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Decision Resources: Benlysta to garner more than $500M in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, following its expected regulatory approval in 2011 in the United States and Europe, Human Genome Sciences/GlaxoSmithKline's Benlysta will garner sales of more than $500 million in 2018 in the systemic lupus erythematosus drug market.

2 Feb 2010

Lawmakers seek details of Obama's closed-door meetings with health industry groups

"In a rare display of bipartisanship,… Rep. Henry Waxman (D-Calif.), chairman of the House Energy and Commerce Committee, said he'd help Dr. Michael Burgess (R-Texas) seek information on the names of representatives from the pharmaceutical, device, hospital, doctor, and insurance sectors, who met with White House officials regarding healthcare reform," Medpage Today/ABC News reports.

2 Feb 2010

Starpharma Holdings, Eli Lilly sign new collaborative drug research and development agreement

Starpharma Holdings Limited today announced the signing of a new agreement with Eli Lilly and Company under which Starpharma's dendrimer drug delivery technology will be applied to enhance compounds in Lilly's human pharmaceutical portfolio.

2 Feb 2010

Shire announces the Canadian availability of VYVANSE prodrug therapy for ADHD treatment

Canadian families managing Attention Deficit Hyperactivity Disorder (ADHD) have a new treatment option. Today, Shire plc, the global specialty biopharmaceutical company, announced the Canadian availability of VYVANSE (lisdexamfetamine dimesylate capsule), the first and only prodrug therapy approved for ADHD treatment in Canada.

2 Feb 2010

DATATRAK International announces multi-center study on Renal Anemia

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the contract signing for a Phase IV, eight-year, 500-site, 5,000-patient study worth approximately $900,000 with a global specialty pharmaceutical and medication delivery company.

2 Feb 2010

TOPICA's IND for onychomycosis antifungal agent accepted by FDA

TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for the use of luliconazole, its lead product candidate, in patients with onychomycosis (nail and nail bed fungal infections).

1 Feb 2010

YM BioSciences-Cytopia merger complete

YM BioSciences Inc., announced that the merger of Cytopia Limited, the Australian biopharmaceutical company, into YM under a Scheme of Arrangement, has been concluded.

1 Feb 2010

Cephalon to acquire Swiss-based pharmaceutical company

Cephalon, Inc. (Nasdaq: CEPH) announced today that it has signed an agreement to acquire Mepha AG and its subsidiaries, a profitable, privately-held, Swiss-based pharmaceutical company.

1 Feb 2010

ISO renewal audit for KIKA Clinical Solutions' U.S. and France operations complete

KIKA™ Clinical Solutions announced the successful completion of its ISO renewal audit for its operations in the U.S. and France. KIKA is the leading provider of advanced EDC solutions for Clinical Asset Management™ for the pharmaceutical, biotechnology and medical device markets.

1 Feb 2010

Lobbyists played major role in health overhaul debate

The New York Times Prescriptions blog explores how millions of dollars were spent lobbying on health care. Although President Barack Obama has blamed lobbyists for helping to stall the legislative effort, "many of those lobbyists actually worked to support his health care overhaul, not oppose it," the Times finds.

31 Jan 2010

Humedica to participate in 7th Annual Healthcare Conference

Humedica, a next-generation clinical informatics company, today announced that it will be presenting at Harvard Business School’s 7th Annual Healthcare Conference: “Policy Reform: An Inflection Point for Healthcare Management?” on Saturday, January 30, 2010.

30 Jan 2010

Structure and activities to drive growth and profitability during pharmaceutical new product planning

With the prospect of health-care reform still looming, pharmaceutical and biotech companies face tremendous pressure to keep the costs of their products down.

30 Jan 2010

MPI Research lauds FDA's current guidance on abuse potential of drugs

On January 26, 2010, the Food and Drug Administration (FDA) released a key draft guidance document, Guidance for Industry Assessment of Abuse Potential of Drugs. When finalized, this guidance will represent the FDA’s current position on the abuse potential of drugs. Noteworthy within the document, Good Laboratory Practices (GLP) specified in the Guidance for Industry S7A Safety 471 Pharmacology Studies for Human Pharmaceuticals and in FDA regulations, 21 CFR 472 part 58, now also apply to abuse potential studies in animals.

30 Jan 2010

Spectrum Pharmaceuticals receives $16M over apaziquone collaboration agreement

Spectrum Pharmaceuticals, Inc., announced today that it has received $15 million from Nippon Kayaku in connection with the collaboration agreement for apaziquone (EOquin®) announced on November 10, 2009, and $1 million from Handok Pharmaceuticals announced on November 23, 2009.

30 Jan 2010

USP develops revised quality guidelines for pharmacists who prepare life-saving drugs

To further protect the safety of patients taking individually prepared medications, the U.S. Pharmacopeial Convention (USP) has developed new and revised quality guidelines for pharmacists who compound-or individually prepare-these life-saving drugs.

30 Jan 2010

Cerner to provide AORN SYNTEGRITY SPF for streamlining EHR perioperative documentation

Helping to streamline electronic documentation processes for perioperative care, CSC and the Association of periOperative Registered Nurses (AORN) announced today that Cerner, a global supplier of healthcare solutions, will be the first to provide AORN SYNTEGRITY™ Standardized Perioperative Framework (SPF) within a surgery and anesthesia management clinical information system. With AORN SYNTEGRITYTM, the amount of clinical staff time needed to configure and support electronic health record (EHR) perioperative documentation can be reduced by as much as 80 percent.

30 Jan 2010

Scientists currently working on 861 new cancer medicines

The Bienville Democrat in Arcadia, LA recently reported that America's pharmaceutical research and biotechnology companies have made great progress in treating cancers, introducing many new, breakthrough medicines.

30 Jan 2010

sigma-tau Group acquires Enzon’s specialty pharmaceutical business

Enzon Pharmaceuticals, Inc. ("Enzon") announced today that it has closed the sale of its specialty pharmaceutical business to the sigma-tau Group ("sigma-tau"). Enzon is a biopharmaceutical company dedicated to the discovery and development of important medicines for patients with cancer and other life-threatening conditions. Enzon's business now consists of its royalties, Peg SN38, LNA and PEG technology platforms.

30 Jan 2010

American PhRMA companies commit $25M in medicines, medical supplies and cash for Haiti relief efforts

As the need for health care assistance mounts after the recent catastrophic earthquake in Haiti, America's pharmaceutical research and biotechnology companies continue to provide help. So far, more than $25 million in medicines, medical supplies and cash have been committed to relief efforts – and that amount is still growing. The total does not include the contributions of PhRMA member company employees and the many companies committed to matching the pledges of their workers.

30 Jan 2010

Government cracks down on drug marketing

Recent crackdown on pharmaceutical companies suggests that drug marketing remains an issue with federal authorities. The Wall Street Journal reports: "Novartis AG's agreement to settle criminal allegations involving marketing of an epilepsy drug is the latest in a string of cases showing that improper marketing practices are still a problem years after the U.S. government started cracking down on them.

30 Jan 2010

Pharmaceuticals News and Research

Decision Resources: Benlysta to garner more than $500M in 2018

Lawmakers seek details of Obama's closed-door meetings with health industry groups

Starpharma Holdings, Eli Lilly sign new collaborative drug research and development agreement

Shire announces the Canadian availability of VYVANSE prodrug therapy for ADHD treatment

DATATRAK International announces multi-center study on Renal Anemia

TOPICA's IND for onychomycosis antifungal agent accepted by FDA

YM BioSciences-Cytopia merger complete

Cephalon to acquire Swiss-based pharmaceutical company

ISO renewal audit for KIKA Clinical Solutions' U.S. and France operations complete

Lobbyists played major role in health overhaul debate

Humedica to participate in 7th Annual Healthcare Conference

Structure and activities to drive growth and profitability during pharmaceutical new product planning

MPI Research lauds FDA's current guidance on abuse potential of drugs

Spectrum Pharmaceuticals receives $16M over apaziquone collaboration agreement

USP develops revised quality guidelines for pharmacists who prepare life-saving drugs

Cerner to provide AORN SYNTEGRITY SPF for streamlining EHR perioperative documentation

Scientists currently working on 861 new cancer medicines

sigma-tau Group acquires Enzon’s specialty pharmaceutical business

American PhRMA companies commit $25M in medicines, medical supplies and cash for Haiti relief efforts

Government cracks down on drug marketing

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