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Takeda to Acquire Maverick Therapeutics for up to $525 Million
Through the acquisition, Takeda will have access to Maverick’s T-cell engager COBRA platform, along with its development portfolio.
CRB Announces Design and Construction Groups Integration
CRB decided to integrate the groups to further focus on end-to-end design and construction organization in order to expand project execution and improve its client and employee experience.
Thermo Fisher to Invest More than $600 Million into Bioprocessing Production Expansions
The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.
Vectura Announces Dry Powder Inhaler Capabilities Expansion at UK Facility
The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.
Amgen to Acquire Five Prime Therapeutics for $1.9 Billion
Through the acquisition, Amgen will have access to Five Prime’s oncology portfolio, which includes bemarituzumab, Five Prime’s Phase-III ready anti-FGFR2b antibody.
Academic Lab to Develop a Nasal Spray COVID-19 Vaccine
Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.
Ashland Completes Expansion of Viatel Bioresorbable Polymer Manufacturing Site
The expansion will allow Ashland to focus on clinical study projects and commercialization activities.
New Lab Will Develop Standards for Continuous Manufacturing
USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.
Tergus Pharma Appoints New Vice-President of Business Development
Heather N. Sugrue will serve as the company’s vice-president of Business Development.
Baxter to Provide Fill/Finish and Packaging Services for Moderna’s COVID-19 Vaccine
Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.
LabVantage Announces Product Enhancements
Validation for SaaS LIMS, advance analytics, and cybersecurity features announced during Pittcon virtual press conference.
Rolling Review of Sputnik V COVID-19 Vaccine Begins in Europe
The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).
Clinical Data on Moderna COVID-19 Vaccine Published
The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.
FDA Protects Consumers Against COVID-19 Scams
The agency is working to identify and obstruct scammers looking to profit from the pandemic.
FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems
The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.
Merck to Manufacture J&J Vaccine
With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
AstraZeneca Progresses Rollout of COVID-19 Vaccine to Low- and Middle-Income Countries
AstraZeneca has announced that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative.
Oxular Completes Financing Round Worth $37 million
Oxular has raised US $37 million in a financing round led by specialist life sciences investor, Forbion.
Arcline Investment Management Acquires ChargePoint Technology
Arcline Investment Management has acquired ChargePoint Technology, strengthening its global presence.
Survey Demonstrates Upswing in Swedish Life Sciences Growth
A recent survey by SwedenBIO has demonstrated a major upswing in the Swedish life science industry.
EMA Recommends Oral Treatment for SMA
EMA has recommended that Evrysdi be granted marketing authorization in the EU for the treatment of patients with certain types of SMA.
Slovakia Approves Sputnik V Vaccine
RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.
EC Launches Structured Dialogue to Address Medicines Supply Vulnerabilities
The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.
Pandemic Spurs Cybersecurity Risks in Laboratories
Pharmaceutical laboratories must work to maintain lab data integrity practices as the pandemic surges on and cybersecurity risks increase.
Demonstrating the Value of Collaboration
The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.
FDA Documents Achievements and Plans for Future
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
Fighting Through This Slow Season of Change
Bio/pharma works hard today to change the calendar to tomorrow.
Meeting CGT Demand
More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.
Nitrosamine Risk Assessment Date Extended
FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.
