Pharmaceutical industry

Opens access to Asia and Africa – potential to save hundreds of thousands of lives

June 5, 2009 -- London UK -- The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals’ vaccine against rotavirus, Rotarix™.Additionally, the WHO's Strategic Advisory Group of Experts (SAGE) also recommended that rotavirus vaccination be included in all national immunisation programmes. Together, these WHO decisions open the door to making rotavirus vaccines available to children worldwide.    » read more »

Tasigna® shows rapid and deep responses in newly diagnosed patients with a form of chronic myeloid leukemia

Basel, June 5, 2009 - New data show that at 12 months newly diagnosed patients taking Tasigna® (nilotinib) to treat a life-threatening form of chronic myeloid leukemia (CML) had rapid responses and a deep reduction in the amount of the abnormal protein that causes this disease.

"Tasigna now demonstrates potential to achieve remarkable responses in newly diagnosed patients," said Gianantonio Rosti, MD, Institute of Hematology Seràgnoli, Bologna University, Bologna, Italy, and lead study investigator. "These positive data suggest that, one day, Tasigna may offer patients another front-line treatment option."    » read more »

Used for the Treatment of Mixed Dyslipidemia

June 4, 2009 -- AstraZeneca and Abbott announced today that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL cholesterol (the “bad” cholesterol), high triglycerides and low HDL-cholesterol (the “good” cholesterol).    » read more »

June 2, 2009 -- London, UK -- GlaxoSmithKline (NYSE: GSK) and Concert Pharmaceuticals announced today that they will collaborate to develop and commercialise deuterium-containing medicines. The deal includes three of Concert’s research and development programs; namely, CTP-518, a protease inhibitor for the treatment of HIV expected to enter Phase I clinical trials in the second half of 2009, a preclinical compound for chronic renal disease, and a third research product in Concert’s pipeline.

Concert will also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop.    » read more »

Novartis Vaccines Institute for Global Health (NVGH) developing bivalent vaccine to prevent Typhoid, which affects over 21 million people worldwide annually

June 04, 2009 -- Basel, June 4, 2009 - Novartis announced that the Novartis Vaccines Institute for Global Health (NVGH) has been awarded a grant from the Wellcome Trust to develop a bivalent vaccine for Typhoid fever, a disease that affects more than 21 million people worldwide every year.    » read more »

Assumes Primary Responsibility for Alemtuzumab in Multiple Sclerosis; Expands Hematologic Oncology Portfolio

June 2, 2009 -- Genzyme Corp. (Nasdaq: GENZ) announced today that it has completed the transaction with Bayer HealthCare to acquire the worldwide rights to Campath®/MabCampath® (alemtuzumab), giving Genzyme primary responsibility for the development and commercialization of this promising multiple sclerosis (MS) therapeutic candidate. Genzyme is conducting two rapidly progressing phase 3 studies of alemtuzumab in relapsing-remitting MS patients.    » read more »

Mechelen, Belgium, (May 28 2009): Virco BVBA has today signed a global research and development, non-exclusive licensing agreement with Siemens Healthcare Diagnostics Inc (NY, USA). Under this agreement Siemens is providing Virco a license which will enable Virco to develop and commercialize a new hepatitis C research service testing platform.

This platform will initially be utilized by pharmaceutical companies for drug development support of the new hepatitis C virus (HCV) antivirals. The platform will have the potential to provide HCV clinical diagnostic testing services in the future.    » read more »

Contributes to effort to bend spending curve to help move health reform forward

June 1, 2009 -- Statement of Nancy H. Nielsen, MD, President, American Medical Association:

“The American Medical Association (AMA) joined with five other organizations in the health sector today to outline initiatives to help achieve President Obama’s goal of decreasing the health-care cost growth rate by 1.5 percent, saving $2 trillion or more over the next 10 years.    » read more »

01 June 2009 -- AstraZeneca and Merck & Co., Inc. today announced a collaboration to research a novel combination anticancer regimen composed of two investigational compounds, MK-2206 from Merck and AZD6244 (ARRY-886*) from AstraZeneca.

Preclinical evidence indicates that combined administration of these compounds could enhance their anticancer properties. This is the first time that two large pharmaceutical companies have established a collaboration to evaluate the potential for combining candidate molecules at such an early stage of development. The collaboration will more quickly advance a potentially promising anticancer treatment. In general, such combinations would only be studied when one or both of the drugs has entered late-stage development or received marketing approval.    » read more »

WHITEHOUSE STATION, N.J., May 29, 2009 - Merck & Co., Inc. today provided the following statement regarding the decision by the U.S. Patent and Trademark Office (PTO) to reexamine the SINGULAIR patent.

Reexamination is an administrative procedure within the PTO that can be initiated by any person. Essentially, if a potential new issue of invalidity is raised, the PTO will examine this issue and determine whether it should take any further action regarding the current claims of the patent. In the event that the PTO decides further action is warranted, it may amend or revoke the claims in the patent.    » read more »

Orlando FL, 29 May 2009 -- GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.    » read more »

Only treatment shown to benefit patients with advanced kidney cancer whose disease progressed following targeted therapy; Phase III trials underway to explore potential in multiple additional cancers

Basel, May 29, 2009 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) supporting European Union (EU) approval of Afinitor® (everolimus) Tablets for the treatment of patients with advanced renal cell carcinoma (RCC)[1].    » read more »

Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk of fractures of hip, spine and wrist.

Basel, June 1, 2009 - Reclast® (zoledronic acid 5 mg) Injection[*] has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose[1]. Reclast, or Aclasta® as it is known outside the US, is already approved in more than 80 countries including the US and EU as a once-yearly infusion for the treatment of postmenopausal osteoporosis[1],[4].    » read more »

Panel Votes in Favor of Use by Physician/Nurse Teams to Deliver Minimal-to-Moderate Propofol Sedation

(May 28, 2009) –Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS® System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD).

The SEDASYS® System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient’s needs.    » read more »

May 29, 2009 -- Genzyme Corp. (Nasdaq: GENZ) today announced that the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted a positive opinion on the marketing authorization application for Mozobil ® (plerixafor injection).

The committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 66 calendar days to act on the CHMP’s opinion.

In the EU, Mozobil would be indicated in combination with granulocyte-colony stimulating factor to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilize poorly.    » read more »