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FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.

16 Feb 2010

EntreMed's ENMD-2076 for AML receives FDA's orphan drug designation

EntreMed, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company's lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML).

16 Feb 2010

BUSACC hosts breakfast panel over reconstruction opportunities in Iraq, covering healthcare and pharma

The reconstruction of Iraq is under way and opportunities for Texas businesses abound. The Bilateral U.S. – Arab Chamber of Commerce (BUSACC) is hosting a business breakfast and panel discussion featuring Iraq’s Ambassador to the United States, the Senior Commercial Counsel and a high level Ministry of Energy official and delegation, along with American risk and security mitigation experts.

16 Feb 2010

Meda publishes 2009 year-end report

“The Meda Group expects to achieve sales of about SEK 13,000 million and an EBITDA of about SEK 4,200 million for full-year 2009.”

16 Feb 2010

VPCI pioneers on-demand GMP consultation services for Pharmaceutical manufacturers

Pharmaceutical manufacturers around the world now have access to high-level, FDA support services at the touch of a button. VPCI (Vectech Pharmaceutical Consultants International) has pioneered a "Virtual GMP Consulting" service. Through the use of high definition video conferencing equipment and collaboration software, Pharmaceutical manufacturers now have access to GMP consultation services on-demand, and at a fraction of the cost.

16 Feb 2010

Overall benefits of HPV vaccination or frequent screening are low for women over 41

The overall potential benefits of human papillomavirus (HPV) vaccinations or frequent HPV screenings for women over the age of 41 are low, concludes a new study published online February 15 in the Journal of the National Cancer Institute. The study found that the rate of new infections preventable by vaccination declines with age. Furthermore, new infections among women at any age typically do not progress to cervical intraepithelial neoplasia grade 2 (CIN 2) or CIN 3, the precursors for cervical cancer.

16 Feb 2010

When blood sugar levels rise in healthy people, insulin signals cells to increase production: Study

In type 2 diabetes, which is occurring at alarming rates, the hormone insulin does not work effectively to lower blood sugars and patients also do not make enough insulin. These two processes have been widely considered as separate.

16 Feb 2010

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

AstraZeneca and Rigel Pharmaceuticals today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications.

16 Feb 2010

Three Dutch life-science sectors announce joint investment to research on personalized medicine

The Netherlands' three Top Institutes for life-science research (the BioMedical Materials program, the Center for Translational Molecular Medicine and Top Institute Pharma) today announced a joint investment of MEUR 28 on innovative research targeted at bringing personalized medicine closer to reality.

16 Feb 2010

Use of non-steroidal anti-inflammatory drugs not associated with risk of squamous cell skin cancer

Contrary to previous hypotheses, the use of non-steroidal anti-inflammatory drugs does not appear associated with risk of squamous cell skin cancer, according to a report posted online today that will appear in the April print issue of Archives of Dermatology, one of the JAMA/Archives journals.

16 Feb 2010

Researchers discover chemical compound to combat malaria and bacterial diseases

Researchers report that they have discovered - and now know how to exploit - an unusual chemical reaction mechanism that allows malaria parasites and many disease-causing bacteria to survive. The research team, from the University of Illinois, also has developed the first potent inhibitor of this chemical reaction.

16 Feb 2010

Teva Pharmaceuticals USA settles famciclovir patent litigation with Novartis

Teva Pharmaceutical Industries Ltd. today announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva’s U.S. generic version of Novartis’ Famvir® (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. Teva launched its generic famciclovir tablets in the U.S. in September 2007.

16 Feb 2010

Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capacity projects

Albemarle Corporation, a leading global provider of custom manufacturing services, announced today it will partner with PharmaCore to provide manufacturing capabilities for customers with projects that require high volume capacity.

16 Feb 2010

Sinovac Beijing expands production capacity with acquisition of buildings and land use rights in Changping

Sinovac Biotech Ltd. (SVA), a leading China-based vaccine manufacturer, today announced the completion by its subsidiary, Sinovac Beijing, of the acquisition of buildings and land use rights. The total consideration for the purchase is approximately RMB120 million ($17.6 million), which will be financed from working capital. The initial payment of RMB56.5 million ($8.3 million) will be paid before February 20, 2010 and the balance of the purchase price will be paid in three installments within three years.

16 Feb 2010

Medivir, Meda announce agreement to commercialize Medivir’s cold sore product, Xerese

Medivir and Meda today announced an agreement for the commercialization of Medivir’s cold sore product which will be marketed in North America under the trade name Xerese™.

15 Feb 2010

ERYtech Pharma announces collaborative research agreement with M. D. Anderson Cancer Center

ERYtech Pharma, a specialty pharma company located in France and in USA (Philadelphia), is pleased to announce a collaborative research agreement in the field of personalized medicine focusing on ERYtech’s flagship product, GRASPA®, which consists of red blood cell-encapsulated L-asparaginase (L-ASP).

15 Feb 2010

Botulinum injection used for cosmetic purposes may reduce migraine headaches

A preliminary study suggests the same type of botulinum injection used for cosmetic purposes may be associated with reduced frequency of migraine headaches that are described as crushing, vicelike or eye-popping (ocular), but not pain that is experienced as a buildup of pressure inside the head, according to a report in the February issue of Archives of Dermatology, one of the JAMA/Archives journals.

15 Feb 2010

Research findings may open door to new therapeutic strategies for serious health problems

Drugs that target the way cells convert nutrients into energy could offer new approaches to treating a range of conditions including heart attack and stroke. Using a new way to screen for potential drugs, a team led by Massachusetts General Hospital (MGH) researchers has identified several FDA-approved agents, including an over-the-counter anti-nausea drug, that can shift cellular energy metabolism processes in animals.

15 Feb 2010

Isogenica enters into agreement with Dstl to develop antimicrobial peptide drugs

Isogenica Ltd today announced that it has entered into an agreement with UK Ministry of Defence agency, the Defence Science and Technology Laboratory. The agreement concerns the development of antimicrobial peptide drugs and follows a successful collaboration to identify highly effective antimicrobial peptides which are active against a broad spectrum of bacteria.

15 Feb 2010

Walgreens Pharmacies postpones withdrawal from Washington Medicaid program

Walgreens will continue filling Medicaid prescriptions at its Washington state pharmacies through March 15. The company, which operates 121 pharmacies in Washington, announced on Jan. 13 it would stop filling Medicaid prescriptions in 64 of its stores because of continued reduction in reimbursement under the State of Washington Medicaid program. The decision to delay the withdrawal from the program comes as constructive talks continue between the state and the company.

15 Feb 2010

Pharmaceutical News

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

EntreMed's ENMD-2076 for AML receives FDA's orphan drug designation

BUSACC hosts breakfast panel over reconstruction opportunities in Iraq, covering healthcare and pharma

Meda publishes 2009 year-end report

VPCI pioneers on-demand GMP consultation services for Pharmaceutical manufacturers

Overall benefits of HPV vaccination or frequent screening are low for women over 41

When blood sugar levels rise in healthy people, insulin signals cells to increase production: Study

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

Three Dutch life-science sectors announce joint investment to research on personalized medicine

Use of non-steroidal anti-inflammatory drugs not associated with risk of squamous cell skin cancer

Researchers discover chemical compound to combat malaria and bacterial diseases

Teva Pharmaceuticals USA settles famciclovir patent litigation with Novartis

Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capacity projects

Sinovac Beijing expands production capacity with acquisition of buildings and land use rights in Changping

Medivir, Meda announce agreement to commercialize Medivir’s cold sore product, Xerese

ERYtech Pharma announces collaborative research agreement with M. D. Anderson Cancer Center

Botulinum injection used for cosmetic purposes may reduce migraine headaches

Research findings may open door to new therapeutic strategies for serious health problems

Isogenica enters into agreement with Dstl to develop antimicrobial peptide drugs

Walgreens Pharmacies postpones withdrawal from Washington Medicaid program

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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