Sun.Jun 16, 2024

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Tiny Algae Microrobots Could Transform Lung Cancer Treatment

AuroBlog - Aurous Healthcare Clinical Trials blog

Part algae, part red blood cell, these microrobots can travel to hard-to-reach tumors deep in the lungs. (Zhang et al., Sci. Adv., 2024/CC BY-NC) Tumors that travel to the lungs, or lung metastases, pose a formidable challenge in the realm of cancer treatment. Conventional chemotherapy often falls short because it’s inefficient.

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EHA 2024: Roche’s Columvi competes in BiTE battle with positive results in DLBCL

Pharmaceutical Technology

Based on the latest STARGLO trial results, there is potential to extend Columvi into earlier lines of therapy for diffuse large B-cell lymphoma (DLBCL).

Trials 130
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AI Enables Individualized Cancer Vaccines

BioSpace

The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.

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Roche's Columvi win in earlier DLBCL faces questions over inconsistent patient survival data

Fierce Pharma

Roche’s up-and-coming Columvi has demonstrated it could save lives when used as a second-line therapy in diffuse large B-cell lymphoma. | Roche’s up-and-coming Columvi has shown it could save lives when used as a second-line therapy in diffuse large B-cell lymphoma. But the company still finds itself fielding questions about the bispecific drug’s market potential thanks to an imbalance noticed in the phase 3 data.

Marketing 103
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Takeda’s Epilepsy Drug Stumbles in Back-to-Back Phase III Rare Disease Failures

BioSpace

Takeda’s soticlestat, licensed from Ovid Therapeutics, did not significantly reduce seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome, respectively, according to two late-stage readouts on Monday.

Licensing 101
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J&J’s nipocalimab raises hope for Sjogren’s patients

pharmaphorum

J&J’s ‘Swiss army knife’ for autoimmune diseases, FcRn inhibitor nipocalimab, has shown efficacy in Sjogren’s disease

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AZ’s Calquence extends disease-free survival in MCL

pharmaphorum

AstraZeneca’s Calquence improved progression-free survival in previously untreated mantle cell lymphoma in the ECHO trial

Trials 86
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AstraZeneca’s Imfinzi Gets FDA Approval for Treating Endometrial Cancer

BioSpace

AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

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New patent for Msd Merck drug RECARBRIO

Drug Patent Watch

Annual Drug Patent Expirations for RECARBRIO Recarbrio is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

Drugs 59
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Novo Nordisk CEO Agrees to Testify at Senate Hearing After Sanders’ Subpoena Threat

BioSpace

Novo Nordisk CEO Lars Jørgensen has agreed to appear before the Senate health committee in a hearing on the prices of its blockbuster drugs Ozempic and Wegovy.

Drugs 92
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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 patent for Blueprint Medicines drug GAVRETO

Drug Patent Watch

Annual Drug Patent Expirations for GAVRETO Gavreto is a drug marketed by Blueprint Medicines and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

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FDA Action Alert: Merck, BMS, Sarepta and More

BioSpace

The FDA has a packed calendar this week, with six decisions on the docket, including ones for Merck’s Keytruda, BMS's Krazati and Sarepta’s Elevidys.

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New patent for Novartis drug PLUVICTO

Drug Patent Watch

Annual Drug Patent Expirations for PLUVICTO Pluvicto is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

Drugs 59
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FDA Slaps BioNTech-MediLink ADC With Partial Clinical Hold Due to ‘Significan.

BioSpace

The hold on BioNTech and MediLink’s antibody-drug conjugate candidate BNT326/YL202 has halted enrollment in a Phase I U.S. trial in patients with non-small cell lung cancer or breast cancer, following multiple deaths.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Electronic Cigarettes vs Varenicline for Smoking Cessation in Adults

JAMA Internal Medicine

This randomized clinical trial examines the relative effectiveness of electronic cigarettes in smoking cessation.

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Opinion: Regulatory Flexibility Can Accelerate Rare Disease Drug Development

BioSpace

Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design.

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New patent for Neurocrine drug INGREZZA SPRINKLE

Drug Patent Watch

Annual Drug Patent Expirations for INGREZZA+SPRINKLE Ingrezza Sprinkle is a drug marketed by Neurocrine and is included in one NDA. It is available from one supplier.

Drugs 59
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J&J’s $6.5B Momenta Buy Pays Off With Phase II Sjögren’s Disease Win

BioSpace

Johnson & Johnson’s FcRn inhibitor nipocalimab in a mid-stage study significantly improved disease activity across various organ systems in patients with the chronic autoimmune Sjögren’s disease.

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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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Turn a Kind Eye—Offering Positive Reframing

JAMA Internal Medicine

This essay describes the importance of physicians using positive reframing with patients.

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Gilead’s Magrolimab Ineffective, Linked to Increase Risk of Death in MDS Patients

BioSpace

A final analysis of Gilead Sciences’ now-discontinued Phase III ENHANCE study showed a worrying trend of increased death risk in myelodysplastic syndromes patients treated with magrolimab.

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Tablet dosed drug patent expirations by year

Drug Patent Watch

This chart shows the patent expirations for tablet dosed drugs over the next decade. The term of drug patents varies.

Drugs 59