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New CMS guidance a "missed opportunity" for future medical innovation, patients
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Orphan & Rare Diseases, Rare Diseases, Cost & Value of Biopharmaceuticals  •  Press Release  •  June 30, 2023
The Centers for Medicare & Medicaid Services (CMS) today released its guidance for the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 (IRA). John Murphy, BIO’s Chief Policy Officer, made the following statement:  "As we have stated in the past, the Medicare price setting provisions of the IRA will have a profound and lasting negative impact on innovative medicine development and access in the US.  Nothing in the final guidance released today will change that. Unfortunately, patients – and their loved ones – will be robbed of the future medical innovation that they're so desperately waiting for as this law rolls out.   "CMS took some limited steps in the final guidance that will modestly improve the environment around transparency. Although much more could have been done.   "Notably, we were pleased to see CMS take the reasonable position of allowing affected manufacturers to control some of their own disclosures and confidentiality protections surrounding the negotiation process.   "Similarly, CMS clarified the ability of interested parties and patients to have a voice in the negotiation process.  Moreover, Part D plans are now on notice that MFP-selected drugs are going to have to be accessible to patients once negotiated. Although, it remains unclear how much CMS will increase formulary review to ensure unreasonable utilization management is not implemented as a barrier to access.   "Yet the Agency missed the opportunity to repair damage to the rare disease community and support more meaningful investment in orphan research by allowing new but unapproved orphan designations to retain the orphan exclusion.  We believe CMS has the authority and discretion to make this clarification and to support rare disease patients.  "BIO and our members will continue to pursue all avenues available to protect patient access to…
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Holiday weekend reading (and a reminder about ticks)
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Good Day BIO Newsletter  •  June 30, 2023
As we head into the holiday weekend, a reminder about tick season and what biotech’s doing about it—plus, some long weekend reads. Good Day BIO will resume publication on Monday, July 10 (but we’ll check in if there’s breaking news). Happy July 4th!  (504 words, 2 minutes, 31 seconds)
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BIO comments to FDA on Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
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Patient Advocacy  •  Letters, Testimony & Comments  •  June 29, 2023
BIO submitted general comments and proposed changes to FDA (Docket No. FDA-2023-D-0026)
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Living in a bacterial world
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Good Day BIO Newsletter  •  June 29, 2023
Madonna was hospitalized with a “serious bacterial infection”—the kind of headline we could see more frequently if we don’t develop new antimicrobials. Here’s what we know, plus a look at a recent report on the life sciences workforce and job market. (507 words, 2 minutes, 32 seconds)
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BIO Office Hours: Ask an Expert About Cybersecurity
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June 28, 2023
Cyber experts from Chubb's Life Science Practice will provide an overview of cyber insurance and how it benefits life sciences companies as part of their risk management programs. Then, Aon experts will hold twenty-minute virtual appointments to answer questions about cyber insurance coverages as well as the pre and post cyber incident services. What to expect in the overview & 20-minute Zoom session: Cyber threats for Small and Medium-sized businesses Overview and Benefits of Cyber Insurance in Cyber Incident Response Review of First and Third Party coverages available Pre and Post incident risk mitigation services available Cyber Index data and claims scenarios   Schedule Office Hour
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New malaria cases raise alarm
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Good Day BIO Newsletter  •  June 28, 2023
Cases of locally acquired malaria have been detected in the U.S.—for the first time in 20 years. Here’s what’s happening. Plus, a new episode of the Vital Transformation podcast features BIO’s Nick Shipley explaining why the IRA is challenging the innovation ecosystem. (540 words, 2 minutes, 39 seconds)
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BIO Files Amicus Brief Supporting Reversal of Court Decision Regarding SEC Regulations on Proxy Advisory Firms
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Intellectual Property, Patents  •  Amicus Brief  •  June 27, 2023
BIO filed an amicus brief in the U.S. Court of Appeals for the Sixth Circuit, seeking the reversal of a lower court's ruling that would set aside the 2022 rescission of the Securities and Exchange Commission (SEC) 2020 Rule regulating proxy advisory firms.Proxy advisory firms are firms that provide consulting services to shareholders, commonly via recommendations, on how to vote on proxy ballot issues. The brief explains the profound influence these firms have come to amass over investors and their shareholder votes, and as a result, their influence on the corporate governance of public companies. Furthermore, when the firms' recommendations miss the mark, the negative impact can be particularly troublesome for specialized industries with small companies—such as the myriad small and emerging companies that make up BIO's membership.This is where the SEC's 2020 Rule comes into focus. The key provisions of the SEC's 2020 Rule regulating proxy advisory firms were established to ensure greater transparency, accuracy, and completeness of the firms' recommendations. The "notice and awareness" provision required that firms provide companies and investors with the same proxy ballot reports concurrently. Additionally, firms were required to notify their clients of any company responses to the recommendations as well as disclose any potential conflicts of interest in their recommendations.Despite the problems and insufficiencies identified in proxy advisory firms and their recommendations, in 2022, the SEC rescinded the provisions. While the disclosure provision remains intact, the brief contends that it is made less effective without the notice and awareness provisions. Moreover, shareholders and companies subject to these recommendations return to the less-than-ideal status quo—one-size-fits-all recommendations that, when inaccurate, can be time-consuming and financially burdensome to correct.Finally, the brief argues that the 2022 rescission was abrupt, unsupported, and…
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Beech leaf disease is running wild
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Good Day BIO Newsletter  •  June 27, 2023
Beech leaf disease is ravaging East Coast beech trees—we explain what’s happening and why biotech offers a glimmer of hope. Plus, a look at how we can grow the biotech workforce with education initiatives. (518 words, 2 minutes, 35 seconds)
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Experts: Benefits of vaccines outweigh risks
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Good Day BIO Newsletter  •  June 26, 2023
Experts presenting at Friday’s CDC ACIP meeting confirmed that the childhood vaccination schedule is safe—and benefits outweigh known and possible risks. Plus, it’s hard to ignore the fact that air quality is getting worse—we explore why it matters to health and how biotech can help. (533 words, 2 minutes, 39 seconds)
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BIO Recommendations on PTAB patent invalidation proceedings
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Letters, Testimony & Comments  •  June 23, 2023
BIO comments on U.S. Patent & Trademark Office proposed reforms to PTAB patent invalidation proceedings.
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