Pharmaceutical News

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FDA proposes major revisions to the physician labeling for prescription drugs

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

28 May 2008

Breakthrough by WHO will give poor countries better access to drugs

An agreement has been reached by world health leaders regarding approaches to drug research and development and improving access to medicines.

27 May 2008

Bliss Nipple Cream warning from FDA

The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

25 May 2008

Pennsylvania State agency seeks to gain control of Medicaid managed care plans' prescription drug benefits

The administration of Pennsylvania Gov. Ed Rendell (D) has proposed shifting control of the prescription drug component of Medicaid managed care plans to the state Department of Public Welfare, the Pittsburgh Post-Gazette reports.

22 May 2008

Pharmaceutical, medical device industries have shifted campaign contributions to Democratic candidates

Pharmaceutical and medical device companies have contributed more to the campaigns of Democratic candidates than Republican candidates in the current election cycle, a "sharp reversal" from previous cycles and "one more sign of the campaign difficulties the GOP could face this November," the AP/Miami Herald reports.

22 May 2008

Merck agrees to pay $58 million to aettle multistate lawsuit that claimed advertisements for Vioxx played down health risks

Merck on Tuesday agreed to a $58 million settlement with 29 states and the District of Columbia to end investigations over allegations that it downplayed cardiovascular risks caused by the COX-2 inhibitor Vioxx in direct-to-consumer advertisements dating back to 1999, the AP/Philadelphia Inquirer reports (Raffaele, AP/Philadelphia Inquirer, 5/21).

21 May 2008

House Committee leaders warn pharmaceutical companies to end use of 'misleading' advertisements

House Energy and Commerce Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) in a recent letter warned four pharmaceutical companies to end the use of "misleading and deceptive" direct-to-consumer advertisements for medications, CQ HealthBeat reports.

21 May 2008

Advaxis files investigational new drug application for Lovaxin C

Advaxis Inc. completed its filing of a new investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA"). This filing follows the successful completion of a Phase I study overseas.

20 May 2008

Report cites 15 New York State HMOs for setting consumer restrictions on prescription drugs to boost profits

Some HMOs in New York state are restricting patients' access to so-called single-source drugs, brand-name medications for specific ailments that do not have lower-cost generic versions, according to a report released on Sunday, the New York Daily News reports.

20 May 2008

FDA approves Entereg (alvimopan) to restore bowel function

The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

20 May 2008

Stiff competition for Viagra in the pipeline

Scientists in Scotland are in the process of developing a drug which could offer stiff competition to the drug Viagra.

20 May 2008

Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

The Biotechnology Industry Organization has issued a letter to Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) to indicate qualified support for a bill (HR 5629) that they have introduced to allow FDA to approve generic biotech medications, CQ HealthBeat reports (McCarthy, CQ HealthBeat, 5/16).

19 May 2008

National Community Pharmacists Association to launch ad campaign to lobby lawmakers for policy changes

The National Community Pharmacists Association this week plans to launch a new advertising campaign that asks lawmakers to address two policies that the group maintains has or will result in closures of community pharmacies, CongressDaily reports. As part of the launch of the campaign, about 500 community pharmacists and independent pharmacy owners will visit Washington, D.C.

19 May 2008

Taiwan approves WTO amendment allowing countries to export lower-cost versions of antiretrovirals, other drugs to developing countries

Taiwan's legislative body the Yuan on Thursday approved the first reading of a proposed World Trade Organization amendment that would allow pharmaceutical companies to make lower-cost versions of generic antiretroviral drugs, as well as drugs for malaria and other diseases, to sell to developing countries, the CNA/Taipei Times reports.

19 May 2008

Spectrum Pharmaceuticals to present data on Ortataxel in breast cancer at major oncology meeting

Spectrum Pharmaceuticals, Inc., will present Phase 2 data on ortataxel at the 44th American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30 to June 3, 2008 at the McCormick Place Convention Center in Chicago, Illinois.

19 May 2008

Nasal gel to fight superbug MRSA

British scientists are well on the way to developing a new drug to fight the 'superbug' Methicillin-resistant Staphylococcus aureus (MRSA).

19 May 2008

First pre-pandemic bird flu vaccine available in Europe

The approval for a licence from the European Commission will place Glaxo ahead of rivals in the vaccine fields and the company says it has already received orders from some governments such as the U.S., Switzerland and Finland.

19 May 2008

Cancer Research UK and AstraZeneca announce innovative deal for promising anti-cancer compound

Cancer Research UK and Cancer Research Technology (CRT) - the charity's development and commercialisation arm - today announced an innovative new arrangement to progress into clinical development a potential anti-cancer compound from AstraZeneca.

19 May 2008

Schering-Plough extends antibody aliance with MorphoSys

MorphoSys AG announced today that Schering-Plough Corporation has decided to extend the current collaboration between the two companies for one year.

19 May 2008

51% of insured U.S. residents regularly take prescription drugs for chronic illnesses

Fifty-one percent of insured U.S. residents last year took one or more prescription drugs for chronic diseases, compared with 50% in the previous four years and 47% in 2001, according to a report released last Tuesday by Medco Health Solutions, the AP/Houston Chronicle reports.

19 May 2008

Pharmaceutical News

FDA proposes major revisions to the physician labeling for prescription drugs

Breakthrough by WHO will give poor countries better access to drugs

Bliss Nipple Cream warning from FDA

Pennsylvania State agency seeks to gain control of Medicaid managed care plans' prescription drug benefits

Pharmaceutical, medical device industries have shifted campaign contributions to Democratic candidates

Merck agrees to pay $58 million to aettle multistate lawsuit that claimed advertisements for Vioxx played down health risks

House Committee leaders warn pharmaceutical companies to end use of 'misleading' advertisements

Advaxis files investigational new drug application for Lovaxin C

Report cites 15 New York State HMOs for setting consumer restrictions on prescription drugs to boost profits

FDA approves Entereg (alvimopan) to restore bowel function

Stiff competition for Viagra in the pipeline

Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

National Community Pharmacists Association to launch ad campaign to lobby lawmakers for policy changes

Taiwan approves WTO amendment allowing countries to export lower-cost versions of antiretrovirals, other drugs to developing countries

Spectrum Pharmaceuticals to present data on Ortataxel in breast cancer at major oncology meeting

Nasal gel to fight superbug MRSA

First pre-pandemic bird flu vaccine available in Europe

Cancer Research UK and AstraZeneca announce innovative deal for promising anti-cancer compound

Schering-Plough extends antibody aliance with MorphoSys

51% of insured U.S. residents regularly take prescription drugs for chronic illnesses

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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