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Health experts discuss how to prepare for future dengue immunization programs

AsiaOne examines how groups are working to prepare policy makers for the availability of a dengue vaccine in the future, following a three-day meeting on the virus held in Singapore this week (Chan, 12/3).

4 Dec 2010

New standard treatment for early stage breast cancer

Spanish Oncology has established a new standard treatment for Breast Cancer at early stages thanks to the results of the study 9805/Target 0 funded by Spanish Breast Cancer Research Group and sponsored by Sanofi Aventis.

4 Dec 2010

ProPublica: Drug Co. used ghostwriters to pen work bylined by academics

An investigative news piece finds that ghostwriters write medical studies, editorials and other works for a major drug company.

4 Dec 2010

Impax confirms challenge of patents in connection with INTUNIV

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Shire Development Inc. in connection with INTUNIVTM (guanfacine hydrochloride), 4 mg.

3 Dec 2010

FDA Advisory Panel recommends approval of Solesta for bowel incontinence

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced that the U.S. Food and Drug Administration's (FDA) Gastroenterology and Urology Devices Panel recommended approval of Solesta™ as a treatment for fecal (bowel) incontinence, a condition afflicting many Americans, primarily women.

3 Dec 2010

Cell Therapeutics submits pixantrone NDA application to treat non-Hodgkin's lymphoma

Cell Therapeutics, Inc. today announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug Application to treat relapsed/refractory aggressive non-Hodgkin's lymphoma.

3 Dec 2010

IP-K signs agreement to continue NITD research deal for new drug candidates

Institut Pasteur Korea (IP-K) has signed an agreements to continue to mine the chemical compound collection of Novartis Institute for Tropical Diseases (NITD) of Singapore for new drug candidates.

3 Dec 2010

Sagent launches chemotherapy agent topotecan hydrochloride for injection

Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA approval and launch of its topotecan hydrochloride for injection, a chemotherapy agent, in conjunction with the innovator's patent expiry. Sagent's topotecan is available in 4 mg single-dose latex-free vials.

3 Dec 2010

IP-K signs agreement with sanofi-aventis to identify new medicines

Institut Pasteur Korea (IP-K) has signed an agreement with sanofi-aventis Research & Development of Toulouse, France to continue research on the identification of new medicines.

3 Dec 2010

More Coloradans lose Medicare Advantage plans, Missouri lawmakers push for doctor's order to buy common cold and allergy meds

The Denver Post: "Nearly 14,000 Coloradans are losing their form of Medicare Advantage plans next year and will need to choose new options, creating a hardship for 1,700 rural Medicare members who won't find similar plans left on the table. Medicare Advantage carriers such as Humana, Anthem, Secure Horizons and MVP dropped some Medicare Advantage plans in Colorado. … The dropped carriers affect 13,936 beneficiaries in Colorado, including 3,832 in the Denver metro area" (Booth, 12/2).

3 Dec 2010

Doctors still prescribe higher-dose menopausal hormone therapy pills

Doctors across the country are still prescribing higher-dose menopausal hormone therapy pills, despite clinical evidence that low doses and skin patches work just as well and carry fewer health risks. That's what researchers at the Stanford University School of Medicine found in a study that will be published online Dec. 2 in Menopause: The Journal of the North American Menopause Society.

3 Dec 2010

Teva comments on Lovenox’s patent infringement lawsuit

Teva Pharmaceutical Industries Ltd. commented today on the patent infringement lawsuit filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc.

3 Dec 2010

SAGE launches two new journals in Drug Safety, Hematology

SAGE Expands Therapeutic Advances series by launching two new journals in Drug Safety and Hematology. SAGE has extended its suite of Therapeutic Advances journals with the launch of a further two titles: Therapeutic Advances in Drug Safety, and Therapeutic Advances in Hematology.

3 Dec 2010

AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

AstraZeneca today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC).

2 Dec 2010

FDA approves Sagent's general anesthetic midazolam

Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA's approval of four presentations of midazolam injection, USP, a general anesthetic. Sagent expects to launch midazolam, which will be offered in latex-free vials, in 2011. According to 2010 IMS data, the annual U.S. market for injectable midazolam approximated $52 million.

2 Dec 2010

FDA approves IDE application to initiate Tryton Side Branch Stent System for coronary artery disease

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced U.S. Food and Drug Administration (FDA) conditional approval for an Investigational Device Exemption (IDE) application to initiate the pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.

2 Dec 2010

FDA panel rejects expansion of drug label

The New York Times: A Food and Drug Administration advisory committee on Tuesday rejected a bid to change the labels of two drugs to say they can reduce the risk of prostate cancer. "If the drugs were approved for that purpose, they would be only the second class of cancer-prevention drugs on the market."

2 Dec 2010

FDA approves Abiomed to begin MINI-AMI trial to evaluate Impella 2.5

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).

2 Dec 2010

ROCHE, Baylor Research Institute partner in human immunology research

Baylor Research Institute (BRI), the research arm of Baylor Health Care System, announced today that it has formed a three-year partnership with Roche (SIX: RO, ROG; OTCQX: RHHBY) to jointly develop programs emerging from the human immunology platforms developed at the Baylor Institute for Immunology Research (BIIR), a component of BRI.

2 Dec 2010

Hybrigenics receives EUR 800,000 payment from Oseo

Hybrigenics (ALHYG), a bio-pharmaceutical group with a focus on research and development of new cancer treatments and a fully-owned subsidiary specialized in protein interactions services, today announces it has received EUR 800,000 as the second and last payment of a EUR 1.4 million refundable grant contract originally signed with France’s innovation agency, Oseo Innovation, in 2008.

2 Dec 2010