Pharmaceutical industry

Decision Underscores Need for Reform at FDA

March 23, 2009 -- A federal district court today ruled the Food and Drug Administration (FDA) violated its own rules when it restricted over-the-counter sales of the emergency contraceptive Plan B to women over 18. The New York City-based court ordered the FDA to reconsider its decisions regarding over-the-counter access and age restrictions and to extend over-the-counter access to 17 year olds within 30 days.    » read more »

Roche intends to acquire all outstanding shares of Genentech for US$95.00 per share in cash

Roche (SWX: ROG.VX; RO.S) and Genentech (NYSE: DNA) announced today that they signed a merger agreement under which Roche will acquire the outstanding publicly held interest in Genentech for US$95.00 per share in cash, or a total payment of approximately US$46.8 billion to equity holders of Genentech other than Roche. The special committee of Genentech’s Board of Directors has approved the agreement and recommends that Genentech shareholders tender their shares in Roche’s tender offer.    » read more »

March 11, 2009 -- WASHINGTON—AARP today applauded the introduction of bipartisan legislation to lower the cost of prescription drugs. The Access to Life-Saving Medicine Act, introduced by Chairman Henry Waxman (D-CA), Rep. Frank Pallone (D-NJ), Rep. Nathan Deal (R-GA) and Rep. Jo Ann Emerson (R-MO), will create a needed pathway for the approval of safe generic versions of costly biologic drugs. A statement from AARP Executive Vice President Nancy LeaMond follows:

“Biologic drugs are treating some of the most devastating diseases Americans face, like cancer, anemia and multiple sclerosis. But for too many people, these life-saving medicines are simply out of reach because of their overwhelming price tags.    » read more »

Combined Company Positioned For Sustainable Growth Through Scientific Innovation And A Stronger, More Diversified Product Portfolio; Powerful Joint R&D Pipeline with Strong Candidates in All Development Phases Doubles the Number of Late-Stage Compounds to 18

WHITEHOUSE STATION, N.J. and KENILWORTH, N.J., March 9, 2009 - Merck & Co., Inc. (NYSE: MRK) and Schering-Plough Corporation (NYSE: SGP) today announced that their Boards of Directors have unanimously approved a definitive merger agreement under which Merck and Schering-Plough will combine, under the name Merck, in a stock and cash transaction.    » read more »

Statement of Brian Wolfman, Director, Litigation Group at Public Citizen

March 4, 2009 -- "We are extremely gratified that the U.S. Supreme Court today in Wyeth v. Levine upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.

Drug companies are not perfect, and they sometimes fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels. Nor is the FDA perfect. It is overworked and underfunded, and it depends almost entirely on drug companies for information about the safety and effectiveness of drugs.    » read more »

Pharmaceutical Companies Allegedly Marketed the Drug Natrecor for a Use Not Approved by the Food and Drug Administration

February 19, 2009 -- WASHINGTON – The United States has intervened in two whistleblower suits filed in the Northern District of California against the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs, the Justice Department announced today. Such an unapproved use is also known as an "off-label" use because it is not included in the drug’s FDA approved product label.    » read more »

Boston, Massachusetts - 01/22/2009 - The following is the statement of Robert Restuccia, Executive Director for The Prescription Project, regarding the revised Physician Payments Sunshine Act filed today.

“We commend Senators Kohl and Grassley for their leadership in crafting a bill to create much needed transparency around the financial relationships between physicians and the drug and medical devices industries.

“Pharmaceuticals and medical devices clearly play a critical role in patient care. However, aggressive industry marketing of new drugs and devices to doctors through undisclosed gifts, consulting payments, speaking fees, classes, and meals can inappropriately influence medical decisions and create conflicts of interest.    » read more »

August 11, 2008 -- LANSING - Michigan Attorney General Mike Cox today announced that funds from a settlement with the pharmacy benefits management company, Caremark, will be used to promote Michigan's drug cost website, www.michigandrugprices.com. Michigan was part of a 28 state settlement with Caremark.

Caremark engaged in deceptive business practices by encouraging doctors to switch patients to different brand name prescription drugs and representing that the patients and/or health plans would save money. Doctors were not adequately informed of the effect this switch would have on costs to patients and health plans.    » read more »

July 18, 2008 -- The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements.    » read more »

Awards recognize best in-class, Microsoft-based solutions in clinical development, sales and marketing, and discovery and product innovation

BOSTON, June 25, 2008 — Microsoft Corp. today announced winners of the 2008 Pharmaceutical and Life Sciences Innovation Awards, honoring companies that have made the most innovative use of Microsoft-based solutions for breakthroughs in business processes and practices throughout the pharmaceutical and life sciences industry.

Announced at the Drug Information Association’s (DIA) 44th Annual Meeting, the awards were presented in the categories of discovery and product innovation, sales and marketing, and clinical development.    » read more »

06/17/2008 -- BOSTON – Senator John Kerry today urged the Food and Drug Administration (FDA) to explain the long delays in getting new generic prescription drugs out on the market.

People across Massachusetts and throughout the nation are facing rising costs for medications they depend on every day. For some, especially the elderly and low-income families, affordable generic drugs can be the difference between life and death.

The FDA is currently required to review a generic drug application within 180 days. However, the median approval time for a generic drug application now takes longer than 21 months - well beyond the 180 day requirement. These delays create a serious backlog of applications.    » read more »

Expired Milk, Eggs, Medicines, and Baby Formula Found in Scores of CVS and Rite Aid Stores Statewide

NEW YORK, N.Y. -- June 12, 2008 – New York Attorney General Andrew M. Cuomo today announced his office is taking legal action against CVS and Rite Aid pharmacies after a statewide investigation into retail drug stores found the companies sold expired products - including milk, eggs, medicines and baby formula - at stores across New York.    » read more »

Subsidiary of BioLineRx Opens U.S. Office in Rockville, Hires Local Business Development Executive

BALTIMORE, MD -- May 29, 2008 – As part of his economic development mission to Israel, Maryland Governor Martin O’Malley today announced that BioLineRx USA, Inc., a wholly-owned subsidiary of BioLineRx, one of Israel’s leading drug development companies, has opened a U.S. office in Maryland.

BioLineRx USA has already hired a local Vice President of Business Development to seek out potential collaborative opportunities for BioLineRx in Maryland and the U.S.    » read more »

May 29, 2008 -- Connecticut Attorney General Richard Blumenthal today announced a lawsuit against McKesson Corporation, a pharmaceutical distributor, for artificially inflating drug costs incurred by Connecticut consumers and state-funded health care programs.

Blumenthal sued on behalf of Department of Social Services (DSS) Commissioner Michael P. Starkowski and Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr.

The inflated costs affected several top-brand drugs, including Allegra, Azmacort, Celebrex, Flonase, Lipitor, Neurontin, Nexium, Prevacid and Valium. These drugs are used to treat a variety of ailments such as asthma, allergies, pain, arthritis and cholesterol.    » read more »

Record-Breaking Agreement Requires Company to Submit Ads to FDA Prior to Airing

May 20, 2008 -- Chicago - Illinois Attorney General Lisa Madigan today announced a landmark financial settlement with Merck and Company, Inc., that also requires the pharmaceutical manufacturer to submit television drug advertisements to the U.S. Food and Drug Administration (FDA) for review before their broadcast.    » read more »