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.
Equipment and Processing Report
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.
FDA Releases Guidance on Self-Selections Studies
Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.
Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.
Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.
Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.
Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue.
USP has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network in China.
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.