Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen. Moreover, Humira’s behemoth status makes their introduction in the US particularly interesting.

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Pharmacy Drugs Generic Drugs FDA Approval 262

NPR Health - Shots

DECEMBER 4, 2022

For decades birth control research focused on women. Now there's a new push to develop gels, pills or other products that could keep men from getting their partners pregnant.

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Scientist Research Development Production 141

pharmaphorum

DECEMBER 4, 2022

Clinical trials of a wireless brain chip developed by Elon Muck’s Neuralink company will be tested in human volunteers within the next six months – and Musk himself says he intends to have one implanted for a future demo event. Neuralink has been promising that the technology will be ready for clinical trials soon for some time – first saying they were around the corner back in 2019 – so the latest announcement by Musk at an update last week may be met with some scepticism.

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Trials Clinical Trials Clinical Trials Medicine 118

NPR Health - Shots

DECEMBER 4, 2022

Sangeeta Siwan lost her job and wasn't able to pay rent or feed her family. Her neighbors helped her survive. A study of giving in India during the pandemic shows she wasn't alone.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

pharmaphorum

DECEMBER 4, 2022

Contrary to Big Tech, historically the pharmaceutical industry has had a good reputation for being a female-positive industry. However, both industries share a common problem: failure to provide women with C-suite opportunities. In fact, women hold only 11% of executive positions at Silicon Valley companies. The biopharma industry is worse, with women only accounting for 8% of CEO roles.

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Clinical Trials Clinical Trials Trials Development 105

BioSpace

DECEMBER 4, 2022

Whether a job search is voluntary or not, the psychological toll of months of interviews, wrangling over pay and benefits and evaluating options has a weighty psychological toll.

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BioSpace

DECEMBER 4, 2022

???????SonoThera closed its Series A round of financing Monday, counting $60.75 million in earnings and will use these proceeds to advance its ultrasound-guided, non-viral gene therapy platform.

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Gene Therapy Gene 97

pharmaphorum

DECEMBER 4, 2022

Amgen is lagging behind rivals like Novo Nordisk and Eli Lilly with its new-generation therapy for obesity, but is sufficiently encouraged by early-stage clinical data to kick off a phase 2 programme for the drug next year. AMG 133 is a bispecific molecule that addresses two targets, GLP-1 and GIPR, and in a phase 1 study achieved clinically significant body weight reductions over 12 weeks in people with obesity and without diabetes, according to Amgen.

Drugs 101

Drugs Genetics Trials Manufacturing 101

BioSpace

DECEMBER 4, 2022

FUJIFILM Diosynth Biotechnologies is offering unique opportunities to join one of the top global CDMOs focused on solving some of the most complex healthcare challenges.

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Medical Xpress

DECEMBER 4, 2022

China on Sunday reported two additional deaths from COVID-19 as some cities move cautiously to ease anti-pandemic restrictions amid increasingly vocal public frustration over the measures.

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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

Trials

BioSpace

DECEMBER 4, 2022

Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.

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NPR Health - Shots

DECEMBER 4, 2022

Many kids are getting sick at the same time. NPR's Ayesha Rascoe asks Vox senior public health reporter Dr. Keren Landman about the concept of "immunity debt.

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BioSpace

DECEMBER 4, 2022

Janssen (Johnson & Johnson) is no longer in the running to acquire rare disease player Horizon Therapeutics, the company announced Saturday. This leaves Amgen and Sanofi at the bidding table.

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JAMA Internal Medicine

DECEMBER 4, 2022

This systematic review and meta-analysis investigates whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US.

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Clinical Trials Clinical Trials Trials 76

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials

BioSpace

DECEMBER 4, 2022

Novartis announced the Phase III PSMAfore trial of Pluvicto for PSMA-positive metastatic castration-resistant prostate cancer met its primary endpoint.

Drugs 77

Drugs Trials 77

Drug Patent Watch

DECEMBER 4, 2022

Annual Drug Patent Expirations for VIIBRYD Viibryd is a drug marketed by Allergan and is included in one NDA. It is available from four suppliers. There are four patents protecting…. The post New patent expiration for Allergan drug VIIBRYD appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

DECEMBER 4, 2022

TauRx Pharmaceuticals and Anavex Life Sciences presented positive results from their candidates at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco, CA.

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Clinical Trials Clinical Trials Life Science Trials 70

Drug Patent Watch

DECEMBER 4, 2022

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Branding Marketing 52

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

NPR Health - Shots

DECEMBER 4, 2022

In New York City, Mayor Eric Adams plans to move homeless people with seeming mental illness to hospitals, possibly involuntarily.

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Drug Patent Watch

DECEMBER 4, 2022

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Branding Marketing 52

Drug Patent Watch

DECEMBER 4, 2022

This chart shows the drugs with the most patents in Eurasian Patent Organization. Patents must be filed in each country (or, in some cases regional patent office) where patent protection…. The post Which pharmaceutical drugs have the most drug patents in Eurasian Patent Organization? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 40