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CareDx Leads the Way in Xenotransplant Organ Surveillance

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CareDx Logo

SOUTH SAN FRANCISCO, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that its non-invasive organ transplant surveillance solutions are being used to help monitor post-operative graft health in the world’s first successful heart xenotransplantation. A genetically modified pig heart was successfully transplanted into a patient at the University of Maryland Medical Center on January 7, 2022.

 

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Emergent underway with $100M in manufacturing upgrades as it gears up for ‘post-pandemic work’ | FiercePharma

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Emergent Logo

After struggling through COVID-19 vaccine production woes in 2021, Emergent BioSolutions has another surprise for its investors in early 2022. 

Last month, Emergent projected revenues of $1.4 billion to $1.5 billion for this year. Now, the company has dropped the figure to $1.3 to $1.4 billion. 

Why the adjustment?

In its quarterly report, Emergent credited its decision to undergo maintenance on its troubled Baltimore Bayview facility “earlier than anticipated,” and to expand the project to set the facility up for “future non-pandemic work.”

 

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BHI’s next EIR Feedback Day is March 16th

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BHI Logo

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

 

To sign-up for any of the EIR dates in 2022, please follow this link.

Opportunity: Entrepreneur-In-Residence Role with BioHealth Innovation, Inc. and NIH

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NIH BHI LogoPOSITION DESCRIPTION – Entrepreneur-In-Residence

EIRs will work in collaboration with SEED to mentor innovators and provide guidance to help them de-risk the technical and business elements of their product development projects. EIRs will also help NIH and individual innovators ensure the long-term success of their projects by facilitating connections with investors and strategic partners who can help achieve commercial success and healthcare consumer access. To be successful in this role, entrepreneurial, commercial or product development experience in areas of social impact including wellness & prevention, healthcare access/community health and a wide network in social impact ventures is required.

This position is currently remote (with opportunity for future in-person activities) and part time (20 hrs/week with potential for expansion); occasional travel may be required (when conditions permit).

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COVID Vaccines Demonstrated the Potential of mRNA Technology but Common Approaches for Managing Quality are Needed

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USP Logo

USP Developing mRNA Quality Guidelines to help companies and regulators bring innovative medicines to market faster   Rockville, Md., February 23, 2022 – U.S. Pharmacopeia (USP), a global independent scientific organization, is seeking scientific input on new draft guidelines, “Analytical Procedures for mRNA Vaccine Quality.” USP and a group of leading mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis and other disorders.

To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.

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The 2022 Women’s Venture Competition is open for applications until February 28, 2022, 11:59 PM Eastern Time

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AIM HI Logo

The AIM-HI Women’s Venture Competition, in its third year, is open for women entrepreneurs! The program provides early-stage funding, coaching, and networking opportunities to women-led oncology startups to address unmet medical needs.

The winning company will receive a total of $1 million in equity investment from AIM-HI and co-investors, subject to due diligence and negotiation. Click here to download the flyer and help spread the word!

 

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BHI’s next EIR Feedback Day is March 16th

BHI Logo

BHI Logo

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

 

To sign-up for any of the EIR dates in 2022, please follow this link.

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