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Aphena Pharma Solutions Announces $21-Million Facility Expansion in Tennessee
The renovations are expected to be completed by Feb. 1, 2021 and, upon completion, Aphena will move its corporate headquarters to the new location.
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.
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.
Metrics Contract Services to Expand Greenville, NC Oral Solid Dosage Manufacturing Facility
The $10 million expansion, which will be completed and fully operational by February 2021, will add on 3760 square feet of production space.
Stevanato Group Partners with Bexson Biomedical on a Wearable Drug Delivery Device
The companies will work together to produce a wearable device that can subcutaneously deliver ketamine therapy as a non-opioid pain treatment.
AstraZeneca and Samsung Biologics to Enter into Long-Term Supply Agreement for Up to $545.6 Million
Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.
Legacy Pharmaceutical Packaging Rebrands as Legacy Pharma Solutions
The rebranding stems from the company’s expanded services which include 3PL services, supply chain transparency solutions, and retail pharma product procurement for over-the-counter medications.
Natoli Installs Tablet Press at its New Research and Training Facility
Natoli installed a NP-RD30 rotary tablet press for R&D at its new lab in Germany.
Roche Closes Agreement with Inflazome for $450 Million
Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.
Catalent and T-knife Enter into a Technology Transfer and Manufacturing Agreement
Catalent will use T-knife´s TCR platform for a T-cell receptor-based cell therapy at its Gosselies, Belgium, site in order to manufacture clinical batches for European trials in 2021.
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.
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.
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.
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.
EMA Endorses Dexamethasone for Use in COVID-19 Patients on Oxygen Therapy
The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.
EMA Recommends Seven Medicines for Approval
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
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.
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.
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.
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.
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.
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.
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.
Vizibl Enters Phase I Partnership with Sanofi
Vizibl and Sanofi have entered into a Phase I partnership to streamline processes around supplier management.