News

Guidance on Submitting Standardized Study Data

October 30, 2020

FDA published guidance for submitting standardized study data in electronic format.

RCPE Awarded FDA Funding to Develop Next-Generation Technology

October 29, 2020

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

The Department of Justice Files a Complaint Against Animal Health Company for the Distribution of Adulterated Animal Drugs

October 29, 2020

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

Takeda, Moderna, and the Government of Japan to Collaborate to Distribute 50 Million COVID-19 Vaccine Doses

October 29, 2020

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

AstraZeneca and Daiichi Sankyo Granted Priority Review for Gastric Cancer sBLA

October 29, 2020

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

Catalent Acquires Bone Therapeutics’ Cell Manufacturing Facility

October 29, 2020

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

3P Biopharmaceuticals and SpyBiotech Sign Vaccine Manufacturing Agreement

October 29, 2020

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

UK BIA Antibody Taskforce Identifies Novel COVID-19 Antibody Therapy Candidates

October 29, 2020

The UK BIA Antibody Taskforce has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

NanoMab Technology Signs Heads of Terms with OncoBeta

October 29, 2020

NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.

Pfizer Gains FDA and EMA Acceptance for Abrocitinib

October 29, 2020

Pfizer has announced that FDA has accepted for filing and granted priority review designation for a new drug application and EMA has accepted the MAA for abrocitinib.