Biologics Drug / Agent News and Research

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MorphoSys obtains license on human cell line technology for use in its antibody research

MorphoSys has announced today a non-exclusive license agreement with Dutch biotechnology company Crucell and DSM Biologics.

8 Sep 2004

Genentech announces FDA approval of Avastin manufacturing

Genentech has announced that the U.S. Food and Drug Administration approved the supplemental Biologics License Application (sBLA) for the manufacturing of Avastin™ (bevacizumab) bulk drug substance at the company's facility in Vacaville, California.

11 Aug 2004

Aventis ships its influenza vaccine, Fluzone

Aventis began to ship its influenza vaccine (Fluzone(R), Influenza Virus Vaccine) today, meeting the company's goal to provide Fluzone vaccine to customers to allow health-care providers to plan successful immunization programs for the upcoming influenza season.

3 Aug 2004

European recommended approval of Remicade for treatment of psoriatic arthritis

Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion recommending approval of expanded labeling for REMICADE(R) (infliximab), in combination with methotrexate, for treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to disease modifying anti- rheumatic drugs (DMARDs).

2 Aug 2004

Framework for systematically incorporating epigenetic information into traditional genetic studies

Scientists at Johns Hopkins are calling for simultaneous evaluation of both genetic and epigenetic information in the search to understand contributors to such common diseases as cancer, heart disease and diabetes.

29 Jul 2004

Roche files for application with FDA to market hepatitis C medication Pegasys(R) for chronic hepatitis B treatment

Roche announced today the submission of a supplemental new biologics license application (sBLA) with the U.S. Food and Drug Administration to market Pegasys(R) (peginterferon alfa-2a) for the treatment of chronic hepatitis B (CHB).

21 Jul 2004

Strategic analysis of the breast cancer therapeutics pipeline

Strategic partnerships between the pharmaceuticals industry and the biotechnology sector are making breast cancer therapeutics one of the most dynamic segments in the overall oncology market.

15 Jul 2004

Myriad Genetics awarded a $14.2 million contract for AIDS and hepatitis research

Myriad Genetics has announced that it has been awarded a five-year, $14.2 million contract by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

10 Jul 2004

Chemotherapy agents as well as the newest biologic and targeted cancer therapy drugs, can harm a patient’s heart

Cancer treatments, including the most commonly used chemotherapy agents as well as the newest biologic and targeted therapy drugs, can harm a patient’s heart, sometimes fatally

29 Jun 2004

First university-based research center devoted to studying epigenetics

With a $5 million, five-year federal grant, The Johns Hopkins University School of Medicine is establishing what is believed to be the first university-based research center devoted to studying epigenetics

28 Jun 2004

Wright Medical Group names new CEO

Wright Medical Group, Inc. has announced that Laurence Y. Fairey, who has been a member of the board of directors of the company since January 2004, will become President and Chief Executive Officer

22 Jun 2004

Erectile dysfunction and type 2 diabetes could mean heart disease

Men who had silent, or symptomless, coronary artery disease (CAD) and type 2 diabetes were nine times as likely to have erectile dysfunction (ED) as were diabetic men who did not have silent heart disease.

22 Jun 2004

Results from study of Rituxan in rheumatoid arthritis show promise

Genentech, Inc., Biogen Idec and Roche have announced that the New England Journal of Medicine published the results of a Phase IIa study showing that two doses of Rituxan® (Rituximab), administered two weeks apart, improved symptoms in patients with moderate-to-severe rheumatoid arthritis (RA) for up to 48 weeks when combined with methotrexate (MTX), compared to MTX alone.

16 Jun 2004

Remicade shows improvement in both the arthritis and psoriasis associated with psoriatic arthritis

In this trial, REMICADE provided a 70 percent improvement (as measured by ACR 70) in symptoms of arthritis in nearly one-third of patients, compared with only 2 percent of patients on placebo at 24 weeks.

10 Jun 2004

A biological agent used without chemotherapy appears to offer a disease-free future to patients with rare leukemia

A biological agent — a drug that wraps vitamin A inside bubbles of fat — used without chemotherapy appears to offer as many as one-third of patients with a rare form of leukemia an opportunity for a long-term, disease-free future, say researchers at The University of Texas M. D. Anderson Cancer Center.

7 Jun 2004

FDA has announced the results of a comprehensive review of all outside activities performed by FDA employees

Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), has announced the results of a comprehensive review of all "outside activities" performed by FDA employees.

5 Jun 2004

Four critical components of cells' protein-building machine don't do what scientists had long assumed

In the hunt for these details, scientists have focused on four RNA building blocks, or nucleotides, deep within the machine that are identical in every species, from bacteria to humans. Because they sit where the protein chain is actually built, these "universally conserved" nucleotides in the ribosome were thought to help that process.

28 May 2004

Finding overturns long held ideas about how cells build proteins

Writing in the May 28 issue of Cell, Johns Hopkins researchers report that four critical components of cells' protein-building machine don't do what scientists had long assumed.

27 May 2004

Research tests the efficacy of a smallpox vaccine candidate known as LC16m8

When used as an aerosolized weapon, smallpox could be controlled by a new vaccine under study at Saint Louis University School of Medicine, according to new data.