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BioWorld - Saturday, June 28, 2025
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Regulatory Convergence 2022

Oncology drug dosing evolving rapidly at FDA's Oncology Center of Excellence

Sep. 13, 2022
By Mark McCarty
The toxicity associated with oncology therapies is the stuff of legend with clinicians and patients, and thus the U.S. FDA and manufacturers have been working to fine tune these dosing regimens. However, the FDA's Oncology Center of Excellence (OCE) includes a programmatic effort to optimize dosing regimens, which led to an editorial by FDA officials that calls on industry to consider whether the maximum tolerated dose paradigm is really the optimal approach to oncology drug development.
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US drug pricing caught between the proverbial ‘rock and a hard place’

Sep. 13, 2022
By Mari Serebrov
Pricing new drugs for the U.S. market, especially those treating rare diseases, is getting a lot more complex now that the Medicare inflation rebate is in play. The rebate provision in the newly enacted Inflation Reduction Act incentivizes companies to set higher launch prices for drugs that will be used by Medicare beneficiaries since their future price increases will be limited to the rate of inflation. Although some of the other drug pricing measures included in the new law won’t kick in for a few years, the Medicare inflation rebate is to become effective next year.
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US FDA finalizes Right to Try rule

Sep. 13, 2022
More than four years after Right to Try legislation was enacted in the U.S., the FDA is issuing a final rule, Annual Summary Reporting Requirements Under the Right to Try Act, specifying the deadline and content for the annual reports the law requires participating drug sponsors or manufacturers to submit.
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Regulatory actions for Sept.13, 2022

Sep. 13, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ark Surgical, Ventris.
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Regulatory actions for Sept. 13, 2022

Sep. 13, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Biolinerx, BMS, Chiesi, Mersana, Vaxxinity.
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Non-Hodgkin lymphoma cells in the blood flow
Cancer

Innocare Pharma cleared to begin clinical trials in China with BCL2 inhibitor ICP-248

Sep. 13, 2022
Innocare Pharma Ltd. has received IND approval from China's National Medical Products Administration (NMPA) to begin clinical trials of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248.
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Man holding hand up to ear
Ear, Nose and Throat

Sensorion receives positive opinion on EU orphan drug designation for OTOF-GT for hearing loss

Sep. 13, 2022
The EMA's Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on Sensorion SA's application seeking orphan drug designation for OTOF-GT, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.
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Sotyktu

No black box for BMS’ Sotyktu in psoriasis; ‘measured’ launch ahead?

Sep. 12, 2022
By Randy Osborne
Bristol Myers Squibb Co. (BMS) dodged a black-box warning on the label of just-approved Sotyktu (deucravacitinib), but hurdles lie ahead for the first-in-class, oral, allosteric tyrosine kinase 2 inhibitor. Designed to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, Sotyktu is priced as $75,000 per year, and will become available during September, BMS said.
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Regulatory Convergence 2022

Pessimism the order of the day in discussion of EU’s Medical Device Regulation

Sep. 12, 2022
By Mark McCarty
The casual observer may be inclined to think that the European Union’s Medical Device Regulation (MDR) is off to a rocky start, but those whose livelihoods are at stake have a more intimate view of the situation. An attendee at a Sept. 12 session at this year’s Regulatory Convergence lamented what she believes is a dismal outlook for EU patients and device makers in the coming year, a testimonial that drew cheers and applause from those in attendance.
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Robert Califf with American flag
Regulatory Convergence 2022

Califf still pounding on misinformation despite FDA’s regulatory failures

Sep. 12, 2022
By Mark McCarty
U.S. FDA commissioner Robert Califf resurrected a litany of complaints about medical product misinformation, including vaccinations for the COVID-19 pandemic, in a televised presentation heard by attendees at the Regulatory Affairs Professional Society (RAPS) annual conference here in Phoenix, where the daytime high temperatures are hovering at or near the century mark.
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