Sun.Dec 17, 2023

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New Breakthrough Points to a Future Treatment For Morning Sickness

AuroBlog - Aurous Healthcare Clinical Trials blog

Sickness in pregnancy, or hyperemesis gravidarum, is common and is thought to affect seven out of ten women at some time in their pregnancy. But, until recently, very little has been known about why it happens.

Hormones 214
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Oncologists Defend CAR-T After FDA Advisory

BioSpace

The agency is investigating reports of secondary blood cancers in patients who have received certain CAR T cell therapies, but experts say the risk is low and is outweighed by the terminal nature of some cancers.

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More needs to be done in Asian diabetic population to design a culturally adaptable lifestyle intervention: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

More needs to be done in the Asian diabetic population to design a more socially and culturally adaptable lifestyle intervention, according to Dr. Hema Venkatraman, consultant endocrinologist and medical advisor, Practo Transform. Dr Venkatraman further informed that diabetes remission as a diabetes management pathway is a relatively new concept.

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FDA Finds Quality Control Problems at Moderna’s Vaccine Facility: Reuters

BioSpace

There is no evidence that the lapses have harmed patients who received Spikevax or clinical trial participants who received investigational shots.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Association Between Daily Toothbrushing and Hospital-Acquired Pneumonia

JAMA Internal Medicine

This systematic review and meta-analysis of randomized clinical trials assesses the association of toothbrushing with hospital-acquired pneumonia, mortality, length of stay, duration of mechanical ventilation, and use of antibiotics in hospitalized patients.

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BMS’ LAG-3 RELATIVITY theory fails futility test

pharmaphorum

Bristol-Myers Squibb has abandoned a bid to extend the indications of its combination of PD-1 inhibitor Opdivo and LAG-3 inhibitor relatlimab into colorectal cancer after it failed the phase 3 RELATIVITY-123 trial.

Trials 90

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Corporate Influences on Science and Health—the Case of Spinal Cord Stimulation

JAMA Internal Medicine

This Viewpoint discusses tactics by corporations to criticize scientific research that may be unfavorable to their industries, recently including the spinal cord stimulator industry.

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In Second Fund, Pivotal Raises $389M to Create and Support Transformative Companies

BioSpace

The new fund brings Pivotal bioVenture Partners’ total capital to $689 million, which the venture capital firm intends to pump into young biotechs developing “innovative and impactful therapeutics.

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Crucial Data Solutions Recognized as a Major Contender in Everest Group’s Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023

Crucial Data Soutions

Reno, NV, December 18, 2023 – Crucial Data Solutions (CDS), the only SaaS platform provider to empower customer-driven global clinical. The post Crucial Data Solutions Recognized as a Major Contender in Everest Group’s Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023 appeared first on Crucial Data Solutions.

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Illumina Loses Long Antitrust Battle, Readies to Divest GRAIL

BioSpace

Following a U.S. appeals court decision, the company said it is preparing to divest GRAIL through a third-party sale or capital markets transaction.

Sales 88
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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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New tentative approval for Teva Pharms drug dasatinib

Drug Patent Watch

Dasatinib is the generic ingredient in two branded drugs marketed by Apotex and Bristol Myers Squibb and is included in three NDAs. There are two patents protecting this compound. Drug… The post New tentative approval for Teva Pharms drug dasatinib appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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FDA Action Alert: Calliditas, Ionis/AstraZeneca, Amgen and More

BioSpace

The year may be coming to a close, but there's no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.

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New tentative approval for Ascent Pharms drug icosapent ethyl

Drug Patent Watch

Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Hikma, Strides Pharma, Teva Pharms Usa, Zydus, and Amarin Pharms and, and is included in… The post New tentative approval for Ascent Pharms drug icosapent ethyl appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Bristol Myers Squibb Puts Kibosh on Trials of Colorectal Cancer Candidate

BioSpace

BMS will halt a trial investigating the Opdulag combination in colorectal cancer after determining that it would not hit its primary endpoint.

Trials 85
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Drug Patent Expirations for the Week of December 17, 2023

Drug Patent Watch

VENTOLIN HFA (albuterol sulfate) Glaxosmithkline Patent: 7,832,351 Expiration: Dec 19, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com… The post Drug Patent Expirations for the Week of December 17, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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Structure’s GLP-1 Drug Shows Efficacy in Phase IIa but Faces Stock Falloff

BioSpace

A GLP-1-based drug from Structure Therapeutics shows clinical promise but not enough for some on Wall Street.

Drugs 92
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Crucial Data Solutions Recognized as a Major Contender in Everest Group’s Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023

Crucial Data Soutions

Reno, NV, December 18, 2023 – Crucial Data Solutions (CDS), the only SaaS platform provider to empower customer-driven global clinical. The post Crucial Data Solutions Recognized as a Major Contender in Everest Group’s Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023 appeared first on Crucial Data Solutions.

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Federal Court refuses to issue injunction on infringed antibody formulation patent

Pharma in Brief

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not in the public interest to force patients to switch to another biosimilar product.

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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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Point and Lantheus’s Radioligand Drug Shows Effectiveness, but Not Enough for Wall Street

BioSpace

While the candidate was effective in Phase III results, Point’s stock price fell following the announcement.

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Which pharmaceutical companies have supplementary protection certificates in the most countries?

Drug Patent Watch

This chart shows the drug companies with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the… The post Which pharmaceutical companies have supplementary protection certificates in the most countries? appeared first on DrugPatentWatch - Make Better Decisions.

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