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Islamist rebel group bans ICRC from southern areas of Somalia under its control

The Islamist rebel group al-Shabab has banned the International Committee of the Red Cross (ICRC) from distributing food in southern areas of Somalia under its control, accusing the organization of delivering out-of-date food, the Guardian reports.

2 Feb 2012

Medical device industry, FDA reach agreement in principle on user fee program

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

2 Feb 2012

Takeda, SPI announce that lubiprostone phase 3 trial on OBD meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

2 Feb 2012

FDA EMDAC to discuss Arena's lorcaserin NDA resubmission in second quarter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified Arena that an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application (NDA) resubmission will be held in the second quarter of 2012. Confirmation and details of the meeting will be published in the Federal Register.

2 Feb 2012

Genentech receives FDA approval for Vismodegib to treat skin cancer

A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the U.S. Food and Drug Administration, a remarkable accomplishment in new drug development.

2 Feb 2012

FDA extends Novartis' Gleevec label to three-year treatment in patients with KIT+ GIST after surgery

Novartis announced today that following a priority review, the US Food and Drug Administration has approved an update to the Gleevec (imatinib mesylate) tablets label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.

1 Feb 2012

FDA clears Roche's new test for detection of CT and NG infections

Roche announced today that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance to the cobas CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs.

1 Feb 2012

FDA clears TearScience's LipiFlow Thermal Pulsation System to treat dry eye

TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow Thermal Pulsation System, a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids.

1 Feb 2012

Cystic fibrosis drug gets FDA approval

A drug – the first of its kind - that treats the root cause of cystic fibrosis won approval Tuesday. This could be a ray of hope for patients with the deadly illness and broader hope for thousands more patients with the inherited disease.

1 Feb 2012

Leading medical groups collaborate to ensure consistent, responsible uptake of TAVR

With the U.S. Food and Drug Administration's recent approval of transcatheter aortic valve replacement (TAVR) for patients with aortic valvular stenosis, the American College of Cardiology Foundation (ACCF), along with the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Thoracic Surgeons (STS), today released an expert consensus document to provide important guidance on its use.

1 Feb 2012

GSA's new resources address pain management, labeling changes for acetaminophen

The pain suffered by older adults is the shared focus of the two newest entries in The Gerontological Society of America's (GSA) From Publication to Practice series.

1 Feb 2012

Study identifies norovirus as major cause of all infection outbreaks in U.S. hospitals

Norovirus, a pathogen that often causes food poisoning and gastroenteritis, was responsible for 18.2 percent of all infection outbreaks and 65 percent of ward closures in U.S. hospitals during a two-year period, according to a new study published in the February issue of the American Journal of Infection Control (AJIC), the official publication of APIC - the Association for Professionals in Infection Control and Epidemiology.

1 Feb 2012

Study finds sharp increase in BMP use for spinal fusion surgery

The use of bone morphogenetic protein (BMP) for spinal fusion surgery has risen sharply over the past decade, increasing costs with no evidence of improved outcomes, reports study in the February 1 issue of Spine.

1 Feb 2012

Novartis' Gleevec receives FDA approval for use in patients with CD117-positive GIST

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors.

1 Feb 2012

Vertex receives FDA approval for Kalydeco to treat rare form of CF

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

1 Feb 2012

Biogen Idec 2011 total revenues increase 7% to $5.0 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its full year and fourth quarter 2011 results.

1 Feb 2012

FDA approves Lannett's supplemental ANDA for Phentermine HCl to treat obesity

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDA) for Phentermine HCl Capsules, 15 mg.

1 Feb 2012

FDA faces legal attack over alleged spying on whistleblowers

A latest lawsuit filed in federal court has accused the Food and Drug Administration (FDA) of electronically spying on whistleblowers who alerted the Obama administration and Congress of alleged misconduct in the agency, particularly relating to what they claim was the push to approve unsafe and ineffective medical devices.

31 Jan 2012

Oral HPV infection more common in men than women: Study

According to a new US study, oral human papillomavirus (HPV) infection is more common among men than women, leading to an increased risk for men of head and neck cancers. HPV causes the majority of cervical cancers, as well as genital and anal - and head and neck cancers.

31 Jan 2012