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GlaxoSmithKline: FDA Advisory Panel Makes Favorable Recommendation For ARZERRA (Ofatumumab)

Orlando FL, 29 May 2009 -- GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.    » read more »

Novartis: Afinitor® Recommended For Use In The EU For Patients With Advanced Kidney Cancer

Only treatment shown to benefit patients with advanced kidney cancer whose disease progressed following targeted therapy; Phase III trials underway to explore potential in multiple additional cancers

Basel, May 29, 2009 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) supporting European Union (EU) approval of Afinitor® (everolimus) Tablets for the treatment of patients with advanced renal cell carcinoma (RCC)[1].    » read more »

American Lung Association Urges Senate Leaders to Pass the Family Smoking Prevention and Tobacco Control Act

Washington, D.C. (May 28, 2009)—The American Lung Association joins the World Health Organization (WHO) in calling attention to the global epidemic of death and disease caused by tobacco use on World No Tobacco Day taking place on Sunday, May 31, 2009.

This year, World No Tobacco Day will focus on the urgent need for graphic health warnings to be placed on all tobacco products in order to reduce the deadly impact tobacco use has on the global community. According to the WHO, tobacco use kills 5.4 million people every year and accounts for one in 10 adult deaths worldwide. In the United States, the tobacco caused death toll ends more than 393,000 lives each year. Another 50,000 American deaths are annually attributed to secondhand smoke exposure.    » read more »

Labor Dept. Reaches $1 Billion Paid To Tennessee Residents Under Energy Employees Occupational Illness Compensation Program Act

05/26/2009 -- WASHINGTON — The U.S. Department of Labor today announced that it has paid more than $1 billion in compensation and medical benefits to 9,134 Tennessee residents under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA).

The act was created to assist those individuals who became ill as a result of working in the atomic weapons industry. Survivors of such individuals may also be eligible for benefits. Since the implementation of the act, the Labor Department has paid 51,331 claimants more than $4.8 billion in compensation and medical benefits nationwide.    » read more »

Merck's GARDASIL First Cervical Cancer Vaccine to Receive WHO Pre-qualification

WHO Pre-qualification Will Help to Facilitate Expanded Global Access and Implementation of HPV Vaccination Programs

WHITEHOUSE STATION, N.J., May 26, 2009 - GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], Merck's cervical cancer vaccine, has been awarded World Health Organization (WHO) pre-qualification. GARDASIL is the first cervical cancer vaccine to receive WHO pre-qualification.

WHO pre-qualification means that GARDASIL is now eligible for procurement by the United Nations Children's Fund (UNICEF) and other United Nations (UN) agencies including the Pan American Health Organization (PAHO), for use in national immunization programs.    » read more »

Senator Reed Seeks to Strengthen Sunscreen Labels to Prevent Consumers from Getting Burned

May 26, 2009 -- PROVIDENCE, RI – In an effort to help Americans better protect themselves from the sun’s harmful rays, U.S. Senator Jack Reed (D-RI) is championing legislation requiring the Food and Drug Administration (FDA) to strengthen labeling and testing standards for sunscreen products.    » read more »

Sandoz To Acquire EBEWE Pharma Specialty Generics Business

Definitive agreement to acquire EBEWE Pharma's specialty injectables business for EUR 925 million (USD 1.2 billion) in an all-cash transaction

May 20, 2009 -- Basel, May 20, 2009 - Novartis has signed a definitive agreement to acquire the specialty generic injectables business of EBEWE Pharma, providing Sandoz - the Group's generic pharmaceuticals division - an opportunity to create a strong global platform for future growth while improving access for patients worldwide to many generic oncology medicines.

Under terms of the agreement, Novartis will acquire this business for EUR 925 million (USD 1.2 billion) in cash. Excluded from this transaction is EBEWE Pharma's separate injectable neurological products business.    » read more »

Genentech and Biogen Idec Submit Applications to the FDA for Rituxan for Most Common Type of Adult Leukemia

Applications Based on Data from Nearly 1,500 Patients in Two of the Largest Studies Ever Conducted in Chronic Lymphocytic Leukemia

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – May 19, 2009 – Genentech, Inc. and Biogen Idec (Nasdaq: BIIB) today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.    » read more »

Senators Dodd and Reed Seek to Improve Sunscreen Safety Standards

May 22, 2009 -- In an effort to help Americans better protect themselves from the sun’s harmful rays, U.S. Senators Chris Dodd (D-CT) and Jack Reed (D-RI) are teaming up with dermatologists and consumer rights advocates to introduce legislation requiring the Food and Drug Administration (FDA) to strengthen labeling and testing standards for sunscreen products.

The FDA has not updated its sunscreen labeling standards to include UVA protection, despite working on it for over 30 years. The current standards only require testing and labeling for UVB rays, known for causing sunburns and increasing the chance of skin cancer. However, they do not require standards for UVA rays, which are a major cause of skin cancer and premature aging.    » read more »

U.S. Now Halfway to Meeting the American Lung Association Smokefree Air Challenge

Wisconsin Becomes 25th State to Pass Comprehensive Legislation Protecting All Workers from Secondhand Smoke

Washington, D.C. (May 18, 2009) -- Today, Wisconsin residents have reason to celebrate. The Dairy State is now the 25th state in the nation, and the second in 2009, to pass a comprehensive smokefree workplace law protecting virtually everyone from secondhand smoke in public places and workplaces.

The American Lung Association applauds Governor Jim Doyle and Wisconsin lawmakers for passing this important legislation that will save hundreds of lives.

According to the U.S. Surgeon General, nearly 50,000 Americans die each year from secondhand smoke exposure. It is also the cause of a host of other diseases and ailments, including lung cancer and heart disease.    » read more »

Senator Dodd Statement on the Mark-Up of the Family Smoking Prevention and Tobacco Control Act

May 19, 2009 -- Senator Chris Dodd (D-CT), a senior member of the Senate Committee on Health, Education, Labor and Pensions, delivered the following statement at today’s committee mark-up, which he chaired, of the Family Smoking Prevention and Tobacco Control Act:    » read more »

Governor Doyle Signs Legislation That Makes Wisconsin Smoke Free

May 18, 2009 -- MILWAUKEE, GREEN BAY, MADISON – Wisconsin Governor Jim Doyle today signed legislation to make public places, including restaurants, taverns, and other indoor workplaces, smokefree. The Governor was joined at bill-signing events around the state today by business owners, health officials and smokefree Wisconsin advocates.

“It’s time for every person in Wisconsin to breathe freely at restaurants, taverns, and workplaces across the state,” Governor Doyle said. “A smokefree Wisconsin will save money in health care costs, improve public health and save lives. I wish the ban would be implemented sooner, but I am proud the state is embracing the healthy direction the world is going.”    » read more »

Compact Cancer-Therapy Particle-Delivery System Patented

Simpler, less expensive design could make precision particle therapy available to more patients

May 12, 2009 -- UPTON, NY — As part of an effort to make high-precision particle cancer therapy accessible to more patients, a physicist at the U.S. Department of Energy’s (DOE) Brookhaven National Laboratory has developed a simpler, less-expensive gantry design for delivering tumor-killing particle beams. Brookhaven Science Associates, the company that manages the Lab for DOE, has applied for a U.S. non-provisional patent on the design, which is now available for licensing and commercial development.    » read more »

Virginia Governor Kaine Signs Restaurant Smoking Ban

Ban will protect workers and patrons and will be strongest in traditional tobacco states

March 09, 2009 --    » read more »

Congress Moves One Step Closer to Ending Big Tobacco’s Reign of Deception

March 4, 2009 -- Statement of Charles D. Connor, American Lung Association President and CEO:

Today in Washington, the Congress has moved one big step closer to ending the grip Big Tobacco has on our nation’s health. The U.S. House of Representatives’ Energy and Commerce Committee sent the Family Smoking Prevention and Tobacco Control Act (HR 1256) to the full House for its consideration. Passage of this important bill will provide the U.S. Food and Drug Administration (FDA) urgently needed regulatory control over the tobacco industry.    » read more »

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