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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drug pricing policy. This will allow other stakeholders (e.g.,

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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. The 505(j) pathway is how you get a multisource generic.

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FDA takes major step to ease access to CAR-T therapy

BioPharma Dive

Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugslabeling, which are used to help manage serious side effects of treatment. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. TechTarget, Inc.s Newton, MA 02466.

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Vertex and NHS England agree reimbursement for Alyftrek

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out?

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Health Canada extends Evkeeza approval for children with HoFH

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out?

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GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market.

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Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

The share price in the company had climbed 3.6% LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. The company has particular emphasis on antibody-drug conjugates (ADCs) and has built several platforms within this modality. How will RFK Jr’s American dream for vaccines play out?