Sanders takes aim at US drug prices of Novo’s Ozempic and Wegovy
Pharmaceutical Technology
APRIL 25, 2024
A Senate Committee is investigating the “outrageously high” US price tags of the blockbuster diabetes and obesity drugs.
tag investigations 
Sanders Launches Probe of ‘Outrageously High Prices’ of Novo’s Ozempic, Wegovy
BioSpace
APRIL 24, 2024
on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags. Bernie Sanders (I-Vt.)
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Biogen’s Alzheimer’s drug: What’s the price tag on hope?
World of DTC Marketing
JUNE 1, 2021
He had recused from the November meeting because he has been a site investigator for aducanumab. If the drug is approved you can bet that it’s going to carry a huge price tag. It could carry a price tag as high as $50,000-a-year per patient, according to drug analysts, adding billions of dollars to the nation’s health tab. .
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STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India
STAT News
JANUARY 10, 2023
Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.
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Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)
Rethinking Clinical Trials
MARCH 1, 2023
For the standard of care arm, treatment is determined by the treating investigator and participant, with the recommendation that the choice of drug is based on NCCN guidelines and dosing administration based on the participant’s previous therapy and disease. One network is the lead, but the trial will be available in all four U.S.
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Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. Krumholz, MD, SM)
Rethinking Clinical Trials
OCTOBER 31, 2023
Participants should have access to investigators and the results of studies. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. A lot of participants have worked with their physician to stop a drug so they can participate.
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Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)
Rethinking Clinical Trials
JULY 6, 2023
The EMA guidance also features an extensive discussion on the need for investigator oversight. The key remaining issues for DCTs include clarification around the roles and responsibilities of health care providers as well as principal investigator (PI) oversight and responsibility.
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Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)
Rethinking Clinical Trials
AUGUST 23, 2022
Three key themes emerged from the Think Tank discussion: build partnerships with participants and communities; improve accessibility of clinical trials; improve representation among clinical investigators. – How do investigators target rural areas to increase diversity? Ask and engage community partners. Learn more.
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Grand Rounds February 16, 2024: Clinical Implications of the MINT Trial: p=0.07 (Jeffrey Carson, MD, MACP)
Rethinking Clinical Trials
FEBRUARY 20, 2024
Speaker Jeffrey Carson, MD, MACP Principal Investigator and Study Chair MINT Trial Provost-New Brunswick, Rutgers Biomedical Health Sciences Distinguished Professor of Medicine Richard C. Prior to the MINT trial, investigators detected very little difference between liberal and restrictive transfusion strategies.
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September 30, 2022: CTTI’s Digital Health Trials Hub Recommendations and Resources to Run Your Digital Health Trial (Marianne Chase, MGH, CTTI Team Lead, Jörg Goldhahn, ETH Zurich, CTTI Team Lead)
Rethinking Clinical Trials
OCTOBER 4, 2022
DCTs range from near-traditional to hybrid to fully remote trials that conduct study visits away from the central study site using strategies such as tele-visits or home delivery of investigational products. Decentralized trials require novel technology and digital endpoints. Find CTTI’s recommendations and resources. pctGR, @Collaboratory1.
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Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)
Rethinking Clinical Trials
APRIL 18, 2023
RECOVER has used cohort data to identify major symptom clusters and develop 5 platform protocols that will investigator priority symptom clusters and their causes; test known and novel interventions across domains; and evaluate treatments to improve Long COVID symptoms.
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Grand Rounds July 29, 2022: Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From The TOGETHER Trial (Edward Mills, PhD, FRCP; Jeffrey S. Glenn, MD, PhD)
Rethinking Clinical Trials
AUGUST 4, 2022
TOGETHER is a randomized adaptive platform trial that was initiated in June 2020 to investigate the efficacy of repurposed treatments for COVID-19 disease among high-risk adult outpatients. Stanford University. TOGETHER, COVID-19, Peginterferon Lambda. Key Points. Learn more about TOGETHER. pctGR, @Collaboratory1.
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130 Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)
Rethinking Clinical Trials
NOVEMBER 16, 2022
For investigators and health systems, there are substantial risks and burdens of data sharing with unclear benefits. For PCTs, data volume is potentially larger, data may be “about” those beyond patient-subjects (i.e. pctGR, @Collaboratory1.
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Bristol Myers Squibb pays $475 million for exclusive rights to Dragonfly Therapeutics' IL-12 immunotherapy programme
The Pharma Data
AUGUST 18, 2020
The main focus of the deal is Dragonfly’s monovalent IL-12 immunoglobulin Fc fusion protein known as DF6002, which the company has been investigating in the treatment of both solid and blood cancers.
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Cancer research drugs: Where is the innovation?
Drug Discovery World
OCTOBER 31, 2022
Click’ chemistry used to tag proteins made by cancer cells. Merck (MSD) and Moderna have revealed plans to work together on the development and commercialisation of an investigational personalised cancer vaccine. A team from the University of Geneva (UNIGE) has found a way to overcome chemotherapy resistance in colorectal cancer.
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Grand Rounds Ethics and Regulatory Series September 9, 2022: Building An Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH)
Rethinking Clinical Trials
SEPTEMBER 16, 2022
Academic medical systems place a high value on faculty autonomy, where individual investigators determine the focus of their research. Traditional faculty incentives in academic medical centers typically include pursuit of investigator-initiated innovation and research, external funding, and publication in prominent journals.
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Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)
Rethinking Clinical Trials
FEBRUARY 14, 2024
It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico.
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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)
Rethinking Clinical Trials
AUGUST 28, 2023
It also aims to set a foundation for practical and feasible expectations around the responsibilities from the sponsor and investigator, encourage a fit-for-purpose approach and incorporate learning from innovative trial design. Even when we have a guideline, we want to lead investigators to think based on the principles of this guidance.
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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)
Rethinking Clinical Trials
AUGUST 28, 2023
It also aims to set a foundation for practical and feasible expectations around the responsibilities from the sponsor and investigator, encourage a fit-for-purpose approach and incorporate learning from innovative trial design. Even when we have a guideline, we want to lead investigators to think based on the principles of this guidance.
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First gene therapy for haemophilia B gets go ahead in Europe
Drug Discovery World
DECEMBER 20, 2022
Concerns about the high price tag have been raised in an article in Nature, particularly whether it will be affordable for low to middle-income countries. . Thank you to all for the role you have played in helping us reach this regulatory milestone in Europe.” . World’s most expensive drug.
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Almirall and IRB Barcelona team up to tackle skin disease
pharmaphorum
JANUARY 18, 2022
The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.
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Scientists turn cancer cells into anticancer agents
Drug Discovery World
JANUARY 9, 2023
Harvard investigators have developed a new cell therapy approach to eliminate established tumours and induce long-term immunity. . The engineered tumour cells were also designed to express factors that would make it easy for the immune system to spot, tag, and remember them, priming the immune system for a long-term antitumour response.
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WHO update on Omicron
The Pharma Data
NOVEMBER 29, 2021
1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). WHO’s TAG-VE will continue to monitor and evaluate the data as it becomes available and assess how mutations in Omicron alter the behaviour of the virus. Recommended actions for countries.
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IBM sells off large parts of Watson Health business
pharmaphorum
JANUARY 24, 2022
IBM said the sell-off is tagged as “a clear next step” as it focuses on its platform-based hybrid cloud and artificial intelligence strategy, but it’s no secret that Watson Health has failed to live up to its early promise. .”
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111 Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)
Rethinking Clinical Trials
DECEMBER 14, 2022
Investigators should provide a justification for choice of stepped wedge CRT. If a cluster randomized trial is justified there are different types of CRT designs, the parallel arm CRT, parallel arm before and after CRT, cluster cross-over, and stepped wedge. pctGR, @Collaboratory1.
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Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)
Rethinking Clinical Trials
OCTOBER 11, 2023
This was an impactful collaboration between NIH investigators and study teams and methodologists. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. The real interest is in finding out about how to improve acceptability, adoption, fidelity, etc.
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Blue Note leukaemia DTx gets FDA breakthrough tag
pharmaphorum
JANUARY 11, 2022
He is the principal investigator for a clinical study that will evaluate the impact of BNT200 on quality of life, mood, and symptoms of patients diagnosed with AML. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on. Other DTxs are aimed at people being treated for breast and lung cancers.
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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag
pharmaphorum
DECEMBER 23, 2021
AZ has already licensed rights to HER2-targeting drug Enhertu (trastuzumab deruxtecan) – which is already on the market for HER2-positive breast and gastric cancers – as well as investigational TROP2 ADC datopotamab deruxtecan in two multibillion-dollar deals.
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Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)
Rethinking Clinical Trials
FEBRUARY 2, 2023
After enrollment, there is an IRB-approved document that includes information on the trial, the investigators, and contact information that patients receive. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W.
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Grand Rounds August 12, 2022: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)
Rethinking Clinical Trials
AUGUST 18, 2022
Because the system and structures have not been built equitability, we will need to invest more and have more transparency and accountability at every level, from the investigator, funder, publisher and journals. Key Points. It is everyone’s responsibility. There is a need to shift our language. Passitonstudy.org/results. New Ideas study.
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ASH: Argenx cues up a second use for efgartigimod
pharmaphorum
DECEMBER 12, 2022
. “This is exciting news because existing treatments fail to improve platelet counts for as many as 30% of adults with chronic ITP,” commented said Catherine Broome of Georgetown Lombardi Cancer Centre in Washington DC, the trial’s lead investigator.
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Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)
Rethinking Clinical Trials
NOVEMBER 6, 2023
Cook, PhD Senior Biostatistics Investigator, Kaiser Permanente Washington Health Research Institute Slides Keywords Individually randomized group treatments; Intervention; Randomization; Clinical trials Key Points In individually randomized trials (IRTs), individuals are randomized to either control or intervention arms. Speaker Jonathan C.
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Preview of Pharma Commercials at Super Bowl 2024: From Touching Down with TUMS to Tackling Menopause
XTalks
FEBRUARY 8, 2024
Along with the hefty price tag for screen time that may not be perceived to be a worthwhile investment, and despite favoring advertising at other major events like the Grammys, pharma tends to stay somewhat clear of all the Super Bowl hoopla.
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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease
The Pharma Data
OCTOBER 9, 2021
This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.
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Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial
XTalks
APRIL 29, 2022
Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.
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J&J builds case for antidepressant Spravato with head-to-head trial
pharmaphorum
NOVEMBER 24, 2022
One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems.
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Targeting a human protein may stop Ebola virus in its tracks
The Pharma Data
MARCH 23, 2022
Their investigation reveals that an experimental drug that targets GSPT1 for degradation can also halt Ebola virus infection in human cells. This special enzyme, once fused to Ebola virus polymerase, enables the polymerase to add a molecular tag to any other protein it interacts with.
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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
The correct STF file-tags are used for datasets and corresponding data definition files. An SDSP is typically presented within an IND’s general investigational plan, and the latest version should be provided to the FDA in a Pre-NDA briefing package. Validation Code. Criteria Being Verified. Code 1734.
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After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer
pharmaphorum
DECEMBER 23, 2022
price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. Add to this the considerable cost of these medications – the first approved CAR-T, Novartis’ Kymriah (tisagenlecleucel), had a U.S. Professional reception of the findings.
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Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data
XTalks
OCTOBER 26, 2021
The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year. Similar gene silencing treatments are being investigated for Huntington’s disease and other rare genetic disorders like amyloidosis.
Zynteglo halt re-ignites viral vector safety concerns; analysts
pharmaphorum
FEBRUARY 22, 2021
In addition to the pause on new treatments, the phase 1/2 study and another phase 3 trial of Zynteglo in SCD have been suspended as the company investigates whether the cancers could be related to the BB305 lentiviral vector used in the therapy. million in Europe.
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Q&A: A decade on, what’s next for CAR-T therapies?
Pharmaceutical Technology
APRIL 5, 2023
But access to these treatments continues to remain limited due to high price tags and variable availability across regions. Currently, all approved CAR-T therapies are autologous, where T cells taken from patients are modified and then re-infused.
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Perfusion MRI and Other Perfusion Imaging Techniques for Clinical Trials
XTalks
OCTOBER 12, 2022
Clinical trials are increasingly using advanced MRI techniques to help evaluate the efficacy of investigational therapeutics. Therefore, early DCE-MRI-based perfusion imaging can be used as a predictive biomarker of drug efficacy and to support further investigation and resources into the drug’s development.
AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials
XTalks
AUGUST 23, 2021
As Dr. Grill alluded to, one of the largest questions that Alzheimer’s researchers must address is whether new investigational therapies should continue to be compared to a placebo in Alzheimer’s clinical trials going forward. Are Placebo Arms Still Ethical in Alzheimer’s Clinical Trials?
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