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Structure and activities to drive growth and profitability during pharmaceutical new product planning

With the prospect of health-care reform still looming, pharmaceutical and biotech companies face tremendous pressure to keep the costs of their products down.

30 Jan 2010

MPI Research lauds FDA's current guidance on abuse potential of drugs

On January 26, 2010, the Food and Drug Administration (FDA) released a key draft guidance document, Guidance for Industry Assessment of Abuse Potential of Drugs. When finalized, this guidance will represent the FDA’s current position on the abuse potential of drugs. Noteworthy within the document, Good Laboratory Practices (GLP) specified in the Guidance for Industry S7A Safety 471 Pharmacology Studies for Human Pharmaceuticals and in FDA regulations, 21 CFR 472 part 58, now also apply to abuse potential studies in animals.

30 Jan 2010

Spectrum Pharmaceuticals receives $16M over apaziquone collaboration agreement

Spectrum Pharmaceuticals, Inc., announced today that it has received $15 million from Nippon Kayaku in connection with the collaboration agreement for apaziquone (EOquin®) announced on November 10, 2009, and $1 million from Handok Pharmaceuticals announced on November 23, 2009.

30 Jan 2010

Lanzoprazole and astemizole hold promise for early detection of AD

Investigators from the International Center for Biomedicine and the University of Chile, in collaboration with the Center for Bioinformatics of the Universidad de Talca, have discovered that two drugs, the benzimidazole derivatives lanzoprazole and astemizole, may be suitable for use as PET (positron emission tomography) radiotracers and enable imaging for the early detection of Alzheimer's Disease. The study is published in the current issue of the Journal of Alzheimer's Disease.

30 Jan 2010

NAPRA issues directive on NHPs, CHFA concerned

The National Association of Pharmacy Regulatory Authorities (NAPRA) has issued a directive to the provinces requesting that pharmacists not sell Natural Health Products (NHPs) without a Drug Identification Number (DIN), Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM). NAPRA did not engage in consultations with industry participants who will be adversely affected by this move.

30 Jan 2010

USP develops revised quality guidelines for pharmacists who prepare life-saving drugs

To further protect the safety of patients taking individually prepared medications, the U.S. Pharmacopeial Convention (USP) has developed new and revised quality guidelines for pharmacists who compound-or individually prepare-these life-saving drugs.

30 Jan 2010

FDA approved 53 new oncology and hematology drugs between 2005 and 2007

Over a two and half year period, beginning in 2005 when the U.S. Food and Drug Administration's oncology drug product's office began reviewing marketing applications, a total of 60 new oncology and hematology drugs were reviewed, of which 53 were approved, according to a new article published online January 29 in the Journal of the National Cancer Institute.

30 Jan 2010

PATH praises Gates Foundation for supporting vaccine development and delivery

Vaccination may be the most effective public health intervention of all time-especially in low-income countries, where many families can't access or afford health care when they are sick. On Friday, January 29, speaking at the World Economic Forum in Davos, Switzerland, Bill and Melinda Gates announced a new ten-year Gates Foundation commitment to funding vaccine development and delivery.

30 Jan 2010

New vaccine effective in preventing TB in HIV patients

Investigators from Dartmouth Medical School (DMS) have reported results of a clinical trial showing that a new vaccine against tuberculosis, Mycobacterium vaccae (MV), is effective in preventing tuberculosis in people with HIV infection.

30 Jan 2010

Scientists currently working on 861 new cancer medicines

The Bienville Democrat in Arcadia, LA recently reported that America's pharmaceutical research and biotechnology companies have made great progress in treating cancers, introducing many new, breakthrough medicines.

30 Jan 2010

American PhRMA companies commit $25M in medicines, medical supplies and cash for Haiti relief efforts

As the need for health care assistance mounts after the recent catastrophic earthquake in Haiti, America's pharmaceutical research and biotechnology companies continue to provide help. So far, more than $25 million in medicines, medical supplies and cash have been committed to relief efforts – and that amount is still growing. The total does not include the contributions of PhRMA member company employees and the many companies committed to matching the pledges of their workers.

30 Jan 2010

PROLOR Biotech reports the EC approval of Merck's ELONVA

PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH) today noted the European Commission (EC) approval of Merck & Co., Inc.'s ELONVA®, a long-acting CTP-modified version of the fertility drug follicle stimulating hormone (FSH).

30 Jan 2010

Canada to donate 5m doses of H1N1 vaccine to WHO; agency has received commitment of 200m vaccines

The Canadian government on Thursday announced the country would donate five million doses of H1N1 vaccines to the WHO from the country's current surplus, the Canadian Press reports (Branswell, 1/28).

30 Jan 2010

FDA approves new drug combination for hormone positive and HER2-positive advanced breast cancer

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

30 Jan 2010

Government cracks down on drug marketing

Recent crackdown on pharmaceutical companies suggests that drug marketing remains an issue with federal authorities. The Wall Street Journal reports: "Novartis AG's agreement to settle criminal allegations involving marketing of an epilepsy drug is the latest in a string of cases showing that improper marketing practices are still a problem years after the U.S. government started cracking down on them.

30 Jan 2010

Mylan's subsidiary receives FDA approval for GoLytely laxative

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely® laxative.

30 Jan 2010

GlaxoSmithKline's Lamictal XR Extended-Release Tablets receive FDA approval

laxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal®XR™ (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures.

29 Jan 2010

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

29 Jan 2010

Bill & Melinda Gates Foundation commits $10 billion for vaccine research and development

Bill and Melinda Gates announced today that their foundation will commit $10 billion over the next 10 years to help research, develop and deliver vaccines for the world's poorest countries.

29 Jan 2010

BioCentric Energy to grow algae strain with high EPA/DHA oil content in V3 Algae-Pro systems

BioCentric Energy is pleased to announce that the final engineering on the V3 Algae-Pro Photobioreactor system is now complete. We have received via shipment from China the 32 Corners for the V3 Alga-Pro system. Also received at the Santa Ana headquarters are the 8,000 lineal feet of proprietary, seven layer tubing. Installation of the V3 Algae-Pro system will commence over the next two weeks.

29 Jan 2010