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FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011.

10 Jan 2011

Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for its new formulation of OPANA® ER designed to be crush resistant.

10 Jan 2011

FDA, EMA accept boceprevir for expedited review

Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.

10 Jan 2011

Underwriters exercise over-allotment option in Amarin ADS public offering

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that, in connection with its previously announced underwritten public offering of American Depositary Shares ("ADSs"), the underwriters of the offering have exercised in full their option to purchase up to an aggregate of 1,800,000 additional ADSs to cover over-allotments.

7 Jan 2011

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Colorectal cancer (CRC) is the third most common cancer in men and women in the USA, with a new diagnosis made every 3.5 minutes and an associated death every 9 minutes.

6 Jan 2011

Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Salix Pharmaceuticals, Ltd. today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company's two pivotal Phase 3 efficacy and safety studies of XIFAXAN (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS.

6 Jan 2011

J&JPRD submits New Drug Application to FDA for rivaroxaban

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

6 Jan 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.

5 Jan 2011

Clinical Data closes sale of genetic, pharmacogenomic testing and biomarker development business

Clinical Data, Inc. today announced that the Company has closed the sale of its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc. for $15.5 million. The sale completes Clinical Data's transformation into a pharmaceutical company with a deep product pipeline, including two promising late-stage compounds, the most advanced of which is vilazodone, a new treatment in development for Major Depressive Disorder.

30 Dec 2010

FDA approves Impax's ANDA for generic Doryx 75 and 100mg tablets

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx® (doxycyline hyclate delayed-release) 75 and 100mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

29 Dec 2010

Intellect obtains pharmacokinetic data from OX1 Phase 1b trial for Alzheimer's disease

Intellect Neurosciences, Inc., a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has obtained a draft pharmacokinetic report from its completed Phase 1b trial for its lead Alzheimer's candidate, OX1. The Company previously reported on the safety aspects of the trial, which demonstrated that OX1 is safe and well tolerated at all dose levels tested.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

King Pharmaceuticals resubmits NDA for REMOXY

King Pharmaceuticals®, Inc. and Pain Therapeutics®, Inc. today announced that King has resubmitted a New Drug Application for REMOXY® to the U.S. Food and Drug Administration in response to a Complete Response letter received by Pain Therapeutics in December 2008.

28 Dec 2010

NDA resubmitted for DURECT's ORADUR technology based REMOXY

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. have announced that King has resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

28 Dec 2010

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS).

24 Dec 2010

Alimera receives FDA CRL for ILUVIEN NDA

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 (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

24 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010