Showing posts with label pharmaceutical. Show all posts
Showing posts with label pharmaceutical. Show all posts

Wednesday, February 23, 2011

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

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Medical News: Supreme Court Sides With Vaccine Maker - in Washington-Watch, Washington Watch from MedPage Today

The Supreme Court has ruled 6-3 that a federal law shields drug companies from being sued over injuries caused by childhood vaccines.

The case was brought by the parents of Hannah Bruesewitz, now a young adult, and charges that she developed a seizure disorder after receiving her third dose of the diphtheria-tetanus-pertussis (DTP) vaccine when she was 6 months old. She has suffered developmental problems ever since, and will likely require medical attention for the rest of her life, her parents say.

The dose of the vaccine in question, TRI-IMMUNOL, came from a lot that generated 65 reports of adverse reactions, including 39 emergency room visits, six hospitalizations, and two deaths, according to documents from the U.S. appeals court that heard the case in 2009.

The National Childhood Vaccine Injury Act of 1986 created a so-called "vaccine court" to address safety claims in an attempt to ease the threat of lawsuits in state courts against pharmaceutical companies and insure against them pulling out of what they claim is an unprofitable vaccine marketplace completely.

Under the law, people injured by vaccines are eligible for compensation for medical care, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.

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Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
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Tuesday, February 15, 2011

Obama budget targets brand name medicines, Health.Yahoo.net

Big pharmaceutical companies could face increased competition from generic drugmakers under two proposals put forth by the Obama administration on Monday despite earlier savings extracted from drugmakers as part of last year's healthcare law.

President Barack Obama, as part of his 2012 budget proposal, called for cutting the number of years drugmakers could exclusively market brand-name biologic drugs to 7 years from 12.

He also set his sights on ending controversial "pay-for-delay" deals that affect traditional, chemical drugs by giving the U.S. Federal Trade Commission power to block them. Under such pacts, brand-name and generic drugmakers settle patent challenges with payoffs that delay lower-cost rivals from reaching the market.

The proposals face a tough challenge of getting through the divided Congress, but could alter the landscape for consumers' access to cheaper medicines.

They quickly drew industry protests.

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Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
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856-415-9617, (fax) 415-9618

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Wednesday, November 17, 2010

Grifols USA

Grifols has been working in the fields of transfusion, blood banking and clinical analysis for more than 70 years. Founded in 1940 by Dr. J.A. Grifols Roig, three generations of the Grifols family have led the company ever since. Our Grifols S.A. President, Victor Grifols, ensures that our company will always remain focused on what matters most - people. This dedication to the progress of healthcare for humankind has led to the distribution of Grifols products worldwide.

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Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
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856-415-9617, (fax) 415-9618

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MedImmune-FluMist

At MedImmune, we seek to develop innovative, high-value products in which we have significant interest, both independently and in collaboration with our partners. By creating cutting-edge biological products, we're improving health, enhancing lives and helping to make a world of difference.

Synagis®

FluMist®

Ethyol®

 

FluMist®

FluMist® (Influenza Vaccine Live, Intranasal) is the first and only nasal spray flu vaccine approved in the United States to help prevent influenza and is indicated for the active immunization of eligible individuals 2 to 49 years of age against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.

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******************************************************

Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
http://www.nursefriendly.com info@nursefriendly.com ICQ #6116137
856-415-9617, (fax) 415-9618

150,000 + Nurse-Reviewed & Approved Nursing Links

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