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biologics
This page shows the latest biologics news and features for those working in and with pharma, biotech and healthcare.
Biogen and Eisai announce FDA submission for early Alzheimer’s treatment
Biogen and Eisai have announced the rolling submission to the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) for lecanemab.
Latest news
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FDA limits use of Janssen’s COVID-19 vaccine
the FDA’s Center for Biologics Evaluation and Research.
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AstraZeneca’s Imfinzi plus chemotherapy accepted for Priority Review in the US
s supplemental Biologics License Application (sBLA), submitted to the US Food and Drug Administration (FDA).
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Sanofi begins construction on the first of two Evolutive Vaccine Facilities in Singapore
The EVFs have been designed to accommodate the ‘agile and flexible’ production of multiple vaccine and biologics platforms, including mRNA, enzymes and monoclonal antibodies.
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Enhertu to provide patients with vital targeted therapy option
AstraZeneca and Daiichi Sankyo have received notification of acceptance concerning the supplemental Biologics License Application of Enhertu (trastuzumab deruxtecan).
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bluebird bio maintains its focus on gene therapy opportunities during structural changes
It is also concentrating on the potential submission of a biologics license application (BLA) for the lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease, planned for the first quarter
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Latest Intelligence
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How early-stage clinical research is facilitating the new wave of personalised medicines
is also being used to treat autoimmune and cardiac conditions, and biologic medicines, which now account for 15% of medicines prescribed in Japan and 30% in the USA (in 2018).
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Piloting a route to the biosimilars opportunities in Europe
These products might take 30-50% less time to develop, and cost up to 70% less than their biologic originals – savings that can be passed on to healthcare providers and patients. ... The increased competition also forces originator/biologic
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Beyoncé vs Paul Simon: achieving launch excellence
Now, let’s apply this to the pharma industry. If you are launching in biologics, CAR-T or immuno-oncology, engaging your target audience is unlikely to be a struggle.
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Keeping up with the developing regulatory requirements for gene and cell therapies
Other safety and manufacturing events such as three patient deaths in the high-dose arm of the Audentes’ ASPIRO trial and an FDA refusal to review the biologics licence application for
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Growing evidence supports the important role of biosimilars in healthcare
In 2019, four of the top five prescription expenditures in the US were biologics and accounted for approximately $46 billion in expenditures. ... An estimated 1.2 million US patients could gain access to biologics by 2025 as the result of increasing
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Latest appointments
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Ex-BMS exec jumps to Gilead to lead research group
That included the expansion of the company’s biologics and biomarker functions, as well as the addition of inflammation, oncology and immunology discovery groups.
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New hires at Crescendo, Healx and Galecto
The latest movers in pharma. Crescendo. Crescendo Biologics has appointed Kenji Hashimoto as its new chief medical officer, who joins Crescendo with over 15 years of experience in oncology and ... Kenji has considerable immuno-oncology expertise and an
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New hires at FibroGen, Saniona and Turbine
Tuna currently serves as chief scientific officer at Adaptate Biotherapeutics, and has over 15 years of experience in biologics drug discovery and development.
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Immunocore names new CEO, Nanoform adds to commercial team and Verona hires CMO
Bahija has more than 25 years of international leadership experience within the pharmaceutical industry, and joins Immunocore from AstraZeneca, where she has served as President of MedImmune, its global biologics research ... A champion for science and
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BMS appoints new commercial leader, Davies joins Eisai and more
Commenting on her appointment, Schuermans said: “Sobi has unique capabilities, a heritage in biologics manufacturing, development and supply, and a very exciting future within the rare disease space.
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Latest from PMHub
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The future of nanomedicine regulation
By putting products into different boxes (e.g. chemical drugs versus biologics), regulators have managed to develop very clear processes that are tailored to the unique characteristics of different treatment types.
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Why you should feel optimistic about the future of healthcare
CytImmune Sciences recently completed a Phase I trial using gold nanoparticles to target drug delivery to tumours; BlueWillow Biologics has developed nanotech that fights viruses and bacteria.
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The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor
During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell
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Integrated NHS finances: what do they mean for High Cost Drugs?
So, those with High Cost biologics are going to have to think carefully about their value proposition.
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Living with psoriasis: a patient perspective
million[i]) received a biologic therapy in the UK in 2012.
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COVID-19 Updates and Daily News
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- Recognising HIV Vaccine Awareness Day
- Scientists discover new approach to treat brain tumours
- Boehringer Ingelheim’s pulmonary fibrosis treatment produces promising phase 2 data
- NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer
- Phase 3 trial of AstraZeneca and Avillion’s PT027 shows promise for asthma patients
- J&J appoints Thibaut Mongon as CEO designate of New Consumer Health Company
- Live Webinar: The Future of MedTech: Streamlined Clinical Data Collection & Management
- Medscape: Connect to the conversation
- A Medscape 4-part video interview series
- Why big pharma needs to be braver
- MadMicrobe Studios Inc Announces New European Venture
- EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
PMHub
Life Healthcare Communications
Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...
Latest intelligence
- Why big pharma needs to be braver
- The last few years have seen the pharmaceutical industry undergo a rapid metamorphosis in the face of unprecedented change, but communications are one area that still needs an injection of...
- Leveraging Real-World Evidence for Cell and Gene Therapies
- Regulators and reimbursement bodies are increasingly turning to real-world evidence (RWE) to understand the long-term value of drugs, in particular novel therapies. Here, Mariam Bibi, Senior Director, Global RWE at...
- Food Allergy – Is avoidance the only option?
- Following on from Allergy Awareness Week 2022, we’re continuing the discussion about food allergies and the experiences of those who live with them. In this blog, we discuss the current...
