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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.…
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,…
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…
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…
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…
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…
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…
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 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…
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, 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…
MichBio was part of a letter under the auspices of the Council of State Bioscience Associations (CSBA) to the Centers for Medicare and Medicaid Services (CMS) regarding the agency’s unprecedented National Coverage Determination (NCD) decision to limit seniors’ access to an entire class of Alzheimer’s drugs. A great op-ed by Dr. Michelle McMurry-Heath, President and…
A petition was refiled with the federal government, in this instance with the Department of Health & Human Services, seeking to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its alleged exorbitant price. March-in rights are rights granted to the federal government. These allow the government to grant patent…
The reauthorization process for the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Biologic Drugs User Fee Act (BDUFA) and Medical Device User Fee Act (MDUFA) is underway. These run on a 5-year cycle and require Congressional enactment that authorizes the Food and Drug Administration (FDA) to collect user fees from…
Original Source Today, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled…