INDUSTRY NEWS

Stay up-to-date on the latest industry, member, and policy related news.

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BIO’s long COVID webinar furthers search for biotech solutions

April 12, 2023

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.…

MMS Partners with I-ACT to Advance Children’s Clinical Trials

April 12, 2023

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…

Legislation to Establish a Michigan Rare Disease Advisory Council to be Introduced on Rare Disease Day

February 27, 2023

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…

Phase IIB Bridge and Small Market Applications Due February 28th, 2023

February 17, 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…

White House Sought Input on Bio-Industry Initiative

February 16, 2023

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…

United States Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) Host Listening Session

February 16, 2023

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…

CMS Seeks Comments on Small Biotech Exemption in Drug Pricing Regulation

February 16, 2023

CMS has posted an Information Collection Request (ICR) on the Small Biotech Exception to the Medicare drug pricing negotiation program established under the “Inflation Reduction Act” just passed by the last Congress in late 2022. Comments must be received by March 27.

White House Warned of Possible Disruption in Medical Device Supply

February 16, 2023

AdvaMed President and CEO, Scott Whitaker, recently sent a letter to President Biden outlining concerns about how more stringent ethylene oxide (EtO) requirements could stop medical devices from reaching patients. “With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage…

FDA Seeks Regulatory Oversight Over CBD Products

February 16, 2023

The Food and Drug Administration (FDA) released a statement indicating the need for a new regulatory pathway to allow for greater oversight and to better manage risks associated with cannabidiol (CBD) products, including products currently marketed as conventional foods and dietary supplements as well as products marketed for animal use. Few details were provided about the proposed…

New Michigan Legislative Session Kicks Off

February 16, 2023

Michigan’s new legislative session for the 2023-24 term is off and running. Turnover in the Michigan House is 52%, whereas the Senate is home to 16 new members (a 45% turnover). Leadership are now in place for both parties, as are committee assignments, with the Democrats in the majority in both chambers for the first…

JASPER HEALTH AND NEW DAY FOUNDATION PARTNER TO PROVIDE FREE RESOURCES TO FAMILIES FACING CANCER

February 16, 2023

ROCHESTER HILLS, MICH., Dec. 13, 2022 –      Jasper Health, an intelligent digital platform that provides end-to-end care guidance and navigation for people living with cancer, and New Day Foundation for Families, a non-profit organization that provides financial assistance and emotional support to families facing cancer, today announce a partnership to help families facing cancer access…

CABRI Awards $40,000 in Fellowships to Ten Undergraduate Researchers

February 16, 2023

ANN ARBOR, MI, DECEMBER 2, 2022—Cayman joins the Cayman Biomedical Research Institute (CABRI) in recognizing the ten undergraduate students who have been awarded fellowships by CABRI for the 2022-2023 academic year. The fellowship awards are given to talented undergraduates that are pursuing a research project of their own under the guidance of a faculty mentor.…

NEW DAY FOUNDATION ANNOUNCES $150,000 GRANT FROM PRIORITY HEALTH AND THE TOTAL HEALTH CARE FOUNDATION

February 16, 2023

Program seeks to remove financial barriers to cancer care in Wayne County   ROCHESTER HILLS, MICH., Feb. 6, 2023 – From the moment of diagnosis, social determinants of health (SDoH) that are beyond a patient’s control — including race, ethnicity, income level, zip code and language — can create financial and clinical barriers to cancer…

MMS Holdings, a data-focused contract research organization, announced today the appointment of a new Chief Operating Officer and Chief Commercial Officer.

February 16, 2023

Original Source CANTON, Mich. (2/7/2023) – MMS Holdings (MMS) – an award-winning, data-focused contract research organization (CRO) – announces the expansion of its leadership team with the appointment of Chris Schoonmaker as Chief Operating Officer and Ashu Tandon as Chief Commercial Officer. This comes as the company was recognized in the 2023 Top Workplace USA…

Vestaron Joins Leading Harvest as Program Supporter

February 16, 2023

Vestaron announces membership with Leading Harvest, an organization dedicated to improving the sustainability and efficiency of the agricultural industry. RTP, North Carolina, Feb 14, 2023 (GLOBE NEWSWIRE) — Vestaron, a leading producer of peptide-based bioinsecticides is proud to announce its membership as a Program Supporter of Leading Harvest, an industry leader in sustainability, created by and…