Industry News
ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
Moderna, Chiesi Group Collaborate on Discovery and Development of mRNA Therapeutics
Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.
Korean MFDS Approves Celltrion’s IND for Phase II/III Trial of COVID-19 Treatment
The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.
Sanofi and GSK to Provide the EU with 300 Million Doses of its COVID-19 Vaccine Candidate
The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.
COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency
Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.
Oklahoma Facility Given FDA Warning
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
EMA Recommends Seven Medicines for Approval
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
Russia Completes Deals with India, Mexico, and Brazil for Sputnik V
The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.
FDA Gives Guidance on Geriatric Information in Labeling
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.
Valneva Enters into $1.6-Billion Partnership with UK Government for COVID-19 Vaccine
Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.
BioNTech to Receive Funding from BMBF for its COVID-19 Vaccine Program
The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.
GenSight Biologics Submits Application to Market Lumevoq in the EU
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
Trump Escalates Drug Pricing War
The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.
FDA Gives Guidance on Manufacturing During COVID-19
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
AZD1222 Clinical Trials Resume in the UK
Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.
Career FDA Leaders Say Science Is Agency’s Guide
In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.
CPhI Releases Virtual Event Agenda
CPhI has released the agenda for its forthcoming two-week virtual event, CPhI Festival of Pharma.
ECCRT and IDDI Partner for Continuous Development
ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members.
FDA’s “Gold Standard” Critical for Biopharma R&D
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
Vaccine Developers Pledge to Stand with Science
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
BIO Message: Keep Drug Development Independence
BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.
FDA Sends Mylan Warning Letter
The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.
Georgia Facility Receives FDA Warning Letter
The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.
Vaccines Advisory Committee to Meet on October 22
Hahn promises transparency in the review and approval of COVID-19 vaccines.
Axol Bioscience Appoints Liam Taylor as CEO
The company has appointed Liam Tayler as CEO to guide the growth of the company’s iPSC technologies, products, and services.
Keytruda Receives Two New Approvals in Japan
Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency.
EC and Moderna Conclude Exploratory Talks on Vaccine Supply for Europe
The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.
FDA Caught in Political Crossfire
FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.
FDA Issues EUA for COVID-19 Convalescent Plasma
FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.
FDA Issues Complete Response Letter to BioMarin for Hemophilia A Gene Therapy
BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.
