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5 days ago | 
bioworld.com | Mari Serebrov
Under new management, ACIP faces intense scrutiny The June 25-26 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) will be anything but business as usual. In wiping the slate clean just two weeks before the panel was to meet, Health and Human Services Secretary Robert Kennedy made sure of that. BioWorld Regulatory Infection Coronavirus Vaccine U.S. Policy
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1 week ago | 
bioworld.com | Mari Serebrov
FDA scrutinizing trials sending US patient cells to ChinaUsing informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient. BioWorld BioWorld MedTech Regulatory Gene therapy China U.S. FDA Legislation
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1 week ago | 
bioworld.com | Mari Serebrov
US universities developing alternative to cover indirect costsAfter years of conversations surrounding indirect research costs, academic groups are now under the gun to quickly come up with an alternative to the NIH’s proposed 15% across-the-board cap on indirect costs and the decades-old university-by-university negotiated rate that can exceed a 50% add-on to a grant. BioWorld BioWorld MedTech Regulatory U.S. NIH Policy
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1 week ago | 
bioworld.com | Mari Serebrov
Too much at stake for dismissed ACIP members to go quietlyThe 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices are not going gently into the night. Instead, they’re raging against what could be the dying of the light. BioWorld MedTech Regulatory Infection Vaccine U.S. Policy
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1 week ago | 
bioworld.com | Mari Serebrov
Too much at stake for dismissed ACIP members to go quietlyThe 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are not going gently into the night. Instead, they’re raging against what could be the dying of the light.
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2 weeks ago | 
bioworld.com | Mari Serebrov
New ACIP members to review data for current vaccine schedulesAnd then there were eight. That is, eight members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP).Two days after dismissing the 17 members of the committee, Health and Human Services Secretary Robert Kennedy named eight new members to the panel. Eight is the minimum required for a quorum, which will be necessary for the June 25-27 ACIP meeting. BioWorld Regulatory Infection Coronavirus Vaccine U.S. Policy
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2 weeks ago | 
bioworld.com | Mari Serebrov
US drug security will come at a priceWhen it comes to the U.S. biopharma market, pricing seems to be the driving focus of most congressional conversations – and government contracts. Rep. Cliff Bentz, R-Ore., hit pause on that conversation at a June 11 House subcommittee hearing on the drug supply chain, when he asked if the U.S. is sacrificing security for price. BioWorld Regulatory Infection Antibiotic U.S. Policy
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2 weeks ago | 
bioworld.com | Mari Serebrov
Vaccines meeting to go on in wake of ACIP demolitionDespite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting. BioWorld BioWorld MedTech Regulatory Infection Vaccine U.S. Legislation Policy
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2 weeks ago | 
bioworld.com | Mari Serebrov
Just hours after reports began surfacing June 9 that four of the 17 members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) had been terminated, Health and Human Services (HHS) Secretary Robert Kennedy announced that all the members have been removed and the committee is being “reconstituted.” The ostensible reason, in Kennedy’s words, is to “reestablish public confidence in vaccine science.” However, HHS noted that all the terminated members were appointed under the...
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2 weeks ago | 
bioworld.com | Mari Serebrov
Canceling claims not an appropriate sanction, USPTO saysAbsent extraordinary circumstances, the Patent Trial and Appeal Board “should never cancel claims it has not determined to be unpatentable as a sanction” for misconduct during a board proceeding, according to the acting director of the U.S. Patent and Trademark Office (USPTO). BioWorld BioWorld MedTech Regulatory Infection Vaccine U.S. Patents
