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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
US announces $3bn funding boost for antiviral COVID-19 treatments
The deal, worth $1.2bn, is contingent upon the US Food and Drug Administration (FDA) issuing an emergency use authorization (EUA) or approval for the treatment.
Latest news
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Biogen discontinues clinical development of anti-tau antibody for Alzheimer’s disease
In contrast, Biogen's Alzheimer’s drug Aduhelm (aducanumab) – an anti-amyloid antibody – was approved by the US Food and Drug Administration (FDA) earlier this month, although the decision has been ... Specifically, the FDA has come under fire
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GSK partners with iTeos Therapeutics on next-gen immuno-oncology drug
tiragolumab. In January, the US Food and Drug Administration (FDA) issued a BTD for tiragolumab in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) in the first-line setting for
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Regeneron’s COVID-19 drug boosts survival in hospitalised patients lacking antibodies
REGEN-COV is currently available in the US under an emergency use authorisation (EUA) issued by the Food and Drug Administration (FDA) for the treatment of high-risk mild-to-moderate
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Novartis’ iptacopan scores positive results in rare blood disorder PNH
Last December, the US Food and Drug Administration (FDA) granted iptacopan a breakthrough therapy designation for the treatment of PNH and a rare paediatric disease designation for C3G.
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G7 expected to donate one billion COVID-19 vaccine doses
At the same time, the FDA has extended the shelf-life of the single-dose J&J vaccine. ... COVAX. FDA extends shelf-life of single-dose J&J vaccine. The US Food and Drug Administration (FDA) has extended the shelf life of Johnson &Johnson’s (J&J)
Biogen discontinues clinical development of anti-tau antibody for Alzheimer’s disease
GSK partners with iTeos Therapeutics on next-gen immuno-oncology drug
Regeneron’s COVID-19 drug boosts survival in hospitalised patients lacking antibodies
Novartis’ iptacopan scores positive results in rare blood disorder PNH
G7 expected to donate one billion COVID-19 vaccine doses
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Latest Intelligence
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How early-stage clinical research is facilitating the new wave of personalised medicines
The first ever siRNA therapy was only approved by the US Food and Drug Administration (FDA) in 2018 – Patisiran for the treatment of the nerve disease (polyneuropathy) – and two further siRNA
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Patient diversity in clinical trials needs to be centre stage
Regulatory pressure, particularly from the FDA and more recently by the MHRA and EMA, is encouraging inclusivity and diversity, she added. ... We heard recently that the FDA responded to one company’s early clinical trial design by saying, basically:
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Your clinical trial participants are precious, so treat them as such
3. Understanding the impact of your medicine on patients’ lives: the FDA no longer requires a drug to solely demonstrate clinical improvements – it also requires you to demonstrate how it has
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Diversity and inclusion in clinical trials
ways, the FDA guidance issued in November that addressed the multidimensional aspects of diversity and inclusion in clinical trials, and the coverage of social unrest with the demand for equity featured ... With this FDA guidance, other regulatory
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The pursuit of patient diversity in clinical trials
These damning figures, the latest in a series of drug trial snapshots published by the FDA, aren’t unusual. ... In November 2020, the FDA issued new guidance to help industry enhance the diversity of clinical trial populations through broadening
Your clinical trial participants are precious, so treat them as such
Diversity and inclusion in clinical trials
The pursuit of patient diversity in clinical trials
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Latest appointments
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New faces at Synergy Vision, Makara Health and JPA Health
regional health communications campaigns. In her new role, she will leverage her expertise in FDA/EMA communications, patient and physician education, scientific communications, issues management and celebrity engagement to serve JPA
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New hires at Nanoform, Leo Pharma and Calliditas
The combination of his strong experience in regulatory affairs, not only with the FDA but on a broad international basis with a proven track record and experience from orphan drug development
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Parexel expands global regulatory services team
US-based biopharmaceutical services company Parexel has bolstered its regulatory services team with the addition of three senior executives from the FDA and pharma. ... He has previously worked for the likes of Novartis, Igenix and the FDA.
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NDA Group appoints Alison McGregor as its principal consultant
Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings
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Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair
Dr Jenkins is also a committee member of the science board to the US Food and Drug Administration (FDA) and serves on the advisory board of its Center for Talent Innovation
New faces at Synergy Vision, Makara Health and JPA Health
New hires at Nanoform, Leo Pharma and Calliditas
Parexel expands global regulatory services team
Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair
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Latest from PMHub
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Is your clinical trial method tried and tested with patients in mind?
COUCH Health are already working with clients on improving the patient experience through trial design, including projects that are part of the FDA’s Complex Innovative Trial Design (CID) Pilot Program.
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The future of dementia and the important role of healthcare communication in raising awareness
Progress was made in February 2018, when the FDA released a draft guidance document categorising Alzheimer’s disease into stages that define preclinical and prodromal disease based on biomarker, cognitive, and
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Training for PI's and study staff has to change now
Study sites and their staff are often under scrutiny from the FDA for not adhering to the study protocol, over-delegation and lack of documentation of principal investigator oversight.
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WHITE PAPER: What's missing in women's health?
31. Transvaginal Mesh Recalls, Discontinued Products &FDA Regulation. Drug. Watch. https:// www.drugwatch.com/transvaginal-mesh/recall/.
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#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
Between 1997 and 2000, the FDA retracted 10 drugs that were on the market.
Is your clinical trial method tried and tested with patients in mind?
The future of dementia and the important role of healthcare communication in raising awareness
Training for PI's and study staff has to change now
WHITE PAPER: What's missing in women's health?
#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
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- Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses
- Novavax announces further delays for regulatory filings of COVID-19 vaccine
- Novartis highlights potential of its radioligand therapy in prostate cancer at ASCO
- AZ, Pfizer/BioNTech COVID-19 vaccines 'highly effective' against Indian variant
- Disappointing results from CureVac’s COVID-19 vaccine as phase 2/3 study shows only 47% efficacy
- Positive late-stage results for Novartis’ radioligand therapy in advanced prostate cancer
- Court rules on AZ and EU’s COVID-19 vaccine dispute
- BMS and Eisai to collaborate in deal worth up to $3.1bn
- US announces $3bn funding boost for antiviral COVID-19 treatments
- Biogen doses first patient in phase 3 systemic lupus erythematosus study
- Kite partners with Shoreline Biosciences to develop allogeneic cell therapies
- ‘Funny’, ha ha: how neurodiverse comedy can help us understand each other
- Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses
- BeiGene’s reveals positive data for Brukinsa in head-to-head Imbruvica trial
- Merck signs $1.2bn supply deal with US government for Molnupiravir
- AZ, Pfizer/BioNTech COVID-19 vaccines 'highly effective' against Indian variant
- Packer Forbes acquired by Four Communications
- AI is transforming pharma R&D – now it can transform pharma marketing
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