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.

Pharmstandard OJSC seeks to bolster its over-the-counter business through acquiring Bever Pharmaceutical.

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.

Amgen, Servier collaborate ivabraline and other cardiovascular products.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

Marken's expansion is fully operational to support clinical-trial material supply.

A simple, rapid analytical method for the determination of palladium in pharmaceutical production samples will speed up development and optimization of reactions involving palladium catalysts.

Synthesis of tetracycline derivatives with novel substituents has been challenging. Using an approach based on a Michael-Dieckmann reaction, new compounds with enhanced antibiotic properties are now being prepared on a large scale.

Jubilant HollisterStier added an ampul filling line utilizing a rigid barrier system.

Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.

The expansion adds commercial specialty ligand, capacity manufacturing.

The initiative enables cleanroom and laboratory operators to recycle used protective garments.

The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.

ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.

Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.

Sanofi Chimie will supply the API avanafil for VIVUS.

The companies initially focused on five biosimilar products.

Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.

Adamis Pharmaceuticals agrees to license and potentially acquire 3M's Taper Dry Powder Inhaler technology.

The guidance describes a risk-based approach to monitoring of clinical trials.