Moderna now in the crosshairs of Sens. Warren, Welch over price tag for COVID vaccine
Fierce Pharma
JANUARY 25, 2023
Warren, Welch over price tag for COVID vaccine kdunleavy Wed, 01/25/2023 - 13:16 Moderna now in the crosshairs of Sens.
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Ultimovacs bags orphan drug tag for mesothelioma vaccine
Pharmaceutical Technology
OCTOBER 9, 2023
The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.
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Pharma running online ads on vaccine misinformation sites
World of DTC Marketing
FEBRUARY 19, 2021
SUMMARY: More than 42,000 programmatic ads from 4,315 brands are running on websites spouting misinformation about the vaccine and COVID over the past year. Included in the programmatic ad errors is Pfizer, who developed a leading COVID vaccine. When will pharma stop using programmatic online ads? How much is enough?
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STAT+: Lawmakers tell Pfizer CEO to ‘back off’ on planned price hike for Covid-19 vaccine
STAT News
DECEMBER 13, 2022
lawmakers wrote Pfizer chief executive officer Albert Bourla that he should “back off” from plans to charge Americans up to $130 for the company’s Covid-19 vaccine, a move they described as “pure and deadly greed.” argued the planned price tag is nearly four times the current $30 price paid by the U.S.
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Behavioural considerations for acceptance and uptake of COVID-19 vaccines
The Pharma Data
DECEMBER 21, 2020
The Behavioural Insights Unit of the WHO released a meeting report of the Technical Advisory Group (TAG) on the special session on acceptance and uptake of COVID-19 vaccines, held on 15 October 2020. The discussion was structured around three key questions. Click here to download image in full size. . Source link.
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Drug Regulatory Affairs Certificate Institutes in India
Pharma Tutor
JULY 18, 2022
Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy. Mon, 07/18/2022 - 15:31.
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Scientists and medics turn to TikTok to reassure public on vaccine safety
pharmaphorum
DECEMBER 17, 2020
Tik Tok is unlikely to spring to mind as a source of reliable information about complex issues, but scientists are using it to fly the flag for COVID-19 vaccines and other health topics. When we talk about vaccines as health professionals, people who are vehemently anti-vaccine can take it out of context for their agenda.
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Healthcare doesn’t give a damn about patients
World of DTC Marketing
JULY 20, 2022
Pfizer, for instance, hiked the cost of its leukemia medication Besponsa again this month, bringing its per-vial price tag to $21,056. “This is PPfizer’sfourth hike on the cancer drug during the Covid-19 pandemic—even as the company enjoys record-shattering profits from its vaccine,” “the analysis notes.
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Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)
Rethinking Clinical Trials
JULY 22, 2022
ACTIV was stood up in about a month, launching on April 17, 2020, to develop a coordinated research response to speed COVID-19 treatment and vaccine options. There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical. pctGR, @Collaboratory1.
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Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)
Rethinking Clinical Trials
NOVEMBER 1, 2022
Important issues early on included COVID-19’s effects on the workplace, vaccine access and willingness, and impact on home life. The HERO TOGETHER study leveraged the HERO Registry to estimate real-world incidence of safety events among vaccinated individuals. Later, burnout and lack of appreciation and support became larger issues.
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Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)
Rethinking Clinical Trials
SEPTEMBER 22, 2022
The DANFLU-1 trial is a large-scale pragmatic RCT that looked at high-dose vs standard-dose flu vaccine to test whether high-dose vaccines might reduce hospitalizations among the elderly, age 65 and older. The aim is to test communication strategies for optimizing the update of the flu vaccine. million U.S.
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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet
The Pharma Data
JANUARY 31, 2021
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
WHY PM MODI ADDRESSED, INDIA AS THE PHARMACY OF THE WORLD
Pharma Tutor
NOVEMBER 19, 2021
We have also exported more than 65 million doses of COVID vaccines to nearly 100 countries this year. We have exported life-saving medicines and medical equipment to over 150 countries during the initial phase of the pandemic. Fri, 11/19/2021 - 16:19. Pharmapedia.
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A broad range of unmet needs remains in the immuno-oncology space
Pharmaceutical Technology
MAY 2, 2023
IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. Oncolytic viruses, cytokines, and therapeutic vaccines currently play a very minimal role in oncology treatment, with substantial efficacy still to be demonstrated for these classes.
Statement on Omicron sublineage BA.2
The Pharma Data
FEBRUARY 22, 2022
As part of its on-going work to track variants, WHO’s Technical Advisory Group on SARS-CoV-2 Virus Evolution ( TAG-VE ) met yesterday to discuss the latest evidence on the Omicron variant of concern, including its sublineages BA.1 Reinfection with BA.2 2 following infection with BA.1 WHO will continue to closely monitor the BA.2
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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). Effectiveness of vaccines : WHO is working with technical partners to understand the potential impact of this variant on our existing countermeasures, including vaccines.
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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates
The Pharma Data
DECEMBER 3, 2020
The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.
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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 and Moderna to develop personalised cancer vaccine. Merck (MSD) and Moderna have revealed plans to work together on the development and commercialisation of an investigational personalised cancer vaccine. The post Cancer research drugs: Where is the innovation?
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Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate
The Pharma Data
JANUARY 31, 2021
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.
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Johnson & Johnson to Participate in Goldman Sachs 42nd Annual Global Healthcare Virtual Conference
The Pharma Data
MAY 7, 2021
Johnson & Johnson COVID-19 Vaccinations Resume Following CDC and FDA Decision. Remarketing tags may not be associated with personally identifiable information or placed on pages related to sensitive categories. See more information and instructions on how to setup the tag on: [link] >. Skip to content. Learn More.
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Scientists turn cancer cells into anticancer agents
Drug Discovery World
JANUARY 9, 2023
In this early research, Khalid Shah, Professor of Neurosurgery at Harvard Medical School and Brigham and Women’s Hospital, and colleagues tested the vaccine in an advanced mouse model of brain cancer glioblastoma, with promising results. The findings are published in Science Translational Medicine. .
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Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? (Carl T. Bergstrom, PhD)
Rethinking Clinical Trials
AUGUST 3, 2023
If you’re working on a paper about vaccine safety, you have to understand the conversation about vaccine safety. Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? What are the debates and controversies in the press and social media?
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Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do? (Susan C. Winckler, RPh, Esq)
Rethinking Clinical Trials
FEBRUARY 7, 2024
– Were you able to examine responses from groups that can be particularly challenging such as vaccine deniers and climate change skeptics? Tags #pctGR, @Collaboratory1 The post Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do?
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Medicare savings won’t make a dent in healthcare costs
World of DTC Marketing
SEPTEMBER 9, 2021
A study put a price tag on American’s bad eating habits: $50 billion a year in health care costs, attributable to cardiometabolic diseases such as heart disease, stroke, and type 2 diabetes. Then there is the cost of people who refuse to get vaccinated against COVID. Then there is the cost of unhealthy Americans.
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Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)
Rethinking Clinical Trials
OCTOBER 26, 2023
There are possible clinical research components that would include research on treatment during pregnancy, vaccine development, and implementation model research. The economic benefits of a Hepatitis C elimination program would save lives and have enormous financial benefits to Medicare and Medicaid, paying for the program within 10 years.
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
During the Ebola crisis, the ethical argument for stepped wedge CRTs was that anything involving a placebo in the control arm was automatically considered unethical if the intervention arm holds a chance of benefit. It’s still important to look at how effective it is and is the juice worth the squeeze in this context? pctGR, @Collaboratory1.
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Further insight into breakthroughs in mRNA drug discovery
Drug Discovery World
JULY 25, 2023
We have shown that the excipient does not only work for our SNAP-tag lipid (SNaP) LNP, but also for the commercialised vaccines. The excipient is listed in the pharmacopoeia as an inactive ingredient and therefore can easily added to an existing formulation.
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3 ways pharma marketers can draw inspiration from digitally-native brands
pharmaphorum
SEPTEMBER 15, 2020
“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. As part of this, a number of big pharma companies are also racing to develop a safe and effective vaccine for the coronavirus.
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Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely.
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Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset
Delveinsight
FEBRUARY 23, 2021
The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases. The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform.
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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.
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Oslo Medicines Initiative asks how to balance innovation incentivisation with security of access
pharmaphorum
JANUARY 21, 2022
And as with many healthcare challenges, it is an issue that has been brought into sharp focus by COVID-19, during which we have seen huge investments in ground-breaking vaccines, quickly followed by inequities in access. There is no easy answer to the question of how to incentivise innovation without restricting access.
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Apellis set to take on Alexion as FDA clears PNH drug Empaveli
pharmaphorum
MAY 17, 2021
C5 inhibitor Soliris – which has a list price in the US of more than $500,000 per year – has been a standard therapy for the rare disorder since 2007, and was joined on the market by longer-acting follow-up Ultomiris in 2018 which launched with a price tag of around $450,000 per year. billion and $1.1
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Patient adherence – the key to restoring trust in pharma
pharmaphorum
JANUARY 31, 2023
With the recent rapid rollout of Covid-19 vaccines, many people have raised questions about whether adequate research was conducted on these vaccines before approval. Given the high price tags placed on many medications, it’s easy to understand why patients often feel that they are being taken advantage of.
Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC)
The Pharma Data
MARCH 8, 2022
The Label-CO-VAC is reviewing available data to optimize vaccine intermediated protection against current circulating variants. Still, to insure COVID-19 vaccines give optimal protection into the future, they may need to be streamlined as new, antigenically distinct variants crop.
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Merck Announces Withdrawal and Refiling under the Hart-Scott-Rodino Act and Extension of Tender Offer to.
The Pharma Data
OCTOBER 29, 2021
Merck has tagged to withdraw its Premerger Notification and Report Form, which was originally filed on October 14, 2021, to give the Federal Trade Commission (the “ FTC”) with fresh time for review, and expects to refile similar form on or about November 1, 2021. About Merck.
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How automation can help to address supply chain challenges in pharma
pharmaphorum
NOVEMBER 27, 2022
For example, many vaccines – including the COVID-19 one – must be kept refrigerated at a specific temperature throughout their journey, and if this isn’t communicated, it can render a whole batch unusable. Mix ups in hand-offs are another large disruptor, especially when drugs have specific shipping requirements.
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The Covid cash cow – a look at the Covid vaccine sales figures
pharmaphorum
NOVEMBER 19, 2021
The race to find and bring vaccines to market to fight Covid was impressive. It’s been almost a year since the first Covid vaccine was authorised for use. Meanwhile, China and Russia have rolled out state-owned vaccines. Pfizer/BioNTech’s vaccine dominates the market. billion in vaccine sales this year.
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How COVID-19 Impacted the Food Supply Chain For Better and for Worse
XTalks
APRIL 6, 2021
Where flour, pasta and other shelf-stable goods once sat in abundance quickly emptied to nothing but price tags. Technology has been at the forefront of many aspects of COVID-19 relief, from treatments and vaccines to how we communicate and work with one another from a distance. The same went for meat and dairy.
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Cytiva supports Clover Biopharmaceuticals to scale up the output of its vaccine candidate
The Pharma Data
NOVEMBER 15, 2020
16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. . SHANGHAI , Nov.
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Omicron Designated as a Variant of Concern by WHO: What We Know About It So Far
XTalks
NOVEMBER 27, 2021
The technical advisory group on SARS-CoV-2 virus evolution (TAG-VE) met on Friday to discuss B.1.1.529, Related: FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Kids 5 to 11. It is also the protein that the current COVID-19 vaccines target. Vaccination Concerns. This includes the US, Canada and the EU.
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A history of Pfizer
pharmaphorum
DECEMBER 2, 2020
And with the company becoming one of the first in the world to get a COVID-19 vaccine approved – via its collaboration with BioNTech – it feels like we’re only on the cusp of seeing where the company could head in the future. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.
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Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform
XTalks
AUGUST 17, 2020
protein-based biologics) and vaccine treatments. Treatment vaccines : these boost the immune system responses to target cells. There are several different types of immunotherapies, including chemical inhibitors, cell-based therapies (i.e. chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune system modulators (i.e.
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Drug Pricing Reform: Never Out of the Headlines
Intouch Solutions
JULY 27, 2021
they pointed out that the COVID-19 vaccines, and the controversial approval of aducanumab for the treatment of Alzheimer’s disease, represented polar opposites in terms of drug pricing reform. In the case of the vaccines, the U.S. In their letter, “ Drug Pricing Reform in 2021 – Going Big or Going Bipartisan?
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