An overview of the biosimilars space
Biosimilar developer Formycon puts the spotlight on the opportunities and challenges for the sector.
Biopharma culture
The FDA has approved Pfizer’s RSV vaccine Abrysvo for adults aged 18 to 59
The US pharma giant Pfizer recently announced that its respiratory syncytial virus (RSV) vaccine Abrysvo has received FDA approval in adults aged 18 to 59 who are at an increased risk of developing lower respiratory tract disease caused by RSV (RSV-LRTD).
Innovations in mass spectrometry accelerate the shift toward precision medicine
Thermo Fisher’s John Lesica discusses how mass spectrometry technology enables scientific breakthroughs in genomics and proteomics to provide valuable insights for drug discovery and development.
Jane Koo on leading regulatory affairs at CTMC: A journey from mAbs to cellular therapies
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 partner to scale up GBS vaccine production
MinervaX and Wacker Biotech announced yesterday that they have entered into a manufacturing agreement for MinervaX’s prophylactic vaccine against Group B Streptococcus infections.
EU approves Regeneron’s bispecific antibody following US rejection
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.
FDA approves updated mRNA vaccines for COVID-19
The US FDA has granted emergency use authorization to several updated COVID-19 vaccines against a new viral strain that is currently circulating.
FDA approval of Regeneron’s myeloma drug delayed due to manufacturing issues
The US regulator has confirmed a delay to the approval of linvoseltamab while a manufacturing issue is resolved with a third-party provider.
Breaking News: Lecanemab approved in UK but unavailable on NHS
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.
Bavarian Nordic readies 2 million vaccine doses to fight mpox outbreak
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.
Incyte and Syndax's immunotherapy for transplant complications receives FDA approval
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.
FDA lifts hold on BioNTech and MediLink's ADC trial After safety revisions
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.
CVC Capital acquires immunomodulatory therapy business for $925 million
CVC Capital Partners has entered an agreement with specialty pharmaceutical company Mallinckrodt to acquire its Therakos business.
Adaptimmune’s Tecelra becomes the first FDA-approved cell therapy for a solid tumor
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.
Boehringer Ingelheim and GoodRx undercut Humira by massive 92% with biosimilar
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 announces positive early results for Angelman syndrome therapy
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.
Top 5 CDMOs driving advanced therapies to market amid rising demand and challenges
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...
Beacon Therapeutics raises $170M in series B to advance gene therapies for eye disease
The fundraising will accelerate the clinical development of Beacon Therapeutics’ lead gene therapy candidate, which is currently in phase 2/3 trials.
Ones to watch - five upcoming companies on the CAR-T scene
CAR-T therapies have big potential to take on blood cancer but also have major drawbacks.
ReciBioPharm’s Edita Botonjic-Sehic, on analytics, AI, and continuous RNA manufacturing
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Mainz Biomed CEO discusses stool test for colorectal cancer vs Galleri blood test
Catching cancer early can save lives because it can be treated before it spreads in the body.
Alvotech and STADA to co-develop biosimilars for bone disease treatments
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.
Oligonucleotides in the spotlight as GSK snaps up RNA startup for up to $50 million
GSK has acquired its San Diego-based collaborator Elsie Biotechnologies to strengthen its efforts in developing oligonucleotide therapeutics.
Three Indian CDMOs ready to seize the BIOSECURE Act opportunity
In the wake of escalating tensions between the United States and China, the Biden Administration is intensifying its strategic focus on biosecurity.
Breaking barriers in bioprocessing: An Interview with Enzene Bioscience's CEO
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.
Roche seeking to revamp pharma inventory management
Pharma giant Roche has launched a new crowdsourcing campaign that aims to capture innovative ways of improving and overhauling inventory management in pharmaceuticals.
Worldwide Clinical Trials' Peter Benton on the outlook for biopharma funding
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.
Top pharma executives say lack of funding stalling digital revolution
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.
International clinical trials day: Treehill's quest for commercial and clinical success
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.
How Hazel Jones is charting new horizons in genomics
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.
Samsung Biologics poised for growth pending BIOSECURE bill approval in US
The US government’s unveiling of the BIOSECURE bill has created a great deal of discussion and debate in the pharma industry.
CPHI North America 2024
Selkirk Pharma: Adapting to regulatory shifts and market demand
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.
Interphex 2024
Pharma goes urban: The rise of city manufacturing facilities
When imagining a pharmaceutical manufacturing facility, many picture it in a vast rural setting, offering ample space for large-scale operations.
Eli Lilly’s double impact: Mounjaro and Donanemab to ‘outshine’ market rivals
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.
Production of tree-saving transformative vaccine adjuvant with in-lab plants
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.
Eli Lilly under pressure: Can it solve GLP-1 supply squeeze?
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.
Recent pharma industry appointments that should be on your radar - KBI Biopharma, Veranova and more
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...
Women in Science: Elisa Cascade on why women should never be afraid to ask
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, how...
Industry lauds Great Ormond Street's child gene therapy expansion
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 accused of 'bringing discredit' on industry with 'unnecessary' vaccine tweet
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.
Breakthrough UTI vaccine could prevent infections for nine years
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.
AACR Annual Meeting 2024: The key announcements you need to read
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.
Novo Nordisk pushes back after price gouging accusations by Bernie Sanders
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.
Simple blood test could help detect Alzheimer’s years earlier
Thousands of people across the UK will be offered a blood test to detect dementia, in a bid to revolutionize the country’s ‘shocking’ diagnosis rate.
REUTERS PHARMA USA 2024
Bringing CAR-T into the community: ‘Healthcare is like politics – it’s local’
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.
Women in Science: Dr Laura Trotta – ‘I joined CluePoints because of the research but also the mindset’
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...
FDA settles ivermectin lawsuit, removes contentious COVID-19 posts
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 ‘deeply humbled’ by award recognising pandemic efforts
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.
REUTERS PHARMA USA 2024
Reshema Kemps-Polanco: No ‘silver bullet’ to address health equity but Novartis making strides
Whether they recognise it or not, the entire pharma industry is involved in the business of health equity and championing it is critically important.
Reuters Pharma USA 2024
GSK’s Maya Martinez Davis: ‘Trust is the most powerful thing in an organization’
“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.”