Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.

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Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Drug Discovery World

FEBRUARY 12, 2024

Why has there been so little progress in medicine? 5 Reliability of animal testing Even the few drugs that go on to be licensed for use in the general population can have unexpected and serious adverse effects once they are prescribed in large numbers. Drug discovery and development tomorrow – Changing the mindset.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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Drug Discovery World

DECEMBER 20, 2022

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . The therapy was also recently approved by the FDA for patients in the US. . World’s most expensive drug.

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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).

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XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Drug Discovery World

JANUARY 15, 2024

Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan. Clinical studies conducted to date have demonstrated OHB-607’s potential to significantly reduce the risk of severe BPD. of Perspective’s shares for up to $33 million.

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Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor.

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pharmaphorum

MAY 4, 2022

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. Once selected, Quris can in-license them, progress them through to phase 1 trials and, those that succeed, can be licensed to pharma companies.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

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The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

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pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. 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. About the Phase 2/3 Study.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. and Roche will develop, manufacture and distribute it outside of the U.S.

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. Official comments .

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies. About Inflection Biosciences.

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The Pharma Data

APRIL 4, 2022

Chief Medical Officer and Head of Global Product Development, Roche. More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”. today announced that the U.S. Actemra/RoActemra is not U.S.

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Delveinsight

DECEMBER 1, 2020

The approval is based on the results of the two clinical trials CELESTIAL (XL184-309), a global, randomized, placebo-controlled, double-blind phase 3 clinical trial, and Cabozantinib-2003 , a phase 2 clinical trial conducted in Japan in patients with advanced HCC who had received prior systemic therapy.

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Drug Discovery World

MARCH 29, 2023

An example of the current disparity, drawn from data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), can be seen in Romania, Poland or Bulgaria, where a recently approved medicine will take more than 800 days on average before it becomes publicly available compared with Germany, where that figure is 133 days 3.

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Camargo

AUGUST 11, 2021

In this two-part blog series, we will explore the regulatory strategy considerations sponsors should bear in mind when working with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with a focus on the development of drug and biologic products.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. . ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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Delveinsight

AUGUST 13, 2020

Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an evaluation of Gilead’s remdesivir clinical trials, which found the studies that flunked to offer an equal representation of Black, Latinx, and Native Americans. F2G raises USD 60.8 F2G has raised USD 60.8

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XTalks

MARCH 1, 2021

Pfizer/BioNTech are executing the three-dose study to also determine the effectiveness of a third dose against evolving variants as part of their clinical development strategy. Our proactive clinical development strategy aims to create the foundation today, that will enable us to address the challenges of tomorrow.

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Drug Discovery World

JULY 2, 2024

In another example, university of Basel spin-off T3 Pharma reached Phase I development of a cancer therapy that harnesses the natural behaviours of live bacteria before being acquired by Boehringer Ingelheim for $509m at the end of 2023. Biopôle Lausanne has been created to provide a focus for life sciences activity in the region.

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The Pharma Data

APRIL 19, 2022

Enhertu is a HER2 – directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. The sBLA is based on data from the registrational DESTINY-Lung01 Phase II trial published in The New England Journal of Medicine, and is supported by the Phase I trial (DS8201-A-J101) published in Cancer Discovery.

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The Pharma Data

NOVEMBER 3, 2020

Nasdaq:LOGC) (LogicBio), a company dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms, announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LEXINGTON, Mass.,

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The Pharma Data

MAY 31, 2022

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Dupilumab Development Program. About Eosinophilic Esophagitis (EoE). In the U.S.,

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