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Covance Shanghai facility receives OECD Good Laboratory Practice certification

Covance Inc. today announced that its early development facility located in Shanghai, China, has received Good Laboratory Practice (GLP) certification from the Belgian GLP Monitoring Authority, a member of the Organization for Economic Cooperation and Development (OECD). The Covance facility in Shanghai provides bioanalytical, toxicology, lead optimization toxicology, in-vivo PK screening, and metabolism services.

24 Oct 2011

First Edition: October 24, 2011

Today's headlines include a variety of health policy news developments, including speculation about how the Supreme Court might review the health law and what's happening with the super committee.

24 Oct 2011

CoreLab Partners releases new semi-automated CalECG v3 solution

CoreLab Partners, Inc. has launched a new semi-automated ECG solution through its ongoing collaboration with Analyzing Medical Parameters for Solutions (A.M.P.S.) LLC.

24 Oct 2011

Cubist signs definitive agreement to acquire Adolor

Cubist Pharmaceuticals, Inc. and Adolor Corporation today announced that they have signed a definitive agreement under which Cubist will acquire all of the outstanding shares of Adolor for $4.25 per share in cash, or approximately $190 million on a fully-diluted basis, net of Adolor's third quarter 2011 cash balance.

24 Oct 2011

SafeMinds praises UNEP's draft treaty ban on use of mercury in pharma products

SafeMinds applauds UNEP's draft treaty language which does not exempt the use of mercury in pharmaceutical products, including vaccines, from the global ban. Governmental regulators, public health officials and pharmaceutical companies have recognized that the toxicity of mercury in pharmaceutical and personal care products, to which people are directly exposed, justifies a preventive approach to minimize all exposures.

24 Oct 2011

Synergy commences plecanatide Phase II/III trial in chronic idiopathic constipation

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced initiation of dosing of patients in a major Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation.

24 Oct 2011

Arrowhead acquires RNA therapeutics assets from Roche

Arrowhead Research Corporation, today announced that it has acquired RNA therapeutics assets from Roche including the state-of-the-art research site in Madison, WI.

24 Oct 2011

Mirna, Silence enter agreement to assess delivery systems for novel microRNAs

Silence Therapeutics plc, a leading RNA interference (RNAi) therapeutics company, today announced that it has entered into an agreement with Mirna Therapeutics Inc., a biopharmaceutical company pioneering microRNA-based therapeutics for cancer, to assess the delivery capabilities of Silence's proprietary AtuPLEX and DBTC delivery systems for Mirna's novel microRNAs.

24 Oct 2011

FDA accepts Ironwood and Forest Laboratories' linaclotide NDA for review

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation.

24 Oct 2011

Abbott, Biogen Idec announce additional results from daclizumab HYP Phase 2b trial for RRMS

Today Biogen Idec and Abbott announced additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate the investigational compound daclizumab high-yield process in people with relapsing-remitting multiple sclerosis.

22 Oct 2011

Small molecule selectively blocks gene activity regulated by thyroid hormone

A small molecule developed at St. Jude Children's Research Hospital advances progress toward more tailored drugs in research that also offers insight into the biology of thyroid hormone.

22 Oct 2011

Ferring reports on FDA approval of labeling supplement for EUFLEXXA to treat knee osteoarthritis

On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.

22 Oct 2011

Janssen announces FDA label update approval for PREZISTA HIV tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for PREZISTA (darunavir) tablets to include 192-week data from the ARTEMIS study.

22 Oct 2011

Brazil to become world supplier of Chagas disease treatment

"Brazil is keen to take part in the international effort to expand access to medicines and to produce its own drugs, and will start by becoming the world supplier of medicines to treat Chagas disease," Health Minister Alexandre Padilha announced "at the World Conference on Social Determinants of Health, which opened Tuesday October 19 in Rio de Janeiro," Inter Press Service reports.

22 Oct 2011

Merz presents XEOMIN clinical data on dystonia at IDS 2011

New data presented at recent neurological congresses and summarized at the IDS indicate that patients treated with XEOMIN for cervical dystonia or blepharospasm (involuntary closing of the eyelids) experienced long-term sustained efficacy with a favorable safety profile in studies of up to 121 and 88 weeks duration, respectively.

22 Oct 2011

Positive top line results from Shire's LDX phase III study on ADHD

Shire plc, the global specialty biopharmaceutical company, today presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder.

22 Oct 2011

Watson receives FDA approval for Androderm lower-dose formulations

Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved its Androderm (testosterone transdermal system) 2 mg and 4 mg formulation.

21 Oct 2011

Preclinical data from Teva's COPAXONE study on multiple sclerosis

Teva Pharmaceutical Industries Ltd. today announced preclinical data demonstrating reparative and neuroprotective effects of treatment with COPAXONE (glatiramer acetate injection) in experimental autoimmune encephalomyelitis (EAE) models.

21 Oct 2011

OncoGenex commences enrollment in OGX-427 Phase II trial for bladder cancer

OncoGenex Pharmaceuticals, Inc. announced today that it has initiated patient enrollment in a randomized, Phase II clinical trial evaluating OGX-427, an inhibitor of heat shock protein 27 (Hsp27), in patients with advanced bladder cancer.

21 Oct 2011

Byetta combination with insulin glargine gets FDA nod in type 2 diabetes

The US Food and Drugs Administration (FDA) has approved Byetta (exenatide) injection as add-on treatment for use with insulin glargine, together with exercise and diet for diabetes type 2 patients who are not responding well enough to glargine alone. Byetta's add-on therapy is for those on glargine with metformin and/or a TZD (thiazolidinedione) or without.

20 Oct 2011