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The current pharma business model is unsustainable

World of DTC Marketing

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

Food and Drug Administration for commercial use in the United States. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. the healthcare subsidiary of Samsung Electronics Co.,

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Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

Legacy MEDSearch

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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First biosimilar to HUMIRA® available in US

European Pharmaceutical Review

Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. Five are FDA-approved in the US and three are approved in the European Union (EU). AMJEVITA (adalimumab-atto), a biosimilar to Humira ® (adalimumab), is now available in the US.

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HeartBeam Announces Acquisition of LIVMOR Assets

Legacy MEDSearch

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

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Healthcare Watch July/August 2022

PM360

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public.

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Shorter timelines, evolving strategies: Four key trends in regulatory approvals of new medicines

Clarivate

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.