News

FDA issues draft guidance to minimize medication errors.

Third compounding pharmacy recalls products due to FDA inspection.

EMA has upgraded its EudraGMP database to include information on GDP in addition to GMP. The new EudraGMDP database is a key deliverable of the Falsified Medicines Directive (FMD) that came into effect in January 2013. The aim is to increase supply chain security in the EU by making supervision of manufacturing and distribution of medicines more robust to ensure supplier compliance.

AstraZeneca and BIND Therapeutics have formed a strategic collaboration to develop and commercialise BIND's Accurin, a targeted and programmable cancer nanomedicine, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca.

Metrics Inc. offers Cleantaste technology, which enables polymer coating of individual drug crystals to produce particles sized 25 um to 125 um.

Allergan has addressed FDA?s concerns with canister filling.

Unique technology expands Entegris? fluid-sensing and control offering.

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.

Eli Lilly has announced positive top-line results for two of its Phase III trials, AWARD-2 and AWARD-4, which evaluated dulaglutide as a once-weekly treatment in patients with type 2 diabetes. Both trials met the primary efficacy endpoints, demonstrating non-inferiority of dulaglutide compared to insulin glargine, measured by a reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose level.

Oval Medical Technologies, an autoinjector company based in Cambridge, UK, reported that a variety of highly viscous solutions have been successfully delivered through a 25-gauge thin-wall needle, in less than 7 seconds, using its innovative autoinjector. The technology provides solutions to problems in the industry for drug containment and the end user.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

The FDA approved updated labeling for Purdue Pharma L.P.?s reformulated OxyContin tablets, but also determined that it will not approve generic versions of the original OxyContin.

New manufacturing route improves availability of ingredient for malaria treatment.

Speakers discuss modularization, single-use systems, and process validation in a series of podcasts available on the Pharmaceutical Technology website.

The facility in Hangzhou will package Merck medicines for China and the Asia-Pacific region.

Amgen Inc. has agreed to pay the United States $24.9 million to settle allegations that it violated the False Claims Act.

$13.6 billion deal strengthens Thermo?s leading role.

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

The parties partner for evidence-based formulations for emerging markets

New facility for Bio-Manguinhos will use plant-based protein expression technology.

FDA's Fiscal Year 2014 budget request includes more than $10 million above the 2012 budget for inspections of products manufactured in China.

The alliance will develop treatments based on Isis' antisense technology.

FDA inspections of compounding pharmacies manufacturing sterile products reveal non-sterile conditions.

Prefilled-syringe line features automation and novel disinfection techniques.

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

The process-driven system reduces total cost of ownership.

Company is notified of GMP violations at facility in Catania, Italy.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products

Catalent Pharma Solutions has acquired a license to market Redwood Bioscience 's proprietary SMARTag precision protein-chemical engineering technology.

Dr. Reddy's Laboratories has announced plans to relocate its North America headquarters and establish a R&D facility in Princeton, New Jersey.