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FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

27 Jan 2011

Quest Diagnostics releases new data on oral fluid testing system

OraSure Technologies, the market leader in oral fluid diagnostics, announced today that Quest Diagnostics Incorporated released new data indicating that oral fluid revealed approximately five times more heroin use in the general U.S. workforce than previously believed.

From Quest Diagnostics 27 Jan 2011

WSJ: Biotech generics battle heats up

A battle is heating up over the meaning of a single word in the health overhaul that could mean billions of dollars to the makers of biotechnology drugs (Mundy, 1/26).

27 Jan 2011

Teva, APP enter agreement for launch of generic Gemzar

Teva Pharmaceutical Industries Ltd. and APP Pharmaceuticals, Inc. announced today the commercial launch of Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials, the generic version of Gemzar®, in the United States, pursuant to a commercialization, manufacture and supply agreement signed by the two companies.

26 Jan 2011

Pill for multiple sclerosis in the pipeline

Multiple Sclerosis or MS is a severely disabling disease that affects 100,000 in the UK. Now a new pill has been developed to treat multiple sclerosis which means there would be no need for injections. European health experts - European Medicines Agency (EMA) have given the new drug Gilenya, the brand name for the drug fingolimod, approval which would grant it EU wide acceptance.

25 Jan 2011

Nordion and Sterigenics sign five year contract for Cobalt-60 supply

Nordion Inc., a leading provider of products and services to the global health science market, today announced it has signed a five-year contract with Sterigenics International, a global leader in contract sterilization and ionization services, for the supply of Cobalt-60. Under the terms of the agreement, this contract extends until October 31, 2015.

25 Jan 2011

Mylan enters settlement agreement with Pfizer for Caduet Tablets litigation

Mylan Inc. today announced that it has entered into a settlement agreement with Pfizer Inc. resolving litigation related to Caduet® Tablets, 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg, known generically as Amlodipine Besylate/Atorvastatin Calcium Tablets.

25 Jan 2011

Nordic Naturals launches one-per-day omega-3 fatty acid gels

Nordic Naturals introduces Daily Omega, a line of three products that offers a simple solution for consumers concerned about what type of product to take on a regular basis to address their need for omega-3 essential fatty acids.

25 Jan 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 2011

Kira For Women introduces two new products for menopause, PMS

Natural women's health brand, Kira For Women, is launching two new products - Kira PMS Relief and Kira Menopause Relief.

25 Jan 2011

Sanofi-aventis acquires world-wide license for ADC products

Oxford BioTherapeutics today announces that sanofi-aventis has acquired an exclusive world-wide license to one of OBT's internal preclinical antibody programs.

25 Jan 2011

Strong opposition to 'prescription-only' measures for OTC medicines with pseudoephedrine

More than 300 million Americans get the common cold, and up to 70 million get the flu annually. But for the 60 million people who also have asthma and allergies, a cold or flu can pose even greater risks. Together, these respiratory diseases take a devastating toll on public health, costing billions of dollars in direct medical expenses, reducing quality of life, lowering workplace and school performance, and can even be life-threatening to high-risk populations, such as asthma patients.

25 Jan 2011

ASA concerned over non-availability of sodium thiopental

The American Society of Anesthesiologists (ASA) and its members are extremely troubled to learn that the anesthetic drug, sodium thiopental (Pentothal®), will no longer be available to patients in the U.S. or any other country due to the unfortunate circumstances in Italy that led the sole manufacturer, Hospira, to cease production of the drug.

25 Jan 2011

SNM commends FDA Advisory Committee recommendation for florbetapir approval

The Society of Nuclear Medicine (SNM) commends the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee on its recent recommendation for conditional approval of a new imaging agent, florbetapir.

25 Jan 2011

Researchers find White-Hispanic disparities in receiving immunization against flu, pneumonia

Seniors of Hispanic descent are far less likely to become immunized against the flu or pneumonia compared to similar White seniors, according to a new RAND Corporation study.

25 Jan 2011

FDA approves Matrix's generic Protonix DR Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix® DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease (GERD).

25 Jan 2011

FedEx launches Deep Frozen Shipping Solution for temperature-sensitive healthcare products

FedEx Corp. today announced the launch of FedEx Deep Frozen Shipping Solution, which offers an innovative end-to-end service for the shipping of temperature-sensitive healthcare products around the world.

24 Jan 2011

PediatRx announces first-ever revenues and successful launch of GRANISOL

PediatRx Inc.is pleased to provide an update on activities for the fiscal third quarter. Among its achievements, the hospital specialty pharmaceutical company reported its first-ever revenues and successfully launched GRANISOL™, the company's first commercial entry.

24 Jan 2011

FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

Spectrum submits Post Approval Supplement for removal of bioscan requirement for Indium-111 ZEVALIN

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement.

24 Jan 2011