INDUSTRY NEWS

Stay up-to-date on the latest industry, member, and policy related news.

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Efforts to Prohibit Animal Research Continue

April 8, 2022

A recent Detroit News article prompted State Rep. Matt Koleszar to ask the Michigan Attorney General for an opinion on the use of animals in experimentation. In his letter, he claims that “the State has ignored its statutory mandate to oversee animal research facilities”. The request relies on the fact that an animal research advisory board…

AdvaMed Revises Code of Ethics on Interactions with Health Care Professionals

April 8, 2022

The Advanced Medical Technology Association (AdvaMed) announced its  revised Code of Ethics on Interactions with Health Care Professionals (HCPs)on March 18, 2022. The medical device industry has relied on the AdvaMed Code for decades to assist with navigating complex rules concerning compliance—particularly rules regarding fraud and abuse stemming from interactions with HCPs. Notable updates to the…

CMS Coverage Decision Finalized

April 8, 2022

Last month, we wrote that MichBio signed on to a letter opposing the Centers for Medicare and Medicaid Services (CMS) unprecedented draft National Coverage Determination (NCD) decision to limit seniors’ access to an entire class of Alzheimer’s drugs. On April 7, CMS released a final decision to limit coverage only to people who receive Aduhelm™…

MDUFA Reauthorization

April 8, 2022

As noted in last month’s update, the process behind developing a new Medical Device User Fee Amendments (MDUFA) has been a slow slog. The current MDUFA IV is set to expire at the end of September 2022 and must be reauthorized by Congress before then or the FDA will have to cease product reviews and…

MichBio Moderates Congressional Briefing on Cures 2.0

April 8, 2022

MichBio was privileged to moderate a Congressional briefing on H.R. 6000, the Cures 2.0 legislation. Several other state groups including BioNJ, Health Institute of New Jersey, California Life Sciences, Life Sciences PA, and Biocom California partnered to co-host the event. The over 125 attendees heard directly from the featured guests and bill’s sponsors, Michigan’s Rep.…

Rep. Fred Upton Announces Retirement

April 8, 2022

U.S. Representative Fred Upton (R-6) announced that the current term would be his last, and he will not run for re-election in November 2022. First elected in 1987, Fred (as he always asked anyone to call him) previously served on the House GOP’s leadership steering committee and chaired the powerful Energy and Commerce Committee. Additionally,…

Get Engaged In the SBIR STTR Reauthorization Discussion

April 7, 2022

The SBIR/STTR Programs are currently set to expire on September 30, 2022. It would be damaging to American innovation and competitiveness if these programs were to expire before a full reauthorization can be passed. The SBIR/STTR Programs enable small businesses to develop and commercialize new innovative technologies and have a proven track record of promoting competition through…

Corium Receives FDA Approval of ADLARITY® (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease

April 7, 2022

Original Source Boston, MA, March 14, 2022 – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) has approved Corium’s ADLARITY (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the…

PE-backed Angstrom Technology pursues acquisitions to fill cleanroom market gaps

April 7, 2022

Original Source WALKER — A couple of recent strategic acquisitions should further prepare cleanroom designer and builder Angstrom Technology Ltd. for overseas projects as the company continues a private equity-backed string of acquisitions. After New York City private equity firm ASGARD Partners & Co. acquired a controlling interest in Angstrom in November 2020, Angstrom has persued deals to expand…

Senior Biopharma Executive Joins MMS Holdings as Principal Medical Director

April 7, 2022

CANTON, Mich. (3/10/2022) – MMS Holdings, a data-focused contract research organization (CRO), announced the addition of Robert Allen, MD, to its team as Principal Medical Director of Global Drug Safety and Pharmacovigilance. Bringing more than 20 years of pharmaceutical industry experience, Dr. Allen has worked at Parke Davis, Pfizer, Adolor, AstraZeneca, Wyeth, Scirex, Premier, and…

Adoption of Research Animals – State Policy

March 4, 2022

MichBio testified before the House Regulatory Reform Committee on HB 4881 and HB 4882, sponsored by Reps. Kevin Hertel (D-St. Clair Shore) and Tommy Brann (R-Wyoming) respectively, would require research facilities to offer dogs or cats used in laboratory research up for adoption prior to euthanizing them. Additionally, facilities would be required to submit annual…

Proposed Formation of Prescription Drug Affordability Board – State Policy

March 4, 2022

Sen. Brinks (D-Grand Rapids) and Rep. Camilleri (D-Trenton) introduced SB 889 and HB 5842, respectively that would establish a Prescription Drug Affordability Board (PDAB), similar to those already established in Colorado and Maryland. These bills, along with other companion bills, make up a package that would determine rates, set limits and cap how much up-charging can be done on…

MichBio Supports Emphasis on Education and Talent Development – State Policy

March 4, 2022

MichBio co-signed a letter from the University Research Corridor (URC) and Michigan Association of State Universities (MASU) as part of a testimony package presented to the Senate Appropriations Subcommittee on Universities and Community Colleges by MASU Director, Dan Hurley. Michigan has an opportunity to do a great many things to set the course for long…

Rare Disease Advisory Council – State Policy

March 4, 2022

Legislation that proposes to establish a Rare Diseases Advisory Council, HB 4654, had a hearing by the Senate Health Policy Committee. MichBio reiterated its desire for some changes, particularly the inclusion of a representative from the Association or a Michigan biotech/pharma company working in rare diseases. A bill substitute containing such language and a few…

BIO Releases Report on Policy Best Practices

March 4, 2022

BIO, in partnership with the CSBA, released a new report on bioscience economic development and legislative policy best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” The report, which reviewed public policy strategies and programs in all 50 states, highlights new and innovative initiatives…