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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
New dosing option for AZ’s Imfinzi approved in the EU and UK
The four-week fixed-dose schedule for Imfinzi in NSCLC was also recently approved by the US Food and Drug Administration (FDA). ... The FDA also approved the additional dosing option for patients with previously treated advanced bladder cancer.
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Bayer’s finerenone scores FDA priority review for chronic kidney disease
FDA priority review is based on data from the phase 3 FIDELIO-DKD trial. ... The FDA submission is based on data from the phase 3 FIDELIO-DKD trial, which evaluated finerenone in patients with CKD and T2D.
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Merck wins speedy FDA review for 15-valent pneumococcal vaccine
Following the fast-track designation, the FDA will plan to reach a decision on Merck's vaccine by 18 July. ... Pfizer’s 20-valent candidate was given a priority review by the FDA in December 2020, with the goal of announcing a decision in June this year
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Lilly’s anti-amyloid antibody donanemab renews Alzheimer’s hopes
Another amyloid-targeting treatment, Biogen’s aducanumab, is currently being reviewed by the US Food and Drug Administration (FDA). ... Although the FDA is not required to follow guidance from expert panel decisions, it usually does so.
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Biogen advances Spinraza study in SMA patients treated with Novartis’ Zolgensma
Novartis’ gene therapy was approved to treat SMA in patients aged two years and younger by the FDA in May 2019, with a price-tag of $2.1m per patient – making
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Moderna’s COVID-19 vaccine could offer protection for ‘a couple of years’, says CEO
The US Food and Drug Administration (FDA) has also given the Moderna vaccine an emergency use authorisation for the prevention of COVID-19 in individuals aged 18 years and older. ... It is the second COVID-19 vaccine to receive an EUA from the FDA
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Latest Intelligence
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The search for effective drug treatments for COVID-19
What were the trial results that led to this EUA? An EUA is a mechanism through which the Food and Drug Administration (FDA) can approve the temporary use of an investigational ... The FDA has approved remdesivir under the brand name Veklury for the
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2021: the year of decentralisation in drug development
As a result, recently published FDA guidance provides recommendations for improving clinical trial diversity, including decentralised strategies such as reducing site visit frequency, when appropriate, in addition to encouraging the use ... In fact,
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Successful product commercialisation: what can we learn from the rare disease setting?
Furthermore, a priority review designation by the FDA or EMA signals to the market an expectation that the drug will provide an improvement over currently available treatment.
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Growing evidence supports the important role of biosimilars in healthcare
Biosimilars – FDA-approved treatments that match their reference medicine in terms of quality, safety and efficacy – have an important role in creating sustainability for overburdened health systems through increased competition. ... Myeloid growth
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After years of potential, cell and gene therapy is ready for the pharmaceutical mainstream
FDA approval – in this case for a project that can treat inherited vision loss. ... body to target motor neurone disease, is FDA approved and developed by Avexis, but it won’t see widespread availability due to a price tag of $2.1m per treatment.
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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
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What NORD’s RareInsights® 30-year comparative analysis means to us and our clients at OPEN Health
In addition to this there has been a huge increase in the number of orphan treatments granted access by the US Food and Drug Administration (FDA) (862 vs 46) but this
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New from the PhRMA: Diversity in clinical trials principles summarised
In November 2020, PhRMA announced the first-ever, industry-wide principles on clinical trial diversity. The principles were approved by the PhRMA Boards of Directors and will take effect in April 2021. PhRMA have taken the existing principles a step
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New from the FDA: Diversity in clinical trials guidance summarised
The FDA provides key examples of how to improve study design and conduct to enhance enrolment:. ... To help minimise underrepresentation in these studies, the FDA outlined some changes in the enrolment process:.
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Live panel discussion: Should diverse representation in UK clinical trials be mandatory?
In the US, for example, the FDA is placing increasing pressure on pharma companies to run trials with patients who better resemble the overall population; a scramble is on to make ... The FDA guidance on patient diversity does not specifically dictate
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The Unknown Unknowns
Regulatory and reimbursement agencies are also starting to allow, if not encourage the patient perspective, with the FDA stating in guidance in 2018 that ‘patient engagement is critical throughout the medical ... Whilst I would agree with the FDA that
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- Celltrion’s investigational mAb cuts COVID-19 recovery time
- Pfizer, BioNTech temporarily slow down shipments of COVID-19 vaccine to EU
- UK pharmacies to begin administering COVID-19 vaccinations
- Bayer’s finerenone scores FDA priority review for chronic kidney disease
- AZ’s COVID-19 vaccine trial to continue after Brazilian volunteer death
- AZ seeks EU approval for its Oxford University-partnered COVID-19 vaccine
- Research Partnership appoints Hannah Osborn to MedTech director role
- Pfizer, BioNTech temporarily slow down shipments of COVID-19 vaccine to EU
- NHS is set to begin offering COVID-19 vaccinations to over-70s this week
- Cambridge University develops DNA test for secondary infections in COVID-19 patients
- 2020 - a year to remember or forget?
- Amgen strikes $240m autoimmune deal with Evoq Therapeutics
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SEVEN STONES
Seven Stones is a creative, independent healthcare communications agency of movers and thinkers. We've been doing health differently since 1991....
Latest intelligence
- 2020 - a year to remember or forget?
- 2020 and the Covid pandemic brought immense challenges, and the need for change felt like it happened overnight. What have we learned and what does the future of agency working...
- The search for effective drug treatments for COVID-19
- PME talks to Julian Cole, Senior Director, Medical Affairs at Gilead Sciences...
- AstraZeneca’s focus on diagnosing and managing chronic kidney disease
- People living with chronic kidney disease are in urgent need of new and improved approaches to diagnosis and care...
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