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Savella - Fibromyalgia treatment approved by FDA

Forest Laboratories, Inc. and Cypress Bioscience, Inc. have announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia.

19 Jan 2009

Eli Lilly to pay $1.415 billion for off-label promotion of Zyprexa

American pharmaceutical giant Eli Lilly and Company today agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the Department of Justice announced today.

19 Jan 2009

FDA approves RiaSTAP for bleeding in patients with congenital fibrinogen deficiency

The U.S. Food and Drug Administration has licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding.

18 Jan 2009

Artificial antibody delivers nanoparticles to tumors

Antibodies that target epidermal growth factor receptor (EGFR) have proven themselves as potent anticancer drugs. Now, a team of investigators led by Shuming Nie, Ph.D., and Lily Yang, Ph.D., both at the Emory University School of Medicine and members of the Emory-Georgia Tech Nanotechnology Center for Personalized and Predictive Oncology, is aiming to capitalize on this targeting ability, using a modified anti-EGFR antibody to delivery nanoparticles into tumor cells.

18 Jan 2009

Toxin-nanoparticle combo inhibits brain cancer invasion while imaging tumors

Working with a nanoparticle designed to target and image glioblastoma, a form of brain cancer, investigators at the University of Washington in Seattle have found that these same nanoparticles inhibit tumor cell invasion, one of the key events that leads to the metastatic spread of cancer. The investigators have also determined how the nanoparticles exert this potentially beneficial effect.

18 Jan 2009

Polymer nanoparticle for oral anticancer drug delivery

One of the problems that cancer patients face is that many of the most potent anticancer therapies can be administered only by injection, which means that cancer patients must travel to receive their medication. But thanks to a new type of nanoparticle developed by researchers at the Johns Hopkins University School of Medicine, future cancer patients may be able to receive their medication in pill form.

18 Jan 2009

FDA issues complete response letter for SAPHRIS (asenapine) sublingual tablets in acute treatment of schizophrenia and bipolar disorder

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

15 Jan 2009

Cell Therapeutics targeting potential Zevalin label expansion,

In meetings held in association with the JP Morgan Healthcare Conference in San Francisco, Cell Therapeutics, Inc. (CTI) reviewed 2009 targeted milestones and 2008 accomplishments.

15 Jan 2009

FDA launches pilot program to improve drug safety and active drug ingredients produced outside U.S.

The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States.

14 Jan 2009

Thumbs down by experts on plans to make certain meds OTC

Government plans to make certain prescription-only drugs for common problems available over the counter have overwhelmingly been given the thumbs down by healthcare professionals, reveals a survey of readers of the influential Drug and Therapeutics Bulletin ( DTB ).

13 Jan 2009

Wyeth and Santaris Pharma to collaborate on RNA-based medicines

Wyeth Pharmaceuticals, a division of Wyeth, and Santaris Pharma have announced that the companies have entered into a worldwide strategic alliance to discover, develop and commercialize new medicines based on Santaris Pharma's proprietary Locked Nucleic Acid (LNA) drug platform, which allows specific targeting and regulation of microRNAs (miRNAs) and messenger RNAs (mRNAs) as a means to affect gene expression mediated by the targeted RNAs.

12 Jan 2009

Pfizer joins URMC initiative for safety of experimental drugs

Pfizer Inc. has agreed to provide the University of Rochester Medical Center (URMC) with a unique set of electrocardiographic data that will help researchers develop new methods to ensure the safety of experimental drugs.

12 Jan 2009

GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

12 Jan 2009

FORMA Therapeutics to collaborate with Novartis on inhibitors

FORMA Therapeutics has announced that it has entered into a license and option agreement through the Novartis Option Fund.

12 Jan 2009

Bristol-Myers Squibb and ZymoGenetics to collaborate on hepatitis C compound

Bristol-Myers Squibb and ZymoGenetics, Inc. have announced a global collaboration for PEG-Interferon lambda, a novel type 3 interferon currently in Phase Ib development for the treatment of Hepatitis C, and its related development program.

12 Jan 2009

Novel low-cost immunotherapy for cancer cells

Molecules of sugar sitting on the surface of cancer cells are keys to the development of a new vaccine aimed at both treating and stopping the spread of certain types of cancers called carcinomas, which include prostate, breast, ovarian and lung, among others.

8 Jan 2009

First artemisinin based malaria drug may meet resistance, expert says

This year, the U.S. Food and Drug Administration is expected to approve the first malaria drug to contain artemisinin, a wormwood derivative from China that has proven effective for malaria in Africa and Asia.

8 Jan 2009

New drugs have longer clinical development times despite faster FDA review

While the U.S. Food and Drug Administration Drug has quickened review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical development times, according to the Tufts Center for the Study of Drug Development.

8 Jan 2009

Sun Pharmaceutical extends tender offer for Taro

Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida), has extended the Expiration Date of the Tender Offer for the purchase of all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd. (Taro).

7 Jan 2009

Sun Pharmaceutical receives FDA approvals for 4 generics

Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from U.S. FDA for several Abbreviated New Drug Applications (ANDA).

7 Jan 2009