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Human Genome Sciences receives FDA feedback for ZALBIN BLA

Human Genome Sciences, Inc. today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks.

14 Jun 2010

M&A issues in bio-pharma mega-mergers

The bio-pharma mega-mergers that grabbed headlines last year - Roche + Genentech, Pfizer + Wyeth, and Merck + Schering-Plough - are now in the critical post-integration period and the acquiring companies are finding out how well they planned and executed their integration plans.

14 Jun 2010

Intellipharmaceutics International files Protonix ANDA with FDA

Intellipharmaceutics International Inc. today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix® (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

14 Jun 2010

ARBs increase risk of cancer: Study

University Hospitals Case Medical Center cardiologists have uncovered new research showing an increased risk of cancer with a group of blood pressure medications known as angiotensin-receptor blockers (ARBs).

14 Jun 2010

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Cell Therapeutics, Inc. today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone.

14 Jun 2010

Australian rainforests may provide potential cancer cure

Queensland scientists have discovered a drug to cure cancer that has effectively worked in animals and is to be tried on humans in the next phase of trials. This drug is plant-derived and is called EBC-46 for trial purposes. The plant from which it is obtained is found in the Australian tropical rainforest. The drug has shown to reduce inoperable tumors in 150 dogs, cats and horses and a ferret to a significant extent. The drug was developed over the past six years from the seed of a rainforest plant found in the Atherton Tablelands. Scientists had cultivated their own plantation of the plant since forming the company QBiotics Limited in 2004.

14 Jun 2010

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Telmisartan, an angiotensin receptor blocker, is one of the best researched drugs worldwide. It has been studied in clinical trials in more than 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years.

14 Jun 2010

Effective antimicrobial products can reduce hospital-acquired infections

The Centers for Disease Control estimate that more than two million people in the United States are affected annually by hospital-acquired infections. Meanwhile, a report released in April by the Agency for Healthcare Research and Quality concluded that this problem, which is worsening, requires urgent attention.

14 Jun 2010

3M Health Care launches new foam adhesive dressings for acute and chronic wounds

3M Health Care today announced the introduction of a full line of new, innovative Tegaderm™ High Performance Foam Adhesive Dressings. In clinical and laboratory tests, these new adhesive foam wound dressings outperform other leading foam adhesive dressings in managing the full range of low- to high-moisture conditions that can be present in chronic and acute wounds.

14 Jun 2010

Researchers transform yellow fever vaccine to fend off mosquito borne parasites that cause malaria

There is no vaccine for malaria, which sickens almost a quarter of a billion people each year and kills a child every 30 seconds. That could be changing: researchers at The Rockefeller University have genetically transformed the yellow fever vaccine to prime the immune system to fend off the mosquito borne parasites that cause the disease.

14 Jun 2010

ACIP's new immunization guidelines for upcoming year

Summer is all about barbeques and lazy days at the pool. It's also a good time to start thinking about preparing for flu season, and the vaccinations you or your child may need for the upcoming year, says Carrie Maffeo, a professor of pharmacy at Butler University, who specializes in immunizations.

14 Jun 2010

Customs Organization to sign declaration against counterfeit drugs

The World Customs Organization will sign a declaration to fight the $200-billion-a-year counterfeit drug industry, Reuters reports.

14 Jun 2010

BIOTECanada congratulates CPHA on 100 years of leadership in public health

As a community partner of the Canadian Public Health Association, BIOTECanada, on behalf of Canada's biotechnology industry, congratulates the CPHA on 100 years of leadership in public health.

11 Jun 2010

FDA grants orphan drug designation for ICT-107

ImmunoCellular Therapeutics announced today that the U.S. Food and Drug Administration has granted orphan drug designation for ICT-107, the company's dendritic cell-based cancer vaccine candidate which targets glioblastoma multiforme. As a result of the orphan drug status, ImmunoCellular will be eligible to receive a number of benefits, including access to grant funding for clinical trials, tax credits, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of up to seven years.

11 Jun 2010

PRA International to host interactive round-table sessions on drug development, lifecycle management

PRA International, a leading Clinical Research Organization, will host five interactive round-table sessions on drug development and lifecycle management at the Drug Information Association's annual meeting in Washington, D.C. 13-17 June 2010.

11 Jun 2010

Waismann Method survey: 88% of individuals taken prescription painkillers for chronic pain relief

According to a recent survey conducted by the Waismann Method of opiate detoxification, doctors prescribing medication for the treatment of chronic pain were found to be the leading source of prescription painkiller use. Approximately 88 percent of all respondents stated they began taking prescription painkillers for chronic pain relief, with an astounding 70 percent of these individuals believing that they experience the same or a greater amount of pain than when originally prescribed painkillers.

11 Jun 2010

Takeda receives pricing approval for NESINA in Japan

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited has received pricing approval for NESINA® (alogliptin) in Japan. NESINA, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, received regulatory approval from the Japanese Ministry of Health, Labour and Welfare on April 16, 2010. Furiex collaborated with Takeda to develop this product.

11 Jun 2010

NeoPharm first-quarter net loss decreases to $1.4 million

NeoPharm, Inc., a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced its first quarter 2010 financial results.

11 Jun 2010

Dabigatran Etexilate anticoagulant as effective as Enoxaparin in preventing venous thromboembolism

Data from the RE-NOVATE® II study presented today at the 15th Annual Congress of the European Hematology Association (EHA) have shown that dabigatran etexilate 220mg once daily is as effective and safe as enoxaparin 40mg in preventing venous thromboembolism (VTE) after total hip replacement surgery.

11 Jun 2010

Eribulin mesylate drug may help extend lives of women with advanced breast cancer

A new drug, based on a natural extract from sea sponge, may help to extend the lives of women with advanced breast cancer, UK scientists have found. A research team at the University of Leeds and St James's Institute of Oncology led an international trial of the new chemotherapy drug, eribulin mesylate.

11 Jun 2010