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Covidien's Exalgo NDA: FDA sets new PDUFA action date

Covidien today announced that the U.S. Food and Drug Administration has set a new action date of March 1, 2010, under the Prescription Drug User Fee Act (PDUFA) for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) Extended-Release Tablets, (CII).

17 Feb 2010

Covidien, IAE POLATOM announce agreement to augment supply of Mo 99 to produce Tc 99m

Covidien, a leading global provider of healthcare products, and the Institute of Atomic Energy in Poland today announced an agreement to augment and further diversify Covidien’s supply of Molybdenum 99 (Mo 99) to produce the medical isotope Technetium 99m (Tc 99m).

17 Feb 2010

FDA approves risk management program on ESA's for treating anemia due to chemotherapy

The U.S. Food and Drug Administration today approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy.

17 Feb 2010

USPTO issues two new patents for EKR Therapeutics' RTU Cardene I.V. Premixed Injection

EKR Therapeutics, Inc., a specialty pharmaceutical company focused on commercializing acute-care hospital products, today announced that the US Patent and Trademark Office has issued two new patents covering methods of treatment and methods of preparation for the Company’s Ready-to-Use (RTU) Cardene® I.V. (nicardipine hydrochloride) Premixed Injection.

17 Feb 2010

AZ&Me Prescription Savings programs help 13% more patients in 2009

AstraZeneca announced today that it provided $769.6 million in savings to 507,475 patients in the United States last year through its AZ&Me™ Prescription Savings programs.

17 Feb 2010

APCER PHARMA to demonstrate pharmacovigilance/drug safety and regulatory services at GPhA meeting

APCER PHARMA executives will discuss and demonstrate their expertise in providing generic drug manufacturers with the best in class pharmacovigilance/drug safety, regulatory and risk management services at the GPhA Annual Meeting, February 16-18, at the Ritz-Carlton in Naples, Florida. APCER will be in Booth #27.

17 Feb 2010

Adding daclizumab to standard treatment reduces enlarged brain lesions in patients with relapsing MS

An international team of researchers has found that adding a humanized monoclonal antibody called daclizumab to standard treatment reduces the number of new or enlarged brain lesions in patients with relapsing multiple sclerosis. This new study was published online Feb. 16, 2010, and in the March edition of the Lancet Neurology.

17 Feb 2010

Combination of daclizumab and interferon beta significantly reduces MS lesion formation

Biogen Idec and Facet Biotech Corporation today announced the publication of Phase 2 data showing that the addition of daclizumab to interferon beta (IFNβ) led to a significant reduction in the number of new or enlarged multiple sclerosis (MS) lesions when compared to IFNβ alone in patients with active relapsing forms of MS.

17 Feb 2010

NanoViricides signs research and development agreement with Dr. Eva Harris’s laboratory at UC Berkeley

NanoViricides, Inc. (the "Company"), reports that it has signed a research and development agreement with Dr. Eva Harris’s laboratory at the University of California, Berkeley (UC Berkeley).

17 Feb 2010

Bedford Laboratories launches Indomethacin for Injection

Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., a provider of select specialty injectables, is pleased to announce the addition of Indomethacin for Injection to its existing product line. This product is AP rated and is equivalent to Indocin® by Lundbeck, Inc. Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.

17 Feb 2010

CMAJ study: Increased dosage of Tamiflu required in treating H1N1 influenza patients

An increased dosage of Tamiflu (oseltamivir) for patients with critical illness is unlikely to be required in the treatment of pandemic (H1N1) influenza, contrary to current international guidelines, found a new study http://www.cmaj.ca/cgi/doi/10.1503/cmaj.092127 in CMAJ (Canadian Medical Association Journal) www.cmaj.ca.

17 Feb 2010

Amgen and Centocor Ortho Biotech Products: FDA approves REMS for Aranesp, EPOGEN and PROCRIT ESAs

Amgen Inc. and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa).

17 Feb 2010

Quark Pharmaceuticals' QPI-1002 receives orphan drug designation from FDA

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today that the US FDA has granted orphan drug designation for QPI-1002 (also referred to as "I5NP"), a synthetic siRNA targeting p53 mRNA for the prophylaxis of delayed graft function (DGF) in kidney transplant patients.

17 Feb 2010

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug dependence, smoking cessation and obesity, announced today that the company has retained Exponential Pharma Ventures LLC to assist in establishing a clinical development partnership for its cocaine dependence program with a fully integrated pharmaceutical company.

17 Feb 2010

TopoTarget pays Celldex Therapeutics $3M sublicense income over Belinostat co-development agreement

Celldex Therapeutics, Inc. today announced that it has received a sublicense income payment of $3 million from TopoTarget A/S as a result of the recent co-development and commercialization agreement between TopoTarget and Spectrum Pharmaceuticals, Inc. for Belinostat, a novel histone deacetylase (HDAC) inhibitor for the treatment of cancer.

17 Feb 2010

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

Pharmaceutical News

Covidien's Exalgo NDA: FDA sets new PDUFA action date

Covidien, IAE POLATOM announce agreement to augment supply of Mo 99 to produce Tc 99m

FDA approves risk management program on ESA's for treating anemia due to chemotherapy

USPTO issues two new patents for EKR Therapeutics' RTU Cardene I.V. Premixed Injection

AZ&Me Prescription Savings programs help 13% more patients in 2009

APCER PHARMA to demonstrate pharmacovigilance/drug safety and regulatory services at GPhA meeting

Adding daclizumab to standard treatment reduces enlarged brain lesions in patients with relapsing MS

Combination of daclizumab and interferon beta significantly reduces MS lesion formation

NanoViricides signs research and development agreement with Dr. Eva Harris’s laboratory at UC Berkeley

Bedford Laboratories launches Indomethacin for Injection

CMAJ study: Increased dosage of Tamiflu required in treating H1N1 influenza patients

Amgen and Centocor Ortho Biotech Products: FDA approves REMS for Aranesp, EPOGEN and PROCRIT ESAs

Quark Pharmaceuticals' QPI-1002 receives orphan drug designation from FDA

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

TopoTarget pays Celldex Therapeutics $3M sublicense income over Belinostat co-development agreement

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

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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