The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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Drug Target Review

AUGUST 28, 2024

What are the main challenges currently faced in the treatment of chronic liver diseases, and how does Resolution Therapeutics aim to address these challenges? Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Many parents are hesitant to pursue testing since it will not affect the patient’s care management, as several of these diseases have no approved treatments, such as Fragile X, a syndromic form of autism. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

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The Pharma Data

JULY 12, 2021

The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021.

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The Pharma Data

JANUARY 15, 2021

for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. .–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. In the U.S., Sammons Cancer Center and the W.W. Caruth, Jr.

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The Pharma Data

JUNE 26, 2021

The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Roche’s Chief Medical Officer and Head of Global Product Development. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S.

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The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. “In Perlmutter, President, Merck Research Laboratories. “We About A2 Biotherapeutics.

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). We look forward to bringing the benefit of this LYNPARZA combination to patients earlier in their treatment.” In the U.S.,

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The Pharma Data

SEPTEMBER 21, 2020

AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation across the European Union for the first-line maintenance treatment with bevacizumab for patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. Photo by D Wells. months versus 35.3 months with bevacizumab.

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The Pharma Data

NOVEMBER 9, 2020

The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC). The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. Merck , also known as MSD outside of the U.S.

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The Pharma Data

AUGUST 24, 2020

It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment. The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

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The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391). About Deucravacitinib.

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The Pharma Data

SEPTEMBER 28, 2021

Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. This positive CHMP opinion is a crucial breakthrough in bringing a replacement immunotherapy treatment option with KEYTRUDA to appropriate patients in Europe with metastatic triple-negative carcinoma. About Triple-Negative carcinoma. About Merck.

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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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The Pharma Data

JANUARY 3, 2021

Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated. The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. NEW YORK and LONDON, Jan.

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The Pharma Data

JUNE 1, 2022

Under her leadership, Pfizer advanced into clinical development or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.

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The Pharma Data

APRIL 28, 2023

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. Preventing or delaying radiographic progression is an important clinical endpoint in assessing oncologic treatment and is very relevant to patients, their caregivers and their families.

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Drug Target Review

OCTOBER 10, 2024

Therapies that showed promise in healthy cell models may fail to achieve desired clinical outcomes in patients. Diseased cells can respond differently to treatment, leading to unforeseen adverse events, including severe toxicity and even death.

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Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

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The Pharma Data

APRIL 8, 2021

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.

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The Pharma Data

JUNE 7, 2023

Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. These results add to the emerging picture of how individualized neoantigen therapy may advance melanoma treatment and the promise it may hold for other types of cancer. The safety profile of KEYTRUDA was consistent with findings from previous studies.

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Precision for Medicine

MAY 24, 2023

About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively.

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Precision for Medicine

JUNE 26, 2023

“This acquisition allows us to vastly expand our capabilities and deliver efficient and strategic solutions that drive the path forward for manufacturing complex treatments while ensuring reliable and consistent drug supply chains.” This convergence is driving faster clinical development and approval.

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The Pharma Data

APRIL 4, 2022

living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. If approved, Dupixent would be the first medicine available in the U.S. About Dupixent.

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The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

These body-on-a-chip (BOC) devices place each tissue type in its own pea-sized chamber and connect them via fluid-filled microchannels into living, integrated biological systems on a laboratory plate. Both tamoxifen alone and the combination treatment showed some off-target effects on heart cells. Sci Transl Med. 2019 Jun 19;11(497).

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The Pharma Data

MARCH 8, 2021

“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At About Molnupiravir.

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The Pharma Data

MARCH 16, 2021

Aligning with a circuitry-based approach to precision psychiatry, the collaboration will leverage Boehringer Ingelheim’s deep experience in central nervous system (CNS) drug discovery and development alongside Lieber’s expertise in centrally acting COMT inhibitors. The Lieber Institute for Brain Development. Hugh Marston, Ph.D.,

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The Pharma Data

JULY 29, 2021

About Kumquat Biosciences Kumquat Biosciences is a privately held drug discovery and development company committed to creating breakthrough medicines for the treatment of cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

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Agency IQ

DECEMBER 1, 2023

Completed development of the EUDAMED Market Surveillance module Q4 2023 Designation of E.U. Reference Laboratories Proposal for five laboratories to receive E.U. Reference Laboratory designation Q4 2023 Critical medicines list [E.U.] Title Call for Evidence Closes Comments Close Planned Adoption Draft E.U.

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The Pharma Data

NOVEMBER 22, 2020

The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments. It holds the rights for the drug in the rest of the world.

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The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. who are unable to control their disease with systemic therapy and are most in need of a treatment option. There are approximately 75,000 people in the U.S.

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The Pharma Data

JUNE 25, 2021

We hope to build on this important research and provide new treatment options to kidney cancer patients.”. “As The late-breaking results will be presented in the Plenary session of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA5) on Sunday, June 6, 2021. KEYTRUDA is currently approved in the U.S.,

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The Pharma Data

JANUARY 24, 2021

In a series of laboratory experiments, StemVacs administration was demonstrated to induce regression of GL261 glioma, CT-26 colorectal cancer, and Lewis Lung Carcinoma tumors grown in mice. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.

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The Pharma Data

OCTOBER 27, 2020

Clynes developed several novel therapeutic approaches in cancer and autoimmunity, including DC targeting for cancer vaccines and Syk and JAK mediated inhibition of DCs and T cells in autoimmunity therapy. Dean A.

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. He spent 27 years at Merck & Co.

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The Pharma Data

JANUARY 20, 2021

In order to do so, the DSMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the trial. The CEC comprises clinical experts in cardiology and Intensive Care and has been established to ensure accurate and consistent assessment of the trial endpoints and/or serious adverse events.

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