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UNITAID concerned about infant HIV medication shortage, drug company says supply is sufficient

Bristol-Myers Squibb's plans this month to close its plant in Meymac, France, that manufactures "the last therapeutic option" for HIV-positive babies has drawn criticism from UNITAID, Reuters reports. In an open letter published in the Lancet, UNITAID writes that "[c]losing this factory means that 4,000 to 7,000 babies currently enrolled in treatment plans in developing countries through UNITAID could be left without the medicines they need."

9 Jun 2010

Endo, Penwest announce settlement of OPANA ER litigation with Impax

Endo Pharmaceuticals and Penwest Pharmaceuticals announced today that the companies have settled litigation with Impax Laboratories, Inc. regarding the production and sale of generic formulations of OPANA® ER (oxymorphone hydrochloride) Extended Release tablets.

9 Jun 2010

USTPO awards Melior Discovery Notice of Allowance for type II diabetes and obesity drug candidate

Melior Discovery, Inc. announced today the United States Patent and Trademark Office (USTPO) has awarded a Notice of Allowance for a broad patent application covering the Company's use of MLR-1023 for, among other things, the treatment of type II diabetes and obesity. The patent will cover use of MLR-1023 for the treatment of type II diabetes, obesity and metabolic syndrome, including its use in combination with other compounds and as a component in other drugs.

8 Jun 2010

Health Canada approves Novartis' Menveo for prevention of meningococcal disease

Novartis Pharmaceutical Canada Inc. announced that Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide CRM197 Conjugate Vaccine), a quadrivalent meningococcal conjugate vaccine was approved by Health Canada for active immunization of adolescents (11 to 18 years of age) and adults (19 to 55 years of age) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

8 Jun 2010

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

8 Jun 2010

Elotuzumab shows promise in treating multiple myeloma: Study

A drug designed to target cancerous plasma cells appears promising in treating multiple myeloma, a type of blood cancer. A multi-center study looked at the drug elotuzumab, an antibody which is designed to target CS1, a protein on the surface of malignant plasma cells. The antibody has the potential to attach to malignant plasma cells and eliminates them by an immune mechanism.

8 Jun 2010

Cegedim Dendrite reports 2010 survey results of bio-pharmaceutical industry's market access

Cegedim Dendrite, the leading provider of CRM software and healthcare data to the bio-pharmaceutical industry, today announces the results of The Cegedim Dendrite Market Access Industry Report 2010; a market research survey conducted in May this year across nearly 200 European executives from marketing, market access, market research and sales departments within bio-pharmaceutical organisations.

8 Jun 2010

Research findings open door to development of new therapies for lymphomas, leukemias

Scripps Research Institute scientists have discovered a new way to target and destroy a type of cancerous cell. The findings may lead to the development of new therapies to treat lymphomas, leukemias, and related cancers.

8 Jun 2010

Vertellus announces new 3-cyanopyridine production unit at Nantong facility

Vertellus Specialties Inc. announced today that it will break ground on a new 3-cyanopyridine production unit at Vertellus' production facility in Nantong, Jiangsu, China. This unit is a continuation of a larger effort to expand production capacity in Nantong. It will increase Vertellus' Vitamin B3 manufacturing capacity in the region by 10,000 metric tons. The capacity increase will enable Vertellus to maintain its position as the world's second largest provider of Vitamin B3 and the largest producer of cyanopyridines in the world.

8 Jun 2010

APP's lyophilized Oxaliplatin for Injection receives FDA marketing approval

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today it received approval from the U.S. Food and Drug Administration to market Oxaliplatin for Injection (lyophilized), 50 mg and 100 mg.

8 Jun 2010

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite's lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite.

8 Jun 2010

Hospira signs licensing agreement to develop and market DURECT's POSIDUR

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, and DURECT Corporation, a specialty pharmaceutical company, today announced that the companies have entered into a licensing agreement to develop and market DURECT's POSIDUR (SABER-bupivacaine) a long-acting version of the anesthetic bupivacaine currently in Phase III clinical trials.

8 Jun 2010

Acella Pharmaceuticals signs license agreement for marketing rights to generic broad-spectrum antibiotic

Acella Pharmaceuticals has signed a licensing agreement for the U.S. marketing rights to a generic version of an intravenous administered broad-spectrum antibiotic.

8 Jun 2010

FDA accepts Depomed's DM-1796 NDA for pain after shingles

Depomed, Inc. today announced that the New Drug Application (NDA) for DM-1796 was accepted by the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

8 Jun 2010

Targeted therapy that benefits patients with metastatic colon cancer fails to help patients with stage III cancer

To the surprise of researchers at Mayo Clinic who led a national clinical trial, a targeted therapy that provides benefit to patients with metastatic colon cancer has failed to help patients with less advanced, stage III cancer. In fact, patients who used the agent, cetuximab, with chemotherapy had outcomes slightly inferior to patients treated with chemotherapy alone.

7 Jun 2010

Elsevier, InfoDesk partner to co-develop federated drug pipeline intelligence solution

Elsevier, a world-leading healthcare and scientific publisher, announced today that it has reached an agreement with Tarrytown, New York based InfoDesk to co-develop a federated drug pipeline intelligence solution for pharmaceutical and life science companies. The combination of Elsevier's business intelligence expertise and InfoDesk's technological know-how paves the way for the development of a powerful search and delivery tool that will increase productivity and improve the quality of results, securely inside or outside of a customer's firewall.

7 Jun 2010

CytRx granted U.S. Patent for bafetinib

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the granting by the U.S. Patent and Trademark Office (USPTO) of U.S. Patent 7,728,131 for oncology drug candidate bafetinib, encompassing claims related to bafetinib's pharmaceutical compound and composition in all indications, as well as for use in methods for treating acute and chronic myelogenous leukemia and acute lymphoblastic leukemia.

7 Jun 2010

PTC receives $5.4M SDD Award to support development of drugs that target Bmi-1

PTC Therapeutics, Inc. today announced the receipt of a $5.4 million Seeding Drug Discovery Award from The Wellcome Trust to support the development of drugs that target Bmi-1, a protein that has been linked to drug resistant cancers.

7 Jun 2010

BioSante's GVAX CML Vaccine granted FDA Orphan Drug designation

BioSante Pharmaceuticals, Inc. today announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA's Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease or condition that affects fewer than 200,000 people in the U.S. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity, among other benefits.

7 Jun 2010

Ranibizumab improves vision in patients with visual impairment due to DME: RESTORE study

Results from a new major diabetes eye health study may have the potential to change the way vision loss due to diabetic macular edema, a serious and devastating complication of diabetes, is treated. One year results from the RESTORE study show that 37 per cent of patients treated with ranibizumab only and 43 per cent of those treated with ranibizumab plus laser therapy, had a significant improvement in visual acuity of 10 letters or more on an eye chart, compared to 16 per cent of patients treated with laser alone - the current standard treatment for visual impairment due to DME.

7 Jun 2010

Pharmaceutical News

UNITAID concerned about infant HIV medication shortage, drug company says supply is sufficient

Endo, Penwest announce settlement of OPANA ER litigation with Impax

USTPO awards Melior Discovery Notice of Allowance for type II diabetes and obesity drug candidate

Health Canada approves Novartis' Menveo for prevention of meningococcal disease

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Elotuzumab shows promise in treating multiple myeloma: Study

Cegedim Dendrite reports 2010 survey results of bio-pharmaceutical industry's market access

Research findings open door to development of new therapies for lymphomas, leukemias

Vertellus announces new 3-cyanopyridine production unit at Nantong facility

APP's lyophilized Oxaliplatin for Injection receives FDA marketing approval

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Hospira signs licensing agreement to develop and market DURECT's POSIDUR

Acella Pharmaceuticals signs license agreement for marketing rights to generic broad-spectrum antibiotic

FDA accepts Depomed's DM-1796 NDA for pain after shingles

Targeted therapy that benefits patients with metastatic colon cancer fails to help patients with stage III cancer

Elsevier, InfoDesk partner to co-develop federated drug pipeline intelligence solution

CytRx granted U.S. Patent for bafetinib

PTC receives $5.4M SDD Award to support development of drugs that target Bmi-1

BioSante's GVAX CML Vaccine granted FDA Orphan Drug designation

Ranibizumab improves vision in patients with visual impairment due to DME: RESTORE study

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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