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Multiple sclerosis drug Gilenya under investigation by FDA and EMA

The US Food and Drugs Administration (FDA) and European Medicines Agency (EMA) are looking at the pros and cons of using Gilenya (fingolimod) in treating the neurological autoimmune disease Multiple Sclerosis (MS).

23 Jan 2012

Risperdal lawsuit settlement: Largest Medicaid fraud case in Texas

Texas and Janssen Pharmaceuticals reach a $158 million settlement on a suit claiming that the company lied about the efficacy of the anti-psychotic medicine.

21 Jan 2012

Exploring how Peru is addressing drug-resistant TB

Discussing the recent reports of so-called "totally drug-resistant" tuberculosis (TDR-TB) in India, journalist John Donnelly in this GlobalPost "Global Voices" blog entry writes, "Overall, the world is treating drug-resistant TB extraordinarily poorly, and that creates more and more cases of resistant TB that aren't being cured."

21 Jan 2012

New data from Infinity saridegib and gemcitabine Phase 1b/2 combination trial on pancreatic cancer

Infinity Pharmaceuticals, Inc. today announced updated data from the Phase 1b portion of an ongoing Phase 1b/2 clinical trial of saridegib in combination with the chemotherapy gemcitabine in patients with previously untreated, metastatic pancreatic cancer.

20 Jan 2012

ARCA biopharma receives method patent for treatment with bucindolol based on genetic targeting

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for determining whether to administer or prescribe bucindolol to a patient based on whether the patient has a specific genotype - homozygous for the arginine 389 polymorphism in the beta-1 adrenergic receptor.

20 Jan 2012

PolyTherics announces acquisition of WEP

PolyTherics Limited, a provider of solutions to biopharmaceutical companies for the improvement of protein and peptide based drugs, is pleased to announce the acquisition of Warwick Effect Polymers, a provider of specialty biopolymers for the modification of biological products.

20 Jan 2012

Platelet receptor could help with diseases that impact RBCs

A receptor found on blood platelets whose importance as a potential pharmaceutical target has long been questioned may in fact be fruitful in drug testing, according to new research from Michigan State University chemists.

20 Jan 2012

Mylan introduces Levetiracetam to treat seizures

Mylan Inc. today announced that its Mylan Institutional business has launched Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL and 1500 mg/100 mL, for intravenous use.

19 Jan 2012

New vaccine for deadly meningococcus B

A new study shows that a new 4-component meningococcal (4CMenB) vaccine for teenagers is effective when administered on a schedule of 2 doses from 1 to 6 months apart. María Elena Santolaya, from the Department of Pediatrics, University of Chile, Santiago, and colleagues performed the study, which was published online January 18 in the Lancet.

19 Jan 2012

Experimental drug helps patients with advanced colon cancer

According to results from a new clinical trial, an experimental cancer drug regorafenib appears to extend survival slightly in patients with metastatic colorectal cancer. Regorafenib is a so-called multikinase inhibitor, which targets several of the ways cancer develops and grows, researchers said.

19 Jan 2012

FDA, pharmaceutical industry reach agreement on user-fee plan for generics

The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement with the industry released by the agency on Friday.

19 Jan 2012

Drug benefit managers unveil ads to explain what they do

The trade group for pharmaceutical benefit managers announced an advertising campaign about PBMs, while Congress and federal regulators weigh a $29 billion merger between Express Scripts and Medco.

19 Jan 2012

Viewpoints: The 'need' to repeal CLASS; Squaring Romney's poverty and tax promises

As a physician, I treated hundreds of patients who needed long-term care, including ones with Alzheimer's. More than 13.5 million seniors could have this disease by 2040. Middle-class families remain dangerously unprepared for these costs. Some people will likely spend more than $100,000 on care. The fictional CLASS daily benefit of $50 per day won't cover this. I urge my House and Senate colleagues to support this CLASS repeal.

19 Jan 2012

Researchers review landscape of smoking cessation over the past 20 years

Smoking is a major public health issue and quitting is the single most important thing smokers can do to improve their health. In the 2012 edition of the prestigious Annual Review of Public Health, researchers at the University of California, San Diego School of Medicine have reviewed the landscape of smoking cessation over the past 20 years.

19 Jan 2012

Rexahn receives approval to initiate RX-3117 Phase I trial in solid tumors

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing oncology and CNS therapeutics, today announced that it has secured Hungarian Regulatory Authority and Ethics Committee approval for Rexahn's initial Clinical Trial Application.

19 Jan 2012

Soligenix reports results from long-term stability studies of SGX204 anthrax vaccine

Soligenix, Inc., a development stage biopharmaceutical company, announced today results from long-term stability studies of its proprietary DNI anthrax rPA subunit protein vaccine, known as SGX204.

19 Jan 2012

Bristol-Myers Squibb agrees purchase of Inhibitex for $2.5Bn

American pharmaceutical giant Bristol-Myers Squibb has agreed the purchase of US biotech company Inhibitex, in a $2.5Bn (£1.6bn) deal which includes the promising new anti-hepatitis C drug INX-189, first designed and prepared in Cardiff University.

19 Jan 2012

Watson introduces new oral contraceptive, Vestura

Watson Pharmaceuticals, Inc. today announced that its subsidiary Watson Pharma, Inc. has launched Vestura(TM), a generic version of Bayer HealthCare Pharmaceuticals Inc.'s Yaz(R) oral contraceptive product.

18 Jan 2012

EMA grants Orphan Drug Designation to Ceptaris' chlormethine gel for treatment of CTCL

Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris' investigational drug, chlormethine gel, for the treatment of Cutaneous T-Cell Lymphoma.

18 Jan 2012

Counterfeit malaria drugs endanger millions of lives

According to researchers fake and poor quality anti-malarial drugs are threatening efforts to control the disease in Africa and could put millions of lives at risk. These counterfeit medicines could harm patients and promote drug resistance among malaria parasites, warns the study, funded by the Wellcome Trust.

18 Jan 2012