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Daily news and top headlines for drug research professionals

Optimer Talks Strategy

February 27, 2013 10:25 am | News | Comments

Shares of Optimer Pharmaceuticals Inc. jumped Wednesday on the possibility of a sale of the drug developer. The Jersey City, N.J., company said its board has started reviewing "a full range of strategic alternatives," to maximize shareholder value, and it named former Pfizer leader Hank McKinnell...


Multipronged Attack Needed Against Skin Cancer

February 27, 2013 3:00 am | News | Comments

Hailed as a major step forward in the effort to develop targeted cancer therapies, a recently approved drug for the most common type of skin cancer has been a mixed blessing for patients. Although the initial response is usually dramatic, the tumors often recur as the cancer becomes resistant to treatment.


Royalty Wants Elan For $6.5B

February 26, 2013 12:13 pm | News | Comments

Royalty Pharma said that it wants to buy Elan Corp. PLC for about $6.5 billion, but has yet to receive a formal response from the Irish drugmaker. The $11-per-share offer was made earlier this month...                


Meth Dependence Drug on Fast Track

February 26, 2013 11:52 am | News | Comments

MediciNova Inc. announced that it has received Fast Track designation from the U.S. Food and Drug Administration for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need.


Antibiotic Meets Second Trial Goal

February 26, 2013 11:40 am | News | Comments

Durata Therapeutics Inc. said its antibiotic dalbavancin met its goal in another late-stage clinical trial. The company said dalbavancin worked as well as vancomycin, an older antibiotic, as a treatment for skin infections like the "superbug" MRSA.


Looking At Yeast For New Drug Targets

February 26, 2013 11:31 am | News | Comments

While studying a mutant strain of yeast, Purdue University researchers may have found a new target for drugs to combat cholesterol and fungal diseases. One of the research team's yeast mutants lacks a methyltransferase called Set1, which is a protein that modifies histones.


J&J Loses $3.35M Over Mesh Implants

February 25, 2013 6:49 pm | by Linda A. Johnson | News | Comments

A New Jersey jury on Monday awarded $3.35 million to a former nurse who blames Johnson & Johnson's vaginal mesh implant for years of severe, chronic pain despite 18 unsuccessful repair surgeries. It's the first verdict in about 4,000 lawsuits filed against the giant health products maker...


Electronic Clinical Trials and the Expectations of the Regulatory Agencies

February 25, 2013 4:32 pm | by Chris Cramer, Vice President, Clinical Data Management; Boston, Mass. | Articles | Comments

In the days of paper case report forms (CRFs), the accurate recording and review of subject data entered into the CRF and diaries was based entirely on trust. The investigator would sign the final page of the CRF to confirm that he or she had reviewed all data contained therein.


FDA Expands Stivarga Uses

February 25, 2013 4:21 pm | News | Comments

The U.S. Food and Drug Administration on Monday expanded approval of a Bayer cancer pill to treat tumors of the intestinal tract that do not respond to other treatments. The drug is called Stivarga and regulators approved it to treat gastrointestinal stromal tumors.


Asthma Treatment Works on Hives

February 25, 2013 11:38 am | News | Comments

An international team of researchers has found that a once-a-month, high-dose injection of omalizumab, a commonly used asthma drug, is highly effective in treating teens and adults chronically afflicted with hives and severe, itchy rash.


Cilengitide Fails to Meet Primary Endpoint

February 25, 2013 10:54 am | News | Comments

Merck announced that the Phase 3 CENTRIC trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy).


Deaths, Hypersensitivity Force Recall

February 25, 2013 8:57 am | News | Comments

Drug companies Affymax Inc. and Takeda Pharmaceutical Co. have issued a recall of their anemia drug Omontys, after reports of severe allergic reactions in some kidney dialysis patients, including some deaths.


J&J Under Federal Scrutiny

February 22, 2013 5:57 pm | by Linda A. Johnson | News | Comments

U.S. prosecutors are investigating Johnson & Johnson's practices in marketing a line of hip replacements recalled in 2010 because many had to be replaced within a few years — part of a string of more than 30 product recalls by the health care giant in the last 3 1/2 years.


Merck Settles Over Vioxx

February 22, 2013 12:26 pm | News | Comments

Pennsylvania's attorney general is announcing an $8.3 million settlement with pharmaceutical giant Merck & Co. over allegations the company did not properly disclose studies about the risks of Vioxx. Proceeds from the settlement will be directed to Pennsylvania's prescription assistance program.


FDA Approves Targeted Cancer Drug

February 22, 2013 12:04 pm | by Mathew Perrone | News | Comments

The U.S. Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones. The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together.



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