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1,2 EMA’s draft reflection paper – implications for drugdevelopers and manufacturers The proposed tailored approach offers opportunities for developers and manufacturers. 4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages.
s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry June 10, 2025 By Christopher Cole News Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.
The framework introduces 80 sector-agnostic and 27 healthcare sector-specific indicators, offering a method to assess risks such as biomedical waste, antimicrobial resistance, and unequal access to care, while also identifying opportunities in areas like green hospital infrastructure, digital health, and affordable drugdevelopment.
and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. First, advanced research and development (R&D) and biologics will be critical. Regulatory bodies in the U.S.
Table of Contents Why Pharma Podcasts Are Gaining Momentum The Best Pharma Marketing Podcasts in 2025 Top DrugDevelopment and Biotech Podcasts Emerging Voices and Niche Pharma Shows Conclusion and FAQs Why Pharma Podcasts Are Gaining Momentum In today’s information-saturated world, audio content has carved out a unique advantage.
Particularly beneficial in the early drug discovery phase, AI can help identify potential drug targets more effectively than traditional methods, accelerating the initial stages of drugdevelopment by quickly sifting through large volumes of data.
The new facility will feature state-of-the-art cleanroom packaging and high-sensitivity analytical testing capabilities. These will allow the company to customize chemistries for product development and provide more tightly controlled parameters beyond compendial limits and a validated control system, according to a press release (1).
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in Harbour BioMed partners Otsuka on new T-cell therapy Madrigal poised to enter European MASH market after CHMP endorsement Themes Sections Artificial Intelligence Cloud Corporate Governance (..)
Carbon contributing factors: The mitigating factors throughout the drugdevelopment process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.
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.
June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook GATC’s MAT platform identifies potential new drugs and provides comprehensive analytic reports. Lisata Therapeutics has formed a strategic partnership with GATC Health to advance AI-driven drug discovery and development.
And even just 10 minutes ago before we got on the call, I was looking up a drug. Sometimes we exclude medications from our protocol, various CYP enzymes and kind of going through a package insert to see, should we exclude this drug or not? So there’s still definitely a lot of PharmD in there.
CPTx is currently working to improve the delivery efficiency in various prototypes while also validating safety and efficacy in animal models with the goal of licensing this DNA nanocarrier delivery solution to drugdevelopers with established payload genes and target tissues. References 1. Tenchov, R. link] org/10.1016/j.jddst.2023.104724
Light Exposure : How will the drug react to different levels of light exposure? This is particularly important for drugs that are sensitive to light. Container Closure System : How will the drug interact with its packaging? This can affect the drug's stability and potency. Share your thoughts in the comments below!
Hesperos, Psilera Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia Patrick Lavery June 9th 2025 Article The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
Recent Videos Related Content BASF Opens GMP Manufacturing Facility in Michigan Susan Haigney June 19th 2025 Article The new facility offers cleanroom packaging and high-sensitivity analytical testing. PharmTech.com , May 8, 2025.
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?
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. How will RFK Jr’s American dream for vaccines play out?
Recent Videos Related Content BASF Opens GMP Manufacturing Facility in Michigan Susan Haigney June 19th 2025 Article The new facility offers cleanroom packaging and high-sensitivity analytical testing. Press Release. June 12, 2025.
BASF Opens GMP Manufacturing Facility in Michigan Susan Haigney June 19th 2025 Article The new facility offers cleanroom packaging and high-sensitivity analytical testing. BASF Opens GMP Manufacturing Facility in Michigan Susan Haigney June 19th 2025 Article The new facility offers cleanroom packaging and high-sensitivity analytical testing.
Few diseases have suffered more drugdevelopment disappointment than amyotrophic lateral sclerosis. Earlier this year, an experimental drug from Denali Therapeutics, and a candidate from Calico Life Sciences and AbbVie, failed in the clinic. Please let us know if you have feedback. Here’s how drugmakers are getting there.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.
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.
Focus on strategic partnering in drug delivery Key Takeaways ·Drug delivery partnerships are evolving, with top pharma leaders outlining strategic evaluation frameworks for external technologies and collaboration models.
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The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. The draft guidance states that a pre-BLA meeting request should be submitted at least 4 months before the anticipated BLA submission.
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