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Impax Laboratories settles FLOMAX litigation, to launch generic tamsulosin hydrochloride product

Impax Laboratories, Inc. today announced that it has reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle pending U.S. litigation with regard to US Patent No. 4,703,063 for FLOMAX® (generic name: tamsulosin hydrochloride) capsules through the entry of a consent judgment confirming the validity and infringement of the patent. FLOMAX® is a treatment for the functional symptoms of benign prostatic hyperplasia.

7 Oct 2009

Baxter receives marketing authorization for CELVAPAN H1N1 pandemic influenza vaccine

Baxter International Inc. today confirmed that the European Commission (EC) has granted marketing authorization for CELVAPAN H1N1 pandemic vaccine using Baxter’s Vero cell technology. CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union.

From Baxter International Inc. 7 Oct 2009

Promotional speaker programs on the latest drug developments help pharma companies attract physicians

In response to increased political and regulatory scrutiny, pharmaceutical companies are rebranding their promotional speaker programs as unparalleled opportunities for physicians to learn or remain current on the latest drug developments and to network with colleagues. The rebranding is helping to attract physicians who are more interested in learning than in getting a free meal. It is also working to improve program ROI and lessen pressures from outside agencies that feel the meetings are payoffs for prescriptions.

7 Oct 2009

FDA reviews Fibrocell Science's BLA for azfibrocel-T

Isolagen, Inc. has reorganized and emerged from bankruptcy as Fibrocell Science, Inc. (OTC Bulletin Board: FCSC), a biotechnology company focused on developing regenerative fibroblast cells for aesthetic, medical and scientific applications.

7 Oct 2009

aTyr Pharma to discuss aminoacyl tRNA synthetases at the BioPartnering Europe Conference

aTyr Pharma, Inc., a biopharmaceutical company discovering and developing a new class of naturally occurring proteins as biotherapeutics, will present at the BioPartnering Europe Conference in London on Monday October 12. Jeff Watkins, CEO of aTyr Pharma, will provide an overview of aTyr Pharma's technology, product engine, and lead program based on naturally occurring resected proteins of the tRNA synthetases.

7 Oct 2009

Deadline for pharmacies to meet Medicare’s DMEPOS accreditation requirements extended, Senate lauded

The National Community Pharmacists Association (NCPA) commended the Senate for passing a bill extending from Sept. 30 to Dec. 31, 2009 the deadline for meeting pharmacy accreditation requirements to continue offering Medicare Part B Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS).

7 Oct 2009

Galapagos receives EUR 500,000 cash payment from GSK

Galapagos NV (Euronext: GLPG) announced today that it has reached the first milestone in its antibacterials and antivirals alliance with GlaxoSmithKline (GSK). For achieving this milestone, Galapagos receives a EUR 500,000 cash payment from GSK.

7 Oct 2009

GlobeImmune to present an abstract of GI-5005 drug at AASLD's annual meeting

GlobeImmune Inc. today announced that a late breaking abstract related to GI-5005, its investigational hepatitis C virus (HCV) product candidate, has been accepted for presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place Oct. 31 through Nov. 4, 2009, in Boston, Mass.

7 Oct 2009

Helix BioPharma's pre-IND meetings with the FDA for Topical Interferon Alpha-2b and L-DOS47 fruitful

Helix BioPharma Corp. today announced progress updates for its ongoing Topical Interferon Alpha-2b and L-DOS47 product development programs following pre-investigational new drug ("pre-IND") meetings with the U.S. Food and Drug Administration ("FDA").

7 Oct 2009

HHS and PEPFAR approve the 100th HIV/AIDS antiretroviral drug

The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.

7 Oct 2009

FDA provides Genzyme a complete response letter for Clolar NDA

Genzyme Corporation announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.

7 Oct 2009

FDA completes inspection of Catalent Pharma's manufacturing facility in Germany

Catalent Pharma Solutions announces that its integrated dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection.

7 Oct 2009

Daily doses of imatinib mesylate double survival rates in Ph+ ALL affected children

Results of a phase two clinical trial published October 5th in the Journal of Clinical Oncology show that adding continuous daily doses of a targeted drug called imatinib mesylate to regular chemotherapy more than doubled three-year survival rates for children with a high risk type of blood cancer called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

7 Oct 2009

Research on malarial drugs for travelers

A new review of existing research finds that a combination drug and the common antibiotic doxycycline allow travelers to fend off malaria with the fewest side effects in areas where the parasite is resistant to a widely accepted preventive treatment.

7 Oct 2009

Opioid drugs may not be effective for osteoarthritis

Should you take opioid drugs for hip and knee pain caused by osteoarthritis? Probably not, suggests a new review of the best research on the subject.

7 Oct 2009

Cochrane Systematic Review finds Abatacept effective against rheumatoid arthritis

Abatacept, a member of a new class of drug that targets immune cells to treat rheumatoid arthritis (RA), is effective against RA, according to a new Cochrane Systematic Review. The review examines recent trials to assess safety and efficacy of the drug.

7 Oct 2009

Combination of leukemia and breast cancer drugs inhibits cancer progression

When breast cancer spreads or metastasizes, it crashes through the body's protective fences. The disease becomes fatal when it travels outside the mammary ducts, enters the bloodstream and spreads to the bones, liver or brain.

7 Oct 2009

Pennsylvania to receive first doses of live attenuated pandemic H1N1 influenza vaccine

Pre-registered and certified providers in the southwest, southeast, and north-central regions of the state have begun to receive the first doses of the live attenuated pandemic H1N1 influenza vaccine, also known by the brand name FluMist, the Pennsylvania Department of Health said today.

7 Oct 2009

Get vaccinated against both H1N1 flu and the seasonal flu, advises Chief Nurse of the American Red Cross

With the first doses of the H1N1 (swine) flu vaccine being shipped and seasonal flu shots underway, people should be getting vaccinations when they can for these flu viruses, said Sharon Stanley, Chief Nurse of the American Red Cross.

7 Oct 2009

PSI-879 nominated as second development candidate for treating HCV infection

Pharmasset, Inc. announced today the nomination of PSI-352879 (PSI-879) as a second development candidate from two series of purine analogs for the treatment of chronic hepatitis C virus (HCV) infection.

7 Oct 2009

Pharmaceutical News

Impax Laboratories settles FLOMAX litigation, to launch generic tamsulosin hydrochloride product

Baxter receives marketing authorization for CELVAPAN H1N1 pandemic influenza vaccine

Promotional speaker programs on the latest drug developments help pharma companies attract physicians

FDA reviews Fibrocell Science's BLA for azfibrocel-T

aTyr Pharma to discuss aminoacyl tRNA synthetases at the BioPartnering Europe Conference

Deadline for pharmacies to meet Medicare’s DMEPOS accreditation requirements extended, Senate lauded

Galapagos receives EUR 500,000 cash payment from GSK

GlobeImmune to present an abstract of GI-5005 drug at AASLD's annual meeting

Helix BioPharma's pre-IND meetings with the FDA for Topical Interferon Alpha-2b and L-DOS47 fruitful

HHS and PEPFAR approve the 100th HIV/AIDS antiretroviral drug

FDA provides Genzyme a complete response letter for Clolar NDA

FDA completes inspection of Catalent Pharma's manufacturing facility in Germany

Daily doses of imatinib mesylate double survival rates in Ph+ ALL affected children

Research on malarial drugs for travelers

Opioid drugs may not be effective for osteoarthritis

Cochrane Systematic Review finds Abatacept effective against rheumatoid arthritis

Combination of leukemia and breast cancer drugs inhibits cancer progression

Pennsylvania to receive first doses of live attenuated pandemic H1N1 influenza vaccine

Get vaccinated against both H1N1 flu and the seasonal flu, advises Chief Nurse of the American Red Cross

PSI-879 nominated as second development candidate for treating HCV infection

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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