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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
FDA clears Sandoz and Pear’s Opioid Use Disorder app
The app incorporates CBT to improve high relapse rates. The FDA has approved the use of a mobile phone app to help those with Opioid Use Disorder (OUD), a follow up ... McCann added: “This ground breaking decision by the FDA ushers in a new standard
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Axovant drops last ‘legacy’ drug to focus on gene therapies
After recent meeting with the FDA, the firm as said it will be able to draw on earlier clinical data with a first-generation version of the gene therapy which was
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eConsent: Busting regulatory myths
The US Food and Drug Administration (FDA), The European Medicines Agency (EMA), The Office of the Human Research Protection Program (OHRP), The Health Insurance Portability and Accountability Act of 1996 (HIPAA) ... In 2016, the FDA released its draft
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Amgen’s BCMA drug on course to challenge CAR-Ts in myeloma
Amgen also revealed that it has fast-track status for AMG 420 from the FDA, and intends to accelerate enrolment into an expanded study population that will include patients in earlier
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FDA fast tracks Novartis’ SMA gene therapy
Novartis has announced that the FDA is to fast-track its investigational gene therapy AVXS-101 candidate for spinal muscular atrophy (SMA) type 1, meaning it could be approved as early ... Its president David Lennon, said: “This important step by the
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Regeneron’s early stage bispecific shows promise
REGN1979 is being investigated in combination with Regeneron’s newly FDA-approved checkpoint inhibitor Libtayo (cemiplimab-rwlc) in an ongoing phase 1 study.
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Latest Intelligence
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Diagnosed Anywhere
In 2018, the FDA approved the third smartphone-enabled home urine testing platform. ... In 2018, the FDA approved IDx-DR, the first autonomous, AI-based diagnostic system authorised for commercialisation in the US.
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Deal Watch October 2018
The termination comes as a consequence of patent infringement litigation which has placed a stay on the FDA’s approval of the biosimilar, Lusduna Nexvue, in the US.
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Innovation in merger control and the impact on the pharmaceutical sector
In the pharmaceutical industry, a recent study shows that only 9.6% of drugs in phase 1 are approved by the US FDA.
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The handover: Pfizer reshapes itself for a new era
In October the FDA also approved Talzenna (talazoparib), a new treatment of deleterious or suspected deleterious germline BRCA (gBRCA)-mutated, HER2-negative locally advanced or metastatic breast cancer.
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Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe
platform. Led by founder and CEO John Maraganore, Alynlam finally crossed the line in August when it gained FDA and EU approval for its first drug, Onpattro. ... disease which is seen as key for patients’ long term survival, and is already under review
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Latest appointments
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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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AZ and Medimmune bolsters immuno-oncology leadership
patients. He most recently served the US Food and Drug Administration (FDA) as its director, division of oncology products in the office of haematology oncology products since 2015 and also had
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Approximately 6 fully matching, plus 41 partially matching documents found.
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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- Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...
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