Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Adicet, F2G, Gilead, Leo, Nevakar, Reven.
To end criminal and civil claims stemming from its marketing of Oxycontin (oxycodone hydrochloride) and other opioid products, Purdue Pharma LP agreed Oct. 21 to pay more than $8 billion and to cease operating as a for-profit private company – provided the court presiding over its bankruptcy agrees.
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Ascentage, Cyclo, Diurnal, Effrx, Hillstream, Pharming, Protagonist, PTC, Roche, TG, Xeris, Zosano.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amacathera, Asklepios, Astrazeneca, Inventiva, Selecta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Agios, Astrazeneca, Bristol Myers Squibb, Dr. Reddy's, Edesa, Exelixis, Genentech, Gilead, Intellia, Matinas, Mereo, Neurelis, Octapharma, Oncopeptides, Prestige, Recce, Roche, Versantis.
While the number of FDA approvals in 2020 are lockstep in line with last year, despite disruptions from the COVID-19 pandemic, the amount of regulatory news this year tracked by BioWorld has risen by 43% over 2019. Compared with 2018, it is 52% higher.
At its October meeting, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of 11 new therapies, two of them for treating cancers and two for treating HIV-1. The European Commission will review the recommendations and make its decisions by the end of 2020.
Once upon a time in an age before the Internet, all things digital and even Hatch-Waxman, the FDA worked in its corner of the government approving drugs and therapeutic equivalents with little fanfare or transparency. Its decisions were duly recorded on paper and filed away. With the files located only at the agency, pharmacies across the country were left to wonder about which drugs could be substituted for another. Their recourse was to pick up the phone and pay for a long-distance call to the FDA every time a question arose. To reduce the number of phone calls it was getting, the FDA printed out a list of approved drugs with their equivalents and sent it to the pharmacies. The year was 1980, and the month was October. Going with the season, the FDA slapped an orange paper cover on the listing, giving birth to the Orange Book.
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