Sun.Feb 19, 2023

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Camrelizumab by Jiangsu Hengrui Medicine for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Camrelizumab is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Camrelizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Medicine 100
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Opinion: In Turkey, Ukraine, and beyond, the necessity of trauma care

STAT News

Watching news reports of the heroic relief efforts underway in Turkey and Syria following the devastating earthquake there, I can imagine the terrible weight of emotional trauma that so many people are experiencing right now because I’ve experienced it myself. A dozen years ago, as a young doctor with a background in emergency medicine, I felt prepared to handle disaster response situations.

Doctors 111
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AT-1412 by Kling Biotherapeutics for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

AT-1412 is under clinical development by Kling Biotherapeutics and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how AT-1412’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Antibody 100
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A kid in Guatemala had a dream. Today she's a disease detective

NPR Health - Shots

Neudy Rojop made a girlhood pledge. When family members fell ill, she says she decided to become a nurse "so I could change my community for good.

Nurses 118
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Annexuzlimab by MedAnnex for Kidney Cancer (Renal Cell Cancer): Likelihood of Approval

Pharmaceutical Technology

Annexuzlimab is under clinical development by MedAnnex and currently in Phase I for Kidney Cancer (Renal Cell Cancer). According to GlobalData, Phase I drugs for Kidney Cancer (Renal Cell Cancer) have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Annexuzlimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Antibody 100
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Correspondence shows troubling interactions between US officials and the alcohol industry

Medical Xpress

There is growing evidence that the alcohol industry uses a variety of strategies to influence public policy in a way that is advantageous to its own corporate interests, rather than the interest of public health. Recent communication between employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and alcohol industry groups shows extensive interaction on policy-relevant scientific issues, according to a new study in the Journal of Studies on Alcohol and Drugs.

Drugs 98

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An Uncommon Cause of Acute Chest Pain

JAMA Internal Medicine

This case report describes a patient in their 50s with 20 minutes of substernal chest pain radiating to the left shoulder and back, which was accompanied by shortness of breath and sweating.

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Zelenoleucel by Marker Therapeutics for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

Zelenoleucel is under clinical development by Marker Therapeutics and currently in Phase II for Refractory Acute Myeloid Leukemia. According to GlobalData, Phase II drugs for Refractory Acute Myeloid Leukemia have a 23% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Zelenoleucel’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Prevalence of Chronic Kidney Disease in China

JAMA Internal Medicine

This cross-sectional study provides periodic nationwide data on the prevalence of chronic kidney disease and the associated behavioral and metabolic risk factors in China.

76
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LYT-200 by Puretech Health for Metastatic Pancreatic Cancer: Likelihood of Approval

Pharmaceutical Technology

LYT-200 is under clinical development by Puretech Health and currently in Phase II for Metastatic Pancreatic Cancer. According to GlobalData, Phase II drugs for Metastatic Pancreatic Cancer have a 32% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how LYT-200’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do?

FDA Law Blog

Hyman, Phelps & McNamara (“HPM”) Director Larry Houck will present “Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do?” at this year’s American Pharmacists Association’s (“APhA’s”) Annual Meeting in Phoenix, March 24-27. Mr. Houck was a diversion investigator with the Drug Enforcement Administration (“DEA”) in the field and at agency headquarters for 15 years before joining HPM in 2001.

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STRO-002 by Sutro Biopharma for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. According to GlobalData, Phase I drugs for Refractory Acute Myeloid Leukemia have a 69% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how STRO-002’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Antibody 100
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New patent expiration for Novartis drug LEQVIO

Drug Patent Watch

Annual Drug Patent Expirations for LEQVIO Leqvio is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nineteen patents protecting… The post New patent expiration for Novartis drug LEQVIO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Takeda’s Vedolizumab Clears Phase III in aGvHD

BioSpace

Takeda’s Vedolizumab Clears Phase III in aGvHD 2/20/2023

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Safely Prescribing Nirmatrelvir and Ritonavir—Avoiding Drug-Drug Interactions

JAMA Internal Medicine

This Teachable Moment discusses drug-drug interactions with nirmatrelvir and ritonavir (Paxlovid) treatment for COVID-19 and considerations when prescribing.

Drugs 46
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FDA Approves Apellis' Syfovre as First Treatment for Geographic Atrophy

BioSpace

FDA Approves Apellis' Syfovre as First Treatment for Geographic Atrophy 2/20/2023

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Which pharmaceutical companies have the most insert dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most insert dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most insert dosed drugs… The post Which pharmaceutical companies have the most insert dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Travere Scores Accelerated Approval for First Non-Immunosuppressive IgAN Ther.

BioSpace

Travere Scores Accelerated Approval for First Non-Immunosuppressive IgAN Ther.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.