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Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. Go deeper with GlobalData Reports Chemotherapy in Pharmaceuticals: Platinum-based cancer drug composi.
The first drugdeveloped employing this technology has received approval in Japan for treating a lysosomal storage disorder. Anticipated next steps involve generating preclinical candidate data packages, which will include non-human primate studies expected in early 2026. How will RFK Jr’s American dream for vaccines play out?
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Give your business an edge with our leading industry insights.
The present clinical trial ecosystem is not equipped nor projected to have the capacity to satisfy this demand, and as a result the ecosystem is facing a potential slowdown in drugdevelopment. 10 “That is simply unsustainable,” Kent Thoelke argues, especially as drugpricing pressures mount in major markets.
July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The early stages of formulation development and analytical testing can be some of the most exciting phases of drugdevelopment, fueled by the anticipation that follows the discovery of a promising new active pharmaceutical ingredient (API) or combination.
Initiatives such as Project Optimus emerged from the need for more rigorous dose-finding studies early in drugdevelopment. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
FDA Commissioner Marty Makary stated: “For far too long, drugdevelopers have been playing a guessing game when navigating the FDA. Drugdevelopers and capital markets alike want predictability. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Give your business an edge with our leading industry insights.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. Achieving good oral bioavailability for TPDs Rebecca Coutts is Senior Director of Pharmaceutical Development at PCI Pharma Services, a world leading CDMO providing integrated end-to-end drugdevelopment.
JCR has also developed a proprietary blood-brain barrier-penetrating technology, J-Brain Cargo, to deliver biotherapeutics into the central nervous system. IZCARGO is the first drugdeveloped with this technology and approved in Japan for treating a lysosomal storage disorder.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
“The integration of genomic data into routine care, combined with streamlined access to clinical trials via the NHS App, has the potential to accelerate drugdevelopment, reduce health inequalities, and unlock new models of preventative care.” How will RFK Jr’s American dream for vaccines play out?
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?
Find out more Office of Management and Budget Director Russell Vought told reporters that the White House is on board with the substitute amendment to the rescissions package. How will RFK Jr’s American dream for vaccines play out? Data Insights The gold standard of business intelligence.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
It is an advanced sterile fill-finish and packaging site supported by more than 200 employees. How will RFK Jr’s American dream for vaccines play out? Find out more The Ridgefield site will continue to produce a range of therapies for Sanofi while expanding its capacity to meet increasing demands from other pharmaceutical and biotech firms.
Given the way the Hub is set up, it can closely engage with the rare disease community—biotechs, advocacy organisations, and more—without conflicts since it is not involved with the drug review process. Moreover, other threats to the early-stage drugdevelopment for rare diseases are also a concern.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
wants to ensure the ensuing the US does not lag behind other countries in drugdevelopment. We want to make sure we are getting rid of the regulatory impediments [that stop drugs getting to market],” RFK Jr stated. Tasos Katopodis / Stringer via Getty Images. Give your business an edge with our leading industry insights.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. How will RFK Jr’s American dream for vaccines play out?
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. Adding to these pressures is the surging demand for specialised capabilities as oncology drugdevelopment moves towards more complex therapies that require technical manufacturing expertise.
Compounded GLP-1RAs have completely disrupted pricing frameworks for Wegovy and Mounjaro, what happens now? Robert Barrie June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The list price for a month’s supply of 2.4mg Wegovy – the drug’s highest does – is $1,350 in the US, whereas the same dose in the UK costs £175.80
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Give your business an edge with our leading industry insights.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Give your business an edge with our leading industry insights.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Give your business an edge with our leading industry insights.
Eli Lilly, a chief Novo rival, uses Catalent for filling and packaging, and has complained openly about the deal. Continue to STAT+ to read the full story…
6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. However, S.6 ASBM surveys of U.S.
REMINDER: 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. However, S.6
The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drugpricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developingdrugs.
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.
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. and reportedly values PCI at $10 billion, according to The Wall Street Journal.
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 million for Hemgenix [AAV5-hFIX-Padua]).
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.
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