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FDA Issues Approvable Letter For Pfizer's Antiretroviral Maraviroc
Pfizer in a statement released on Wednesday said it has received an approvable letter from

2007-06-25 03:00

Shire Receives FDA Approvable Letter For INTUNIV (guanfacine) ER, A Nonstimulant ADHD Treatment
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist that has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

2007-06-24 14:00

Sandoz Receives Positive EU Opinion For Approval Of Epoetin Alfa Biosimilar
Sandoz is the first company to receive a positive opinion from European Union regulators supporting the approval of a biosimilar version of epoetin alfa, achieving another important milestone in its efforts to bring follow-on biological medicines to patients. More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, and similar medicines to regulate the formation of red blood cells.

2007-06-24 02:00

European Medicines Agency Agrees On Action Plan Following The Recall Of Viracept And Recommends Suspension Of The Marketing Authorisation
The European Medicines Agency agreed on an action plan to follow-up patients who were exposed to contaminated Viracept (nelfinavir). Viracept, from Roche Registration Limited, is an antiretroviral medicine used to treat HIV-1 infected adults, adolescents and children of 3 years of age and older.

2007-06-23 03:00

Rules And Guidance For Pharmaceutical Distributors 2007, UK
The Rules and Guidance for Pharmaceutical Distributors reproduces those elements of the 2007 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the "Orange Guide") specific to the wholesale supply and distribution of medicines for human use.

2007-06-23 03:00

Biotechnology Industry Organization Issues Call For Session Proposals For 2008 BIO International Convention
The Biotechnology Industry Organization (BIO) invites leaders in science, finance, business, law, and government policy to submit proposals for breakout sessions at the 2008 BIO International Convention to be held June 17-20 at the San Diego Convention Center. The day pattern will change from previous years to Tuesday-Friday.

2007-06-21 03:00

Congress Should Avoid Efforts To 'Manage' Prescription Drug Safety Risk In Bill To Reauthorize PDUFA, Opinion Piece States
"Congress would do well to strip out the efforts to 'manage' risks and thus regulate medical practice" from legislation to reauthorize the Prescription Drug User Fee Act and focus on efforts to "improve measures for surfacing safety-related information through advances in postmarket monitoring," former FDA deputy commissioner Scott Gottlieb, a physician and resident fellow at the

2007-06-20 17:00

Presidential Candidate Obama Says Prescription Drug Proposal Could Save $157B Over 10 Years
Presidential candidate Sen. Barack Obama (D-Ill.) on Saturday in Iowa said that his prescription drug proposal could save Medicare beneficiaries an estimated $157 billion over the next 10 years, the AP/San Francisco Chronicle reports.

2007-06-20 07:00

European Medicines Agency Workshop On First-in-man Clinical Trials Draft Guideline
The European Medicines Agency held a workshop on 12 June 2007 as part of the public consultation on the draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products.

2007-06-20 03:00

EMEA-FDA Regulatory Cooperation Expanded
The US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas. At a meeting June 14-15, 2007, the US and the EU reviewed the past year's activities under the existing Implementation Plan for the confidentiality arrangement.

2007-06-20 03:00

Warner Chilcott To Pay $5.5M To Settle Suit Alleging Company Kept Generic Contraceptive From Entering Market
Warner Chilcott will pay $5.5 million to settle a lawsuit that alleges the company conspired with Barr Pharmaceuticals to block a generic form of Warner's oral contraceptive Ovcon from entering the market, New York state Attorney General Andrew Cuomo (D) said on Tuesday,

2007-06-19 17:00

Op-Ed, Editorials Address Bill That Would Allow FDA To Approve Follow-On Biologics
Newspapers published an opinion piece and editorials examining a bill (S 623) being considered by the Senate Health, Education, Labor and Pensions Committee that would allow FDA to approve follow-on versions of biotechnology medications. Summaries of the pieces appear below.

2007-06-19 16:00

Prescription And Over-The-Counter Diet Pills May Increase Unhealthy Behavior
Glaxo Smith Kline's Alli™, the first FDA-approved over-the-counter weight loss pill, has hit shelves nationwide. Whether or not it succeeds depends a large part on its multilingual, multi-million dollar marketing campaign. A new study by Wharton professors and doctors at the University of Pennsylvania School of Medicine provides applicable new insight into consumer thinking about health remedies.

2007-06-19 10:00

MHRA Second Communications Strategy Published, UK
The MHRA is responsible for safeguarding public health by making sure that medicines and medical devices work, and are acceptably safe. If it is to be successful in this mission, the Agency must effectively communicate accurate and timely information about the benefits and risks of medicines and medical devices to key stakeholders, including the public, patients, healthcare professionals, researchers and industry.

2007-06-19 03:00

Vermont Governor Signs Bill That Aims To Increase Use Of Generic Prescription Drugs
Vermont Gov. Jim Douglas (R) on Monday signed into law legislation that is expected to increase the use of generic prescription drugs by providing patients and physicians with information about their effectiveness, the Burlington Free Press reports.

2007-06-18 19:00

House Leaders Reschedule Markup Of Bill To Reauthorize PDUFA Because Of Complaints From Republican Lawmakers
Members of the House Energy and Commerce Committee on Tuesday rescheduled a Health Subcommittee mark up of draft legislation that would reauthorize the Prescription Drug User Fee Act after Republicans complained the committee was moving too quickly, CongressDaily reports.

2007-06-18 15:00

Biotechnology And The EU - Speech By Peter Mandelson, EU Trade Commissioner
In this speech to the European Biotechnology Open day in Brussels EU Trade Commissioner Peter Mandelson strongly defends an open European approach to biotechnology and GM food; one that prioritises strict science-based health and safety testing but which recognises that safe biotechnology has a crucial role to play in agriculture and agricultural trade both in Europe and the developing world.

2007-06-16 03:00

House Faces 'Likely Battle' In Prescription Drug User Fee Reauthorization Negotiations With Senate, CQ HealthBeat Reports
House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) and committee Chair John Dingell (D-Mich.) "face a likely battle in conference negotiations to work out differences with" the Senate on a bill to reauthorize the Prescription Drug User Fee Act that includes a number of prescription drug safety provisions,

2007-06-15 21:00

Pennsylvania Program Aims To Counter Influence Of Pharmaceutical Representatives With 'Academic Detailers'
The Philadelphia Inquirer on Tuesday examined a Pennsylvania program that pays "academic" detailers to "give doctors objective information about the cost and benefits of all kinds of treatments, including diet and exercise." Under the program, called the

2007-06-15 07:00

Yale University To Expand Medical And Scientific Research Programs With Acquisition Of Bayer Complex
President Richard C. Levin announced that Yale University's efforts to expand and strengthen its medical and scientific research programs will take a major leap forward with the acquisition of the Bayer HealthCare complex in West Haven and Orange, Connecticut.

2007-06-15 03:00

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