News

Under the agreement, ERS Genomics will license its gene-editing technology to Aelian Biotechnoloy to support its commercial functional genomic screening platform.

The companies are entering into a development and manufacturing collaboration for the advancement and production of human monoclonal antibodies for the potential treatment of novel coronavirus.

Takeda announced the acquisition after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

The expansion gives the company diversified capacity running cell production lines featuring Sartorius-brand 2000-L disposable bioreactors and now GE-brand 2000-L single-use bioreactors.

The company presented data on its G2 glycosylation studies at the 15th European Conference on Fungal Genetics in Rome on Feb. 19, 2020.

The All-Party Parliamentary Group (APPG) for Life Sciences, aimed at raising awareness of the United Kingdom’s life sciences among parliamentarians and to explore the challenges and opportunities facing the sector, was relaunched on Feb. 27, 2020.

The decision was made after it was determined that many of the event’s largest stakeholders would be unable to travel to the conference due to the novel coronavirus outbreak.

Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).

The partnership will begin in the second half of 2020.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

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.

US and European regulatory officials continue to anticipate supply shortages in multiple areas.

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

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

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

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

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.

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.

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

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

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.