All News

The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.

The approval marks the first time a new glass composition has been approved by FDA since the approval of borosilicate glass more than 100 years ago.

GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.

Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.

The agency’s implementation of the SUPPORT Act has included new guidance documents and actions to restrict illicit drugs entering the US.

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

The CPhI Pharma Index points to Germany as having consolidated itself into a leading pharma industry.

Under the agreement, gene and cell therapy companies can go directly to Aldevron for NTC’s technology without acquiring a license from NTC.

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.

Through the agreement, Foamix will have access to $20 million of financing to fund the commercial launches of the topical treatments.

The transaction is set to be completed in the first quarter of 2020.

The transaction is anticipated to close by the end of 2019.

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.

Nonacus has revealed the launch of its new capture kit, ExomeCG, which has been designed to simplify molecular and cytogenomics data generation and interpretation.

GammaDelta Therapeutics has unveiled the formation of a new spin-out company, Adaptate Biotherapeutics, aimed at developing antibody-based therapies that modulate gamma delta T-cells.

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.

The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.

The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.

The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.

The transaction is set to be completed at the end of the first quarter of 2020.