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Kyowa Hakko Kirin enters into distribution agreement with Hisamitsu Pharmaceutical

Orexo AB announces today that its partner Kyowa Hakko Kirin Co., Ltd. has entered a joint distribution agreement for the cancer pain drug KW-2246 (Orexo’s sublingual fentanyl product) with the pharmaceutical company Hisamitsu Pharmaceutical Co., Inc.

2 Feb 2010

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.

1 Feb 2010

MPI Research lauds FDA's current guidance on abuse potential of drugs

On January 26, 2010, the Food and Drug Administration (FDA) released a key draft guidance document, Guidance for Industry Assessment of Abuse Potential of Drugs. When finalized, this guidance will represent the FDA’s current position on the abuse potential of drugs. Noteworthy within the document, Good Laboratory Practices (GLP) specified in the Guidance for Industry S7A Safety 471 Pharmacology Studies for Human Pharmaceuticals and in FDA regulations, 21 CFR 472 part 58, now also apply to abuse potential studies in animals.

30 Jan 2010

FDA approved 53 new oncology and hematology drugs between 2005 and 2007

Over a two and half year period, beginning in 2005 when the U.S. Food and Drug Administration's oncology drug product's office began reviewing marketing applications, a total of 60 new oncology and hematology drugs were reviewed, of which 53 were approved, according to a new article published online January 29 in the Journal of the National Cancer Institute.

30 Jan 2010

Mylan's subsidiary receives FDA approval for GoLytely laxative

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely® laxative.

30 Jan 2010

NIDA supports Omeros' Addiction program

Omeros Corporation today announced that the National Institute on Drug Abuse (NIDA) is providing support for the Company's Addiction program. NIDA will fund substantially all of the costs of a Phase 2 clinical study to be conducted by New York State Psychiatric Institute researchers.

28 Jan 2010

Celgene reports total revenue of $758M for fourth-quarter of 2009

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54 for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3 million, or diluted loss per share of $0.33.

28 Jan 2010

MPM Capital leads Alnara Pharmaceuticals' $35M Series B venture capital financing

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing non-systemic, orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that it has secured $35 million in Series B venture capital financing. The round was led by new investor MPM Capital, joined by current investors Third Rock Ventures, Frazier Healthcare and Bessemer Venture Partners. In conjunction with the MPM investment, managing director Ashley Dombkowski, Ph.D., will join Alnara’s board of directors.

28 Jan 2010

Pfizer's new pipeline shows growth and diversity in research and development

Pfizer Inc. today provided an update to its pipeline for the first time since the close of the acquisition of Wyeth in October, 2009. The new development pipeline, composed of assets from both legacy companies, includes 133 programs from phase 1 through registration, and shows growth and increased diversity in each of the areas where the company invests in research and development.

28 Jan 2010

Sepracor's STEDESA NDA: FDA extends PDUFA action date

Sepracor Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency now anticipates completing its review of the STEDESA™ (eslicarbazepine acetate) New Drug Application (NDA) on April 30, 2010, which is a three-month extension to the original Prescription Drug User Fee Act (PDUFA) date of January 30, 2010.

28 Jan 2010

Gilead Sciences reviewing Notice Letter regarding Teva Pharmaceuticals' generic Viread ANDA

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals 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 Viread® (tenofovir disoproxil fumarate).

27 Jan 2010

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).

27 Jan 2010

U.S. court decision favors Teva in generic Temodar ANDA litigation

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough’s brain tumor treatment Temodar® (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct.

27 Jan 2010

FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration.

27 Jan 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.

25 Jan 2010

Elan Drug Technologies issues statement on FDA approval of AMPYRA

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS).

25 Jan 2010

FDA approves fampridine-SR drug for treatment of multiple sclerosis

The Food and Drug Administration has approved the drug fampridine-SR for the treatment of multiple sclerosis. Researchers at the University of Rochester Medical Center (URMC) have been evaluating the effects of the drug in MS for more than 10 years- it is the first medication shown to enhance some neurological functions in people with the disease - and their efforts helped pave the way for today's action by the FDA.

23 Jan 2010

NicOx receives EMEA approval for naproxcinod MAA

NicOx S.A. today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009. NicOx is seeking approval for an indication for the relief of the signs and symptoms of primary osteoarthritis. This follows the acceptance for filing of a New Drug Application (NDA) by the US Food and Drug Administration (FDA) in November 2009.

22 Jan 2010