An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

The supplier will add Allied Laboratories and AR Brown to its list of global partners.

The product, marketed as Sirdupla in the United Kingdom, is the generic version of GSK’s beta agonist and corticosteroid combination treatment for asthma.

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.

As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.

Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.

At this year’s ACHEMA, Malvern brings to the exhibition floor, its expertise and tools for measuring particle size and shape, zeta potential, molecular weight, and rheological properties for the characterization of dispersed systems.

The design of the shovel means that less drive power is required compared with a standard shovel, thus resulting in substantial energy savings.

Talks will explore key trends and issues in the pharmaceutical space and address the “latest industry buzz.”

Pioneering system provides induction sealing integrity analysis for 100% of bottles without packaging line slowdown.

Bosch’s market launches at the show include a new bioreactor for laboratory-scale API development, a water-for-injection unit, and a new generation of pure steam generators with high yields.

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

Porvair has developed a 2-ml 96 round-well deep-well plate that enables scientists to use the full 2.00 ml well capacity.

PSL has developed a dispensary isolator with a contained drum hoist mechanism for highly potent API production.

Saint-Gobain Seals is featuring several sealing and polymer solutions at ACHEMA including the OmniSeal spring-energized seals for liquid chromatography and the Rulon wear components for pharmaceutical manufacturing equipment.

GEA will showcase the ConsiGma continuous coater and the PCMM (portable, continuous, miniature, and modular) manufacturing technology platform for continuous production of oral solid dosage forms.

Technologies for serialization and aseptic packaging are being displayed at the show.

Telstar has developed an innovative in-line vial management system for recognition and marshaling of vials in automatic loading and unloading systems.

The Green Cross facility in Canada will produce intravenous immunoglobulin and albumin.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

Machine manufacturer IMA is showcasing a number of technological advances for the processing and packaging of pharmaceutical products at ACHEMA 2015.

The Hapa 862, from Hapa AG, is a modular, CMYK/spot-color inkjet printing system for the in-line packaging printing of foils and labels.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.