FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company?s new biomanufacturing facility.

Reversible nanoencapsulation technology may make it possible to deliver high molecular weight drugs directly to target cancer cells, increasing efficacy and reducing side effects.

Akorn will acquire Hi-Tech Pharmacal for $640 million.

AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Siegfried is proceeding with its expansion in China and Switzerland.

Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.

Vical's restructuring will leave the company with approximately 74 employees.

Top four graduate students to be hosted at GE Healthcare Life Science's Uppsala site.

Andrew Derodra will join Skyepharma in the fourth quarter of 2013.

Takeda Peru will be headquartered in Lima and will be responsible for sales and marketing of Takeda's products in Peru.

Parameter Stability Storage adds validated space in anticipation of pending contracts.

The MHRA has issued a warning to the public not to use unlicensed traditional Chinese medicines after discovering that some of them contain dangerously high levels of lead, mercury and arsenic.

Experts, including researchers at I Holland, Natoli, and Rutgers University’s Engineering Research Center for Structured Organic Particulate Systems, are seeking a greater understanding of the fundamental causes of tablet sticking and are developing predictive models to more quickly find solutions to specific sticking problems.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Companies exhibit developments for pharmaceutical packaging to meet needs, such as e-pedigree and inspection requirements.

Agencies collaborate to ensure consistent product quality.

INTERPHEX and the Parenteral Drug Association (PDA) announced a three-year sponsorship agreement, which aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry.

FDA has granted Novartis breakthrough therapy designation to BYM338 for sporadic inclusion body myositis.

The acquisition expands SeraCare's portfolio of products designed to help diagnostic researchers develop in vitro diagnostic assays.

ABPI toolkit provides guidance to pharmaceutical companies on how to meet clinical trial transparency requirements

The closure will impact 240 employees through a multistage process starting in December 2013.

The fund's first investment will be in SetPoint Medical, a California company.

ViiV Healthcare, a specialist HIV pharmaceutical company of GSK, Pfizer, and Shionogi gains approval for new HIV-1 treatment.

Alpha Packaging's new line will consist of more than a dozen injection blow molded and extrusion blow molded bottles.

CDER withdraws some outdated guidance documents and makes plans to finalize others.