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Education and caution needed before taking nutritional supplements to reduce cancer risks

Men and women should educate themselves and use caution before taking nutritional supplements to reduce their cancer risks, according to experts at UT MD Anderson Cancer Center.

20 Aug 2010

Ohio appeals court reinstates claim that diet drug Redux should not have been marketed

An Ohio Federal Court of Appeals ruling issued yesterday is reinstating the late victim's claim that the recalled diet drug Redux (commonly called fen-phen) linked to her death should never have been marketed to the American people by Wyeth due in part to its pre-approval concerns about potentially lethal side effects.

20 Aug 2010

Cerulean Pharma to assemble scientific experts at ACS National Meeting symposium

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced it will assemble a group of leading scientific experts at the American Chemical Society's ("ACS") 240th National Meeting & Exposition for a three-day thought leadership summit on the advancement of nanotechnology in the pharmaceutical and diagnostic industries.

20 Aug 2010

FDA Advisory Committee votes in favor of expanding pain indications for Eli Lilly's Cymbalta

The U.S. Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee voted 8-6 in favor of expanding the pain indications for Eli Lilly and Company's (NYSE: LLY) Cymbalta® (duloxetine HCl) to a broader pain population that will be further defined by the FDA, if approved.

20 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Research marks new direction to treat Pneumocystis, inflammatory diseases

A drug to treat inflammation plays a surprising role reducing the level of infection caused by an opportunistic bug that is deadly for AIDS and cancer patients and others with weakened immune systems.

20 Aug 2010

FDA grants priority review designation of BENLYSTA for systemic lupus erythematosus treatment

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration has granted a priority review designation to BENLYSTA (belimumab) as a potential treatment for systemic lupus erythematosus.

20 Aug 2010

Gilead receives Notice Letter of Sigmapharm's ANDA submission for generic Hepsera

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Sigmapharm Laboratories, LLC submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Hepsera® (adefovir dipivoxil).

20 Aug 2010

Quality issue roundup: J & J revamping controls; The odds for orthopedic surgery; Automatic prescription refills and patient compliance

The New York Times: Johnson & Johnson has said it will "revamp its quality controls, creating a single framework for its drug, medical device and consumer health care divisions." The move comes after the drugmaker saw a number of recalls of its medicines, such as Tylenol and Motrin, as well as probes by a congressional committee and the FDA into actions at its McNeil Consumer Healthcare subsidiary.

20 Aug 2010

Scientists suggest combination vaccine prevents pertussis

If you think you shouldn't be worried about your child's—or your—lingering, nagging cough, think again. Pertussis has reemerged on the scene. In what some public health officials are calling the worst outbreak in 50 years, pertussis, better known by its unique sound—whooping cough, has been found in six states with 1,500 cases reported, six of them fatal.

19 Aug 2010

Novartis sales representatives increase calls to healthcare providers by 7%: SDI report

In the first 6 months of 2010, according to SDI, calls made by Novartis sales representatives to physicians, nurse practitioners, and physician assistants increased 7% compared with the last 6 months of 2009.

19 Aug 2010

PharmaVentures announces global expansion of PharmaDeals Agreements

PharmaVentures, the company behind the PharmaDeals(R) range of business information, announced today the expansion of its PharmaDeals Agreements coverage that includes exclusive interviews with deal makers around the world. The announcement follows major enhancement of its dedicated, market leading platform delivering deal data and information to the pharmaceutical and biotechnology sector.

19 Aug 2010

Effects of illegal drugs on health

Illegal drugs are responsible for up to 1,600 deaths a year in the UK, and destroy thousands of relationships, families and careers. Find out about the most commonly used illegal drugs in England and Wales and the effects they can have on your health.

19 Aug 2010

Treatment with DMARDs reduces rheumatoid arthritis disability: Study

For people living with rheumatoid arthritis (RA), the level of disease activity measured using the standard DAS 28 score is the factor most strongly affecting the level of RA-related disability, according to a study in Journal of Clinical Rheumatology.

19 Aug 2010

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Sun Pharma announced that USFDA has granted an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Venlafaxine Hydrochloride Extended Release tablets.

19 Aug 2010

Scientists suggest immunization against oncogenic herpesviruses can prevent cancer

Viruses that can invade host cells, initiate cancer and then flee fromb their own trail of destruction could be stopped in their tracks, say researchers writing in the September issue of the Journal of General Virology.

19 Aug 2010

New clues to molecular action of Alzheimer's drug memantine

Alzheimer's disease destroys brain cells and their connections (called synapses), causing memory loss and other cognitive problems that disrupt work, hobbies and daily life. Symptoms can be alleviated, in part, by the drug memantine (marketed in the United States as Namenda), which is currently FDA-approved to treat moderate-to-severe Alzheimer's disease and was, in part, developed by Stuart A. Lipton, M.D., Ph.D., Director of the Del E. Web Center for Neuroscience, Aging and Stem Cell Research at Sanford-Burnham Medical Research Institute (Sanford-Burnham).

19 Aug 2010

Scientists reveal lab approach method to treat neuroblastoma in children

A study led by scientists at The Hospital for Sick Children (SickKids) reveals a new method of identifying drugs to treat children suffering from fatal cancers for which an effective treatment has not been found. Rather than developing a new drug from scratch, which is a complicated and time-consuming process, they tried a different approach: in the lab, they tested existing drugs on cancer stem cells from young patients with neuroblastoma, one of the common cancers of infants and children.

19 Aug 2010

FDA accepts to review Bristol-Myers Squibb's ipilimumab for melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.

19 Aug 2010

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.

19 Aug 2010

Pharmaceutical News

Education and caution needed before taking nutritional supplements to reduce cancer risks

Ohio appeals court reinstates claim that diet drug Redux should not have been marketed

Cerulean Pharma to assemble scientific experts at ACS National Meeting symposium

FDA Advisory Committee votes in favor of expanding pain indications for Eli Lilly's Cymbalta

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Research marks new direction to treat Pneumocystis, inflammatory diseases

FDA grants priority review designation of BENLYSTA for systemic lupus erythematosus treatment

Gilead receives Notice Letter of Sigmapharm's ANDA submission for generic Hepsera

Quality issue roundup: J & J revamping controls; The odds for orthopedic surgery; Automatic prescription refills and patient compliance

Scientists suggest combination vaccine prevents pertussis

Novartis sales representatives increase calls to healthcare providers by 7%: SDI report

PharmaVentures announces global expansion of PharmaDeals Agreements

Effects of illegal drugs on health

Treatment with DMARDs reduces rheumatoid arthritis disability: Study

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Scientists suggest immunization against oncogenic herpesviruses can prevent cancer

New clues to molecular action of Alzheimer's drug memantine

Scientists reveal lab approach method to treat neuroblastoma in children

FDA accepts to review Bristol-Myers Squibb's ipilimumab for melanoma

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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