Pharmaceutical Technology Editors

FDA has granted breakthrough therapy designation to padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy keytruda (pembrolizumab).

Aprecia, which has an FDA-approved 3D-printed medication, will collaborate with Purdue’s College of Pharmacy to accelerate development in 3DP pharmaceuticals.

The companies aim to develop novel cell therapies for treating multiple cancers.

Through the agreement, Lilly will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational mAb designed to bind interleukin-13 with high affinity.

The Office for Life Sciences of the government of the United Kingdom has designated six new locations in the country as ‘Life Sciences Opportunity Zones’, of which the Harwell Science and Innovation Campus is one.

Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.

At the event, Centogene will also announce its plans to host the annual International Rare Disease Film Festival in Berlin in 2021.

The 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.

The “I am RARE, hear me ROAR” event will feature patient artists hoping to raise awareness about their rare diseases.

FDA will observe Rare Disease Day on Feb. 29, 2020, with events surrounding the day’s 2020 theme, “Reframe Rare for Rare Disease Day.”

The European Commission (EC) has approved Pfizer’s treatment for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis).

WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.

Sanofi will use a recombinant DNA platform that produces a genetic match to proteins found on the surface of COVID-19 to formulate the vaccine.

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.

The agency is taking steps to monitor the supply chain and assist in the development of treatments.

Ongoing coronavirus outbreak prompts date change to ensure safety of trade show participants.

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

Under the agreement, Roche will have access to Promedior's lead product candidate, PRM-15, a recombinant form of human pentraxin-2 that can possibly treat a range of systemic fibrotic diseases.

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.

If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.

The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.

According to executive search firm Odgers Berndtson, its recent poll has highlighted that senior executives in life sciences believe there is a positive future for the United Kingdom’s sector outside the European Union.

The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.

The report details OPQ’s accomplishments over the past five years.

Inhalation drug delivery company Vectura announces new organizational structure to drive innovation, customer focus, and growth.

Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site.

The acquisition will bring four new GMP-compliant facilities to the PCI network in the United States, Germany, and Canada.