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3SBio files APX001 IND application with SFDA in China

Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of Shenyang, China, filed an Investigational New Drug (IND) application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China.

16 Aug 2012

George Washington University releases 'Obesity Drug Outcome Measures'

The George Washington University School of Public Health and Health Services (GW) today released a report representing consensus findings from a cross-section of stakeholders that could help transform the process used to evaluate interventions to treat obesity, a public health crisis that now affects one in three adults. The report, "Obesity Drug Outcome Measures," results from a stakeholder dialogue group convened by GW that, over a period of nine months, explored why development and approval of obesity drugs have proven so difficult.

15 Aug 2012

Spectrum Pharmaceuticals initiates enrollment in Phase 2b ozarelix study for prostate cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced initiation of patient enrollment in the second part of the Company's randomized Phase 2 clinical program of ozarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in men with prostate cancer for whom hormonal treatment is indicated.

15 Aug 2012

Study investigates ability of bifidobacteria to remove glycans from milk glycoproteins

A research team at the University of California, Davis, has found that important and resourceful bacteria in the baby microbiome can ferret out nourishment from a previously unknown source, possibly helping at-risk infants break down components of breast milk.

15 Aug 2012

TAIN project aims to optimise treatment for babies with adrenal insufficiency

Groundbreaking research into rare neonatal diseases, conducted by the University of Sheffield, is set to improve the treatment of babies who lack the stress hormone cortisol.

15 Aug 2012

Cathepsins may attack one another instead of the bodily proteins

Researchers for the first time have shown that members of a family of enzymes known as cathepsins - which are implicated in many disease processes - may attack one another instead of the bodily proteins they normally degrade. Dubbed "cathepsin cannibalism," the phenomenon may help explain problems with drugs that have been developed to inhibit the effects of these powerful proteases.

15 Aug 2012

Medicine brand choices: an interview with Dr Lynn Weekes

In Australia, people will only be offered a choice when the brands are bioequivalent, meaning they contain the same active ingredient (i.e. the chemical in the medicine that makes it work) and have been proven to work the same in the body.

15 Aug 2012

AstraZeneca enters agreement with Pfizer for OTC NEXIUM

Pfizer Inc. today announced that it has entered into an agreement with AstraZeneca for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).

14 Aug 2012

Medicaid expansion would have major effect on state economy

The Atlanta Journal-Constitution examines issues surrounding the expansion of Medicaid coverage under the health law and notes that the extra federal money coming into the state would have a $72 billion economic impact over 10 years.

14 Aug 2012

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Santarus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013.

14 Aug 2012

Health law critically important to women; Expanding Medicaid could spur state education cuts; Misuse of antipsychotics in dementia patients

If we can set aside the political wrangling and focus on the benefits of the Affordable Care Act, what becomes obvious is its critically important impact on women's health. The fact is while women are the primary coordinators of health care for families and comprise the majority of U.S. health-care workers, they also put their own health-care needs behind those of their children. Cost is too often the reason.

13 Aug 2012

State roundup: Fla. groups ask Gov. for essential benefits hearings

In a reversal of a law passed 4 years ago, physicians in Massachusetts will now be allowed to accept "modest" meals and refreshments provided by pharmaceutical or medical device companies.

13 Aug 2012

CBIS initiates CS-TATI-1 GMP development plan

Cannabis Science (CBIS), a pioneering U.S. Biotech Company developing pharmaceutical to meet global public health challenges is pleased to announce the initiation of GMP development plan for CS-TATI-1 with the initial production of CS-TATI-1 to be performed in Colorado under C-GMP conditions evaluated by the FDA for initial human studies to treat HIV associated Kaposi Sarcoma.

13 Aug 2012

Quintiles acquires premier provider of genomics testing and analysis

To help biopharmaceutical companies dramatically improve drug development productivity and deliver greater value, Quintiles today announced the acquisition of Expression Analysis, Inc. (EA), a premier provider of genomics testing and analysis to biopharma, academic, government and non-profit customers.

13 Aug 2012

FDA accepts Teva's NDA for Quartette oral contraceptive

Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd., today announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets).

13 Aug 2012

FDA extends PDUFA action date for NPS Gattex NDA

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012.

13 Aug 2012

Meritage commences OBS Phase 2 clinical trial for eosinophilic esophagitis

Meritage Pharma, Inc. announced that it has initiated a Phase 2 clinical trial to evaluate oral budesonide suspension (OBS) for the treatment of adolescents and young adults with eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus. EoE is a chronic disease characterized by symptoms related to esophageal dysfunction and eosinophil-predominant inflammation.

13 Aug 2012

Verastem second quarter net loss increases to $6.8 million

Verastem, Inc., a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, today reported financial results for the quarter ended June 30, 2012, and also commented on certain corporate accomplishments and plans.

13 Aug 2012

Medical ethics: an interview with Anita Silvers

Medical ethics assists healthcare professionals to make decisions respectful of persons who happen to be their patients.

13 Aug 2012

Taro, Sun Pharma enter merger agreement

Sun Pharmaceutical Industries Ltd. and Taro Pharmaceutical Industries Ltd. announced today that they have entered into a merger agreement together with certain affiliates of Sun Pharma.

13 Aug 2012