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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
Roche undercuts price of Bayer cancer drug after winning FDA approval
The FDA approvals of Rozlytrek and Vitrakvi cover all patients with NTRK gene fusions, regardless of where the tumour is located in the body. ... Roche is working with Foundation Medicine to prepare a filing for FDA approval of the companion diagnostic,
Latest news
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Regeneron scores positive data in phase 3 cholesterol trial
These results follow the FDA in the US granting evinacumab Breakthrough Therapy designation in 2017, for the treatment of hypercholesterolemia in patients with HoFH.
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Sanofi patent case win holds off generic rivals for key cancer drug
Companies including Actavis and Mylan have received tentative US Food and Drug Administration (FDA) approvals for copies of Jevtana in recent years. ... In replying to the companies’ filings, the FDA pointed to the presence of patents that protect
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AZ, Merck’s Lynparza scores market-expanding clinical success
The limited information that is available paints the trial as another win for Lynparza, which is already FDA approved for first-line maintenance use in ovarian cancer patients with germline or
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Imbruvica gains expanded use in Europe
As of August 2019, it is looking even more likely to catch up to Imbruvica, with the FDA in the US granting Calquence Breakthrough Therapy Designation as a monotherapy treatment for
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Novartis chooses internal replacement for US pharma president role
Novartis have been accused of manipulated Zolgensma data. Earlier this month, the FDA issued a statement that AveXis, a Novartis company, had been aware of manipulation of early stage animal trials ... According to the FDA, the data issue only affected a
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Latest Intelligence
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The evolution of real-world studies
Ned Sharpless, Acting FDA Commissioner. Similar discussions are taking place across the Atlantic. ... Elsewhere, the EMA has compared the FDA’s real-world Sentinel safety system favourably to.
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Real-world studies
Advances like that which we saw in November last year, when the FDA unveiled its own MyStudies app for the collection of real-world data, will continue to drive the use
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Streamlining clinical trials – why better data use is key
Big data, blockchain technology and artificial intelligence have given industry the chance to streamline drug trials, say experts, who agree with recent FDA calls for more efficient clinical research models. ... Dr Scott Gottlieb’s brief, energetic
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25 Women Leaders in UK Healthcare
Ruth has more than 80 publications to her name, and led the first genome-wide FDA submission of a hepatic adverse event and the first tumour-based analysis of an AstraZeneca
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Rare disease trials Q&A
In its updated draft guidance on rare diseases published in February 2019, the US Food and Drug Administration (FDA) encourages pharma companies to involve patients, caregivers.
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Latest appointments
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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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Teva's Mark Salyer joins Amarin
The 8, 000-patient study involves its first FDA-approved product, the omega-3 fatty acid-based Vascepa.
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Latest from PMHub
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Battling breast cancer with precision medicine (Part 2)
I had to cook something up. I submitted an application to the Food and Drug Administration (FDA) for a single patient use. ... First, I asked the company to supply pills for Laura, then I got special permission from the FDA for a single patient clinical
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Parachuting Behind Enemy Lines: OncoSec’s Attack on Visceral Tumors via Its New Visceral Lesion Applicator (VLA)
Poster 717/Abstract 11375. 15. US Food and Drug Administration. Drugs. FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib. ... Accessed March 5, 2019. US Food and Drug Administration. Drugs. FDA grants accelerated
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Practical Patient Centricity
Should the FDA require patient input to be included in trial design, then companies will be forced to adapt rapidly and bring the patient’s perspective into the development of medicines.
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Apple Watch Series 4: A life-saving tool or just making us more health obsessed?
It should be noted that while the FDA has approved the Apple Watch’s ECG feature as an approved medical device, this does come with caveats, stating that, “the ECG data
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The dark side of direct-to-consumer genetic tests
In 2017 the FDA approved the first direct-to-consumer genetic test. However, the approval came with a caveat preventing test results being used to ascertain a consumers’ overall risk for
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- The relevance of patient perspectives to value
- Sanofi patent case win holds off generic rivals for key cancer drug
- Leo Pharma to market AstraZeneca’s brodalumab outside Europe
- Regeneron scores positive data in phase 3 cholesterol trial
- Roche undercuts price of Bayer cancer drug after winning FDA approval
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90TEN is an award-winning healthcare communications consultancy that puts people at the heart of everything we do. Our Life.Changing. campaigns...
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