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Plymouth, MI – May 23, 2022 – Phenomics Health Inc., a bioinformatics-based precision medicine company, today announced the commercial integration of six PrecīsMed® pharmacometabolomic (PMx) and PredictScript™ pharmacogenomic (PGx) clinical products to comprehensively support individual patient medication treatment. Phenomics Health novel product platforms can now provide clinicians with multiple tools to enhance treatment outcomes through…
CANTON, Mich. (05/24/2022) – MMS Holdings Inc. (MMS) – an award-winning, data-focused contract research organization (CRO) – announced a collaboration with THREAD® as its partner of choice for its decentralized clinical trial platform (DCT) and DCT-enabled services. THREAD’s next-generation DCT technology enables faster, more efficient clinical trials while improving access for research participants with higher quality data…
The U.S. House Energy and Commerce (E&C) Health Subcommittee on Wednesday advanced to the full committee legislation reauthorizing user fee programs, including PDUFA and MDUFA. The legislation, H.R. 7667, the Food and Drug Amendment Act, passed 30-0 on a bipartisan vote with provisions to increase clinical trial diversity, modify the accelerated approval pathway and promote generics. On the…
May 2022 Update: In last month’s newsletter we informed that State Rep. Matt Koleszar asked the Michigan Attorney General (AG) for an opinion on the requirement to register facilities who use of animals in research and only permit those doing so in a “humane” manner. Due to several administrative reorganizations and transference of powers some…
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…
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™…
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 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…