Posts by alishab
Grave Concerns Resulting from Court Decision to Suspend Abortion Pill Approval and Access
MichBio, like many other stakeholders in the life sciences industry, has serious concerns over the recent Texas Court decision to suspend the FDA approval of abortion pill mifepristone and what it may mean more broadly for the FDA’s ability to regulate drug reviews and approval. The decision, should it stand upon appeal, would set a…
Read MoreNew Traceable Opioid Material® Kit Expands Coverage to Other Emerging Drugs of Concern in Seized Samples and Toxicological Casework
ORIGINAL SOURCE ANN ARBOR, MI, APRIL 26, 2023—Cayman Chemical and the Centers for Disease Control and Prevention (CDC) have released a new addition to the Traceable Opioid Material® Kits (TOM Kits®) product line that expands testing laboratory capabilities beyond synthetic opioids to include additional emerging drugs of abuse that are commonly found as co-drugs in fentanyl-containing samples. The new Fentanyl…
Read MoreAdvaMed Responds to Proposed Rules Governing Ethylene Oxide’s Role in Sterilizing Medtech
ORIGINAL SOURCE WASHINGTON, D.C. – The Environmental Protection Agency (EPA) today released its proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act. The EPA also released its proposed update of EtO registration as a sterilant under the…
Read MoreMMS Scientific Advisory Board’s New Members Expand CRO’s Therapeutic Expertise
CANTON, Mich. (3/21/2023) – MMS Holdings, an award-winning, data-focused CRO, announced today the addition of Dr. Philip Breitfeld and Dr. Bernhardt Zeiher to its board of scientific advisors. Both industry leaders in innovative clinical trial delivery solutions, Dr. Breitfeld and Dr. Zeiher’s additions as advisors expand MMS’ therapeutic area expertise to support growth in different…
Read MoreBIO’s long COVID webinar furthers search for biotech solutions
ORIGINAL SOURCE When it comes to long COVID, health care providers and the biotech industry must be aware of what is already known, but we still need to learn much more, participants at an online long COVID webinar co-organized by the Biotechnology Innovation Organization (BIO) were told yesterday. “While significant research efforts by the U.S.…
Read MoreMMS Partners with I-ACT to Advance Children’s Clinical Trials
CANTON, Mich. (February 21, 2023) – MMS Holdings, a data-focused contract research organization (CRO) – announced its partnership with the Institute for Advanced Clinical Trials (I-ACT) to accelerate the development of life-saving therapeutics, including vaccines, medicines, and medical devices for children. MMS is a sponsor of I-ACT’s Spin Challenge, a creative way to raise funds to…
Read MoreLegislation to Establish a Michigan Rare Disease Advisory Council to be Introduced on Rare Disease Day
Giving a voice to the one million Michiganders with a rare disease. February 27, 2023 – Lansing, MI – Representative Jason Morgan (D) Ann Arbor to introduce legislation to establish a Rare Disease Advisory Council (RDAC) in Michigan. The council will gather stakeholders from the patient community, the life sciences industry, health insurance, provider…
Read MorePhase IIB Bridge and Small Market Applications Due February 28th, 2023
The NHLBI Phase IIB Bridge (RFA-HL-23-009) and Small Market Award (RFA-HL-23-008) Programs can provide up to $3 Million over three (3) years to continue the commercialization of novel products in the NHLBI mission space, specifically towards the completion of milestones necessary to achieve regulatory approval. This work must represent an extension of work completed under an…
Read MoreWhite House Sought Input on Bio-Industry Initiative
The Biden administration, via its Office of Science & Technology Policy (OSTP) requested input recently on implementing the new National Biotechnology and Biomanufacturing Initiative. BIO (Biotechnology Innovation Organization, of which MichBio is a state affiliate), responded with recommendations, which include, among others: Reduce trade barriers that interfere with the biotech supply chain. Increase capacity for surges in manufacturing to enhance…
Read MoreUnited States Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) Host Listening Session
The USPTO and FDA held a joint listening session focused on the patent system for drugs. Speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies weighed in on the relationship between patents and affordable access to medicines. The session stemmed from a joint July 2022 announcement that the two agencies…
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