructuring charges, primarily in the first quarter of 2011, of approximately $3.8 million in connection with one-time employee termination costs.

28 Jan 2011

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Pain Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY (controlled-release oxycodone) and has classified it as a Class 2 resubmission.

27 Jan 2011

FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

27 Jan 2011

Johnson & Johnson fourth quarter sales decreases 5.5% to $15.6 billion

Johnson & Johnson today announced sales of $15.6 billion for the fourth quarter of 2010, a decrease of 5.5% as compared to the fourth quarter of 2009. Operational sales declined 5.1% and the negative impact of currency was 0.4%. Domestic sales declined 8.1%, while international sales declined 3.1%, reflecting an operational decline of 2.3% and a negative currency impact of 0.8%.

25 Jan 2011

New Drug Application News and Research

FDA sets new PDUFA date for AstraZeneca's ticagrelor

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

ZIOPHARM prices underwritten public offering of 9,600,000 shares of common stock

FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA

FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

FDA approves NCI's Sodium Fluoride F18 NDA for use in bone scans

Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA

FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma

FDA approves ultrasmall silica inorganic nanoparticle INDA for targeted molecular imaging of cancer

MAP Pharmaceuticals, Allergan collaborate for LEVADEX to treat acute migraine in adults

Endo Pharmaceutical partners receive Paragraph IV Certification for generic version of LIDODERM

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

King Pharmaceuticals awards payment to Pain Therapeutics for abuse-resistant medications

BioTime announces acquisition of CTI assets

FDA approves Mylan's ANDA for ER Tablets

Arena reduces workforce by 25% and provides update on lorcaserin

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

Johnson & Johnson fourth quarter sales decreases 5.5% to $15.6 billion

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