Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
MinervaX and Wacker Biotech announced yesterday that they have entered into a manufacturing agreement for MinervaX’s prophylactic vaccine against Group B Streptococcus infections.
Just months after facing a rejection in the US, the bispecific antibody odronextamab (Ordspono) has been approved by the European Commission for the treatment of two types of blood cancer in patients that have failed to respond to previous treatments.
Eisai and Biogen’s new Alzheimer’s treatment, lecanemab, received a green light from UK regulators, marking a significant advance in treating early-stage Alzheimer’s disease.
The Danish company Bavarian Nordic plans to supply up to 2 million vaccine doses this year in response to the World Health Organization’s declaration of mpox as a Public Health Emergency of International Concern (PHEIC) earlier this month.
The US FDA has granted approval to Niktimvo for the treatment of chronic graft-versus-host disease, a serious immune condition affecting the recipients of stem cell transplants.
Two months after placing a partial hold on a phase 1 clinical trial evaluating an antibody-drug conjugate (ADC) in cancer patients, the FDA is allowing the study to proceed with the lower doses of the treatment.
The FDA has granted accelerated approval to Adaptimmune’s Tecelra, a T cell therapy for the treatment of synovial sarcoma when other lines of treatment do not work.
In a bid to make biologic treatments more accessible to patients, Boehringer Ingelheim is harnessing the reach and scale of the prescription savings platform GoodRx to provide its Humira biosimilar adalimumab-adbm at a low price.
Ionis Pharmaceuticals antisense therapy for Angelman syndrome achieved good early safety and efficacy results and the company now plans to advance the therapy to phase 3.
Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry – a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward...
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Alvotech of Iceland and STADA Arzneimittel of Germany have extended an existing partnership to co-develop a clinical-stage biosimilar for Prolia and Xgeva, Amgen’s therapies for bone conditions based on the antibody drug denosumab.
With a rich background in biochemistry and extensive experience in the pharmaceutical industry, Himanshu Gadgil shares insights into Enzene's journey, its innovative approach to biosimilars.
Pharma giant Roche has launched a new crowdsourcing campaign that aims to capture innovative ways of improving and overhauling inventory management in pharmaceuticals.
Peter Benton is president and CEO of Worldwide Clinical Trials, a full-service global CRO. We spoke with him about his insights into recent trends and factors influencing biopharma investment decisions.
A new report from Graphite Digital has revealed that 36% of senior leaders in pharma agree that funding is the biggest barrier to digital adoption and transformation, despite increasing spend.
At the ASCT 2024 conference a few weeks ago, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, highlighted a crucial issue in the future of clinical trials.
Hazel Jones is the CEO at Enhanc3D Genomics. We sat down with her to discuss her leap of faith into 3D genomics, and how she is scaling the business and driving operational change.
Ahead of CPHI North America, we caught up with Lisa Stiles, director, business development at Selkirk Pharma, an exhibitor at the event, to find out how the CMO is navigating regulatory changes, challenges and more.
Eli Lilly may be on the brink of reshaping the pharma landscape, with its treatments, Mounjaro (tirzepatide) for obesity and the highly anticipated donanemab for early symptomatic Alzheimer’s disease.
During DCAT this year, CEO Gaston Salinas from Botanical Solution Inc., (BSI), sat down with Liza Laws, the senior editor of OSP and BPR to discuss his company’s pioneering work in revolutionizing vaccine adjuvant production.
Specific doses of Eli Lilly’s GLP-1 blockbuster drugs Mounjaro and Zepbound are currently facing a supply shortage, and frustrated patients are urging the pharma giant to act – fast.
Bio Pharma Reporter and Outsourcing Pharma is back with our latest instalment of movers and shakers - breaking down all the key pharma industry appointments that you should know about. KBI Biopharma, Veranova and Kindeva Drug Delivery are among the companies...
Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinical research company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome,...
Great Ormond Street Hospital (GOSH) has announced its new plan to ‘revolutionise’ how children living with rare diseases can gain access to cutting-edge gene therapy.
Pfizer has been accused of ‘bringing discredit’ on the pharma industry after senior employees promoted its ‘unlicensed’ COVID-19 vaccine through social media at the height of the pandemic.
Recurring urinary tract infections (UTIs) can be prevented for up to nine years with a simple oral spray vaccine, a ‘breakthrough’ British trial has shown.
Last week (April 5), the American Association for Cancer Research (AACR) welcomed the industry to the San Diego Convention Center for the AACR Annual Meeting 2024.
Pharma giant Novo Nordisk is firing back after Senator Bernie Sanders took a stand against the ‘outrageous’ prices of its wildly popular drugs, Ozempic and Wegovy.
Today, just two in ten patients have access to CAR-T therapy in the US. Considering this challenging landscape, the shift has focused from academic centers to community clinics, as they may be able to serve more patients.
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess...
The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice...
AstraZeneca CEO Sir Pascal Soriot has been awarded one of the highest honours by science institution SCI for his role in ‘accelerating scientific innovation’ and for leading the company’s global COVID-19 vaccination programme.
“When you have people who like what they do and believe they’re having an impact, you can do anything – more than any project or investment. Prioritise your teams and people because they’re your biggest asset.”
This week, the pharma industry will descend on Pennsylvania Convention Center for Reuters Pharma USA, North America’s largest cross-functional pharma gathering.
Dr. Claudia Zylberberg is a scientist and founder, board member and former CEO of Akron Biotech, a company that makes materials and technologies to support advanced therapy development. We spoke to her about her career, personal triumphs and candidacy...
AstraZeneca recently announced its £650 million investment in the UK, held up by Chancellor Jeremy Hunt as a ‘vote of confidence’ in the country’s life sciences sector.