Sun.Jun 02, 2024

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GSK builds case for return of multiple myeloma drug Blenrep

Bio Pharma Dive

Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.

Drugs 289
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Orange Peels Could Have Surprising Health Benefits For Your Heart

AuroBlog - Aurous Healthcare Clinical Trials blog

The bitter peel of an orange is there to protect the fruit, and it could protect our own insides, too, if only we stopped throwing the rinds away. The zest of oranges has now been found to contain a novel, bioactive compound, called feruloylputrescine (FP), that could benefit heart health when eaten.

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AstraZeneca immunotherapy extends survival by two years in rarer type of lung cancer

Bio Pharma Dive

The findings, from a trial testing Imfinzi in limited-stage small cell lung cancer, could help AstraZeneca expand the drug's use.

Trials 288
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CDSCO releases updated version of guidance for PAC in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released an updated version of the guidance for Post Approval Changes in Biological Products, regarding the quality, safety and efficacy documents in order to align with the updated standards and digital formats developed after the previous version was rolled out. The new version, the Version 1.

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

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With new Enhertu data, an ADC could overtake chemo in breast cancer

Bio Pharma Dive

The results are a step forward for antibody-drug conjugates, which Enhertu makers AstraZeneca and Daiichi Sankyo see replacing chemo in many tumors.

Antibody 170
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ASCO24: Enhertu aims to replace Herceptin in first-line metastatic breast cancer

Pharmaceutical Technology

If Enhertu gets approved in the first-line setting metastatic breast cancer setting, 4,200 patients a year could be eligible to receive it.

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ASCO: Conversational AI tackles missed colonoscopies

pharmaphorum

An AI tool has shown impressive results in raising colorectal cancer screening rates in underserved populations, according to data presented at ASCO

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Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think?

Fierce Pharma

On the eve of the American Society of Clinical Oncology’s annual meeting last week, a piece of news set off vigorous discussions. | After Akeso and Summit's ivonescimab beat Keytruda in a head-to-head trial in non-small cell lung cancer, analysts are trying to sort out the financial ramifications while biopharma insiders are eager to see the exact data.

Trials 115
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Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities

JAMA Internal Medicine

This randomized clinical trial investigates whether long-term use of Jinlida granules decreases the incidence of diabetes in participants with impaired glucose tolerance and multiple metabolic abnormalities.

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New tentative approval for Annora Pharma drug brivaracetam

Drug Patent Watch

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms and, and is included in seven NDAs.

Drugs 59
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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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Buyer’s Checklist for selecting the right CTMS vendor

Cloudbyz

Selecting the right Clinical Trial Management System (CTMS) is crucial for the success of your clinical trials. A robust CTMS not only streamlines trial management but also ensures regulatory compliance, improves data quality, and enhances overall efficiency. Given the complexity and diversity of clinical trials, it is essential to choose a CTMS that aligns with your specific needs and workflows.

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New tentative approval for MSN drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five… Source

Drugs 59
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ASCO: Gilead sifts lung cancer data for efficacy crumbs

pharmaphorum

ASCO: Gilead sifts lung cancer data for efficacy crumbs Phil.

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Traditional Chinese Medicine to Prevent Type 2 Diabetes—A Difficult Path Forward

JAMA Internal Medicine

Safe and effective treatments for preventing type 2 diabetes in persons at high risk for the disease are needed. In this issue of JAMA Internal Medicine, Ji and colleagues randomized patients with impaired glucose tolerance and multiple metabolic abnormalities to receive either a traditional Chinese medicine preparation, Jinlida (JLD) granules, 9 g 3 times/d, or placebo.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Which drugs have supplementary protection certificates in the most countries?

Drug Patent Watch

This chart shows the drugs with the most supplementary protection certificates (SPCs).

Drugs 59
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Increasing Risk for Tick-Borne Disease

JAMA Internal Medicine

This clinical insights article examines reasons behind the increase in tick-borne diseases and what clinicians should know about diagnosis and mitigation.

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Women’s Health a Focus for FDA and Biden Administration

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary. This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Given that FDA was founded in 1906 and the Federal Food, Drug and Cosmetic Act went into effect in 1938, the OWH’s thirty years of existence, while an important milestone, constitutes a very small amou