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BioWorld - Friday, June 26, 2026
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Home » Topics » BioWorld, Regulatory

BioWorld, Regulatory
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Sen. Raphael Warnock at RFK confirmation hearing

Kennedy advances toward confirmation as HHS secretary

Feb. 4, 2025
By Mari Serebrov
Robert F. Kennedy Jr. moved a step closer Feb. 4 to becoming the next secretary of the U.S. Department of Health and Human Services (HHS). The Senate Finance Committee voted 14-13 along party lines to send Kennedy’s nomination to the Senate floor for confirmation. While “no” votes were expected from the 13 Democrats serving on the committee, a big question mark had hung over which way Sen. Bill Cassidy, R-La., would vote, given the comments he made at two committee hearings on the nomination. In the end, Cassidy voted along with his 13 Republican colleagues, offering no comment on his vote at the meeting.
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Illumina sign, building

China blacklists Illumina as part of US tariffs counter

Feb. 4, 2025
By Marian (YoonJee) Chu
The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
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Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 3, 2025
By Tamra Sami
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
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RFK Senate-hearing2 1-29

One vote could keep RFK from getting out of committee

Feb. 3, 2025
By Mari Serebrov
Whether Robert F. Kennedy Jr. (RFK) advances in his quest to become the top health care voice in the Trump administration could come down to one vote – that of Sen. Bill Cassidy. The Louisiana doctor is one of 14 Republican members of the Senate Finance Committee, which is scheduled to vote Feb. 4 on whether to send Kennedy’s nomination as Health and Human Services secretary to the full Senate for confirmation. If all 13 Democrats on the committee vote against it, one no vote from a Republican could stop the process.
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Novo Nordisk to appeals court: Hurry up, please, on IRA challenge

Jan. 31, 2025
By Mari Serebrov
Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.
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Post-CRL, Symbravo hurrah at last for Axsome in migraine

Jan. 31, 2025
By Randy Osborne
Complete response letter hurdles overcome and U.S. FDA clearance in hand, Axsome Therapeutics Inc. will disclose pricing in about four months, closer to the launch of Symbravo to treat adult migraine with or without aura.
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EMA icons

Leqembi review stalls again at European regulator

Jan. 31, 2025
By Nuala Moran
EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
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Journavx bottle and tablet

Vertex wins FDA nod for Journavx, new mechanism for acute pain

Jan. 31, 2025
By Jennifer Boggs
An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is cleared for use as a non-opioid option for treating moderate to severe acute pain.
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Tablets on conveyor belt

Rx manufacturers caught between 340B, IRA requirements

Jan. 30, 2025
By Mari Serebrov
One of the uncertainties in the changing of the guard in both the U.S. administration and Congress is the future of 340B reforms. Now the Inflation Reduction Act makes reforms more critical than ever, as it requires manufacturers of drugs selected for price negotiations to certify that they’re giving 340B entities the lowest price, be it the 340B discount or the maximum fair price set by the CMS as part of the negotiation process.
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2025 rebate hike in UK pricing deal putting sector at risk, says ABPI

Jan. 30, 2025
By Nuala Moran
The five-year voluntary pricing deal between pharma companies and the U.K. Department of Health is under severe pressure after the rebate the industry is due to pay leapt from 15.3% in 2024 to 22.9% for 2025. That has put “a very real strain” on companies, which have not factored this into their 2025 budgets because they were planning around an agreed forecast that the 2025 rebate rate would remain at around 15%, according to the Association of the British Pharmaceutical Industries (ABPI).
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