Pharma in Brief

AUGUST 9, 2021

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs.

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pharmaphorum

MARCH 23, 2022

The US Senate will vote in the coming weeks on whether to introduce a $35 cap on the monthly cost of insulin to patients that was endorsed by President Joe Biden in his 2022 State of the Union address. Assuming the bill is later passed by the Senate and signed into law by President Biden, the insulin cap would take effect beginning in 2023.

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The Pharma Data

DECEMBER 28, 2020

Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product. Additionally, the Company sells insulin API products.

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FDA Law Blog

NOVEMBER 16, 2021

139001 lays out a process by which the Secretary would: Identify “negotiation-eligible drugs” from among qualifying single-source drugs that are among the top 50 with the highest Part D spending, the top 50 with the highest Part B spending, and insulins. Here are the important points from the MedPac summary: Sec.

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XTalks

SEPTEMBER 20, 2023

Cost Plus Drugs Initiative by Mark Cuban The Mark Cuban Cost Plus Drug Company is a public-benefit corporation launched by billionaire entrepreneur Mark Cuban with a mission to improve public health by revolutionizing pharmaceutical industry operations.

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XTalks

AUGUST 2, 2023

It is a dipeptidyl peptidase-4 inhibitor that keeps insulin levels stable and reduces the amount of glucose produced by the body. 5) Toujeo (insulin glargine) Toujeo is very similar to Lantus in that both are insulin glargine, except Toujeo is more concentrated. First approved by the FDA in 2000, NovoRapid generated 15.46

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The Pharma Data

MAY 6, 2021

Lilly inks smart insulin pen deals with Roche, Dexcom and more ( Fierce ). million to resolve claims it paid drug kickbacks through charity ( STAT ). Generic-Drug Makers Knock States’ Objection To Sanctions ( Law360 ). Government, Regulatory & Legal.

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Pharmaceutical Technology

DECEMBER 4, 2022

For example, the first-to-market status was beneficial when it came to insulin biosimilars. Still, according to Hlávka, there could be a certain benefit of being the first available biosimilar. Being first could give Amgen a leg up in negotiations and in market penetration, he says.

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Pharmacy Checkers

MARCH 11, 2020

Permit personal drug import waivers to individual patients who must apply for the waivers, including with consent from their licensed practitioners. These are general examples of how the agency can implement (J)(2) to expressly permit more forms of safe personal drug importation, ones that don’t include ordering medicines online.

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