PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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The Pharma Data

NOVEMBER 19, 2021

government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral seeker, PAXLOVID ™ (PF-07321332; ritonavir), subject to nonsupervisory authorization from theU.S. government will acquire 10 million treatment courses to be delivered by Pfizer beginning latterly this time and concluding in 2022.

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The Pharma Data

OCTOBER 28, 2021

GOVERNMENT AN Fresh 50 MILLION PEDIATRIC Boluses OF COVID-19 VACCINE TO SUPPORT Farther PREPAREDNESS FOR FUTURE NEEDS. government has bought 50 million further boluses of the companies’COVID-19 vaccine. government has exercised its final purchase option under its beingU.S. PFIZER AND BIONTECH TO GiveU.S. With this order, theU.S.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.

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Conversations in Drug Development Trends

AUGUST 10, 2023

The event provided a unique opportunity to interact with a large and diverse group of fellow stakeholders, expanding my perspective on the impact of psychedelic clinical trials. Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.

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ProRelix Research

JANUARY 12, 2023

In India, the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Government of India is the National Regulatory Authority (NRA) responsible for the approval of […].

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PPD

SEPTEMBER 7, 2023

Case in point: Roughly 41% of infectious disease studies are HIV-related, showing significant industry investment across pharmaceutical and biotech companies and government entities. A CRO with a longstanding commitment to patient diversity in HIV trials can ensure proper representation within your trial.

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The Pharma Data

NOVEMBER 17, 2021

Nasdaq VIR) moment blazoned US government contracts totalling roughly$ 1 billion (1) (USD) to buy sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, which the US Food and Drug Administration (FDA) granted Exigency Use Authorization (EUA) in May 2021.

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Conversations in Drug Development Trends

AUGUST 15, 2023

You have access to our senior leadership, enabling effective project governance. With regular governance meetings and our executive oversight, you can be confident you have the access you need, and your study gets the attention it deserves. Discover the difference we can make for your trial.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Earlier this month, the US Government announced that it would purchase 100 million doses of the Moderna vaccine in a deal worth $1.53

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Drug Patent Watch

DECEMBER 9, 2024

This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceutical companies seek to protect their investments through patents. This patent was later revoked after the Indian government challenged it, citing ancient Ayurvedic texts that documented this use of turmeric.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. Gree USA’s Chief Executive Officer, Charley Loh, and the Chief Administrative Officer, Simon Chu, however, did not agree to the plea deal for the corporate entity, and elected to go to trial.

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on supply of bamlanivimab and etesevimab together. Bamlanivimab alone. Source link:[link].

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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DrugBank

APRIL 25, 2024

This tech can speed up everything from drug design to clinical trials by processing complex datasets more efficiently. Focus on building robust systems to manage and analyze a vast array of data types, ensuring top-notch data governance and quality. Data Management: AI thrives on data.

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The Pharma Data

NOVEMBER 9, 2021

Merck , known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics moment blazoned that the United States government will exercise two of its options to buy a aggregate of1.4 government has now committed to buy a aggregate of roughly3.1 government has now committed to buy a aggregate of roughly3.1

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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The Pharma Data

JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government under its existing supply agreement to 500 million. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. This press release features multimedia. Eligible U.S.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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The Pharma Data

NOVEMBER 18, 2021

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.

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The Pharma Data

AUGUST 31, 2021

The randomised, active-controlled global trial will enrol around 4,000 participants from a range of countries and will aim to evaluate GBP510’s safety and immunogenicity compared to an active comparator – the AstraZeneca/Oxford University COVID-19 vaccine.

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DrugBank

JULY 18, 2024

It commences with preclinical studies in animal models to assess safety and immunogenicity, followed by three phases of human clinical trials. Phase IV trials, also known as post-market surveillance studies, continue to monitor the vaccine's safety and effectiveness in the real world.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.

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The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

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Broad Institute

NOVEMBER 2, 2023

The research is guided by joint project and governance teams. As a result of this collaboration, Bayer’s mutant EGFR/HER2 inhibitor is currently in Phase I of clinical trials.

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The Pharma Data

MARCH 22, 2021

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.

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FDA Law Blog: Biosimilars

JULY 8, 2024

The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” Here are some brief facts of the case. This did not end the analysis, however.

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Cytel

APRIL 24, 2023

In the last 10 years, the Asia-Pacific (APAC) region has become a hotspot for clinical trials: the region contributed almost 50% of new clinical trial activity globally.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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The Pharma Data

APRIL 11, 2021

Basel, 12 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals.

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The Pharma Data

APRIL 8, 2022

NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer Inc.

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The Pharma Data

MARCH 29, 2022

The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial.

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