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A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

The deal is expected to close during the first half of 2021.

The therapy works by transferring pathogen-specific antibodies from plasma gathered from recovered individuals into an infected patient, which may help the patient’s immune system respond and increase recovery.

The organization is postponing its annual meeting to July 2020 because of the developing COVID-19 outbreak.

Under the agreement, Takeda will divest the rights, title, and interest to 18 over-the-counter and prescription products sold in Brazil, Mexico, Argentina, Colombia, Ecuador, Panama, and Peru.

The acquisition will give Gilead access to Forty Seven’s investigational lead product candidate, magrolimab, a monoclonal antibody in clinical development for the treatment of numerous cancers.

As patent disputes within the scientific community continue, drug developers consider the intellectual property unknowns associated with this emerging technology.

The partners will use ProBioGen’s DirectedLuck transposase technology to support development and large-scale manufacturing of ImmunOs’ biologics.

With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

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 events will feature activities and discussion panels for patients, patient advocates, health care providers, researchers, industry representatives, and government employees.

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.