Sun.Feb 04, 2024

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Testosterone and Progression From Prediabetes to Diabetes in Men With Hypogonadism

JAMA Internal Medicine

This randomized clinical trial evaluates whether testosterone replacement therapy prevents progression from prediabetes to diabetes or induces glycemic remission in middle-aged and older men with hypogonadism.

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Drug Patent Expirations for the Week of February 4, 2024

Drug Patent Watch

NATESTO (testosterone) Acerus Patent: 8,784,869 Expiration: Feb 4, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit… The post Drug Patent Expirations for the Week of February 4, 2024 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Officer-Involved Killings of Unarmed Black People and Racial Disparities in Sleep Health

JAMA Internal Medicine

This repeated cross-sectional study using difference-in-differences analyses assesses sleep duration changes in Black individuals after officer-involved killings of unarmed Black people.

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New patent expiration for Am Regent drug INJECTAFER

Drug Patent Watch

Annual Drug Patent Expirations for INJECTAFER Injectafer is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are ten patents… The post New patent expiration for Am Regent drug INJECTAFER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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State Prescription Drug Affordability Boards: A Road of Good Intentions Paved with Price Controls & Contract Impairment

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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FDA Approval Fuels Boehringer’s Biosimilar Challenge to AbbVie’s Humira

BioSpace

Boehringer Ingelheim on Wednesday won the FDA’s approval for a high-concentration and citrate-free version of its Humira biosimilar Cyltezo, targeting AbbVie’s blockbuster drug.

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Regeneron Misses Q1 Earnings on Lower-Than-Expected Eylea Sales

BioSpace

Regeneron Pharmaceuticals on Thursday reported $1.4 billion in sales of its blockbuster eye drug in the first quarter of 2024, falling short of Wall Street’s expectations of $1.86 billion.

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FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

FDA Law Blog

By Steven J. Gonzalez & Gail H. Javitt & Allyson B. Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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Novartis Buys Mariana Oncology in $1B Acquisition, Bolsters Radiopharma Assets

BioSpace

The Swiss drugmaker is paying $1 billion and committing up to $750 million in milestones for Mariana Oncology’s preclinical cancer pipeline and clinical supply capabilities, the companies announced Thursday.

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Novo’s Q1 Revenue Grows 24%, Raises Guidance as Wegovy Sales Surge

BioSpace

Novo Nordisk on Thursday reported a jump in first-quarter 2024 revenue, driven by a more than 100% increase in sales of weight-loss drug Wegovy and the strong performance of type 2 diabetes medication Ozempic.

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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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Moderna Walks Away from Potential $3B Gene Editing Deal with Metagenomi

BioSpace

Citing a strategic prioritization by Moderna, Metagenomi announced Wednesday that the partners have “mutually agreed” to terminate their gene editing agreement.

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BridgeBio Spins Out Oncology Company with $200M in Financing

BioSpace

The new company, BridgeBio Oncology Therapeutics, is looking to advance two KRAS inhibitors and a blocker of the interaction between the RAS and PI3K pathways.

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Astellas Inks Second CAR-T Agreement with Poseida to Develop ‘Convertible’ Cancer Therapies

BioSpace

Astellas Pharma and Poseida Therapeutics have entered into a second CAR-T contract to develop novel and flexible allogeneic cell therapies in oncology.

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15 Soft Skills You Should Consider for Your Resume

BioSpace

By incorporating soft skills in your resume, you showcase your ability to work well with others, which is important to employers.

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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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5 Mistakes People Make When Quitting—and What to Do Instead

BioSpace

It’s important to quit your job the right way so you can exit on a positive note, which could benefit you in the future.

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