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Home » Topics » Regulatory » Legislation

Legislation
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US CRS weighs in on improving gene therapy regulatory landscape

Oct. 28, 2024
By Mari Serebrov
Although more and more gene therapies are getting the FDA stamp of approval, concerns persist about their potential long-term risks. U.S. lawmakers have proposed several pieces of legislation over the past few years to address some of the uncertainties. Now the Congressional Research Service (CRS) is suggesting other requirements Congress may want to consider to improve the regulatory landscape for gene therapies, especially those intended to treat blood disorders.
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Gold dollar sign and gray question marks

Uncertainties plague short-term ‘win’ of US price negotiations

Oct. 25, 2024
By Mari Serebrov
If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.
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US effort to claim share of big pharma profits resurfaces

Oct. 21, 2024
By Mari Serebrov
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists.
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Complete Genomics seeks way out of Biosecure Act

Oct. 15, 2024
By Mari Serebrov
With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove the California-based subsidiary of MGI from the bill.
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Complete Genomics seeks way out of Biosecure Act

Oct. 9, 2024
By Mari Serebrov
With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove the California-based subsidiary of MGI from the bill.
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PBM private labels: Good or bad for US biosimilar market?

Oct. 7, 2024
By Mari Serebrov
A growing foray of pharmacy benefit managers’ (PBMs) private labels into the U.S. biosimilar space is intensifying concerns about the antitrust aspects of PBMs’ vertical integration that has them serving as price negotiator, formulary setter, payer, group purchasing organization, pharmacy, provider and now drug "manufacturer."
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Sen. Cassidy: Time for US FDA to reclaim its Orange Book duties

Oct. 2, 2024
By Mari Serebrov
It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner Robert Califf to task for letting the FTC do the FDA’s job.
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Document illustration

Given no choice, J&J yields to government on 340B rebate model

Sep. 30, 2024
By Mari Serebrov
Meeting the deadline the U.S. Health Resources & Services Administration imposed in a Sept. 27 final warning letter, Johnson & Johnson (J&J) notified the agency Sept. 30 that it would not implement its proposed 340B rebate model pending resolution of the issues.
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U.S. Capitol building

US Congress avoids government shutdown, extends voucher program

Sep. 26, 2024
By Mari Serebrov
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20.
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U.S. Capitol building

US Congress avoids government shutdown, extends voucher program

Sep. 26, 2024
By Mari Serebrov
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20. The spending bill is now awaiting President Joe Biden’s signature.
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