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This is progressing through a phase 3 trial and includes comparator arms with standard-of-care treatments like daratumumab, bortezomib (Velcade; Millennium/Takeda and Janssen PharmaceuticalCompanies), and lenalidomide. 2 We’re still trying to figure out where these new treatments best fit.
From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. As of January 1, 2023, CMS has begun issuing unique J-codes to 505(b)(2) drugs dating back to 2003. “In In 2022, based upon a complaint filed by a pharmaceuticalcompany, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.
Pharmaceuticalcompanies have responded with growing investment in the research and development of novel eye treatments and drug delivery systems designed to address key challenges in ocular therapy. 2023 39 (2), 102-116. link] Gautam, M.; Intracameral Drug Delivery: A Review of Agents, Indications, and Outcomes.
SHOW MORE EMA is phasing out animal testing and is asking pharmaceuticalcompanies to use new approach methodologies. In October 2023, EMA published a concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs testing approaches (4). EC.europa.eu. EC.europa.eu.
and outperformed maternal vaccines in public health programs. Vaccines to treat RSV normally start in early fall, and having these additional shipments in advance is expected to give healthcare providers (HCPs) an additional assurance and confidence. Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages.
The company also noted that the label update meets an unmet need, with up to 80% of patients with atherosclerotic cardiovascular disease (ASCVD) facing challenges in achieving the LDL-C guideline-recommended target of less than 70 mg/dL. He also explains dark social, how to combat misinformation, closing the trust gap, and more.
In recent years, leading pharmaceuticalcompanies, such as Sanofi, successfully launched smart factory programmes. Li Yang, PhD Vice President of CMC Development, Altruist Biologics Dr Li Yang brings over 10 years of industry expertise in biological drug and vaccine development, manufacturing and registration.
Either way, reforms to the 340B program, which was created by Congress in 1992 and requires pharmaceuticalcompanies to provide outpatient drug discounts to safety net hospitals, could be on the table.
Go deeper with GlobalData Reports State of the Biopharmaceutical Industry 2023 Reports Greece Healthcare (Pharma and Medical Devices) Market Analysis, Reg. Find out more This trade deal puts the pharmaceutical industry at risk of losing between $13bn and $19bn, with consequences that extend beyond short-term financials.
SHOW MORE Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash. He had just begun advancing a regulatory overhaul that emphasized tighter standards for product review—especially around COVID-19 vaccines and cell and gene therapies (1). EndpointNews.com.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News Manufacturing issues at Novo facility disrupt Regeneron drug review Issues were picked up during an FDA inspection of Novo Nordisk-owned Catalent’s mammoth filling plant. Regeneron’s problems with Catalent’s filling site are not unexpected.
He was also CEO of La Jolla PharmaceuticalCompany from 2011 to 2019, leading the development of a blood pressure drug that failed to meet sales expectations. Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies.
It feels like in the US, pharmaceuticalcompanies are capitalising on people’s frustration and desperation to lose weight.” Telehealth platforms selling compounded GLP-1RAs flourished in 2023 and 2024 amid shortages of semaglutide and later tirzepatide.
Scientific experts are concerned about what role vaccines will play in US public health strategy under the Trump administration. Robert Barrie June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook RFK Jr has embarked on a mission to reset vaccine regulation and evidence generation in the US.
Positive interim results from Moderna’s Phase I/II trial of mRNA-1083 , an investigational vaccine designed to immunise against both influenza and COVID-19, have been released. There are several benefits of the combination vaccine as a preventative measure against these respiratory conditions, according to the pharmaceuticalcompany.
Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.
US-based biopharmaceutical company Blue Water Vaccines has signed an asset purchase agreement with Veru to buy its Entadfi (finasteride and tadalafil) capsules business, for a total consideration of $100m. The company plans to optimise strategies around sales, distribution and marketing of the drug to increase its access.
The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).
In this context, several industry players have demonstrated high inclination towards supporting and advancing the development of next generation RNA-based therapeutics, vaccine and technologies. The below given figure provides an illustrative summary of the benefits of next generation RNA-based vaccines and RNA-based therapeutics market.
In this final instalment of IQVIA EMEA Thought Leadership’s Nine for 2023 three-part series, focusing on issues that will change the direction of healthcare and the pharmaceutical industry this year, three key competitive issues for pharmaceuticalcompanies in 2023 are assessed.
RSV researchers at major pharmaceuticalcompanies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceuticalcompanies are pushing to develop drugs and vaccines for RSV with these populations in mind.
One such emerging technology, artificial intelligence (AI), is expected to play an important role in the pharmaceutical sector in 2023. With more pharmaceuticalcompanies tapping into AI technology to enhance the processes within their value chains, AI will continue to evolve over time.
After a long period of inactivity in RSV vaccine development , two pharmaceuticalcompanies are now approaching regulatory decisions for their RSV vaccines. Both Pfizer and GSK have major approval decisions regarding the use of their RSV vaccines for older adults this May.
For more than 240 years, Takeda has focused on delivering transformative treatments in the therapeutic areas of gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Applications must be submitted by 4 December 2023. WANT TO LEARN MORE? Register Now!
on National Health Service (NHS) sales of branded medicines in 2023, almost double that of the previous year, has sent shock waves through the pharma industry. Full details of the government’s 2023 VPAS payment calculation may be accessed on the UK Department of Health and Social Care (DHSC) page here. billion ($4.1
Pharmaceuticalcompanies such as Sanofi and AstraZeneca are currently conducting several high-potential clinical development programmes in oncology in collaboration with Innate Pharma. Final results from the TELLOMAK study are expected by the end of 2023, as well as preliminary data from the Phase Ib trial in PTCL.
This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.
While most supply chains were impacted by the Covid-19 pandemic, the demands it placed on pharmaceutical and medical supply chains were immense and underlined the importance of transparency and security. A number of pilot projects are underway to speed the way to a blockchain solution for the pharma industry.
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