The Pharma Data

JUNE 13, 2025

FDA Approves KEYTRUDA® (Pembrolizumab) for Perioperative Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma Merck known as MSD outside the United States and Canada, recently announced that the U.S. Importantly, these side effects may manifest during or after treatment with KEYTRUDA.

FDA Approval

PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials

Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

Laboratories

The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. Source link: [link].

FDA Approval

The Pharma Data

JULY 28, 2021

– If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1. TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1), 2 a chronic neurological disorder that alters the sleep-wake cycle.

Clinical Development

The Pharma Data

APRIL 15, 2022

Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Designed computationally and refined in the laboratory, the new protein therapies thwarted infection by interfering with the virus’ ability to enter cells. Food and Drug Administration (FDA). Food and Drug Administration (FDA). 2 omicron subvariant.

Treatment

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

Clinical Trials

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 and $86.01

Laboratories

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].

Treatment

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).

Drugs

The Connected Lab

APRIL 8, 2020

The cost to develop a new prescription medicine that gains market approval has gone up 145% to $2.6 billion and takes an average of 10 years to develop 1. For patients suffering from an illness with no approved treatment, the wait can be unnerving. A Tough Road: Cost To Develop One New Drug Is $2.6 Nature , vol.

Pharma Companies

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.

Trials

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.

Clinical Trials

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.

Therapies

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.

Research Laboratories

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.

FDA Approval

Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

Clinical Research

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.

Trials

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.

Disease

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

Pharmacokinetics

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.,

FDA Approval

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.,

Licensing

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.

Small Molecule

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.

Small Molecule

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.

Small Molecule

The Pharma Data

JUNE 26, 2021

Global Development Head, Oncology at Sanofi. Together with Regeneron, we’re committed to addressing gaps in the treatment of advanced forms of non-melanoma skin cancer.”. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo. Adamson, M.D.,

Trials

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.

Vaccine

The Pharma Data

MARCH 5, 2021

” “While covalent BTK inhibitors and venetoclax have transformed the treatment of CLL, we now see many patients needing new therapeutic alternatives,” said Brian Koffman, MDCM (retired), chief medical officer of the CLL Society. chief medical officer of Loxo Oncology at Lilly. About Loxo Oncology at Lilly.

Clinical Trials

New Drug Approvals

JANUARY 3, 2023

1] It is being developed by Mirati Therapeutics. [1] 1] It is being developed by Mirati Therapeutics. [1] Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer.” 2] Research It is undergoing clinical trials. [5] 1] It is taken by mouth. [1]

FDA

The Pharma Data

DECEMBER 3, 2020

Monti is a pioneer in the research and development of neuroactive steroids known as pherines, which includes VistaGen’s intranasal treatment candidate PH94B for anxiety disorders and PH10 for depression. Zai Lab – Alan Sandler was appointed to the newly created role of president and head of Global Development in Oncology.

Pharmaceuticals

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.,

FDA

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.

Clinical Trials

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.

Science

Precision for Medicine

JANUARY 23, 2023

“By joining QuartzBio’s amazing team, we will be able to provide the comprehensive solution our clients need to get precision treatments out to patients faster. This convergence of trials, labs and data sciences is driving faster clinical development and approval. We are honored to be a part of this journey.”

Clinical Research

The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. chief medical officer, oncology at Lilly.

Research

The Pharma Data

NOVEMBER 18, 2021

Senior Vice President, Early Clinical Development, Hematology/ Oncology and Cell Therapy and San Francisco point head. “ LabCentral offers completely permitted laboratory and office space for as numerous as 70 startups comprising roughly 500 scientists and entrepreneurs. AboutBioLabs@NYULangone( New York, NY).

Molecular Biology

The Pharma Data

NOVEMBER 19, 2020

Structure-based design approach has identified potent compounds for further development as oral treatments for SARS-CoV-2 infection and related human coronaviruses. Program focused on inhibitors of SARS-CoV-2 main protease, a highly conserved protein essential for viral replication. References.

Small Molecule