A Misguided Op-Ed, a Key Report, and Why Holding the US Lead in the Life Sciences is More Important Than Ever

“As those involved in these efforts at the National Institutes of Health will readily attest, companies working with them to develop critically needed drugs and vaccines to combat COVID-19 are hardly getting a free ride. They are assuming the majority of the costs and all the risks.” Ulysses and the Sirens by JW Waterhouse: https://www.ngv.vic.gov.au/explore/collection/work/4457/ … Read more

Calls for WTO to Suspend IP Rights for Vaccine Innovation Would Jeopardize Incredible Progress

“Weaking intellectual property protections, as the WTO wavever proposal would do, will not increase access to the tools we need to fight COVID-19; In fact, they would hinder access to the COVID-19 tools we’ve already discovered.” The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong … Read more

Advancing Medical Affairs to be a Value-Based Strategic Partner

Over the past decade, the healthcare landscape has changed engagement with an increased emphasis on to a broader set of stakeholders and an expanded focus on value-based therapies. Most importantly, demonstrating real-world utility beyond regulatory approval has become the new hallmark of success. Medical Affairs is uniquely positioned to address these dynamics as the only … Read more

Should the Biden Administration Look to Pharma for New USPTO Director?

“Strong patent rights that are enforceable against infringers are crucial for firms that engage heavily in research and development activities, and now is a perfect time for the pharmaceutical sector to inform the public debate on how enforceable patent rights encourage a strong innovation economy.” The United States is not even two weeks into the … Read more

Industry Briefs April 2022 | PM360

Collaboration Aims to Revolutionize Vaccine Development The physIQ Sensor System is a medical-grade biosensor that will be used as part of a new study examining vaccination responses. physIQ, a pioneer in digital medicine, and CellCarta, a global contract research organization (CRO) specializing in precision medicine services, announced a partnership on a study to monitor individual … Read more

Pfizer Rejects Accusations it Infringed COVID-19 Vaccine Assay Technology

“’The alleged patent infringement—asserted uses by Pfizer and BioNTech of the patented invention to generate data from clinical trials in support of seeking FDA approval—are precisely the type of activity that is protected by the ‘safe harbor’ from patent infringement claims under 35 USC § 271(e)(1).”’ – Pfizer Memorandum on Motion to Dismiss Pfizer and … Read more

What now? Alzheimer’s drugmakers ponder the path to approval

Listen to the article 7 min This audio is auto-generated. Please let us know if you have feedback. Last week, Medicare rendered a fateful decision that’s become the latest flashpoint in Biogen’s ongoing saga with Aduhelm. As part of a new finalized policy, the Centers for Medicare and Medicaid Services (CMS) will limit coverage for … Read more

Industry Comments on Proposed Changes to Bayh-Dole Regulations Zero in on March-In Language

“Skeptics mistakenly believe – on purpose – that Bayh-Dole should be used as part of a price control regime to lower drug prices…. No one likes to pay high prices, of course. So, why not just have the federal government mandate price controls? They seem to think innovation will continue to happen even though profit … Read more

Test to Treat: pharmacists say Biden’s major new Covid initiative won’t work | Coronavirus

A major new Biden administration initiative to facilitate access to Covid-19 antivirals will have a limited impact and fail to mitigate certain health inequities, major pharmacist groups argue, because pharmacists are restricted from prescribing the pills. Announced in Joe Biden’s State of the Union address, the “Test to Treat” program is meant to address the … Read more