Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease. Tor Biering-Sørensen, MD, PhD, MPH. Key Points.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 12, 2023

The Central government has notified the administrative Rules for the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory Committee to regulate and monitor experiments on animals to prevent cruelty to animals, with provisions for deemed approval and grading of animal house facilities in medical colleges, pharmacy colleges, (..)

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XTalks

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

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The Pharma Data

DECEMBER 22, 2020

CanSino Biologics has enrolled more than 20,000 participants in a global phase 3 study of its COVID-19 vaccine candidate, Ad5-nCoV, co-developed with a research arm of the Chinese military. The trial is being conducted in Argentina, Pakistan, Russia, Mexico and Chile. Source link.

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XTalks

SEPTEMBER 22, 2023

In time for respiratory virus season this fall and winter, the US Food and Drug Administration (FDA) approved updated COVID vaccines from Pfizer/BioNTech and Moderna last week, followed by an endorsement from the Centers for Disease Control and Prevention (CDC) a day later. The updated COVID vaccines target the XBB.1.5

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Pfizer

MARCH 28, 2023

Improving COVID-19 Vaccine Access in Partnership with Amref Health Africa carterda Tue, 03/28/2023 - 16:45 Improving COVID-19 Vaccine Access in Partnership with Amref Health Africa Tuesday, March 28, 2023 - 05:00pm Share A community member while receiving a COVID-19 vaccine in Uganda.

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pharmaphorum

MAY 20, 2022

In recent years the retail pharmacy chain has begun to delve more and more deeply into the healthcare sector – by constantly expanding the basic healthcare services offered at their instore Minute Clinics, and by buying into the health insurance insurance space with their $69 billion purchase of Aetna in 2017.

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XTalks

NOVEMBER 16, 2020

Moderna announced today that its highly anticipated COVID-19 vaccine candidate appears to be 94.5 This is according to preliminary trial data from the company’s ongoing study that involves 30,000 people in the US. Moderna’s mRNA vaccine candidate — mRNA-1273 — was developed using its proprietary mRNA technology platform.

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pharmaphorum

FEBRUARY 10, 2022

CVS Health has said it will beef up its clinical trials operations, improving its ability to recruit patients from a broad demographic spectrum, via an agreement with digital health company Medable. Pharmaceutical industry organisation PhRMA says that most delays to trials occur in the start-up phase.

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ACRP blog

JUNE 21, 2022

The recent launch by the Walgreens pharmacy store chain of clinical trial business operations will improve patient diversity in medical studies and boost trials as a care option, says Ramita Tandon, chief clinical trials officer for the Illinois-based company. Author: Michael Causey.

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pharmaphorum

SEPTEMBER 14, 2022

With countless media stories regarding COVID-19 published over a period of several years, it was obvious that people around the globe were tuned in to every step of the fight against the pandemic, eagerly learning about everything from symptoms to vaccine development. Leveraging patient perspectives. Interest by demographics. counterparts).

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XTalks

FEBRUARY 22, 2021

(NASDAQ: PFE ) and BioNTech SE (Nasdaq: BNTX ) revealed they have submitted new data to the US Food and Drug Administration (FDA) that demonstrates the stability of their COVID-19 vaccine when stored at common freezer temperatures of -25°C to -15°C for pharmaceutical products. The vaccine is injected at room temperature by medical staff.

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Pharmaceutical Technology

JANUARY 20, 2023

In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA technology. billion in Covid-19 vaccine sales.

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Delveinsight

AUGUST 26, 2021

The company then utilizes the de-identified records to improve the design of clinical trials and quality of life measurements. Through the collaboration, the companies focus on connecting clinical trial data with specialty pharmacy information, natural history, registry data, and broad claims databases.

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XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. One country that has already vaccinated 1.8 Combating COVID-19 Vaccine Misinformation.

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Pharmaceutical Technology

JUNE 9, 2023

The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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ACRP blog

JANUARY 10, 2024

Views from ACRP Members Topics highlighted include diversity and inclusion, decentralized clinical trial (DCT) elements, workforce challenges, and a possible role for sponsors and contract research organizations (CROs) in supporting outreach by sites based in diverse communities.

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The Pharma Data

DECEMBER 31, 2020

million doses of the approved Pfizer and Moderna COVID-19 vaccines had been distributed across the United States by Monday morning, just 2.1 That’s far too slow a pace, said one official charged with spearheading the vaccination of Americans. million vaccination tally — compiled by the U.S. . THURSDAY, Dec.

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The Pharma Data

MAY 7, 2021

Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). The US opened pandora’s box on IP waivers for Covid-19 vaccines. . In Focus: US. What happens now?

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Sciensano

MARCH 27, 2024

Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021. Pharmacies that sell medicines online must display the European logo for Internet pharmacies on every page of their website.

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The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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The Pharma Data

AUGUST 21, 2020

Regeneron claims REGN-COV2, which is currently being studied in two Phase 2/3 clinical trials, provides a much-needed treatment option for Covid-19 that has the potential to prevent infection and thus slow down the spread of the pandemic on a global scale. McKesson supports OWS to centralize distributor of future Covid-19 vaccines.

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The Pharma Data

NOVEMBER 12, 2020

12, 2020 — Early COVID-19 vaccine BNT162b2 trial results announced by Pfizer this week caused hopes to soar for a swift end to the pandemic that has killed more than 242,000 and infected more than 10 million in the United States alone. Pfizer is making the vaccine at facilities in Kalamazoo, Mich., THURSDAY, Nov.

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Pharmacy Checkers

MAY 8, 2020

A good portion of this blog takes on Big Pharma for their funding of misleading public information campaigns and programs against drug importation and the practice of safe international online pharmacies. Longer and more involved clinical trials are still necessary for the drug to obtain full approval. Canada, India or anywhere.

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The Pharma Data

AUGUST 21, 2020

In non-COVID-19 news, Amazon has entered the pharmaceutical market by launching ‘Amazon Pharmacy’ in India, while Johnson & Johnson is set to buy the Cambridge-based Momenta Pharmaceuticals for $6.5 Top Russian doctor quits over questionable ethics that rushed through coronavirus vaccine approval. Amazon Pharmacy launches in India.

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pharmaphorum

JANUARY 27, 2021

Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. And how long did the trial last?

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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The Pharma Data

DECEMBER 30, 2020

Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. © 2020 HealthDay. All rights reserved. Posted: December 2020. Source link.

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ACRP blog

APRIL 17, 2023

Disruption and innovation are key to driving needed improvements in the clinical trial ecosystem. Perseverance is required to transform clinical trials to advance drug development for the benefit of patients. Our retail pharmacies are a great asset here—with 78% of the U.S.

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The Pharma Data

MAY 13, 2021

CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ). US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ). Covid vaccines may not protect people with immune disorders. NIH trial seeks answers. (

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World of DTC Marketing

SEPTEMBER 9, 2021

New technologies are being developed that allow for virtual clinical trials and other cost-lowering development costs. Collectively, hospitals boast a margin of 8 percent, a level higher than margins in the pharmacy industry or the insurance industry. Then there is the cost of people who refuse to get vaccinated against COVID.

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XTalks

NOVEMBER 27, 2023

Huh is a versatile scientist and pharmacist with 20 years of experience in pharmaceuticals, pharmacy and contract research organizations (CROs). Dhingra is a pharmaceutical professional with over 15 years of experience in various fields including pharmacovigilance for drugs, biologics, medical devices and vaccine safety.

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Pfizer

SEPTEMBER 27, 2022

That’s why Pfizer invests in research and development: to produce groundbreaking treatments, like the COVID-19 vaccine, that improve people’s lives. In the current broken rebate system, insurers and pharmacy benefit managers negotiate substantial rebates with pharmaceutical companies to lower the price of medicines. COVID-19, Vaccines.

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The Pharma Data

DECEMBER 23, 2020

A watershed moment for Pfizer and BioNTech as they announced Covid-19 vaccine was 90 per cent efficient. In early November, Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, was more than 90 per cent effective in preventing Covid-19 in cases where participants had shown no evidence of being infected with coronavirus.

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pharmaphorum

JUNE 17, 2022

In clinical trials, 5.6 A major blind spot in the data is how effective Paxlovid is at treating vaccinated patients who contract COVID-19. Although preliminary trial data from Pfizer found rebound in 1 to 2 percent of patients, it occurred in both placebo and treatment groups.

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XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. The list also included melatonin. The results still require further validation, including experimental and clinical evaluation.

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