Cytel

DECEMBER 21, 2022

Here are some of our most-read interviews of 2022.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Poster at ISSX/MDO 2022 Seattle meeting. [6] We hope it was a useful two-parter! Acta Pharm Sin B.

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Drug Target Review

OCTOBER 11, 2023

Prior to this, he led global high throughput medicinal chemistry, natural product and antibody drug conjugate departments across Germany, France, and the US, and has contributed to the advancement of many projects into clinical development across several therapeutic areas. References England Rare Diseases Action Plan 2022.

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New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

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Drug Target Review

JANUARY 15, 2024

Previously, as a member of the faculty at Harvard Medical School , Dr Kavanagh was engaged in preclinical and clinical development of cellular immunotherapy and products. Journal for ImmunoTherapy of Cancer 10:e004281 (2022). Frontiers in Immunol, Mar 3:13:835762 (2022). Engineering soluble T-cell receptors for therapy.

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Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin.

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Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. The Journal of Clinical Investigation. 2022 Jul 1;132(13).

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Vial

APRIL 10, 2024

increase at constant currency compared to the corresponding period in 2022. Positioned as a technology-centric CRO, Vial aims to revolutionize clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes. increase on a reported basis and an 4.8%

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The Pharma Data

FEBRUARY 22, 2022

He began his oncology development career at Rhône Poulenc Rorer Inc. In 1999, he joined the Aventis Group as Senior Director, Oncology Global Clinical Development. The composition of the Board’s specialized committees will be reviewed following the Annual General Meeting of Shareholders scheduled for May 3, 2022.

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LifeSciVC

APRIL 2, 2024

Our engagement with investors started well before our launch out of stealth and the Series B in 2022. The insights from these internal discussions refined our messaging and helped demonstrate the compelling opportunity we have to advance a truly groundbreaking clinical development program.

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The Premier Consulting Blog

OCTOBER 21, 2024

The 2022 FDORA Omnibus Act, enacted on December 29, 2022, further solidified this shift by making confirmatory trials a key component of the clinical development plan, contrasting with earlier practices where they were often a post-approval requirement.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. billion to be paid upon the achievement of certain paediatric clinical development milestones. The transaction is expected to close in the third quarter of 2022. GSK will account for the transaction as a business combination.

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The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. billion to be paid upon the achievement of certain paediatric clinical development milestones. The transaction is expected to close in the third quarter of 2022. GSK will account for the transaction as a business combination.

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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.”. In connection with the acquisition, Arena’s shares of common stock will be delisted from the Nasdaq Global Select Market on or about March 11, 2022.

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The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Zuranolone is being evaluated in the LANDSCAPE and NEST clinical development programs. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc.

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LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J.

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The Premier Consulting Blog

JULY 9, 2023

Formally, both of these documents apply solely to marketing approval; informally, however, they are often used as general guidelines during clinical development to avoid obstacles that could result in extensive process changes, product reformulation, or safety qualification efforts. evaluating the safety of) impurities and degradants.

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Cytel

JANUARY 4, 2023

In 2022, Cytel laid the foundations for many projects that will bear fruit this year. Returning to Cytel after the winter holidays, I am excited to begin a year that will likely prove memorable for both my colleagues at Cytel and the industry at large.

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DrugBank

SEPTEMBER 26, 2024

For instance, Inflectra , a biosimilar of Remicade, underwent a comprehensive clinical development program, including a Phase III trial demonstrating comparable efficacy and safety to the reference product in patients with rheumatoid arthritis.

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The Pharma Data

MARCH 28, 2022

mg in the United States in the second quarter of 2022. About the SUSTAIN clinical programme The SUSTAIN clinical development programme for once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 11,000 adults with type 2 diabetes.

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Labcorp Drug Development

FEBRUARY 17, 2023

In December 2022, Labcorp and Biomakers signed an agreement that will positively impact thousands of cancer patients in Latin America through greater access to diagnostic molecular profiling and participation in clinical trials.

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Labcorp Drug Development

APRIL 17, 2023

In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an … The post Alcohol-related liver disease: Inherent Challenges and Strategies for Successful Clinical Trial Conduct appeared first on Insights From Our Labs to Yours.

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The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June.

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The Pharma Data

MARCH 1, 2022

Closing of the transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act, which is expected in March or April of 2022.

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The Pharma Data

DECEMBER 21, 2020

The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

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The Pharma Data

MARCH 29, 2022

The pCR data from CheckMate -816 were presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, and the EFS results will be presented in a clinical trials plenary session at the AACR Annual Meeting 2022 on April 11, 2022, beginning at 10:15 a.m. CT, in New Orleans, Louisiana.

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The Pharma Data

MAY 31, 2022

Initiation of global non-interventional study for patients with Parkinson’s planned for the second half of 2022 as next step. BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer?AG, Senior Vice President, Clinical Development, BlueRock Therapeutics. “We AG, announced?the

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Vial

MARCH 1, 2024

Recent and significant activities among these top CROs based in the US include the acquisition of Pharmaceutical Product Development (PPD), a global industry leader in clinical development and analytical services, by Thermo Fisher Scientific Inc. Labcorp, IQVIA, ICON, and WuXi Clinical (based on 2022 annual revenue).

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Creative Biolabs

MAY 25, 2022

Fu, 2022) Clinical research progress of ADC After decades of efforts, more than 100 ADCs are currently under clinical development. The overview of the mechanisms of ADC for killing cancer cells via different approaches. (Fu,

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Agency IQ

JULY 13, 2023

October 1, 2022 December 31, 2022 [link] PDUFA 36 Establish and communicate publicly a pilot Advancing RWE Program intended to: Identify approaches for generating RWE that meet regulatory requirements in support of labeling for effectiveness (e.g.,

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The Pharma Data

OCTOBER 27, 2020

Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. The funds will be utilized to support the clinical development of Prokarium’s microbial immunotherapy for non-muscle invasive bladder cancer as well as expansion of its pipeline across multiple solid tumors.

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LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots.

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The Pharma Data

JANUARY 27, 2021

We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them,” said Bruce Goldsmith, Ph.D., We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.

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The Pharma Data

APRIL 24, 2023

“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

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