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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 drugpricing policy. This will allow other stakeholders (e.g.,
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 drugdevelopment, and offers potential market exclusivity for up to 7 years. The 505(j) pathway is how you get a multisource generic.
Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, 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.
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.
The share price in the company had climbed 3.6% LaNova’s drugdevelopment 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?
This can be achieved by taking responsibility for warehousing, packing and labelling, order management, distribution, freight audit, and transportation trend management of pharma materials. How will RFK Jr’s American dream for vaccines play out? 3PLs can unlock cost savings that their customers might find harder to achieve.
Based on conversations with physicians, it “could be positioned well, and ahead of Augtyro,” he wrote, adding that Wednesday’s sell off in shares was “overdone on any potential launch and label optics concerns.” You can unsubscribe at anytime. Sanofi’s $9.1 Sanofi’s $9.1 Registered in England and Wales. TechTarget, Inc.s
July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? This comes just days after Sarepta said it has agreed to change the black box on the Elevidys label to include ALF and acute liver injury (ALI) warnings.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals DrugPricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. You can unsubscribe at anytime. Kennedy Jr.,
One in five samples contained dangerously inaccurate levels of active ingredients, according to a report from The Bureau of Investigative Journalism — with some pills holding as little as a quarter of what the label promised. Others contained too much. Continue to STAT+ to read the full story…
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Perhaps unsurprisingly given the extraordinary focus on drugpricing in the last decade, generic competition—FDA’s only real way to have an effect on drugpricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drugdevelopment.”
FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.
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Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals DrugPricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.
XH4D via Getty Images A group of private equity firms are pouring funding into PCI Pharma Services, betting the contract drugdevelopment and manufacturing organization’s business is poised to grow in the years ahead. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. TechTarget, Inc.s
Payers also value biosimilars that have a similar formulation to Stelara, as well as interchangeability status and label breadth. In the spring of 2024, Humira was removed from CVS Caremark’s commercial formularies in favor of the private-labeled Sandoz biosimilars produced by CVS Health’s brand-new subsidiary, Cordavis.
Despite knowing about the most recent patient death for weeks, and having already discussed Elevidys labeling changes with Sarepta, the agency on Friday asked Sarepta to stop shipping the drug to Duchenne patients. You can unsubscribe at anytime. The FDA appears angered as well. Registered in England and Wales. TechTarget, Inc.s
Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. Many, however, were already on the record holding similar views as Makary on the warning label.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals DrugPricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.
Plus, we note that GLP-1 drugs can increase a person’s risk of aspiration when undergoing surgery. This story first appeared in The Readout newsletter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox. Good morning!
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