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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
Genfit claims FDA breakthrough status for liver disease drug
Elafibranor up for speedy US review. Genfit’s most advanced liver disease drug elafibranor has today achieved a breakthrough tag from the US FDA following positive data from a phase 2 ... The FDA’s decision to grant elafibranor the Breakthrough
Latest news
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Novartis makes case for gene therapy Zolgensma in SMA
New data revealed ahead of FDA review. Novartis has released some new phase 3 data from its recently-acquired gene therapy Zolgensma, and the results build on the drug’s already ... If the drug gets approval from the FDA, which analysts have tipped as
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Hemlibra off to a flyer as Roche raises 2019 forecasts
The FDA approved use of the antibody last October beyond its first indication of haemophilia A with inhibitors, antibodies that bind to factor VIII drugs and stop them working properly, to
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First-in-class hepatitis B/D drug raises cure hope
It has been given a breakthrough designation by the FDA, Priority Medicines (PRIME) status by the EMA and has been awarded a Promising Innovative Medicine (PIM) designation from the MHRA in
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Gilead drives NASH development with insitro collaboration
The chances of that being a Gilead candidate is overshadowed by Intercept’s recent FDA filing of its own NASH candidate Ocaliva, although that drug is making investors nervous with its
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Catalent preps for complex therapy boom with $1.2bn Paragon buy
The FDA said recently that it expects to receive up to 200 applications to start gene and cell therapy trials every year from 2020.
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Latest Intelligence
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Vertex: a vision of treating all CF patients worldwide draws closer
with sickle cell disease or beta thalassemia with FDA Fast Track Designation.
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Cell and gene therapy
Interest in cell and gene therapies is undeniable. In January, US FDA Commissioner Scott Gottlieb outlined policies designed to accommodate an anticipated surge in cell and gene therapy submissions.
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2019: CRISPR and therapeutic gene editing comes of age
The FDA placed the CTX001 programmed in beta thalassemia and a planned trial in sickle cell disease on a clinical hold shortly afterwards, but relaxed that last October. ... tested in gene therapies (and the technology which caused the FDA to raise
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Immuno-oncology in 2019: the rapid evolution continues
In December the FDA approved its use in combination with Avastin and chemotherapy in non-squamous NSCLC patients, based on results from the IMpower150 study. ... On 28 December, Keytruda gained FDA clearance for use in Merkel cell carcinoma.
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Drug launches to watch in 2019
GW Pharma gained an historic approval for its drug Epidiolex from the FDA in June last year, becoming the first ever prescription medicine derived from cannabis. ... The product gained EMA approval in November and FDA approval on 26 December.
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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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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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Mastering the precision medicine opportunity
Last year the FDA made a pioneering move in this space and approved Keytruda for use in adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or
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Training the next generation of biotech leaders
In this year alone, the FDA has taken the groundbreaking step of approving two CAR-T therapies.
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- With Spiriva under pressure, Boehringer moves to bolster pipeline
- Genfit claims FDA breakthrough status for liver disease drug
- Mereo’s shareholders back OncoMed takeover
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- From lay summaries to patient engagement programmes: how patient-centricity is finally becoming a reality
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