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.
Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
FDA Cites Travel Restrictions in CRL
Nabriva Therapeutics reports that FDA says travel restrictions are preventing the on-site inspection of a European contract manufacturer.
FDA Revokes EUA for Hydroxychloroquine
Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.
Novavax Secures $60 Million in Government Funds
Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.
Are We All In This Together?
Achieving herd immunity will require testing, data, a vaccine, and public support.
Ajinomoto Bio-Pharma Services, Humanigen in Manufacturing Agreement for COVID-19 Biologic
The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.
Novavax Acquires Praha Vaccines, Expands Large-Scale Vaccine Manufacturing Capacity
The acquisition gives Novovax an annual operating capacity of more that one billion doses of COVID-19 vaccine antigen.
NIIMBL Funds Projects with $10 Million for Advances in Biopharma Manufacturing Innovation
This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.
mRNA Vaccine Shows Positive Interim Phase I Results
Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.
Catalent, Arcturus Therapeutics Sign Vaccine Deal
Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.
How Fast Is Too Fast?
Will moving at “warp speed” to develop a vaccine impact efficacy or safety?
Remdesivir Approved for Emergency Use
FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.
Catalent to Manufacture J&J’s Lead COVID-19 Vaccine Candidate
Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.
Studies Report Effectiveness of Remdesivir
NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
J&J Ramps Up COVID-19 Vaccine R&D
Johnson & Johnson announces clinical trial plans for COVID-19 vaccine candidate, as well as plans to produce 1 billion vaccine doses.
Innovations in CAR-T Therapies Across APAC Region Intensify Global Market Competition
Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.
Coronavirus Response: Reaction or New Reality?
Emergency action to protect patients and the drug supply may have long-term implications.
WuXi Biologics Provides Update on Operations in Light of Coronavirus Outbreak
The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.
Novartis, Kite, and Cardinal Health Invest in Cell and Gene Therapy Infrastructure
New funding brings competitors, and a leading healthcare products distributor, into the standardization effort.
Building a Business Case for Quality Management Transformation
Can the pharmaceutical industry embrace the goals of Quality 4.0?
Growth in Biologics Market Inspires Outsourcing
CDMOs and CMOs will continue to invest in biopharmaceutical services and facilities as the bio/pharmaceutical industry looks to biosimilars and personalized medicine.
Drug Prices: Revisiting the Social Contract
While the US public and law makers push for price controls, pharma’s venture capitalists have other ideas for balancing innovation and affordability.
Nationwide Children’s Hospital Forms Gene Therapy Company, Andelyn Biosciences
The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.
Public Opinion: Can Pharma Chart a New Course?
As the high cost of drugs continues to erode public opinion, experts ask whether price controls are the best, or only, way to improve access to medicines and regain the public’s trust.
Avacta, Daewoong Pharmaceutical Form Immunotherapy Joint Venture
The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.
US Maintains Lead in Drug Development Despite Fewer Approvals in 2019
FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
Choices for Climbing the Career Ladder
With a positive employment market, some bio/pharma professionals explore options for career advancement.
Riverside Acquires Pharma and Food Ingredients Biz from Ferrer
The divestment of the pharma and food ingredients business is in line with Ferrer’s new strategy to focus on the core business of branded pharmaceuticals.