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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…
KALAMAZOO—Visitors to the city’s downtown pedestrian mall may not notice that a door to an important link in Michigan’s $28 billion life sciences industry is tucked into a busy parking deck. This office is where Genemarkers recognized during the early weeks of the COVID-19 pandemic that its lab, which performed R&D testing for skin care products, could turn…
Original Post Not all heroes wear capes — some wear lab coats. Personal care products, pharmaceuticals, and medical devices need to be tested to ensure they meet industry standards for our safety. Think: anesthetics are delivered directly into the human body, so they must be uncontaminated; heart medications need to navigate through the body and…
Original Source ALACHUA, Fla., Jan. 4, 2022 /PRNewswire/ — RTI Surgical, a global private label OEM company, announced today that the company will spin off its Metals business, creating two independent companies that are focused on the needs of customers and patients in their distinct market segments. Ownership of both companies will be retained by Montagu,…
CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of…
With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to address the urgent public health need Companies plan to submit additional data on…
Original Source For personal and political reasons, I strongly supported Joe Biden for president. He never wavered on climate change, women’s rights, immigration or other issues I care about. Paul Hastings is CEO of Nkarta Therapeutics in San Francisco and chairman of the Biotechnology Innovation Organization, a biotech trade group. Perhaps most compelling, though, was his…
Original Source Lansing-based food and animal safety products manufacturer Neogen Corp. plans to combine with conglomerate 3M’s food safety business. The two companies say they signed a definitive agreement for a deal to create a new global food safety and security company valued at $9.3 billion. Shareholders at Neogen (Nasdaq: NEOG) would hold about 49.9 percent of the…