News

Harlan announces Hiroharu Okochi as president of Harlan Japan.

Johnson&Johnson will open a network of partnering offices across the UK.

AstraZeneca will receive $76 million in damages from Apotex Corp., Apotex, and Torpharm.

Shire's United States subsidiary enters supply agreement for Adderall XR.

Bristol-Myers Squibb has elected Thomas Lynch, Jr., MD to its board of directors.

OGD is under pressure to improve review operations.

ScinoPharm completes new API manufacturing plant in Changshu, China.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

Octapharma and Pfizer form an agreement for the future marketing and commercialization of human prothrombin complex concentrate.

Researchers at Massachusetts recently reported on the development of a drug-eluting contact lens designed to provide prolonged delivery of the glaucoma medication, latanoprost.

Novasep expands its presence in India with the opening of Novasep Process Engineering Services, a part of its industrial business unit.

GDUFA is off to a good start from a facility inspection perspective, but there are storm clouds on the horizon.

Standards for ferrules and cap overseals focus on explicit warnings.

FDA cites cGMP violations and data-integrity issues and raises concerns over the company's ability to implement a robust and sustainable quality system.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

The flexible biomanufacturing system uses single-use technology.

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.

LSNE appoints Shawn Cain as COO, a new position within the company.

Facility in Germany provides space for evaluating continuous pharmaceutical processing equipment.

A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

EMA revises its polices on fee reductions for orphan drugs for 2014.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Scientists can share time and pharmaceutical knowledge with high school students.

SGS Life Science Services announced that its bioanalytical laboratory in Poitiers, France has received GMP certification, following approval from ANSM.

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Aptuit appoints Jonathan Goldman as CEO.

American Association of Pharmaceutical Scientists Foundation to assist current and future scientists.

EMA hosted a workshop on Nov. 26, 2013, which brought together regulators, health-technology-assessment (HTA) bodies and the pharmaceutical industry to discuss how to generate evidence in drug development and improve medicines access.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.