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Pharmaceutical News

Regulatory Filing For FACTIVE Tablets Submitted In Europe

Fri, 09 May 2008 02:00:00 PDT

Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI) commercialization partner for FACTIVE® (gemifloxacin mesylate) tablets, Menarini Group, a leading European pharmaceutical company based in Italy, has submitted a regulatory filing seeking approval of FACTIVE in Europe.

UK Architects RMJM To Design $90m Biotech Facility In Beijing

Fri, 09 May 2008 01:00:00 PDT

UK architecture firm RMJM has been appointed design architect for a state-of-the-art $US90 million biotechnology research and development centre in Beijing , it was announced recently. The new facility is for Genzyme Corp. The facility is to be built at Zhongguancun (ZGC) Life Science Park which is dedicated to academic and government research centres as well as pharmaceutical and biotechnology companies.

Senate Subcommittee Votes To Boost FDA Funding By 275 Million Dollars

Thu, 08 May 2008 14:00:00 PDT

In an important first step towards achieving increased funding for the Food and Drug Administration (FDA), members of a Senate appropriations subcommittee approved an additional $275 million in appropriations for the agency. The additional resources would provide a significant boost to the FDA's ability to monitor drug safety.

Industry Distribution Of Journal Articles Ineffective, ASHP Tells FDA

Thu, 08 May 2008 07:00:00 PDT

The pharmaceutical industry's distribution of journal articles on off-label uses to healthcare providers is ineffective and inappropriate; ASHP recently told the Food and Drug Administration (FDA) in comments on its draft guidance outlining good reprint practices for drug manufacturers to follow when providing health providers with information on off-label uses. In its comments, ASHP urged the FDA to reinstitute its formal review of manufacturer-distributed journal articles.

Better Regulation Of Medicines Initiative - Third Report Launched, UK

Thu, 08 May 2008 03:00:00 PDT

The Medicines and Healthcare products Regulatory Agency (MHRA) is to publish its third report on the new and innovative scheme; Better Regulation of Medicines Initiative (BROMI) on 08 May 2008. BROMI is a ground breaking initiative which is changing medicines regulation in order to deliver new updated medicines to patients faster.

Developers Finding Success Of Injectable Drugs Dependent On Numerous Factors -Analysis Trends And Prospects For Six Key Drug Classes

Thu, 08 May 2008 02:00:00 PDT

Technology has a way of providing benefits that create complexities, a lesson that drug developers and their supply chain partners are learning to deal with. Historically, the success of new drugs has focused on tolerability, safety, and pharmacokinetics. The challenges of biologically-derived drugs have added new requirements to successful drug development.

Birkman Method Helps Pharma Reps Find New Jobs

Wed, 07 May 2008 02:00:00 PDT

Eight of the world's largest drug makers recently announced the loss of 42,000 jobs, including such household names as Pfizer and Wyeth. The job losses fell disproportionately on their U.S. sales forces. Clearly, the days of growth for drug sales reps are seemingly over.

On The Eve Of ''ILSI-Biomed Israel 2008'' Week: Chief Scientist Approves More Than 305 Million NIS For The Life Science Industry

Wed, 07 May 2008 02:00:00 PDT

Figures reported by the Chief Scientist office towards the "ILSI-Biomed Israel 2008" Week, which will be held in Tel Aviv from May 27-29, show that in the six months from November 2007 to April 2008, the Chief Scientist office earmarked 305.4 million NIS in budgets for the life science industry. When broken down into industry segments, bio-pharma received 77 million NIS, biotechnology 153.9 million NIS, and medical devices 74.5 NIS.

Oculus Innovative Sciences Announces Initial Chinese Commercialization Plan For Launch Of Microcyn(R) Technology

Wed, 07 May 2008 02:00:00 PDT

Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform that is intended to treat infections in chronic and acute wounds, announced that the Oculus development team completed meetings this past week in Beijing, China with Chinese partners at China Bao Tai and Sinopharm regarding commercialization plans for the product launch of Microcyn Technology in China.

FDA Official Pulls Back On Estimates Of Cost To Inspect Foreign Drug Makers Properly

Mon, 05 May 2008 07:00:00 PDT

FDA Center for Drug Evaluation and Research Director Janet Woodcock on Thursday during a House hearing "backed away" from a Tuesday comment that the agency would need an estimated $225 million to improve inspections of foreign medication manufacturing plants, the Wall Street Journal reports (Mundy, Wall Street Journal, 5/2).

FDA Sends Warning Letter To Merck About Manufacturing Problems At Pa. Plant

Mon, 05 May 2008 06:00:00 PDT

FDA on April 28 sent a warning letter to Merck officials informing them that agency investigators discovered manufacturing deficiencies at the company's vaccine plant in West Point, Pa., the Wall Street Journal reports.

Briefcase-Sized Portable Anti-Counterfeit Drug Analyzer Provides Real-Time Analysis Anywhere, Anytime

Mon, 05 May 2008 03:00:00 PDT

ASD Inc. introduces the RxSpec® 700Z anti-counterfeit drug analyzer , a lightweight fully-portable lab-quality system contained in a rugged aluminum briefcase. For the first time in history, field agents from industry, government, and law enforcement have the ability to test drugs on the spot, anywhere, anytime, to determine whether the actual pill, rather than the packaging, is authentic or counterfeit.

President Bush Is Right On Biofuels

Mon, 05 May 2008 00:00:00 PDT

Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), issued the following statement today lauding President Bush's avowal yesterday that ethanol production is responsible for only a small part of food inflation: "President Bush accurately recognizes that the rise in global food prices is the result of a variety of factors and that only a small part is due to increased demand for corn to produce ethanol.

BIO Testifies On Drug Safety Provisions Of Draft FDA Globalization Act

Fri, 02 May 2008 04:00:00 PDT

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on his testimony before the House Energy and Commerce Subcommittee on Health regarding the drug safety provisions of the discussion draft of the Food and Drug Administration Globalization

Public Private Partnerships Are Essential To Address Medicines Discovery Slowdown

Fri, 02 May 2008 04:00:00 PDT

The decline in biopharmaceutical innovation is multi-factorial. Scientific challenges are increasingly complex and R&D costs are higher than ever before. At the same time, higher regulatory hurdles are slowing down new product approvals, while the downward pressure on prices continues and framework conditions in Europe are not innovation-friendly. In this context, only a partnership-based approach can help to accelerate the discovery and development of new medicines, according to Arthur J.

Medicines Australia Calls For Bold Response To Innovation Challenge

Fri, 02 May 2008 04:00:00 PDT

Medicines Australia has called on the Government to reduce the corporate tax rate to 20 per cent and set up an effective industry development program to secure the longterm viability of Australia's $10 billion pharmaceuticals industry.

Biotech Solutions For Food And Fuel Highlighted At World Congress On Industrial Biotechnology

Fri, 02 May 2008 02:00:00 PDT

Biotechnology is the key to meeting rising worldwide demand for food and alternative fuels, by boosting agricultural production, producing biofuels from energy crops, and increasing the efficiency of biofuel production, according to many of the speakers at BIO's World Congress on Industrial Biotechnology and Bioprocessing. The annual conference of more than 1200 scientists, business leaders, and government officials ended today in Chicago.

Medical Schools Should Implement Bans On Pharmaceutical, Medical Device Industry Gifts, Editorial States

Wed, 30 Apr 2008 05:00:00 PDT

A report released on Sunday by a task force of the Association of American Medical Colleges that recommends new restrictions on what physicians, staff members and students at U.S. medical schools can accept from drug companies and medical device makers is "encouraging," but it "flinched" on some important issues, a

Kohl, Durbin Investigate AMA Program Allowing Doctors To Opt-Out Of Having Prescribing Data Sold To Drug Companies, USA

Wed, 30 Apr 2008 02:00:00 PDT

Senator Herb Kohl (D-WI), Chairman of the Special Committee on Aging, and Senator Dick Durbin (D-IL), Assistant Majority Leader, sent a letter yesterday to the American Medical Association (AMA) to inquire about a program allowing physicians to opt-out of having their prescribing data sold to pharmaceutical companies.

Association Of American Medical Colleges Proposes Ban On Pharmaceutical Company Gifts To Physicians, Staff, Medical Students

Tue, 29 Apr 2008 11:00:00 PDT

All 129 U.S. medical schools should not allow pharmaceutical and medical device companies to provide food, gifts and travel to physicians, faculty members and students, according to a report released on Sunday by the Association of American Medical Colleges, the New York Times reports.

Sustainability Is Watchword For Industry, Say Speakers At World Congress On Industrial Biotechnology

Tue, 29 Apr 2008 03:00:00 PDT

Sustainability was on the minds of many of today's speakers at the World Congress on Industrial Biotechnology and Bioprocessing, an annual conference attracting more than 1200 scientists, business leaders, and government officials that began in full today in Chicago. John Heissenbuttel of Heissenbuttel Natural Resource Consulting announced a new industry initiative to ensure that advanced biofuels are produced in a sustainable manner.

Global Health, Sustainable Agriculture And International Business Issues Focus Of 2008 BIO International Convention

Tue, 29 Apr 2008 03:00:00 PDT

Global issues such as intellectual property protections, follow-on biologics/biosimilars, international networking for research and development of neglected diseases and sustainable agriculture in developing countries will all be primary focus areas of the 2008 BIO International Convention.

State RFS Waivers Could Derail Advanced Biofuels

Tue, 29 Apr 2008 03:00:00 PDT

Granting Texas' or other states' requests for a federal waiver of the Renewable Fuel Standard (RFS) would not reduce food prices but could hinder or delay advanced biofuel research, the Biotechnology Industry Organization (BIO) said. BIO opposes Texas Gov. Rick Perry's request to the U.S. Environmental Protection Agency for a 50 percent waiver of the RFS.

Purdue Expert Says U.S. Has Low Risk Of Receiving Contaminated Drugs

Tue, 29 Apr 2008 02:00:00 PDT

A Purdue University expert says distribution of contaminated pharmaceuticals in the United States is a concern, but an individual's risk of receiving such a drug is very low. "Tragic events such as the recent deaths and illnesses caused by contaminated heparin are alarming, but are extremely rare," says Stephen R. Byrn, the Charles B. Jordan Professor of Medicinal Chemistry and head of the Department of Industrial and Physical Pharmacy.

GE Healthcare Completes Acquisition Of Whatman Plc

Mon, 28 Apr 2008 03:00:00 PDT

GE Healthcare, a unit of General Electric Company (NYSE:GE) announced that it has completed the acquisition of Whatman plc, a global supplier of filtration products and technologies. The acquisition expands GE Healthcare's offering for life science research and biopharmaceutical manufacturing, a key area of growth for the company.

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