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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. Updated June 24, 2025. Subscribe Now!
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. So, the pharmaceuticalcompanies then pushed to get their 505(b)(2) drugs declared sole source,” Soefje said. “If This went into effect in January 2022.” Subscribe Now!
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. Challener News Article Hydrogels, drug-eluting contact lenses, and other implant technologies show real promise. Siemens Finalizes $5.1B
SHOW MORE EMA is phasing out animal testing and is asking pharmaceuticalcompanies to use new approach methodologies. Removes Thimerosal from Flu Vaccines Patrick Lavery Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.
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.
link] HIGHLIGHTS OF PRESCRIBING INFORMATION. link] Newsletter Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers. Accessed August 1, 2025. Accessed August 1, 2025.
Waite further emphasizes the need for pharmaceuticalcompanies to quickly build internal capabilities in customs compliance, including tariff classification, country of origin documentation, and accurate customs valuation. It may contain errors, informal language, or omissions as spoken in the original recording. Subscribe Now!
How will RFK Jr’s American dream for vaccines play out? Developed by US biotech ARS Pharmaceuticals and under exclusive license in the UK by Danish pharmaceuticalcompany ALK-Abelló, the single-dose nasal spray is indicated for use in adults and children weighing over 30kg and delivers its entire contents (2mg) upon activation.
Skip to main content CONTINUE TO SITE ➞ Dont miss the most important voices in pharma Let PharmaVoices free newsletter keep you informed on what industry leaders are saying, straight from your inbox. By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime.
The platform provides a means of technical exchange on high-quality, ready-to-fill primary packaging between pharmaceuticalcompanies, contract manufacturers, and contract development and manufacturing organizations.
Allen, PhD, chief scientific officer, Chimerix, a Jazz PharmaceuticalsCompany, in the press release. " Glioma Prevalence According to a study published in The National Center for Biotechnology Information, there are approximately six cases of gliomas diagnosed per every 100,000 people in the United States.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News FDA gives accelerated approval to Jazz Pharma’s diffuse midline glioma therapy Modeyso is expected to be commercially available in late summer 2025. The overall response rate (ORR) was 22%, with a median duration of response of 10.3
It may contain errors, informal language, or omissions as spoken in the original recording. As I just said, this investigation, this section 2 3 2 investigation which is nearing its conclusion by all accounts, threatens to impose substantial tariffs against pharmaceuticals and API and other ingredients imported into the United States.
How will RFK Jr’s American dream for vaccines play out? Zentiva Group has entered into a licence and supply agreement with pharmaceuticalcompany Lupin for the commercialisation of the latter’s biosimilar Certolizumab Pegol, a tumour necrosis factor alpha (TNFα) inhibitor medicine, across several markets.
How will RFK Jr’s American dream for vaccines play out? This report looks at marketed therapies and their sales projections, pipeline drug trends, and key development challenges for pharmaceuticalcompanies, as well as the role of CDMOs in targeted modality development and what to look for in a development and manufacturing partner.
Thus, if you are a healthcare or pharmaceuticalcompany that still hasn’t implemented any business intelligence tools, now is the best time to consider them. In healthcare, every single piece of information about either the patient, the treatment, or the patient care provider could play a vital role.
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. This could hinder innovation and pipeline investment, reducing the much-needed pace of therapeutic innovation across the industry.
How will RFK Jr’s American dream for vaccines play out? Leading parenteral packaging provider Datwyler, for example, operates its FirstLine® manufacturing facilities across North America, Europe, and Asia, enabling pharmaceuticalcompanies to procure stoppers and plungers that meet the same high standards from around the world.
How will RFK Jr’s American dream for vaccines play out? The initiative comes at a crucial time, as British pharmaceuticalcompanies are significantly increasing their investments in the United States. GSK invested $800m in drug substance and drug product manufacturing facilities in the US in October 2024.
How will RFK Jr’s American dream for vaccines play out? The government therefore is advocating for the creation of the new drug regulatory agency to expedite economic growth, streamline drug approvals and attract international pharmaceuticalcompanies to invest in the country.
How will RFK Jr’s American dream for vaccines play out? Image credit: PeopleImages.com – Yuri A via Shutterstock With tighter budgets, regulatory challenges, and uncertainty from tariffs, pharmaceuticalcompanies are turning to third-party logistics (3PL) suppliers to deliver efficiencies.
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.
Katarina Zahedi, pharma analyst at GlobalData, comments: “These investments reflect a growing trend among pharmaceuticalcompanies to bolster domestic operations in response to geopolitical pressures and potential tariffs on imported pharmaceuticals.” Give your business an edge with our leading industry insights.
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. Give your business an edge with our leading industry insights.
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News Pharma CEOs downplay impact of tariffs amid rising cost concerns Analysis by GlobalData characterises an uncertain pharma landscape, though big pharma CEOs allay investor concern. Give your business an edge with our leading industry insights.
Skip to main content CONTINUE TO SITE ➞ Dont miss the most important voices in pharma Let PharmaVoices free newsletter keep you informed on what industry leaders are saying, straight from your inbox. By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime.
It feels like in the US, pharmaceuticalcompanies are capitalising on people’s frustration and desperation to lose weight.” I don’t understand why medication costs are so much higher in the US compared to Europe, though I’ve noticed prices can vary across European countries too,” said Helena. “It
Robert Barrie and Ross Law June 10, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The removal ACIP members marks the most significant upheaval to the current vaccine landscape under Trump’s administration. lev radin via Shutterstock. lev radin via Shutterstock.
Key Takeaways The launch of Aetna Care Paths provides members a new simple way to view and manage their health care information. This new technology also provides members suffering from certain medical conditions a personalized outlook of relevant benefit information paired with a care team to aid and support them throughout their journey.
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.
The report also says that the administration is considering splitting CBER into two groups, with one focused solely on vaccines. One would be focused on overall therapeutics, while the other would focus solely on vaccines. However, 17 experts who were part of a government panel on vaccines were all ousted. July 31, 2025.
an environmental activist and vaccine critic, as the secretary of the Department of Health and Human Services has thrown the health care sector into disarray. as someone who was smart on health, there was a tendency for investors in biotechnology and pharmaceuticalcompanies to downplay Kennedy’s role.
It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they need – especially with digital innovation driving new vaccine development. Pfizer’s Josh Raysman, Saad Saeed, and Shanaya Deboo discuss vaccine awareness, access, and innovation.
Even with extremely rapid vaccine development, limitations in production capabilities can have real-life implications. This has led pharmaceutical equipment manufacturers to react quickly, while maintaining due levels of diligence and social responsibility.
The UK company reveals the results from a partner-led survey to discover the rates of vaccination for adults, why levels are lower than expected, and what can be done to improve this. The result of the improving knowledge of vaccines’ role in society initially led to a rise in interest in receiving a COVID-19 vaccine.
As the prophylactic landscape for malaria has changed in recent years with vaccine approvals, major issues still remain with ensuring access in remote communities. However, making sure the vaccine reaches everyone can be challenging due to the storage requirements. The Mosquirix vaccine contains two vials.
A recent Accenture survey found that a majority of HCPs (82%) think pharma companies have increased the value of what they communicate in the last 18 months, delivering not just product information but also support that meets pressing needs, such as education on how to better treat patients remotely. About the interviewee.
The ways in which we communicate and consume information are constantly transforming. An excellent example of this is COVID-19 vaccine trial data; press releases are eagerly followed in almost real-time by HCPs and the public alike. How many of us are guilty of signing up for a webinar, only to miss it when the time comes?
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.
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