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BioWorld - Wednesday, July 6, 2022
Home » Topics » Regulatory

Regulatory
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FDA vaccine illustration

US guidance on next-gen boosters a new era in COVID-19

July 1, 2022
By Mari Serebrov
No Comments
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
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Mantle cell lymphoma

Genmab preps US FDA filing for bispecific antibody epcoritamab in lymphoma, with CAR Ts in its sights

July 1, 2022
By Richard Staines
No Comments
Genmab A/S, of Copenhagen, Denmark, said it intends to file a BLA with the U.S. FDA for its subcutaneous bispecific antibody epcoritamab, for patients with relapsed/refractory large B-cell lymphoma in the second half of 2022.
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Regulatory actions for July 1, 2022

July 1, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Livemetric, Xoran Technologies.
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Regulatory actions for July 1, 2022

July 1, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Ascentage, Aura, Bavarian Nordic, Nurix, Pfizer, Phanes, Skye.
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GE Healthcare issues class I recall for ventilators due to battery issues

July 1, 2022
By Mark McCarty
No Comments
GE Healthcare issued a class I recall for Carescape R860 ventilators that covers more than 4,000 units distributed in the U.S., which was necessitated by problems with the battery backup component. No injuries or deaths have been reported in connection with the problem.
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Laptop displaying FDA logo

MDSAP remote audit program extended one last time

June 30, 2022
By Mark McCarty
No Comments
As was the case for all medical device inspections, the Medical Device Single Audit Program (MDSAP) was hampered by the COVID-19 pandemic, but the participant regulators agreed to allow the use of remote audits to fill in for live MDSAP inspections. This program has been renewed again through the end of September 2022, but the sponsoring regulatory agencies said this will be the last extension, barring exceptional circumstances.
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South Korea approves first homegrown COVID vaccine

June 30, 2022
By Tamra Sami
No Comments
South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine.
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Sanofi campus in Gentilly, France

FDA action puts cloud over Sanofi’s $3.68B Principia buy

June 30, 2022
By Richard Staines
No Comments
The U.S. FDA has put five phase III studies of Sanofi SA’s potential multiple sclerosis and myasthenia gravis blockbuster tolebrutinib on partial clinical hold after several cases of liver injury were identified after exposure to the drug. Sanofi said new recruitment in the U.S. is paused and participants who have been part of the trial for fewer than 60 days should stop taking tolebrutinib, although those taking the drug for longer can continue.
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Regulatory actions for June 30, 2022

June 30, 2022
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intuitive, Siemens Healthineers.
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Regulatory actions for June 30, 2022

June 30, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alx, Bristol Myers Squibb, Endevica, Freya, Inflarx, Ipsen, Obseva, Regeneron, Sanofi, Santhera, Teraimmune, Unibio.
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