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FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

FDA approves Jevtana to treat men with prostate cancer

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

NuGEN Technologies receives State of California cGMP certification

NuGEN Technologies, the provider of innovative RNA and DNA amplification and sample preparation technologies for breakthrough genomic analysis, today announced it has received the State of California cGMP (current Good Manufacturing Practices) certification following a rigorous audit process. NuGEN is one of the first sample preparation companies to receive this certification, which allows the company to manufacture and ship any of its products under cGMP compliance.

17 Jun 2010

My Metabolic Makeover's highly expected free health-and-weight-loss workshop is back

My Metabolic Makeover's highly anticipated free health-and-weight-loss workshop is back. Now that the word is out in Brooklyn, seats are expected to fill up quickly for the upcoming event near the border of Mill Basin and Bergen Beach.

17 Jun 2010

Study: Low-salt foods may be harder for some people to like than others

Low-salt foods may be harder for some people to like than others, according to a study by a Penn State College of Agricultural Sciences food scientist. The research indicates that genetics influence some of the difference in the levels of salt we like to eat.

17 Jun 2010

MoniQA collaborates with experts to harmonise worldwide food quality and safety monitoring strategies

Funded by the European Union, MoniQA (Monitoring and Quality Assurance in the total food supply chain) involves experts from around the globe collaborating to harmonise worldwide food quality and safety monitoring and control strategies. The project has developed a database of food quality and safety issues and corresponding analytical tools for food production and the supply chain.

17 Jun 2010

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Kun Run Biotechnology, Inc., a leading bio-pharmaceutical company in China focusing on manufacturing and sales of peptide-based and small molecule drugs, today announced that they have obtained the manufacturing approval for Entecavir from the China State Food and Drug Administration (SFDA).

17 Jun 2010

FDA should reduce nicotine levels in cigarettes to non-addictive levels: Former FDA commissioner

Today at Legacy's Warner Series Lecture on the impact of the Family and Smoking Prevention and Tobacco Control Act (Food and Drug Administration authority over tobacco), Dr. David Kessler, former commissioner of the FDA, called on the FDA to reduce the nicotine level in cigarettes, reducing the yield to non-addictive levels.

17 Jun 2010

Study: Free-range eggs may not be healthier than regular eggs

Contrary to popular belief, paying a premium price for free-range eggs may not be healthier than eating regular eggs, a new study reports. Scientists found that free-range eggs in Taiwan contain at least five times higher levels of certain pollutants than regular eggs. Their findings appear in ACS' bi-weekly Journal of Agricultural and Food Chemistry.

17 Jun 2010

HGS, GSK announce full presentation of BLISS-76 Phase 3 BENLYSTA trial results for SLE at EULAR 2010

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-76, one of two pivotal Phase 3 trials of BENLYSTA® (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The results will be presented today in Rome at the 2010 Congress of the European League Against Rheumatism (EULAR).

17 Jun 2010

FDA seeks public input on regulation of laboratory-developed tests

The U.S. Food and Drug Administration today announced plans to hold a public meeting on July 19-20, 2010, to discuss how the agency will oversee laboratory-developed tests (LDTs).

17 Jun 2010

Scientists find antibiotic-resistant bacteria in seven species of sharks and redfish

Scientists have found antibiotic-resistant bacteria in seven species of sharks and redfish captured in waters off Belize, Florida, Louisiana and Massachusetts. Most of these wild, free-swimming fish harbored several drug-resistant bacterial strains.

17 Jun 2010

CINJ researchers combine series of vaccination injections to treat prostate cancer

Looking to harness the body's own immune system to target prostate cancer that has spread to the bones (metastatic) and is unresponsive to standard treatment, investigators at The Cancer Institute of New Jersey have just launched a clinical trial focusing on a combination of vaccine and radiation drug therapy.

17 Jun 2010

Gabapentin shows effective in patients with locked-in syndrome, opsoclonus-myoclonus syndrome

For patients with quadriplegia, mutism and lower cranial nerve paralysis (locked-in syndrome), their only means of interacting with others is through vertical gaze and upper eyelid movements, using eye-coded communication strategies.

17 Jun 2010

FDA: Potential risk of overdosing infants with liquid vitamin D

Some liquid vitamin D supplement products come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.

17 Jun 2010

Stimuvax clinical program resumed in patients with NSCLC

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that they are resuming their Stimuvax (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer which includes the Phase III studies, START and INSPIRE. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

17 Jun 2010

Merck Serono, EMD Serono resume Stimuvax clinical program for NSCLC

Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax® (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

17 Jun 2010

Food News and Research

FDA approves new indication for Tasigna in treatment of rare blood cancer

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

FDA approves Jevtana to treat men with prostate cancer

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

NuGEN Technologies receives State of California cGMP certification

My Metabolic Makeover's highly expected free health-and-weight-loss workshop is back

Study: Low-salt foods may be harder for some people to like than others

MoniQA collaborates with experts to harmonise worldwide food quality and safety monitoring strategies

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

FDA should reduce nicotine levels in cigarettes to non-addictive levels: Former FDA commissioner

Study: Free-range eggs may not be healthier than regular eggs

HGS, GSK announce full presentation of BLISS-76 Phase 3 BENLYSTA trial results for SLE at EULAR 2010

FDA seeks public input on regulation of laboratory-developed tests

Scientists find antibiotic-resistant bacteria in seven species of sharks and redfish

CINJ researchers combine series of vaccination injections to treat prostate cancer

Gabapentin shows effective in patients with locked-in syndrome, opsoclonus-myoclonus syndrome

FDA: Potential risk of overdosing infants with liquid vitamin D

Stimuvax clinical program resumed in patients with NSCLC

Merck Serono, EMD Serono resume Stimuvax clinical program for NSCLC

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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