Stay up-to-date on the latest industry, member, and policy related news.
MichBio members can submit news to be shared here, on our social media, and in our monthly newsletter.
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…
Original Source Ad hoc announcement pursuant to Art. 53 LR With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1 Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease (ASCVD) on…
Original Source Today, the Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released a new report on bioscience economic development best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” Now in its sixth edition, the report serves as…
Original Source Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s: “The announcement by CMS sets a dangerous and far-reaching…
HB 5558, sponsored by Rep. Albert and others, was recently introduced and seeks that “Research shall not knowingly be performed on an organ, tissue, or cell taken from a dead embryo, fetus, or neonate obtained from an abortion.” This legislation is the latest attempt to criminalize and restrict fetal tissue research conducted legally and ethically.…