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FDA grants tentative approval for Impax Laboratories' generic Opana ER

Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Opana® ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets.

14 May 2010

Inhibitex reports net loss of $4.8M for first-quarter 2010

Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.

14 May 2010

DMC recommends Celsion to continue enrollment in ThermoDox clinical study for primary liver cancer

Celsion Corporation announced today that after reviewing data from 294 patients including data from 12 Japanese patients enrolled in the pivotal Phase III ThermoDox® clinical study (HEAT Study) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

14 May 2010

Neurologix reports lower net loss of $3.5M for first-quarter 2010

Neurologix, Inc., a biotechnology company developing innovative gene therapies for the brain and central nervous system, today announced its financial results for the quarter ended March 31, 2010.

14 May 2010

ARYx Therapeutics decreases first-quarter net loss to $6.4 million

ARYx Therapeutics, Inc. today reported results of operations and provided an update on its business activities for the first quarter ended March 31, 2010.

13 May 2010

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Repligen Corporation announced today that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for a Phase 1 study of RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor. This is a double-blind, single ascending dose, Phase 1 study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects.

13 May 2010

PAREXEL further expands presence in China with offices in Chengdu and Guangzhou

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that the Company has opened offices in Chengdu and Guangzhou, China to support a growing requirement for a broad range of clinical development and regulatory consulting capabilities in the country and throughout the Asia/Pacific region.

From Parexel 13 May 2010

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today reported financial and operating results as at and for the three months ended March 31, 2010.

13 May 2010

FDA Advisory Committee planned to review Lux Biosciences' NDA for voclosporin

Isotechnika Pharma Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration is scheduled to review partner, Lux Biosciences', New Drug Application for voclosporin on June 28, 2010.

13 May 2010

Transcept Pharmaceuticals reports revenue of $3.13M for first-quarter 2010

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced financial results for the three months ended March 31, 2010.

13 May 2010

pSivida reports consolidated net loss of $2.7 million for third-quarter 2010

pSivida Corp., a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its third quarter and nine months ended March 31, 2010.

13 May 2010

Merck hosts R&D and Business Briefing

Merck & Co., Inc. today hosted its first R&D and Business Briefing since the completion of the Merck and Schering-Plough merger. The event included a comprehensive review of the company's late-stage pipeline, as well as the company's commercial strategy and progress made in the integration of Merck's worldwide operations.

12 May 2010

FDA Dermatology and Ophthalmology Drugs Advisory Committee to review Lux Biosciences’ Luveniq NDA

Lux Biosciences, Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review its New Drug Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye on June 28, 2010.

12 May 2010

Sucampo reports $0.3M net loss, $14.8M total revenue for first-quarter 2010

Sucampo Pharmaceuticals, Inc. today reported its consolidated financial results for the quarter ended March 31, 2010.

11 May 2010

Orexigen Therapeutics first-quarter net loss decreases to $14.1 million

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the first quarter of 2010. For the quarter ended March 31, 2010, Orexigen reported a net loss of $14.1 million, or $0.30 per share attributable to common stockholders, as compared to a net loss of $19.3 million, or $0.56 per share attributable to common stockholders, for the first quarter of 2009.

11 May 2010

Alexza Pharmaceuticals first-quarter net loss increases to $13.4 million

Alexza Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2010 and provided a business update.

11 May 2010

FDA approves Cipher's CIP-TRAMADOL ER for chronic pain

Cipher Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration has approved CIP-TRAMADOL ER, the Company's extended-release tramadol product, for the treatment of moderate to moderately severe chronic pain in adults.

10 May 2010

Data comparing NUCYNTA to oxycodone IR for osteoarthritis pain presented at 29th APS

A post-hoc analysis of a Phase 3 safety study demonstrated that NUCYNTA® (tapentadol) tablets were associated with a lower incidence of nausea, vomiting and constipation when compared to oxycodone immediate release (IR) tablets in elderly patients with moderate to severe low-back or osteoarthritis pain.

7 May 2010

Arena Pharmaceuticals reports lower net loss of $31.3 million in first-quarter 2010

Arena Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2010.

7 May 2010

Intellipharmaceutics generic Effexor XR ANDA accepted for filing by the FDA

Intellipharmaceutics International Inc., today announced that the Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for a generic version of the antidepressant Effexor XR® (venlafaxine hydrochloride).

7 May 2010