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biologic
This page shows the latest biologic news and features for those working in and with pharma, biotech and healthcare.
AstraZeneca's Enhertu receives FDA grant for priority review
AstraZeneca and Daiichi Sankyo’s jointly developed drug, Enhertu (trastuzumab deruxtecan), has received a notification of acceptance of the supplemental Biologics License Application (sBLA), alongside a grant for priority review.
Latest news
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Biogen and Eisai present new data for controversial Alzheimer's drug Aduhelm at AAIC
Woodcock has asked for the process for review of Biogen’s biologics licence application (BLA) for Aduhelm to be investigated.
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Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery
The FDA had previously rejected a supplemental biologics licence application in this indication. ... In March 2021, the US Food and Drug Administration (FDA) issued Merck &Co a complete response letter (CRL) rejecting a supplemental biologics licence
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FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm
Woodcock has asked for the process for review of Biogen’s biologics licence application (BLA) for Aduhelm to be investigated.
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FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval
Now, Woodcock wants the process for review of Biogen’s biologics licence application (BLA) for Aduhelm to be looked at again, including an ‘ongoing focus on interactions’ between Biogen and FDA
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FDA grants priority review for AZ, Amgen’s tezepelumab for asthma
the availability of inhaled and biologic medicines,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.
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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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Approximately 8 fully matching, plus 48 partially matching documents found.
Latest from PMHub
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Why you should feel optimistic about the future of healthcare
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: how is it affecting prescribing patterns?
because as generic biologics get approved, use of branded biologics goes down and the arthritis pathway becomes cheaper to run. ... Yet, Gilenya aside, we found the medications trending upward were orally administered, which demonstrates a market
Why you should feel optimistic about the future of healthcare
Living with psoriasis: a patient perspective
More from PMHub
Approximately 7 fully matching, plus 40 partially matching documents found.
COVID-19 Updates and Daily News
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- AstraZeneca’s Imfinzi and tremelimumab show unprecedented survival rate in liver cancer patients
- Sanofi and Regeneron’s Dupixent receives second positive phase 3 trial results
- Why pharma must get smart in its approach to customer engagement
- GSK appoint Tony Wood as chief scientific officer
- Merck and Eisai share crucial phase 3 trial results for advanced endometrial carcinoma treatment
- Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis
- Lucid Group Welcomes a New Cohort of Graduates into its Futures Academy
- Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19
- SMC approves Parkinson’s disease treatment Ongentys
- Superstar congresses and conferences will stay centre stage but now share the limelight with virtual and hybrid events
- Home or away: where next for pharmaceutical symposia?
- PM announces plans to lift England’s COVID-19 restrictions
- Why pharma must get smart in its approach to customer engagement
- AstraZeneca's Enhertu receives FDA grant for priority review
- Pfizer lifts 2021 guidance as sales of its BioNTech-partnered vaccine continue to climb
- NAVIGATING 2022: THE FIVE CRITICAL SHIFTS PHARMA NEEDS TO EMBRACE
- Amgen’s Lumykras receives conditional marketing authorisation from EC
- SMC approves Parkinson’s disease treatment Ongentys
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Merrill Brink International is a leading provider of life sciences, legal, financial, manufacturing and corporate language solutions for global companies....
Latest intelligence
- Superstar congresses and conferences will stay centre stage but now share the limelight with virtual and hybrid events
- With the pandemic having dimmed the lights on pharma conferences, their virtual and hybrid replacements have grasped the opportunity and are here to stay...
- Cervical Cancer Prevention Month
- In this first 2022 blog, the Innovative Trials' Equality & Diversity committee will be looking at raising awareness around Cervical Cancer...
- 6 critical success factors for flawless execution of a rapid first commercial launch
- Annemarie Armstrong, Executive Vice President, US Head of Client Services, shares the key considerations for launching a first commercial product, particularly on a rapid timeline....
