Drug Development

Supply chain consortium establishes a working group to address quality problems in India.

Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

CombiLac is a lactose-based, co-processed excipient, designed to ease oral solid dosage form development and manufacture in direct compression.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

BASF announces that it will sell its custom synthesis business and parts of its API business to focus its expertise on pharmaceutical excipients.

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.

Bayer announces that it will pay up to $155 million, plus royalties, for the rights to Isis Pharma’s anti-clotting drug, ISIS-FXI.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

An integrated pilot plant tests heteronucleation and continuous crystallization.

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

Virtualization has been mainstream in information technology (IT) for decades.

Pharmaceutical companies should take into consideration intellectual property protection when outsourcing the packaging of their products.

Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate’s anti-NKG2A antibody.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

MaxCyte announces a strategic partnership with Johns Hopkins University to develop CAR T-Cell therapies for cancer.

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

Endolysin technology targets unwanted bacteria, including resistant strains

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.