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FDA warns consumers not to take Venom HYPERDRIVE 3.0

The U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine.

29 Jan 2009

Medarex announces allowance of IND application for antibody-drug conjugate, MDX-1203

Medarex, Inc. has announced the allowance of an investigational new drug (IND) application filed with the U.S. Food & Drug Administration (FDA) for MDX-1203, the Company's first Antibody-Drug Conjugate (ADC) candidate generated from its proprietary technology.

29 Jan 2009

Mylan receives final FDA approvals for generic Lamictal tablets

Mylan Inc has announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets.

29 Jan 2009

SAFC Pharma augments assay development capabilities

SAFC Pharma, a business segment of SAFC, a member of the Sigma-Aldrich group, today announced that it has commenced operations at its 7,000 sq. ft. state-of-the-art laboratory complex in Carlsbad, CA.

29 Jan 2009

Imported diet pills from South America are dangerous

Americans who use illegal diet pills from South America are taking amphetamines without knowing it and seriously risking both their health and their jobs.

27 Jan 2009

Aspirin shown to help prevent liver damage

According to scientists at Yale University ordinary aspirin may help prevent liver damage in millions of people suffering from the side effects of common drugs, alcohol abuse and obesity-related liver disease.

27 Jan 2009

New nano-insulin pill could replace injections for diabetics

Indian scientists suggest that people currently controlling their diabetes with daily insulin injections will soon be able to use an insulin pill instead.

27 Jan 2009

Topical microbicide protects against genital herpes

A topical microbicide that silences two genes can safely protect against genital herpes infection for as long as one week, according to a joint study by researchers at the Albert Einstein College of Medicine of Yeshiva University and Harvard Medical School.

21 Jan 2009

Arpida receives FDA complete response letter for Iclaprim

Arpida Ltd. has announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for intravenous iclaprim for the treatment of complicated skin and skin structure infections (cSSSI).

19 Jan 2009

CSL Behring receives FDA approval of RiaSTAP

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for RiaSTAP(TM), the first and only treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

19 Jan 2009

Roxane Labs launches Levetiracetam tablets and oral solution

Roxane Laboratories, Inc. has announced the approval of their Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250mg, 500mg, 750mg, 1000mg, and Oral Solution 100mg/mL.

19 Jan 2009

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