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Positive results from Alnylam’s ALN-PCS Phase I trial on severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive results from its Phase I clinical trial of ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of severe hypercholesterolemia.

21 Apr 2012

Depomed, Valeant file suit against Watson over generic Glumetza

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Metformin Hydrochloride Extended-release Tablets USP, 1000 mg.

20 Apr 2012

Impax announces data from IPX066 Phase III study on Parkinson's

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., today announced that data from the ASCEND-PD Phase III clinical study involving IPX066 will be presented in a Platform Presentation at the 64th Annual Meeting of the American Academy of Neurology in New Orleans, Louisiana, held from April 21 to April 28.

19 Apr 2012

Synthon receives tentative approval for tadalafil tablets

Synthon has announced that its subsidiary Synthon Pharmaceuticals, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for tadalafil tablets, 20 mg on April 13, 2012. Synthon's product is a generic and bioequivalent version of Eli Lilly & Co and United Therapeutics’ Adcirca® tablets, which are indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.

16 Apr 2012

Mylan receives final FDA approval for generic Lescol Capsules ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules.

16 Apr 2012

Impax initiates challenge of patents related to generic Gralise

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Gralise (gabapentin tablets, 300 mg and 600 mg).

12 Apr 2012

AcelRx commences dosing in second ARX-01 Phase 3 clinical trial for acute post-operative pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported dosing of the first patient in the second of three planned Phase 3 studies that will form the basis of a planned New Drug Application for the Sufentanil NanoTab PCA System, ARX-01.

12 Apr 2012

MacuCLEAR to initiate MC-1101 Phase III studies on early-stage AMD

MacuCLEAR, Inc., a clinical stage specialty pharmaceutical company focused on discovering and developing novel solutions for vascular disorders of the eye, announced today it is beginning Phase III studies for its lead compound, MC-1101, for early-stage (Dry) age-related macular degeneration (AMD), based on positive feedback during the company's end-of-Phase II meeting with the FDA.

12 Apr 2012

QRxPharma completes MoxDuo CR Phase 1 studies on chronic pain

QRxPharma announced today successful completion of two Phase 1 studies in healthy volunteers for MoxDuo CR, a controlled-release Dual-Opioid utilising a 3:2 ratio of morphine and oxycodone.

11 Apr 2012

Tonix completes TNX-102 pharmacokinetic study on fibromyalgia syndrome

Tonix Pharmaceuticals Holding Corp., a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system completed a pharmacokinetic (PK) study of the first formulation of its lead drug, TNX-102, for the treatment of fibromyalgia syndrome.

6 Apr 2012

Sucampo announces positive results from lubiprostone phase 3 trial on OBD

Sucampo Pharmaceuticals, Inc. today announced positive top-line results from an open-label phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.

6 Apr 2012

Astellas' mirabegron for OAB receives FDA advisory committee approval

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration voted that the overall risk/benefit assessment supports approval of mirabegron for the treatment of overactive bladder.

6 Apr 2012

Mylan seeks to overturn FDA decision on generic Provigil

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil.

6 Apr 2012

Keryx does not meet primary endpoint in perifosine + capecitabine Phase 3 trial for colorectal cancer

Keryx Biopharmaceuticals, Inc. reported today that the Phase 3 "X-PECT" clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

3 Apr 2012

Teva introduces generic Provigil

Teva Pharmaceutical Industries Ltd. announces the launch of the authorized generic of Provigil (modafinil).

31 Mar 2012

Enrolment complete in Veloxis LCP-Tacro Phase III study in de novo kidney transplant patients

Veloxis Pharmaceuticals A/S today announced that enrolment has been completed in its pivotal LCP-Tacro Phase III study in de novo kidney transplant patients. The LCP-Tacro 3002 study is designed to demonstrate non-inferiority versus the gold standard therapy Prograf and has randomized over 540 patients at approximately 90 clinical sites around the world.

29 Mar 2012

FDA extends review period for Almirall and Forest Labs' aclidinium bromide NDA

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease.

29 Mar 2012

Spherix 2011 net loss decreases to $3.5 million

Spherix Incorporated – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today reported financial results for the year ended December 31, 2011, and recent and upcoming business highlights.

29 Mar 2012

AHF calls on FDA Commissioner Hamburg to step down

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS organization, today called on Food and Drug Administration (FDA) Commissioner Margaret Hamburg to step down in response to the agency's gross mismanagement of new product reviews and a lack of transparency.

29 Mar 2012