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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 severe asthma treatment approved in EU for self-administration

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

Latest news

Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval

Eisai has also submitted a supplemental biologics application (sBLA) to the FDA for approval under the traditional pathway, the companies said.
bluebird bio sells second FDA priority review voucher for $95m

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
Amgen and Synaffix sign licensing agreement worth up to $2bn

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
FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

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
Roche shares phase 3 Polivy data for previously untreated diffuse large B-cell lymphoma

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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Latest Intelligence

How diversity and inclusion continues to be incorporated in dermatology

References. 1 Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use.
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).
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
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.
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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Approximately 5 fully matching, plus 91 partially matching documents found.

Latest appointments

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.
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
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.
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
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

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.
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.
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
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.
Living with psoriasis: a patient perspective

million[i]) received a biologic therapy in the UK in 2012.

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Approximately 7 fully matching, plus 42 partially matching documents found.

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