The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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Drug Discovery World

MARCH 7, 2023

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials.

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Drug Discovery World

JUNE 1, 2023

Roberto Iacone, CEO at Alentis Therapeutics, said: “There are huge unmet needs in organ fibrosis and cancer, and this funding enables us to continue with the important work we’re doing in the CLDN1 space and generate clinical data from both our programs.

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Broad Institute

NOVEMBER 2, 2023

We look forward to continuing our work with renowned Broad scientists to advance additional innovative cancer targets into clinical development.” 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

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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Conversations in Drug Development Trends

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.

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The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. NIH tests antibodies in Covid-19 clinical trial alongside Eli Lilly and AbCellera .

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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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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By geographical region, the global CRO services market in 2023 was dominated by North America.

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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

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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SugarCone Biotech

APRIL 2, 2024

Contributed by Paul Rennert There is a lot to worry about as your biotech moves from discovery work to IND filings to clinical development. Finally, both WuXi Apptec and WuXi Bio are accused of having deep ties with the Chinese military, which are kept hidden from Western companies and governments. such things as drug approvals.

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Drug Discovery World

MAY 16, 2023

Investment landscape In 2023, Matthieu de Kalbermatten, CEO of CellProthera, looks forward to presenting the final safety and efficacy results of the company’s Phase II clinical trial, and for moving into Phase III. Entering pivot trials with a low-throughput, high-cost, highly variable, paper-based process is no longer acceptable.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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The Pharma Data

AUGUST 12, 2020

Moderna continues to rise to meet the demands of the pandemic, signing a new deal with the US Government to supply 100 million doses of its messenger RNA (mRNA) vaccine candidate for the prevention of COVID-19. Under the terms of the deal, the US Government will also have the option to reserve a further 400 million doses of the vaccine. “We

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The Pharma Data

OCTOBER 28, 2020

We appreciate the confidence of the MHLW in Moderna and mRNA-1273, which we hope will help address the pandemic, especially given the encouraging data we have recently published together with the NIH related to the clinical trial in the elderly and older adult population,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

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Drug Target Review

APRIL 3, 2024

The results from these trials will build the basis for addressing therapy-induced GDF-15-mediated resistance of cancers, a problem that represents a significant challenge across several therapeutic classes, including approaches currently in advanced stages of clinical development. in North America) in late 2017.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

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Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Many companies are unable to develop these niche therapies because of the associated costs and limited financial return.

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 1-3 Evusheld was generally well-tolerated in the trial.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. I have participated in many trials and studies.

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The Pharma Data

APRIL 4, 2022

Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic. The extensive Actemra/RoActemra RA intravenous (IV) clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.

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The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. About IDHIFA. WARNINGS AND PRECAUTIONS.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

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Drug Discovery World

OCTOBER 16, 2023

Government investment of £1.3 CellProthera selected the UK centres for their excellence in the conduct of clinical research with dedicated staff, equipment, availability of imaging platforms and high interest in cell therapy cardiovascular trials especially University Hospital of Birmingham equipped with a bi-plane Cathlab.

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The Pharma Data

MARCH 13, 2022

In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.”. Arena has previously indicated that it expected the results of the Phase 3 ELEVATE-UC trial of etrasimod in ulcerative colitis during the first quarter of 2022.

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The Pharma Data

APRIL 26, 2022

Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in the third quarter of 2022, subject to regulatory approval.

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The Pharma Data

OCTOBER 29, 2020

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions. “We About Avance Clinical www.avancecro.com.

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Precision for Medicine

JUNE 26, 2023

Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences and advanced manufacturing solutions. This convergence is driving faster clinical development and approval.

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The Pharma Data

JANUARY 3, 2021

TLC19 Hydroxychloroquine Liposome Inhalation Suspension was thus incubated, with Phase I clinical trial currently taking place in Taiwan and Australia. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. Cautionary Note on Forward-Looking Statements.

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The Pharma Data

APRIL 29, 2022

In this trial, compared to placebo, Pfizer observed risk reductions of 32% and 37% in adults who received PAXLOVID for five and ten days, respectively, to prevent infection. Analyses of all secondary endpoints and sub-groups are ongoing, and results will be included in the publication or presentation of the final study results. “We

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The Pharma Data

MAY 26, 2023

4,5) The FDA approval of PAXLOVID is based on the totality of scientific evidence shared by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program. government will continue to oversee the distribution of PAXLOVID, and U.S. 11) At this time, the U.S.

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