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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
UPDATED: Senate officially confirms Stephen Hahn as FDA commissioner
MD Anderson exec Stephen Hahn (pictured above) breezed through a final Senate vote yesterday, which confirmed he will now take on the formidable FDA commissioner title. . ... Following the final confirmation, Hahn will now go on to head the FDA and
Latest news
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FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection
the ongoing confirmatory clinical trial,” said Billy Dunn, head of the FDA’s Office of Neuroscience. ... The company has a third therapy, called casimersen, which it is planning to file shortly with the FDA and targets exon 45 mutations.
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Roche’s Tecentriq combo scores in first-line melanoma
For Roche, it looks like combination treatments are paving the way for success, after its Tecentriq/chemotherapy combo scored approval from the FDA earlier this month as a first-line treatment ... The full, detailed results are set to be presented at an
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UCB/Amgen’s Evenity finally cleared for osteoporosis in Europe
A second trial called ARCH was also positive but raised some concerns about Evenity’s cardiovascular safety, which led to a rejection by the FDA in 2017 and held up approval ... The FDA only gave the go-ahead to the drug with a label warning that it
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AZ, Daiichi Sankyo strengthen case for HER2 candidate
The partners picked up a priority review for the drug from the FDA in October, on the strength of data from the Destiny-Breast01 trial.
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Correvio crumbles as FDA panel rejects AFib drug
unlikely that the FDA will deliver an early Christmas present to Correvio and approve the drug by the scheduled 24 December action date. ... That restriction is still in place, and the FDA also rejected another attempt to file in 2017.
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Latest Intelligence
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As the opioid crisis grabs the headlines, the search for safe treatments continues
for opioid addiction, and the long-acting injectable Perseris for schizophrenia in adults, which got FDA approval this year.
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Delivering the promise of regenerative medicine
In any case, EU and UK regulators need to prioritise the standardisation of regulations governing manufacturing, quality control and the supply chain to keep up with advancements made by the FDA
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European biotech: a new generation of leaders emerges
It had promising new trial data unveiled in May this year for its lead candidate the anti-CD19 antibody tafasitamab (MOR208), and an FDA filing expected by the end of this ... Another of its partners, Horizon Therapeutics recently submitted to the FDA
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Encouraging signs in biomarker R&D
He also cited an FDA-approved TMB test developed by Foundation Medicine and Memorial Sloan Kettering Cancer Center as an example. ... is quite a difference between FDA and EMA in policy here, as the latter requires larger RCT.”.
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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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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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Generating data on long-term outcomes with gene and other advanced therapies
Bio-pharma are required to adhere to strict regulations set by the FDA and EMA on monitoring long-term outcomes when launching advanced therapeutic medicinal products (ATMPs).
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Why aren't doctors using digital therapeutics?
Across the Atlantic, the United States Food and Drug Administration (FDA) is also currently still in the pilot stage of its Software Precertification Program, which is redefining how the FDA regulates
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Understanding the evolving CAR-T market
In August 2017, Novartis made history after receiving FDA approval for Kymriah, the world’s first chimeric antigen receptor T-cell (CAR-T) therapy.
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How ready are you for launch?
In 2018, the U.S. Food and Drug Association (FDA) approved a record number of generic drugs as part of its Drug Competition Action Plan.
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Three strategies for managing loss of exclusivity successfully
In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. Eli Lilly responded by launching an LOE strategy that tapped into patients’ desire for a stable treatment plan. ... Famously developed as a blood pressure treatment, Viagra soon
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Approximately 1 fully matching, plus 40 partially matching documents found.
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- Genital herpes vaccine candidate heads for human studies
- Armed with new data, BMS plans filings for Celgene CAR-T liso-cel
- AZ, Daiichi Sankyo strengthen case for HER2 candidate
- Sangamo steps up BioMarin chase with haemophilia gene therapy data
- Sanofi’s new CEO cuts first deal, adding Synthorx for $2.5bn
- China updates drug reimbursement list, agrees price cuts
- Frontera proud finalists for the 2020 PM Awards
- Brexit nears as Conservatives sweep to victory in election
- Roche’s Tecentriq combo scores in first-line melanoma
- House Democrats finally pass landmark drug pricing bill
- UPDATED: Senate officially confirms Stephen Hahn as FDA commissioner
- FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection
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Wisepress is a medical bookseller promoting and selling books worldwide, both online and via the 200 European medical conferences that...
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