Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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STAT

DECEMBER 22, 2023

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter  here.

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Big Molecule Watch

SEPTEMBER 14, 2023

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other interested groups have filed lawsuits challenging the Program. Becerra et al.

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STAT

DECEMBER 22, 2023

Damian here with the final edition of this newsletter for 2023. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hello, everyone. We’re taking a break for the holidays and will be back in your inbox bright and early on Jan.

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Putting Patients First Blog

MAY 22, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. is the largest dedicated food and drug law firm in the country.

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STAT

OCTOBER 17, 2023

Damian here with the latest twist in the GLP-1 saga, some drama in the world of Covid-19 booster shots, and the debut of the 2023 STAT Wunderkinds.   Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Read the rest…

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STAT

JUNE 4, 2023

But complaints about steep prices for drugs have grown louder, sparking a backlash in Washington, D.C., that threatens to disrupt the biotech business model crucial to the Massachusetts economy. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

DECEMBER 27, 2022

Drug pricing was a hot-button topic, and William Newton found that while e-commerce chains could cut insulin prices , any major change won’t happen overnight. Tracking drug development. Alzheimer’s disease drugs were constantly in the news, and not always for the right reasons. See you in 2023!

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Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. Read it here.

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Safe Biologics

OCTOBER 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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European Pharmaceutical Review

DECEMBER 26, 2023

Production cost is currently a fundamental concern for many gene therapy developers, particularly given that some treatments cost millions of dollars per single dose (eg, $3.5 Scientific American; 2022 [cited 2023 Jun]. 2023 [cited 2023 Jun]. 2023 [cited 2023 Jun]. 2023 [cited 2023 Jun].

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Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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STAT

JUNE 14, 2024

employer health plans are offering coverage of GLP-1 drugs for both diabetes management and weight loss, up from last year , Reuters writes, citing a survey of global employers released on Thursday by the International Foundation of Employee Benefit Plans. Only about 26% of employers offered the drugs last year. About one-third of U.S.

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Safe Biologics

SEPTEMBER 11, 2023

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. 1] 90% of new cancer drugs are available in the U.S.

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