FDA

FDA approves generic olanzapine injection

Thursday, October 27, 2011 10:40 AM

The FDA has approved INNOPHARMA’s Abbreviated New Drug Application (ANDA) for olanzapine injection (the generic equivalent of ZyprexaR injection).

More... »

Life Technologies, GSK ink cancer research agreement

Wednesday, October 26, 2011 10:55 AM

Life Technologies has signed an agreement with GlaxoSmithKline to develop a diagnostic to be used as a companion test with a GSK candidate cancer immunotherapy. Life will develop a qPCR-based molecular diagnostic assay for GSK's MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the immunotherapy.

More... »

Cubist acquires Adolor in an agreement worth $415 million

Monday, October 24, 2011 01:00 PM

Cubist Pharmaceuticals and Adolor have signed a definitive agreement under which Cubist will acquire all of the outstanding shares of Adolor for approximately $190 million on a fully-diluted basis, net of Adolor's third quarter 2011 cash balance. The total transaction is valued at up to $415 million, net of Adolor's third quarter 2011 cash balance, and is expected to be accretive in 2012.

More... »

Middle East region poised for clinical trials growth

Monday, October 24, 2011 08:00 AM

With sponsors and CROs still on the hunt for emerging markets rife with treatment-naive patients and good infrastructure, interest in the Middle East is increasing.

More... »

Imagen Biotech secures $40 million in Series A financing

Thursday, October 20, 2011 10:22 AM

Imagen Biotech has secured up to $40 million in Series A financing from SV Life Sciences, Novo Ventures, and Fidelity Biosciences to pursue the identification and development of breakthrough treatments for blinding diseases with high unmet medical needs, including dry age-related macular degeneration. Matthew Feinsod, MD, an ophthalmologist who was formerly at Eyetech Pharmaceuticals and a medical officer in the FDA's Ophthalmology Division, will lead these efforts as chief medical officer for Imagen. Additional terms will not be disclosed.

More... »

TOPICA secures $27 million in Series B funding

Tuesday, October 18, 2011 01:52 PM

TOPICA Pharmaceuticals has raised $27 million in a Series B financing, led by Third Rock Ventures and existing investors Prospect Venture Partners and Yasuda Enterprise Development. Proceeds of the financing will be used to advance the company's broad-spectrum topical antifungal agent, luliconazole, for the treatment of onychomycosis, fungal infections of the nail.

More... »

VIVUS resubmits NDA for Qnexa

Monday, October 17, 2011 11:37 AM

VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential.  The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

More... »

Pearl IRB expands into compliance and consulting

Monday, October 17, 2011 08:00 AM

Indianapolis-based Pearl IRB is expanding. The commercial institutional review board, launched just last year, is now adding a regulatory and compliance division, as well as a consulting division that will focus on helping life sciences startups.

More... »

Anavex names executive director

Wednesday, October 12, 2011 11:52 AM

Anavex Life Sciences has named Dr. George Tidmarsh executive director. 

More... »

FDA approves Fluoxetine 60mg tablets

Tuesday, October 11, 2011 12:55 PM

Edgemont Pharmaceuticals has reported that the FDA has approved its New Drug Application (NDA) for Fluoxetine tablets 60 mg.

More... »