Biopharma News
Novartis Gets EMA Approval for Two European Commercial CAR-T Manufacturing Sites
The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.
SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology
The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.
J&J in $1-Billion Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine
The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.
Sanofi and GSK to Supply COVID-19 Vaccine to US Government and European Union
Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.
FDA Approves First Cell-Based Gene Therapy for MCL
The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.
Polyplus-transfection Launches Residual Test for Transfection Reagents
The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.
MOBILIon’s SLIM Technology Enhances R&D Analytics
The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.
Vico Therapeutics Raises $31 Million in Series A Financing Round
Vico Therapeutics has raised $31 million (€27 million) in a Series A financing round, which the company will use to further advance its Antisense OligoNucleotides lead platform.
Avacta, Daewoong Pharmaceutical Expand Collaboration to Include COVID-19 Therapy
Avacta Group has expanded its partnership with Daewoong Pharmaceutical to include Affimer molecules that target viruses, such as coronavirus.
DuPont and Rutgers University Enter Research Collaboration
DuPont Nutrition and Biosciences has entered into a research collaboration in microbiome science with the Center for Advanced Biotechnology and Medicine at Rutgers University.
UK Government Provides Cash Boost for COVID-19 Vaccine Manufacture
The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.
EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines
The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.
Stevanato Group, Colanar Partner Up on Fill/Finish Capabilities
Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.
Novavax and Fujifilm Diosynth Biotechnologies Begin Manufacturing of COVID-19 Vaccine Candidate
Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.
Catalent Invests Millions to Create European Clinical Manufacturing Center of Excellence
Catalent has unveiled investment plans to create a European center of excellence for clinical biologics formulation development and drug product fill/finish services.
AstraZeneca and IQVIA Partner on Potential COVID-19 Vaccine
The project will focus on providing a faster route to clinical studies for AstraZeneca’s potential COVID-19 vaccine, AZD1222.
Innovate UK Awards Epsilogen Further Funding for Ovarian Cancer Treatments
Innovate UK has awarded Epsilogen with further grant funding for the development of the next generation antibody treatments for ovarian cancer.
CureVac Receives Funding, Collaborates with GSK on mRNA and mAbs
GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.
UK Government Secures Early Access to Millions of COVID-19 Vaccine Doses
The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.
Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.
mRNA Vaccine Produces Immune and T-cell Response
Preliminary data from a German Phase I/II trial shows Pfizer/BioNTech COVID-19 vaccine candidate produces immune response.
CanSino Vaccine Produces Immune Response
Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.
AstraZeneca Vaccine Shows Antibody and T-cell responses
Strong immune response by patients receiving two doses of vaccine suggests a possible treatment strategy.
AstraZeneca/Oxford Vaccine Shows Antibody and T-cell Responses
A strong immune response by patients receiving two doses of AZD1222 vaccine suggests a possible dosing strategy for COVID-19 vaccine.
Industry Welcomes Global AMR Action Fund
Industry has welcomed the launch of the Global AMR Action Fund, which aims to bring two to four new antibiotics to patients by 2030 to tackle antimicrobial resistance (AMR).
Merck and Dewpoint Team Up for HIV Treatment Plan
Dewpoint’s condensate platform works to target individual molecules and interacting groups of molecules within condensate communities to create new treatments for incurable and untreatable diseases.
A Novel Method for Host Cell Protein Analysis
This method is expected to help bring gene therapies to market faster, safer, and cheaper.
VAR2 Pharmaceuticals Wins MilliporeSigma’s Advance Biotech Grant
VAR2 Pharmaceuticals has been selected for its development of a drug-conjugated malaria protein that potentially selectively binds to most human tumor types.