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US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.

September 2, 2019

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ASCO 2018: Optimism As Industry Resets And Looks To What Is Next

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The tone of the 2018 ASCO annual meeting was one of regrouping, resolve, and refinement that may have left investors apathetic, but signaled a commitment to getting it right going forward to those in pharma. Examine the key takeaways from ASCO 2018.

June 4, 2018

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‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

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The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.

August 2, 2019

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R&D Heads At GSK & AZ Say Key To Success Lies In Smart Risk Taking

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What’s the secret to successfully transforming research and development innovation into drug launches? Taking risks, but doing so in a focused, smarter way, say the heads of Britain’s two largest pharma companies. Read more about the secrets to their success here.

November 15, 2018

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New Year Present For Takeda As Shire Close Nears?

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The wheels are turning for Takeda’s huge acquisition of Shire, assuming the European Commission’s approval on antitrust concerns, and the approval of the respective companies’ stakeholders. The $62.4b deal is the biggest overseas M&A deal in Japanese history, and brings with it speculation of future divestments by Takeda.

November 12, 2018

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Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

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Abbott’s Merlin patient care network works with the CardioMEMS HF sensor system. The Merlin 10.0 update to the network allows physicians to share custom messages directly with their patients. Medtech Insight looks closer at the software and its intended benefits.

September 2, 2019

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Nail Polishes Contain Undeclared DEHP, Among Other ‘Regrettable Substitutions’ – Study

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Plasticizer Dibutyl phthalate (DBP) is said to have been phased out of use in nail polishes, but a recent study by Harvard public health researchers wonders what is being used to replace the ingredient, and whether it is any safer than DBP.

October 12, 2018

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Engaging Patients and Navigating Laws: What To Consider When Developing Health Apps

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Victoria Hordern and Amy Merrick discuss initiatives in the EU to help app developers navigate the unclear rules on mobile health and explain why engaging patients during product development is key.

February 5, 2018

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Bayer’s Consumer Chief Initiates Turnaround Plan In Bid To Return Troubled Business To Growth

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Bayer AG is seeking to turn around its troubled Consumer Health division through implementing key portfolio changes and embracing growth-focused innovation, according to Heiko Schipper, President of Consumer Health. Find out what’s in store for Bayer AG’s Consumer Health group, straight from its top leadership.

December 17, 2018

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Novartis’s Zolgensma Loses EU Accelerated Assessment

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Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.

July 26, 2019

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Sanofi Prioritizes Cancer And Rare Diseases In Pipeline Shake-Up

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Shortly after US FDA approval of its blood-disorder drug Cablivi, Sanofi announced “a rigorous pipeline prioritization review.” It’s fast-tracking 17 programs and discontinuing 13 development and 25 research projects. What’s left? Will Sanofi divest its animal health and/or consumer healthcare units? Find out what experts are saying.

February 7, 2019

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Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

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On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.

September 30, 2018

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Into 2019: Risk, Uncertainty And A Return To Product Focus

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ZS’ Brian Chapman’s five predictions for medtech in 2019 sound generally positive. Find out about what makes him optimistic–such as the use of real-world evidence to drive reimbursement discussions. Gain insights into why he’s concerned about the impact of geopolitical uncertainty.

January 9, 2019

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How To Pay For The New Wave Of Gene Therapies

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Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, recently told Scrip, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”

August 2, 2019

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