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Regulatory actions for May 4, 2023

May 4, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognixion, Formus Labs, Foundation Medicine.
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British flag

Work begins on next UK voluntary drug pricing scheme

May 4, 2023
Negotiations were set to begin in the U.K. May 4 on a new voluntary pricing scheme for brand drugs to replace the one that will expire this year.
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Regulatory actions for May 4, 2023

May 4, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Bloomsbury, BMS, Idorsia, Kamada, Kempharm.
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Arexvy

US FDA approves Arexvy from GSK, the country’s first RSV vaccine

May 3, 2023
By Lee Landenberger
The U.S. FDA has approved the country’s first-ever respiratory syncytial virus (RSV) vaccine, Arexvy, from GSK plc. The adjuvanted vaccine is also the first for older adults anywhere on the planet. GSK now has a head start to vaccinate the U.S. market, but other big companies, such as Sanofi SA and especially Pfizer Inc., are in late-stage development and will pose strong challenges in the coming year. Pfizer’s PF-0692831/RSVpreF, an RSV vaccine for treating lower respiratory tract disease caused by RSV, has a priority BLA with a May 31 PDUFA date.
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Regulatory actions for May 3, 2023

May 3, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centricity Vision, Femasys.
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As USTR calls foul over trade secrets theft, FDA accused of the same

May 3, 2023
By Mari Serebrov
While the U.S. continues to call out other countries for weak enforcement of intellectual property rights, trade secret theft and forced technology transfers in the life sciences sector, some companies in the sector claim similar things are happening in the U.S. In its 2023 Special 301 Report, released April 26, the Office of the U.S. Trade Representative (USTR) noted “the growing need for trading partners to provide effective protection and enforcement of trade secrets.”
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Regulatory actions for May 3, 2023

May 3, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amolyt, Avadel, Boehringer Ingelheim, Elicera, Eloxx, Hyloris, Memo, Neurobo, Pharmather, Protara, Sirpant, Tenaya.
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Regulatory actions for May 2, 2023

May 2, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Directsync Surgical, Jogo Health, Kurin, Olympus.
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Drug capsule and dollar sign

HELP! Sanders fends off mutiny amid bounty of support for US drug pricing bills

May 2, 2023
By Mari Serebrov
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices.
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Regulatory actions for May 2, 2023

May 2, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquavit, Arcutis, Ascendis, Atsena, Biomea, BMS, Cabaletta, Erasca, Kiromic, Medincell, Neurosense, Onquality, Sanofi, Teva.
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