Clinical Trials need to assess drug efficacy before first-in-human trials

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On 17 January 2016, a healthy man was declared brain-dead after receiving an experimental drug in a first-in-human trial in France. Four of five other subjects receiving the same dose have serious, ongoing neurological complications. Investigations into the trial described many troubling safety practices, such as steep increases in dose levels delivered to sequential subjects without sufficient delays to check for safety. In the wake of the tragedies, the French medicines safety agency (ANSM) ordered an examination of the information that the drug developer, Bial, based in Trofa, Portugal, had supplied to ethics committees and potential researchers before the trial. The report notes that the 63-page Investigator Brochure describing the trial included fewer than two pages of evidence that the drug had the desired pharmacological activity. It identified only two studies presented as evidence for efficacy, both problematic. A lack of emphasis on evidence for the efficacy of drug candidates is all too common in decisions about whether an experimental medicine can be tested in humans. There is a need to call for infrastructure, resources and better methods to rigorously evaluate the clinical promise of new interventions before testing them on humans for the first time, to ensure safety from bogus medicines.

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Chronic Obstructive Pulmonary Disorder

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To understand COPD and know about it, please click INFOGRAPHIC_6thFEB.

Source: Chronic Obstructive Pulmonary Disorder

Statistical Insight on Some Common Cancers

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Cancer is the leading cause of morbidity and mortality worldwide and one in every seven deaths is due to cancer. It has the worst incidence and mortality statistics. According to the International Agency for Research on Cancer (IARC), an estimated 14.1 million new cases of cancer occur with mortality of 8.2 million worldwide. There are more than 100 types of cancer, and this article discusses the statistics related to breast cancer, lung cancer, colorectal cancer and prostate cancer.

Read more: Statistical Insight on Some Common Cancers

The Business Cocktail

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ALCMI, ALCF and Scancell partner to evaluate SCIB2 cancer vaccine for NSCLC

Sun looks to unload Ohm Labs New Jersey plants in manufacturing consolidation

Takeda and Ovid join forces to co-develop Drug for Rare Pediatric Epilepsies

Guardant and MD Anderson collaborate for liquid biopsy deal

Glooko and Ascensia integrate their offerings to boost diabetes management

Source: The Business Cocktail

The Business Cocktail

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Payers block Kaléo’s expensive EpiPen challenger

TC settlement clears Endo from pay-for-delay liability; Watson, Allergan charged

Amgen hikes prices by single digits, with Enbrel matching AbbVie’s Humira boost

Baxter paying $18M to settle federal case over sterile plant failings

Source: The Business Cocktail

Science Events of the Year

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On 11 February, researchers announced that they had finally sensed the ripples in the structure of space-time known as gravitational waves — capping a decades-long quest.

A tumultuous US presidential campaign ended in a surprise victory for Republican businessman Donald Trump in November. Researchers struggled to understand how a Trump administration would treat science — in part, because it did not feature prominently on the campaign trail.

Representatives of a record 174 countries and the European Union gathered on Earth Day, 22 April, to sign the international climate agreement forged in Paris in December 2015.

In February, the World Health Organization (WHO) declared that clusters of birth defects linked to outbreaks of Zika virus in Brazil constituted a global public-health emergency.

In January, a computer program beat a world-class human player at the ancient game of Go for the first time. But the ultimate showdown was in March, when the artificial intelligence (AI), called AlphaGo, trounced Lee Sedol — one of the world’s top players.

Source: Science Events of the Year