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Mylan receives final FDA approval for Montelukast Sodium Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Tablets, 10 mg, the generic version of Merck's Singulair Tablets.

7 Aug 2012

First Edition: August 7, 2012

Today's headlines include reports that HCA, the largest for-profit hospital chain in the U.S., is facing scrutiny about the medical necessity of some of the cardiac procedures done at some of its facilities.

7 Aug 2012

U.N. WFP to begin delivering food aid to North Korea after severe flooding destroys crop lands

North Korea's official Korean Central News Agency on Friday reported that nearly 170 people have died, 400 people are missing, and more than 84,000 people are homeless because of severe flooding in the country, the Guardian reports, noting that the World Food Programme (WFP) "announced on Friday the details of its first batch of emergency food aid to the country, although it did not state when it would arrive."

7 Aug 2012

NCH conducts workshop to teach participants how and when to use EpiPen

Many children with severe allergies carry injectable epinephrine (EpiPens) - syringes filled with epinephrine to delay an allergic reaction - but the EpiPens sometimes require the help of an adult to dispense. School nurses are often the only school officials authorized to handle medications, leaving the educators who are with the children most of the day untrained. According to doctors at Nationwide Children's Hospital, this lack of training is exactly what becomes most dangerous for children with severe allergies.

7 Aug 2012

Michigan State University to improve food security and nutrition in Africa and Asia

Michigan State University will use a $7.3 million federal grant to cultivate the next generation of agricultural scientists in Africa and Asia, in hopes of improving food security and nutrition there.

7 Aug 2012

Commercial cattle vaccine can effectively reduce levels of E. coli by more than 50%

A commercial vaccine for cattle can effectively reduce levels of E. coli by more than 50 percent, a Kansas State University study has found. The vaccine is also effective using two doses instead of the recommended three doses, which can help cut costs for the beef industry.

7 Aug 2012

Curemark receives FDA clearance for enrollment of children aged 9-12 in CM-AT study for autism

Dr. Joan Fallon, founder and CEO of Curemark, a Rye, New York-based drug research and development company focused on the treatment of Autism and neurological diseases, today announced that the company has received clearance from the Food and Drug Administration (FDA) to commence direct enrollment of children 9-12 years of age into its open-label extension study of CM-AT for children with Autism.

6 Aug 2012

FDA grants 510(k) clearance to VICTUS Femtosecond Laser Platform

Bausch + Lomb, the global eye health company, and Technolas Perfect Vision GmbH, a leading ophthalmology laser company, announced today that the VICTUS Femtosecond Laser Platform received 510(k) clearance from the U.S. Food and Drug Administration.

6 Aug 2012

ABP, Alembic enter into development and license agreement for Accu-Break tablet technologies

Accu-Break Pharmaceuticals, Inc. announced today that it has entered into a development and license agreement with Alembic Pharmaceuticals Limited of Gujarat, India to develop new brand products that will use ABP's innovative Accu-Break tablet technologies.

6 Aug 2012

Mylan receives final FDA approval for generic Amidate ANDA

Mylan Inc. today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials.

6 Aug 2012

Mylan launches 18 antiretroviral products in India to treat HIV/AIDS

Mylan Inc., one of the world's leading generic and specialty pharmaceutical companies, today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has commenced commercial operations in India, starting with the launch of a comprehensive portfolio of 18 antiretroviral (ARV) products for the treatment of HIV/AIDS.

6 Aug 2012

First generic versions of Singulair receive FDA approval for treatment of asthma, allergies

The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

6 Aug 2012

Sanofi-aventis receives FDA approval for Zaltrap to treat colorectal cancer

The U.S. Food and Drug Administration today approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

6 Aug 2012

USDA's Economic Research Service report examines global food security

In a post on the USDA Blog, economists Stacey Rosen and Shahla Shapouri of the Economic Research Service's (ERS) Food Security and Development Branch describe the latest ERS International Food Security Assessment, which covers 76 countries in Asia, Latin America, North Africa, and sub-Saharan Africa.

3 Aug 2012

Risky prenatal use of steroid to prevent intersex, tomboys and lesbians

A new paper just published in the Journal of Bioethical Inquiry uses extensive Freedom of Information Act findings to detail an extremely troubling off-label medical intervention employed in the U.S. on pregnant women to intentionally engineer the development of their fetuses for sex normalization purposes.

3 Aug 2012

Widespread use of current technologies 'essential' to improve global health

Noting that this week's issue of the Lancet explores the theme of "[a]ccess to beneficial health technology, including essential medicines and medical devices, for those most in need," a Lancet editorial states, "Maximizing use of current health technologies (drugs, devices, biological products, medical and surgical procedures, support systems, and organizational systems) is essential to improving global health."

3 Aug 2012

U.S. announces additional $12M in humanitarian aid to Syria

"The United States announced Thursday it would hike its humanitarian aid to Syria, adding another $12 million to provide food, water, medicine and other necessities for battered and displaced people" affected by violence in the Syrian conflict, the Los Angeles Times blog "World Now" reports.

3 Aug 2012

DNA inherited from mother can speed up male ageing

Women outlive men by about five to six years but why? By age 85 there are roughly six women to every four men and by age 100 the ratio is more than two to one.

3 Aug 2012

Strawberry extract protects against UVA rays

An experiment has shown that strawberry extract added to skin cell cultures acts as a protector against ultraviolet radiation as well as increasing its viability and reducing damage to DNA. Developed by a team of Italian and Spanish researchers, the study opens the door to the creation of photoprotective cream made from strawberries.

3 Aug 2012

Longer looks: Mississippi learns from Iran's health care system

Sabrina Seeling seemed too young to die. ... One night she stayed up all night translating a Latin text into English for a college paper. ... During the all-nighter, Ms. Seelig took Ephedra, a stimulant diet drug that had been banned by the Food and Drug Administration three years earlier, and had a few beers. ... When she felt sick, she called Poison Control for help, and spoke very clearly, a recording of the call shows.

3 Aug 2012