December 15th

GE jumps in to biologics, vaccine manufacturing game Read more: GE jumps in to biologics, vaccine manufacturing game

GE Healthcare is gearing up to give established pharma companies competition in emerging markets. The company announced this week it’s teaming with German engineering firm M+W Group to help countries worldwide learn to manufacture biologics like vaccines, insulin and biosimilars.

December 14th

Medidata Solutions Broadens CRO Partner Accreditations to Field Increasing Product Demand

Medidata Solutions MDSO +0.77% , a leading global provider of SaaS-based clinical development solutions, today announced that it has expanded its accreditation program for services partners to include seven additional Medidata products, in response to the increasing global demand for its product portfolio. The accreditations are available through the Medidata Partner Program, which selects and [...]

December 14th

BMS, Simcere to Co-Develop Early-Stage Cardiovascular Disease Candidate

Bristol-Myers Squibb (BMS) and Simcere have expanded an existing drug development partnership to include co-development of BMS’ cardiovascular disease candidate, BMS-79531, a preclinical-stage small molecule inhibitor of the cholesteryl ester transfer protein (CETP) . Under terms of the deal, Simcere will receive an exclusive license to develop and market the drug in China, with BMS retaining exclusive rights in all other markets. The firms will work together to define a development plan for BMS in the treatment and prevention of cardiovascular disease. Simcere will run and fund initial development work.

December 14th

NICE denies AZ breast cancer drug, OKs Roche arthritis med

The U.K. drug cost-effectiveness watchdog zeroed in on two Big Pharma companies’ drugs today, sending one of them packing with a negative opinion and giving the other a nod with certain limits on use. The U.K. continues to keep the effectiveness bar high for paying for new meds, much to the dismay of drugmakers that are hungry for new sources of revenue as they face thinning profit margins.

December 12th

Lilly Oncology Reveals Findings From Study of JAK2 Inhibitor for Blood Cancers at ASH Meeting

Eli Lilly and Company LLY +0.89% announced data from an oncology pipeline molecule today at the 53rd Annual Meeting of the American Society of Hematology (ASH). At the meeting, Lilly Oncology presented Phase I data from the investigational therapy LY2784544, a small-molecule Janus kinase 2 (JAK2) inhibitor, in development for the treatment of certain types of myeloproliferative neoplasms (MPNs), a group of blood cancers[1] characterized by abnormal production of red blood cells or myeloid cells (non-lymphocyte white blood cells).[2]

December 12th

Ligand Pharmaceuticals Inc. : Ligand Announces Positive Preclinical Data on Small-Molecule GCSF Receptor Agonist at the 53rd Annual Meeting of the American Society of Hematology

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced that data from preclinical studies on its granulocyte colony stimulating factor (GCSF) receptor program were featured in a poster presentation today at the 53rd Annual Meeting of the American Society of Hematology in San Diego. Ligand has discovered a novel series of small molecules, exemplified by the lead compound LG7455, that selectively activate human GCSFR function in a manner distinct from GCSF, but similar to the mechanism of small-molecule human thrombopoietin receptor (hTPOR) agonists, such as eltrombopag (Promacta®).

December 12th

Lannett Receives FDA Approval for Triamterene with Hydrochlorothiazide 37.5/25mg Capsules

Lannett Company, Inc. (NYSE AMEX: LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Triamterene with Hydrochlorothiazide 37.5/25mg Capsules. Triamterene with Hydrochlorothiazide 37.5/25mg Capsules is therapeutically equivalent to the reference listed drug, Dyazide® Capsules, 25/37.5mg, of SmithKline Beecham. Sales of Triamterene Hydrochlorothiazide 37.5/25mg Capsules, at Average Wholesale Price (AWP) were approximately $111 million for the 12 months ending October 2011, according to Wolters Kluwer.

December 12th

FDA Outlines Review Issues In Onyx Pharma Blood Cancer Drug Application

Onyx Pharmaceuticals Inc. (ONXX) said the U.S. Food and Drug Administration outlined potential review issues tied to a new drug application for its blood cancer drug, a disclosure that sent shares of the company tumbling in premarket trade.

December 9th

Novartis joins exodus from traditional R&D neuroscience drug work

Novartis ($NVS) is joining the global exodus from the field of traditional drug research for brain disorders. Nature reports that the pharma giant has set in motion plans to shut down its neuroscience division in Basel, Switzerland, signaling a fresh retreat as it joins GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) in abandoning some of its longstanding drug development efforts in the field.

December 9th

Updated: J&J locks in blood cancer compound in $975M pact

A unit of Johnson & Johnson ($JNJ) has made big bet on the future of developer Pharmacyclics’ ($PCYC) experimental compound in midstage testing for blood cancers, shelling out $150 million in upfront money to seal the deal and promising up to $825 million in milestone payments.