This page shows the latest biologic news and features for those working in and with pharma, biotech and healthcare.
pen the first and only severe asthma biologic approved in the EU with no phenotype of biomarker limitations. ... Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids, many severe asthma
Eisai has also submitted a supplemental biologics application (sBLA) to the FDA for approval under the traditional pathway, the companies said.
The company is now resuming the enrolment and treatment of patients aged between two to 17 years of age and said it remains ‘on track’ to submit a Biologics License Application
The business model of Synaffix is target-specific technology out-licensing, shown through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen, Innovent Biologics, ProfoundBio, Kyowa Kirin, Genmab, Macrogenics and
The company can now resume the enrolment and treatment of patients aged two to 17 years and said it remains on track to submit a Biologics License Application to the FDA
The US Food and Drug Administration has accepted Roche’s supplemental Biologics License Application for the treatment and its decision is expected by 2 April 2023.
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References. 1 Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use.
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).
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
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.
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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That included the expansion of the company’s biologics and biomarker functions, as well as the addition of inflammation, oncology and immunology discovery groups.
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
Tuna currently serves as chief scientific officer at Adaptate Biotherapeutics, and has over 15 years of experience in biologics drug discovery and development.
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
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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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.
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.
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
So, those with High Cost biologics are going to have to think carefully about their value proposition.
million[i]) received a biologic therapy in the UK in 2012.
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