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EMA COMP issues positive opinion to Albireo for A4250

Albireo AB, a biopharmaceutical company specializing in gastroenterology, today announced that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for the company's lead hepatology candidate, A4250.

25 Jul 2012

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

BioCryst Pharmaceuticals, Inc. announced favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment.

25 Jul 2012

Recent release: Examining next steps for corporate responsibility programs in India

In this post in the Results for Development Institute's "Center for Global Health R&D Policy Assessment" blog, Aarthi Rao, a program officer at the institute, examines whether corporate social responsibility (CSR) programs within Indian pharmaceutical companies can help fight neglected diseases.

24 Jul 2012

Study identifies MDM4 protein as promising target for treatment of melanoma

A melanoma is a malignant form of skin cancer and is one of the most aggressive types of tumors there is. Treatment is particularly difficult, because melanomas are usually resistant against conventional chemotherapy treatments.

24 Jul 2012

Questcor second quarter net sales increase to $112.5 million

Questcor Pharmaceuticals, Inc. today reported financial results for the second quarter and six months ended June 30, 2012.

24 Jul 2012

Microneedles can deliver drug formulations into the eye

Thanks to tiny microneedles, eye doctors may soon have a better way to treat diseases such as macular degeneration that affect tissues in the back of the eye. That could be important as the population ages and develops more eye-related illnesses - and as pharmaceutical companies develop new drugs that otherwise could only be administered by injecting into the eye with a hypodermic needle.

24 Jul 2012

FDA approves 152 antiretroviral drugs in association with PEPFAR to treat HIV/AIDS

Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

24 Jul 2012

Novel combination drug regimen could be more effective than existing treatments for TB

A novel approach to discover the first new tuberculosis (TB) combination drug regimen cleared a major hurdle when Phase II clinical trial results found it could kill more than 99 percent of patients' TB bacteria within two weeks and could be more effective than existing treatments, according to a study published today in the Lancet.

24 Jul 2012

Corporate leaders call on 46 countries to lift travel restrictions for people living with HIV

Two dozen corporate leaders on Sunday signed a statement calling on 46 countries to lift restrictions on travelers who are living with HIV because the policies are discriminatory and bad for business, VOA's "Breaking News" blog reports.

24 Jul 2012

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.

24 Jul 2012

TB combination drug trials progress

A novel approach to discover the first new tuberculosis (TB) combination drug regimen cleared a major hurdle when Phase II clinical trial results found it could kill more than 99 percent of patients’ TB bacteria within two weeks and could be more effective than existing treatments, according to a study published today in the Lancet. These results add to a growing body of evidence that the new regimen could reduce treatment by more than a year for some patients.

24 Jul 2012

Scientists identify mechanisms by which GLP-1 protects against kidney disease, diabetes

Scientists at Joslin Diabetes Center have identified biological mechanisms by which glucagon-like peptide-1 (GLP-1), a gut hormone, protects against kidney disease, and also mechanisms that inhibit its actions in diabetes.

24 Jul 2012

Roundup: Plan for new Md. hospital advances; Outsourcing of prison health care gets scrutiny; Alaska Native medical center seen as model

Maryland officials are preparing to unveil this week a detailed plan for a $600 million regional hospital to replace the ailing Prince George's Hospital Center and establish a new health-care network throughout Prince George's County. The plans are part of a broad effort to improve health care in a county where an estimated 150,000 residents lack health insurance or have insufficient coverage and often rely on hospital emergency rooms for primary care.

24 Jul 2012

Bioniche receives U.S. and Canadian approval for first of two canine oncology products

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced that the first of two canine oncology products has received approval by regulators in both the U.S. and Canada.

24 Jul 2012

Forest Pharmaceuticals receives FDA approval for Tudorza Pressair to treat COPD

The U.S. Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

24 Jul 2012

Tiny microneedles to treat macular degeneration

23 Jul 2012

Berg Pharma initiates BPM 31543 clinical trial for chemotherapy-induced alopecia

Berg Pharma, a Boston-based pharmaceutical company focused on discovery and development of new treatments in cancer and metabolic diseases, announced the initiation of a clinical trial entitled "Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 in Adult Patients Receiving Chemotherapy for the Treatment of Breast Cancer."

23 Jul 2012

Alexza obtains $20 million flexible financing facility from Azimuth Opportunity

Alexza Pharmaceuticals, Inc. announced today that it has obtained a committed equity financing facility under which it may sell up to $20 million of its registered common stock to Azimuth Opportunity, L.P., over an approximately 24-month period.

23 Jul 2012

FDA meeting confirms Orexo regulatory submission of OX219 NDA on track

A meeting with the US regulatory agency FDA held on July 17 has confirmed that the Swedish pharmaceutical company Orexo is on track with its preparation for a regulatory submission of a new drug approval (NDA) for its medicine for treatment of opioid dependency, OX219.

23 Jul 2012

Researchers uncover protein structure that regulates blood cell formation and activity

A Finnish research team together with researchers from New York, USA, has uncovered a protein structure that regulates cell signalling and the formation of blood cells. The team's results, published in Nature Structural & Molecular Biology, the most prestigious journal in the field, shed light on the mechanisms at play in haematological disorders and provide new opportunities for the design of disease-specific treatment.

23 Jul 2012

Pharmaceuticals News and Research

EMA COMP issues positive opinion to Albireo for A4250

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

Recent release: Examining next steps for corporate responsibility programs in India

Study identifies MDM4 protein as promising target for treatment of melanoma

Questcor second quarter net sales increase to $112.5 million

Microneedles can deliver drug formulations into the eye

FDA approves 152 antiretroviral drugs in association with PEPFAR to treat HIV/AIDS

Novel combination drug regimen could be more effective than existing treatments for TB

Corporate leaders call on 46 countries to lift travel restrictions for people living with HIV

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

TB combination drug trials progress

Scientists identify mechanisms by which GLP-1 protects against kidney disease, diabetes

Roundup: Plan for new Md. hospital advances; Outsourcing of prison health care gets scrutiny; Alaska Native medical center seen as model

Bioniche receives U.S. and Canadian approval for first of two canine oncology products

Forest Pharmaceuticals receives FDA approval for Tudorza Pressair to treat COPD

Tiny microneedles to treat macular degeneration

Berg Pharma initiates BPM 31543 clinical trial for chemotherapy-induced alopecia

Alexza obtains $20 million flexible financing facility from Azimuth Opportunity

FDA meeting confirms Orexo regulatory submission of OX219 NDA on track

Researchers uncover protein structure that regulates blood cell formation and activity

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