The India specific findings of the CPhI Annual Report highlight that India has seen significant jump across all (six) categories, improving its overall score by a massive 11.06% in a single year. The country showed the largest gains…
FDA Commissioner Warns of Shutdown’s Impact on Clinical Trials
As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.”…
Pharma R&D returns fall to lowest level in nine years
A new analysis that finds the soaring costs of clinical trials are eating away at return on R&D investments should serve as a wakeup call to the entire industry, a top executive says. Clinical trial professionals need to rethink the…
The power of digital tools to transform mental healthcare
The global burden of mental illness, both in terms of human suffering and economic loss, is catastrophic and rapidly growing. Worldwide, mental health conditions affect more than a third of the world’s population. Just two conditions alone – depression and…
Turnover Within CRO Companies Remains Persistently High, According to BDO Report
CHICAGO–(BUSINESS WIRE)–Clinical Research Outsourcing (CRO) companies are battling high turnover levels, but a new report from BDO USA, LLP, finds that compensation strategies generally have not made significant enough adjustments to their compensation strategy to address this issue. The 2018/2019…
Factory CRO and Boston Biomedical Associates Announce Merger
BILTHOVEN, Netherlands & MARLBOROUGH, Mass.—Factory-CRO Group, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), and Boston Biomedical Associates(BBA) a premier full-service Medical Device/Biotechnology CRO and Consultancy based in the United States announce…
FDA Proposes Informed Consent Waivers for Some Clinical Trials. Would this be possible anytime in India?
Researchers in low-risk clinical trials could experiment on patients without obtaining informed consent if they meet at least four conditions, the FDA proposed last week in a new rulemaking notice. The agency will grant waivers if researchers can prove: A…
Boost for MNCs as price cap removed for first 5 years on innovative drugs
New-Delhi: The government on Thursday exempted innovative medicines developed by foreign companies from price control for five years, giving Indian patients access to drugs that are currently only available abroad. These include orphan drugs that are used for treating rare medical…
FDA-cleared, wearable blood pressure device hits market
Dive Brief: A Chicago area health devices company said Thursday it would begin pre-sales of an FDA-cleared blood pressure monitor that can be worn on the wrist, the latest example of a medical device that has been adapted to smart…
Modi Government Set To Remove Compensation Clause From New Clinical Trial Rules
Earlier the World Health Organisation had written to the Indian government, saying stringent rules would push away pharma companies from conducting clinical trials in India while also ‘hampering’ WHO’s work. The Bharatiya Janata Party-led NDA government is reportedly set to remove a…
