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13 Skylar Jeremias, “The IRA’s Unintended Consequences for Drug Pricing and Coverage,” The American Journal of Managed Care , April 2, 2025, [link] www.ajmc.com/view/the-ira-s-unintended-consequences- for-drug-pricing-and-coverage. Food and Drug Administration, FDA Patient-Focused DrugDevelopment Guidance Series , March 21, 2025.
By GlobalData Learn more about Strategic Intelligence A study conducted by FDA researchers in 2015 found that companies did not publicly acknowledge 85% of safety and efficacy concerns raised by the agency. FDA Commissioner Marty Makary stated: “For far too long, drugdevelopers have been playing a guessing game when navigating the FDA.
A 2015 cross-sectional study published in BMJ found that drugdevelopers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Unprecedented Move Previously, the FDA had not routinely shared CRLs publicly. Sponsors often disclosed minimal information when announcing a non-approval.
billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023. billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023.
In 2015, the FDA began reporting on the representation of individuals in clinical trials, with the hope that raising awareness would drive meaningful change. Lack of diversity occurs at all levels of the pharmaceutical ecosystem, from the makeup of C-suite and research staffs to participation in clinical trials.
DRUGDEVELOPMENT based on targeted protein degradation (TPD) has progressed rapidly since the publication in 2015 of three landmark papers 1-3 that highlighted important early-stage breakthroughs with drug-like molecules in this area of research.
In 2015, Alzheimer’s Therapeutics International found there was an estimated 46.8 According to Alzheimer’s Therapeutics International in 2015, 58 percent of people with dementia live in developing countries, but by 2050 this will rise to 68 percent. percent, and driven largely by collaboration of existing players, reach $6.8
Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drugdevelopment process, effectively slashing time to market for drugs. 2015; 13:8-17. 2015; 12(10):931-934. IEEE J Biomed Health Inform. 2018; 22(5):1589-1604. Kourou K, Exarchos TP, Exarchos KP, et al.
AI also speeds up the drugdevelopment process, which could translate into cheaper drugs for patients. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. 3D printing.
The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.
There are many benefits of including patients at every stage of the drugdevelopment process, as well as ways to involve them in the early stages of drugdevelopment. It helps to focus the drugdevelopment process on its main element – the patient, and it also makes good business sense, too.
GlaxoSmithKline has thrown its financial and drugdevelopment weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. Greg Verdine – LifeMine.
Dr Eric Hughes joins Teva with experience in all phases of drugdevelopment at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. He will be based out of Teva’s US headquarters in Parsippany, New Jersey. . Dr Hughes earned his MD and PhD at Yale School of Medicine.
At Parexel, Sandra held roles in Phase I project management and business development, before being promoted to a senior portfolio director in 2015. The company supports global drugdevelopment in primarily conducting Phase II and Phase III clinical trials.
Together, we aim at making the drug discovery process more efficient and effective in particular when very limited information is available to support drug design.”. A recent report from GlobalData predicted that pharma spending on AI drug discovery would hit $3 billion in 2025.
is to acquire the 2015-established Amryt Pharma Plc. The development is for expansion of the company’s in-house drugdevelopment of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. in an all-cash transaction at $14.50
This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis, and the 43rd biosimilar approved by the FDA since 2015. 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. Read more about the approval here.
As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. As a result, there is a need for continued innovation and increased efficiency in terms of drugdevelopment to manage cost, complexity and speed to provide potentially transformative therapies for cancer patients.
The FDA has studied the importance of caregivers to drugdevelopment and regulatory decision-making. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Additional concerns for the caregiver include a strain on physical and mental health.
In 2015, China reformed its regulatory system, which introduced review designations, including fast-track programmes to increase drugdevelopment for unmet medical needs such as rare diseases and serious conditions.
Although this evolution has led to life-changing medications, it also calls on drugdevelopment and manufacturing experts to identify new, more efficient ways to deliver high‑quality products. Pharmaceutical development is driven by quality by design (QbD) – an approach recommended by regulatory agencies. 2015; 7(5): 881-90.
Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA). Note the light service has been incorporated into the standard service. Light was previously aimed at small and medium sized enterprises. Great job!”.
Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. VivoSense software is developed specifically for analysis of data from wearable sensors”, explains Tabakin. “The
All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”. New cancer cases in China increased from 4 million in 2015 to 4.4 million in 2019, and are estimated to increase to 5.7 million in 2030. of the global oncology market in the same year.
Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.
In a bid to resolve both physical and financial restrictions inhibiting equitable access to quality medicines, the Jan Aushadhi scheme was launched in 2008 and envisaged the setting up of dedicated Janaushadhi Kendras to provide quality generic medicines at capped prices for the general public.
He is currently group leader of the Technology Development and Discovery Group at the Bioprocess Laboratory of the ETH. His research activities led to the foundation of five startup companies active in disciplines ranging from drugdevelopment to industrial biotech within the past 15 years. Green Chem 2015, 17, 123‒145.
billion, with London’s AIM seeing the highest levels of investment (£515 million) since 2015. The third was diagnostics company Verici Dx’s listing on the AIM which raised £14.5 million to support its next-generation sequencing platform to guide kidney transplants.
In fact, a study published in 2023 in The Lancet HIV revealed that women and men with HIV at age 40 had an average of 39 and 37 years of life left, respectively – only a few years less than that of the general population – if they started antiretroviral therapy (ART) after 2015. World Health Organization. The Global Health Observatory.
FDA, Guidance for Industry, Naming of Drug Products Containing Salt Drug Substances (CDER, June 2015). USP, USP General Chapter , “Nomenclature,” USP35–NF30 (Rockville, MD, 2011). FDA, USP Salt Policy (December 2014). YouTube.com , Dec. 1, 2014 (accessed April 29, 2025).
A representation of the country’s rapidly developing capability can be seen in the example of WuXi Biologics, which is a contract development and manufacturing organisation, that was created in 2015 and is now in the top five companies in terms of manufacturing capacity for biologics.
The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drugdevelopment. 2015; 35(3):1437-45. Anticancer Res.
FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs. Biopharmaceutical Research & Development: The Process Behind New Medicines. Why 90% of clinical drugdevelopment fails and how to improve it? link] [Cited 25 September 2022].
Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Another 563 new nanomedicines were under clinical trial or in other stages of drugdevelopment. Yet in 2021, 100 nanomedicines had been marketed.
Well, Kim believes that “by leveraging the power of genetics and functional genomics, coupled with a ‘human-first’ mindset, innovative analytics, and scalable compute power” there is “the ability to take a fundamentally different approach to drugdevelopment”. It also bodes well for improving clinical trial success rates.
Sitra joined Avexis in 2019 as Head of Clinical Development for SMA. In 2015, she joined Astellas Pharma, Northbrook, IL, and served as Global Lead for Immunology, CNS and Neuromuscular Indications and eventually as Global Medical Lead for the Muscle TA.
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