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Researchers reveal how antipsychotics affect metabolism by SMAD3 activation

In a paper published January 31 in the journal Molecular Psychiatry, researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham) reveal how antipsychotic drugs interfere with normal metabolism by activating a protein called SMAD3, an important part of the transforming growth factor beta (TGFbeta) pathway.

2 Feb 2012

Multiple exposures to anesthesia associated with higher rates of ADHD in children

Mayo Clinic researchers have found that multiple exposures to anesthesia at a young age are associated with higher rates of attention-deficit/hyperactivity disorder.

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

AstraZeneca, Impax enter license agreement to commercialize Zomig in the U.S.

Impax Pharmaceuticals, the branded products business unit of Impax Laboratories, Inc., announced today that it has licensed from AstraZeneca the exclusive United States (U.S.) commercial rights to Zomig (zolmitriptan) tablet, orally disintegrating tablet, and nasal spray formulations.

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

Counterfeit Drugs - New technology to combat counterfeit

A brand new and patented technology has recently been launched that protects patients from buying and using counterfeit medicines. Pharmaceutical companies can now effectively and very economically protect their products and supply chain with this technology, thus avoiding damages and incalculable liabilities resulting from falsified products.

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

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

BU scientists create unique material and drug delivery mechanism

Long duration, controllable drug delivery is of wide interest to medical researchers and clinicians, particularly those seeking to improve treatment for patients with chronic pain or to prevent cancer recurrence after surgery. Now a team of researchers led by Boston University Biomedical Engineer and Chemist Mark Grinstaff has developed a unique material and drug delivery mechanism that could pave the way for implants that release a drug at a designated rate for months.

1 Feb 2012

General anesthesia may lower recurrence risk in patients with HCC

For patients undergoing a minimally invasive treatment for liver cancer, the risk of recurrent cancer appears lower with general anesthesia compared to regional (epidural) anesthesia, reports a study in the February issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

1 Feb 2012

Continuous wound infusion with local anesthetic reduces pain after hip surgery

In patients undergoing hip replacement surgery, using a special wound catheter to infuse local anesthetic directly into the hip joint provides significant and lasting improvements in postoperative pain control, reports a study in the February issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

1 Feb 2012

NanoViricides files FluCide pre-IND briefing document with the FDA

NanoViricides, Inc. announced today that it has submitted a pre-IND briefing document to the US FDA. This submission provides the required information for the Company's highly effective anti-influenza drug candidate, FluCide, in support of a pre-IND Meeting.

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

Crizotinib can treat ROS1-driven tumors

A report from investigators at the Massachusetts General Hospital (MGH) Cancer Center has defined the role of a recently identified gene abnormality in a deadly form of lung cancer. Tumors driven by rearrangements in the ROS1 gene represent 1 to 2 percent of non-small-cell lung cancers (NSCLC), the leading cause of cancer death in the U.S.

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

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

Milestone for Starpharma's drug delivery program

Starpharma Holdings today released animal data which demonstrated that its dendrimer-docetaxel formulation applying Starpharma’s dendrimer technology to the leading chemotherapy drug docetaxel was significantly more efficacious than docetaxel (Taxotere®) in a breast cancer model.

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