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BioWorld - Monday, December 22, 2025
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SEC looks to ease administrative burdens of quarterly reporting

Sep. 3, 2019
By Peter Winter
Quarterly financial reporting for public companies is costly and ties up senior management and board members for several days before each quarterly earnings report is released and the 10-Q is filed. Could this process be made more efficient and less frequent, such as a semi-annual filing like many reporting companies based in Europe have implemented? That was one of the questions considered by a roundtable hosted by the SEC's Division of Corporation Finance where key stakeholders delved into the impact of short-termism on U.S. capital markets and whether the SEC's current reporting system needs to be changed to ease administrative and other burdens on reporting companies.
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Canadian medicine chest not big enough for both Canada and the U.S.

July 30, 2019
By Mari Serebrov
Even as the Trump administration is committing itself to helping states implement laws that would allow drug importation from Canada as a way to combat higher U.S. prescription drug prices, Canadians are pushing back against the idea.
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Senate Finance keeping to bipartisan script of Rx pricing bill

July 26, 2019
By Mari Serebrov
The role of the government in restraining U.S. prices was the underlying subplot of the Senate Finance Committee's markup Thursday of the Prescription Drug Pricing Reduction Act (PDPRA).
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Price no longer an obstacle to a hepatitis C cure in Louisiana

July 25, 2019
By Mari Serebrov
In a historic first, all prisoners and people covered through Medicaid in Louisiana got access last week to Asegua Therapeutics LLC's hepatitis C drug, even if they were in the early stages of the disease, thanks to a modified subscription program that's likely to serve as a model for other states in the U.S. looking for ways to pay for pricey cures and treatments emerging from the pipeline.
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Predictability continues to be in short supply for False Claims Act cases

July 25, 2019
By Mark McCarty
The U.S. False Claims Act has been the subject of a substantial body of jurisprudence and policymaking, but the legal terrain has not necessarily grown any more predictable for makers of drugs and medical devices. A new update on FCA prosecutions by the law firm of Gibson Dunn highlights the fluidity of considerations such as the materiality of an allegation of a false claim despite a Supreme Court decision in 2016 (Universal Health Services, Inc. v. United States ex rel. Escobar) that was expected to provide a more stable interpretation of the law, just one example of a legal landscape that still creates substantial uncertainty for companies in the life sciences.
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Biogen profits buoyed by MS franchise, but sales of Spinraza for SMA miss mark

July 24, 2019
By Michael Fitzhugh
Growing sales of its multiple sclerosis (MS) therapies and lower R&D expenses led Biogen Inc. to beat both top- and bottom-line expectations during the second quarter, despite lower-than-expected sales of its spinal muscular atrophy (SMA) drug, Spinraza (nusinersen).
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Be it from the House or Senate, biopharma won't like what's coming

July 24, 2019
By Mari Serebrov
Amid all the bills aimed at shining light into the black box of U.S. drug pricing and ending anticompetitive games, the House is planning on rolling out legislation in September that would directly impact the price of what could be hundreds of drugs by requiring Health and Human Services (HHS) to negotiate some prices.
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The fix isn't in yet, as prices, politics and pay-fors prolong passage of Rx remedy

July 19, 2019
By Mari Serebrov
The best way to score political points is to actually do something about U.S. prescription drug prices. That's the message members of the New Democrat Coalition Health Care Task Force delivered Wednesday to their party leadership in the House, as they requested another vote next week on a package of bipartisan drug pricing bills – this time minus the partisan provisions that Democrats knew would never fly in a Republican-controlled Senate.
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Unintended consequences of BPCIA dog insulin prices

July 17, 2019
By Mari Serebrov
Perhaps the hardest hit by the unintended consequences of well-intentioned legislation, U.S. insulin products continue to be the congressional poster child of all that's wrong with drug prices in America.
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Suboxone marketing ploy leads to $1.4B settlement, and more to come

July 16, 2019
By Mari Serebrov
In the largest U.S. opioid-related settlement yet, Reckitt Benckiser Group plc agreed to pay a total of $1.4 billion to end federal civil and criminal investigations into its role in delaying generic competition to Suboxone, an opioid-addiction treatment drug.
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