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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
Inovio slips on “positive results” for COVID-19 vaccine
That goes against conventional thinking in vaccine development, and could explain the fall-off in its share price, although may also reflect new FDA guidance that has been interpreted as raising
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Novo Nordisk gets another OK for oral GLP-1 drug Rybelsus
The green light from the Japanese Ministry of Health, Labour and Welfare (MHLW) follows an FDA approval for Rybelsus (semaglutide) last October, and a recommendation for approval in the EU in
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Vertex’s triple CF therapy scores recommendation from CHMP
The triple therapy was approved by the US Food and Drug Administration (FDA) in October last year, and scored that approval only a few months after filing the combination treatment with ... Turalio was previously approved by the FDA for the treatment of
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BMS scores EU okay for first-in-class anaemia drug Reblozyl
Originally developed by Acceleron as ACE-536 and licensed by Celgene in 2011, Reblozyl was approved by the FDA for anaemia associated with beta thalassaemia last year, and for the MDS
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Early knockback for AbbVie as FDA rejects Allergan eye drug
AbbVie’s $63bn takeover of Allergan was always more about cash flow than extending its pipeline, but an FDA rejection of one of the latter’s late-stage drugs will nevertheless ... AbbVie said it would meet with the FDA to work out the next steps with
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FDA approval for Merck’s Keytruda threatens Libtayo in skin cancer
Merck &Co has claimed FDA approval for its checkpoint inhibitor Keytruda in cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, muscling in on territory held by ... Approval of Merck’s market-leading PD-1 inhibitor in
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Latest Intelligence
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The search for treatments for Parkinson’s disease
We have to work with the FDA and EMA to find more appropriate ways to do tests to get these drugs approved. ... The regulators haven’t yet gotten around to saying exactly what kind of results from wearable data they will consider, but you get the
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The impact of COVID-19 on clinical trials
Managing the impact of COVID-19 in the near term. The FDA, EMA and several national-level European governments have all issued guidance on conducting clinical trials during the pandemic, recognising ... Consistent with guidance from the FDA and EMA,
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Guiding star of science leads AstraZeneca to breakthrough in child tumour therapy
Global product lead George Kirk hails the triumph of selumetinib, which has just won FDA approval. ... Selumetinib was given ‘breakthrough therapy’ status and rapidly green-lit by the FDA last month (April) following a promising National Cancer
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The far-reaching impact of the COVID-19 pandemic on clinical trials
The US FDA also quickly mobilised by launching its Coronavirus Treatment Acceleration Program (CTAP). ... The FDA claims it will respond to new clinical trial applicants within a day and provide realtime input into applications, although requests are
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Emerging use cases of blockchain in healthcare and the life sciences
One significant example of blockchain implementation in this area is the public-private partnership between the US Food and Drug Administration (FDA) and IBM.
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Approximately 2 fully matching, plus 141 partially matching documents found.
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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Latest from PMHub
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Why we need to improve diverse representation in clinical trials
residents. The Federal Drug Administration (FDA), meanwhile, is considering the development of incentives for sponsorship of trials specifically targeting underrepresented populations.
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Social listening report: Is COVID-19 impacting clinical trial recruitment?
The FDA has encouraged clinical trials to pause unless they serve an immediate benefit.
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War on drugs: the use of controlled substances in medicine
Ketamine has shown efficacy in the treatment of mental health conditions with the FDA approving a version of it, esketamine nasal spray, in March 2019 for treatment-resistant depression. ... Earlier this year, the FDA granted application for an Expanded
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Will COVID-19 necessitate a change in thinking around clinical trials?
For instance, the FDA regulations state:. “Each IRB must follow written procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity, and ensuring that changes in
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The growing clinical importance of patient-reported outcomes (PROs)
Indeed, the Food and Drug Administration (FDA) suggests that companies develop PROs specifically tailored to the disease of interest. ... The FDA is strict on defining the therapeutic benefit and having very clear endpoints.
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Approximately 2 fully matching, plus 46 partially matching documents found.
COVID-19 Updates and Daily News
Featured jobs
- Sinovac reveals positive preliminary data for COVID-19 vaccine
- How will the events and exhibitions industry change post-Coronavirus?
- Finalists 2020 - Communiqué Awards
- Novartis pulls EU filing for $3.4bn eye therapy Xiidra
- Abivax doses first patient in phase 2b/3 COVID-19 clinical trial
- The best work in healthcare communications shines at virtual Communiqué Awards
- Syneos Health appoints trio of senior hires
- Syneos Health appoints Tim Pantello as president of communications
- The best work in healthcare communications shines at virtual Communiqué Awards
- Mearns & Pike, Electric Putty and Evoke KYNE make a clean sweep at Communiqué 2020
- 90TEN scoops Communiqué Communications Consultancy of the Year Award for the Second Year Running
- NHS test and trace system ‘still not good enough’ says health leader
PMHub
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
- The search for treatments for Parkinson’s disease
- The research requires resilience but pharma is urged to ‘keep innovating, keep trying’...
- Margot Hannah, OPEN Health - A personal perspective of LGBT+ and diversity.
- Ditch the Label – it’s just me....
- The impact of COVID-19 on clinical trials
- As all industry sectors work to assess both the impact and the optimal path forward, the effects are expected to be diverse and long-lasting...
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