Biologics Drug / Agent News and Research

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Bio manufacturers poised to follow Senate victory with house win

"A veteran California lawmaker with ties to the biotechnology industry said she thinks her proposal to protect brand-name biologic makers has enough support to carry in the House Energy and Commerce Committee," Dow Jones Newswires/Wall Street Journal reports.

15 Jul 2009

HELP Committee approves protection for high tech drug companies from generics

"Senators agreed Monday to give high-tech biologic drugs 12 years of market protection before generic versions can compete," according to The Associated Press.

15 Jul 2009

White House: Shield biotech drugs from generics for only seven years

White House officials said Thursday that biotech drugs (also known as biologics) should only be protected from generics competition for seven years, Reuters reports.

29 Jun 2009

Roche files MabThera as a first-line biologic treatment for rheumatoid arthritis in Europe

Roche has announced that it has submitted a combined filing to the European health authorities (the European Medicines Agency) for three new indications to extend the label for MabThera to use as a first-line biologic therapy for patients with rheumatoid arthritis (RA).

28 Jun 2009

Finance Committee seeks to trim cost of bill

"A draft proposal in the Senate to overhaul the nation's health-care system would require most people to buy health insurance, authorize an expansion of Medicaid coverage and create consumer-owned cooperative plans instead of the government coverage that President Obama is seeking," the Washington Post reports.

21 Jun 2009

The Federal Government should have limited, but crucial, role in comparative effectiveness

Federal officials are expected to offer recommendations this month on one of the first installments of health reform - a new initiative to compare the value and merits of competing medical treatments.

18 Jun 2009

Senate Health Committee to begin reform mark up today, finance to follow next week

Senate Democrats are scrambling to reduce the price tag of reform proposals, which initial estimates place at $1.6 trillion, The Wall Street Journal reports.

18 Jun 2009

Jeffrey Friedman receives Shaw Prize for discovery of leptin

Jeffrey M. Friedman, Marilyn M. Simpson Professor and head of the Laboratory of Molecular Genetics at Rockefeller University, has received the 2009 Shaw Prize in Life Science and Medicine. The prize was announced today by the Hong Kong-based Shaw Prize Foundation.

16 Jun 2009

Study shows promise for new cancer-stopping therapy

Researchers at Nationwide Children's Hospital and Johns Hopkins University have discovered that delivering a small molecule that is highly expressed in normal tissues but lost in diseased cells can result in tumor suppression.

12 Jun 2009

Dodd: Health reform bill lacks detail

Sen. Chris Dodd, D-Conn., said Tuesday morning that the most contentious issues in health care reform such as a public plan and employer mandate will be left out of a bill for now, Politico reports.

9 Jun 2009

Medtronic announces appeal decision in patent case with DePuy Spine

Medtronic, Inc. has announced results from a Federal Circuit Court review of a December 2007 patent infringement verdict regarding the Vertex line of multiaxial screws, which are no longer on the market.

1 Jun 2009

Impact of Medicare Part D on access to and cost sharing for specialty biologic medications for beneficiaries with rheumatoid arthritis

Biologic disease-modifying antirheumatic drugs (DMARDs) such as adalimumab, etanercept and infliximab are effective at reducing symptoms and slowing progression of rheumatoid arthritis (RA). These drugs act more quickly, require less laboratory monitoring, and are better tolerated than nonbiologic DMARDs, but they are also up to 100 times more expensive.

1 Jun 2009

Bioniche updates on phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer

Bioniche Life Sciences Inc. has provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company announced that recruitment had been completed in its initial Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guérin (BCG).

25 May 2009

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec 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).

20 May 2009

Resverlogix files two patents on compounds for inflammatory diseases

Resverlogix Corp. has announced today that it has made significant advancement in the Company's research and development (R&D) program for inflammatory diseases.

19 May 2009

Discovery of mutant genes in acute lymphoblastic leukemia

A research team has pinpointed a new class of gene mutations, which identify cases of childhood acute lymphoblastic leukemia (ALL) that have a high risk of relapse and death. The finding suggests specific drugs that could treat this high-risk leukemia subtype in children, particularly because such drugs are already in clinical trials for similar blood diseases in adults.

19 May 2009

What is the formula for sustainable healthcare reform?

A new report, released today by the Manhattan Institute's Center for Medical Progress and authored Douglas Holtz-Eakin, the former Director of the Congressional Budget Office, makes the fiscal and political case for bipartisan healthcare reform.

18 May 2009

Obama campaign contributors being asked to donate to effort supporting health care reform

The Washington Times on Friday examined how President Obama's "former campaign apparatus is cranking up a full-tilt drive for passage of a health care overhaul this year" by "tapping his 13-million-strong e-mail list" for financial contributions to fund advertising efforts, hire staff and open election-style offices.

15 May 2009

2010 budget for FDA invests substantially in food and medical product safety

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget.

7 May 2009

FDA approves new flu vaccine production facility

The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

6 May 2009