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Napo Pharmaceuticals hosts educational panel to address global health and environment

Napo Pharmaceuticals, Inc. (Napo) recently hosted an educational panel to address the impact of the lack of access to clean water and enteric disease on global health, the environment, and human rights.

8 Oct 2009

APP Pharmaceuticals receives FDA approval to market Sumatriptan Succinate Injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths.

8 Oct 2009

Biostar Pharmaceuticals' new drug application granted clearance for clinical trials

Biostar Pharmaceuticals, Inc. ("Biostar" or "the Company"), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions, today announced that the Chinese Military Drug Administration has granted clearance to begin clinical trials on the Company's new drug application, the Zushima Analgesic Aerosol Spray.

7 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009

Government handout of samples of potassium iodide helps to boost sales for Nukepills.com

The recent localized government handout of samples of potassium iodide has sky-rocketed sales for online merchant Nukepills.com. Recent retail orders of Iosat(TM) Potassium Iodide have increased by almost 400% and wholesale orders to vendors and medical facilities have surged as well for the authorized national distributor.

7 Oct 2009

Nutra Pharma to launch prescription analgesic for severe chronic pain treatment

Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today its intent to launch a prescription analgesic, Nyloxin Rx, for the treatment of severe (Stage 3) chronic pain.

7 Oct 2009

Shire publishes efficacy study results of FOSRENOL and Renagel

Shire plc, the global specialty biopharmaceutical company, today announces the publication in Clinical Nephrology of findings from a head-to-head clinical study comparing the efficacy of two non-calcium based phosphate binders, FOSRENOL(R) (lanthanum carbonate) and sevelamer hydrochloride (Genzyme's Renagel(R)) in chronic kidney disease (CKD) patients on haemodialysis.

7 Oct 2009

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

Pharmaceutical News

Napo Pharmaceuticals hosts educational panel to address global health and environment

APP Pharmaceuticals receives FDA approval to market Sumatriptan Succinate Injection

Biostar Pharmaceuticals' new drug application granted clearance for clinical trials

FDA approves Daiichi Sankyo's sNDA for Welchol

Government handout of samples of potassium iodide helps to boost sales for Nukepills.com

Nutra Pharma to launch prescription analgesic for severe chronic pain treatment

Shire publishes efficacy study results of FOSRENOL and Renagel

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

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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