All
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.
Lonza, Humanigen Partner to Expand Manufacturing of Lenzilumab for Potential COVID-19 Therapy
The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.
Novavax in COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India
The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.
Lilly and Amgen in Manufacturing Collaboration for COVID-19 Antibody Therapies
The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.
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.
Eli Lilly and Amgen Partner for COVID-19 Therapy Manufacturing Capacity
The companies aim to scale up production of Eli Lilly’s potential COVID-19 antibody therapies, pending regulatory approval.
BioNTech to Acquire Novartis GMP Facility for COVID-19 Vaccine Production
BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.
Takeda Opens New R&D Cell Therapy Manufacturing Facility
The new facility will produce cell therapies for clinical evaluation from discovery through to Phase 2b trials while expanding Takeda’s abilities to develop next-generation cell therapies.
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.
Beckman Coulter Life Sciences Launches the MET ONE 3400+ Portable Air Particle Counter for Cleanroom Compliance
The new particle counter allows users to import their standard operating procedure routine environmental monitoring maps and sampling configurations into the counter, which reduces human error and can improve data integrity.
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.
Cytiva Introduces the Xcellerex Automated Perfusion System
The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.
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.
Thermo Fisher to Invest More than $140 Million into its Lab Plastics Consumables for COVID-19 Testing
In addition to increasing production, Thermo Fisher will create 1000 jobs across its global manufacturing sites to further automation capabilities and optimize warehouse and sterilization capacity.
Merck Announces Two Oncology Collaborations with Seattle Genetics
The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).
Cytiva Invests $500 Million Over 5 years to Expand Global Capacity
The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.
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.
Vectura and Monash University to Develop Inhaled Oxytocin for the Prevention of Postpartum Hemorrhage
Vectura will support the product from Phase I through to commercial launch.
Gilead to Acquire Immunomedics for $21 Billion
The acquisition will give Gilead access to an anti-cancer antibody drug conjugate in clinical development for treating breast and bladder cancers.
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.
AstraZeneca Gains EU Approval for Imfinzi to Treat ES-SCLC
Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.
CPhI Releases Virtual Event Agenda
CPhI has released the agenda for its forthcoming two-week virtual event, CPhI Festival of Pharma.
Cobra and CombiGene Sign Agreement for Plasmid Production for Gene Therapy
The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy.
ECCRT and IDDI Partner for Continuous Development
ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members.
PRAC Recommends Marketing Authorization of Ulipristal Acetate be Revoked
PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.
