BioSpace’s Post

BIG PHARMA DECOUPLING FROM CHINA MANUFACTURING ALREADY UNDERWAY With less than 4 months to the US Presidential and Congressional elections, any vote in the House of Representatives will likely be symbolic because all will await a new Congress in January. However, US (West in general) decoupling from China regarding strategic supply lines is assured. While key ingredient-to-API, will take more time, future contracts will be dead in the water because the belligerence of CCP geopolitics have made urgency of such actions indisputable.  Political recalcitrance has consequences! #china #pharmaceuticals #drug #manufacturing #cdmo #cmo #cro #decoupling #biosecureact #wuxiapptec #wuxibiologics #lekconsulting #uscongress #fda #phrma #bio #efpia #firecepharma https://lnkd.in/erMGVwMF

Defense Production Act activated for essential medicines! Biden writes “[I] find that action to expand the domestic production capabilities for essential medicines, medical countermeasures, and critical inputs is necessary to avert an industrial resource or critical technology item shortfall that would severely impair national defense capability." Enthereal's been tracking the shortages of essential medicines well before the Biden administration was elected into office. If Enthereal's modest request as part of our pitch had been funded in 2021 — when we first outlined the technology and business — we'd be well on our way to have a new, fit-for-purpose, lower-carbon way to produce the ADHD medication ingredient that millions of Americans rely upon. Join the movement for sustainable, accessible pharmaceuticals. Let's get real! Enthereal. #essentialmedicine #pharmainnovation #nationalsecurity #defenseproductionact

So special to be able to help organize this conference.

HOT OFF THE PRESS! #NORD's latest analysis why the Biden Administration's proposed use of Bayh-Dole March-in rights to control drug pricing will harm #raredisease patients and families, waste billions in government-funded #biomedical #research, and stifle #rarediseaseresearch for decades to come - and how to improve the relevant National Institute of Standards and Technology (NIST) framework for the use of march-in rights instead. March-in rights were created more than 40 years ago by the #BayhDole Act to ensure timely commercialization of government-funded inventions. In essence, the act gives #governmentcontractors the right to retain title to #inventions made with #governmentfunding. In exchange, the government in some situations has the right to require the contractor (or assignee or licensee) to negotiate a fair licensing agreement with a third party; under some very narrowly defined circumstances, and if the licensing negotiations fail, the government has the right to 'march in' and issue the license itself. To date, the government has NEVER exercised this right to initiate march-in proceedings. Moreover, whether price of the invention alone is sufficient justification to exercise march-in rights has been subject to extensive debate and considerable rule-making. Prior #NIH experience with "reasonable pricing clauses" strongly demonstrates the chilling impact of mixing drug-pricing with research funding. This is particularly concerning for rare diseases given the vital importance of government-funded research through National Center for Advancing Translational Sciences (NCATS), FDA, and other government agencies to the rare disease field. That is why the National Organization for Rare Disorders is deeply concerned about the prospect of callously using march-in-rights, and wants to ensure #patients and other end-users have a seat at the table. Read our full analysis and recommendations here: https://lnkd.in/eu-MiXwz

Want an efficient way to kill #innovation? Seizing intellectual property rights via "march-in" certainly fits the bill. This development should worry everyone in the #biopharma industry, as it is a clear escalation of policies, first requiring price "negotiation" in Medicare, and now saying that the government can simply take intellectual property if otherwise unsatisfied. Given how risky and capital-intensive medical #researchanddevelopment is, high prices for successful products are an essential way to recover the risk-adjusted cost of discovering and developing these medicines. Without that incentive, one has to question why investors would continue to support the industry, which delivers so many innovative treatments to those with serious disease. Furthermore, doesn't a "march in" policy seem to be a clear violation of the "takings clause" in the Fifth Amendment, which states, "Nor shall private property be taken for public use, without just compensation"? https://lnkd.in/gvx42cB2

The House Oversight Committee is expected to mark up the bill on May 15. In an unusually swift action, House leadership is considering reserving a floor vote for the BIOSECURE Act this month. A bipartisan group of lawmakers introduced the House bill in January, aiming to block certain “biotechnology companies of concern” from accessing federal funding through their biopharma customers. To secure positions on Medicare and Medicaid, drugmakers would need to cut ties with the Chinese contractors. WuXi AppTec and genome sequencing firms BGI, MGI and Complete Genomics were the initial targets of the bill. But the U.S. government would be tasked to identify other “foreign adversary biotech companies of U.S. national security concern” for future inclusion, should the law be enacted. My thought: This is an opportunity for Korean/Indian CDMO markets if they can develop and comply with high-standard SOPs, which are highly related to human resources and cultural behaviors. The news: https://lnkd.in/g6K6cZkt

Do we need new safety definitions for the use of remote monitoring in #clinicaltrials? Does a #medicaldevice need FDA approval for use in a clinical trial? If you have questions on these topics, do not miss this opportunity to engage in discussion with FDA regulators, industry and academic experts.  Join these impactful discussions— proceedings that will be published in a leading peer reviewed journal— to help define the future of mobile cardiac monitoring.  ➡️ https://bit.ly/4598muH #CardiacSafety #Biotech #Pharma

As the global 10-year drug strategy hits its halfway point next year, and in the absence of a thorough official evaluation, today International Drug Policy Consortium launches #OffTrack2024 —a civil society Shadow Report. Read on & share:

The U.S. Senate unanimously passed the bipartisan Affordable Prescriptions for Patients Act on Thursday.  The legislation aims to reduce the cost of prescription drugs by zeroing in on the pharmaceutical industry’s patent practices. Specifically, it would prevent what’s known as “patent thicketing." This is when drugmakers pile on secondary patents to create a complicated thicket of intellectual property that can, essentially, keep competitors out of the market or delay their entry. The bill would crack down on patent thicketing by restricting the number of patents a drugmaker can assert in litigation on a single biological product. That leads today's Gist Healthcare Daily podcast.