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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

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Asian Pharma Stocks Dropping As US Cuts Drug Prices

Pharma Marketing Network

accelerates its crackdown on drug pricing through new legislation and regulatory enforcement, pharma companies in China, India, Japan, and South Korea are feeling the ripple effect. This article explores whats behind the sudden slump in Asian pharmaceutical equities and why U.S. As the U.S. Table of Contents The U.S.

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Dive

billion buyout of Blueprint Medicines is the sector’s second-largest M&A deal this year and represents the highest value paid for an immune drug developer since April 2023. Track the deals that are happening here. Sanofi’s $9.1 Track the deals that are happening here. Sanofi’s $9.1 TechTarget, Inc.s

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COVID-19 is causing a renaissance in the UK biotech sector, we must ensure it lasts

pharmaphorum

Over the past five to ten years US investors have focused on technology and internet companies, and relatively little on new biotech or pharmaceutical companies. The first is that the development of vaccines is utilising cutting edge technologies. This precision has significant advantages in efficacy and production.

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