Biohealth Innovation - 534th Edition, November 22, 2022

Biohealth Innovation

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November 22, 2022

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MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab

ROCKVILLE, MD, Nov. 17, 2022 (GLOBE NEWSWIRE) --

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today reported that the U.S. Food and Drug Administration announced the approval of the Biologics License Application (BLA) for teplizumab, an anti-CD3 monoclonal antibody that was previously developed by MacroGenics. Teplizumab was acquired by Provention Bio, Inc. in May 2018 pursuant to an asset purchase agreement.

"We are very pleased to see the culmination of years of effort by Provention, MacroGenics, and tireless champions in academia and government, with the achievement of the approval of teplizumab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We applaud this outcome, which represents an advancement for individuals and their families dealing with the risks and consequences of type 1 diabetes."

Emergent scores a DoD award to evaluate its chikungunya vaccine in the field – Endpoints News

Emergent BioSolutions is looking to make progress with its chikungunya vaccine and has received a $10 million US government grant to help it along.

Emergent announced that it has been handed a research award from the Department of Defense Congressional Directed Medical Research Programs to evaluate the efficacy of its single-dose chikungunya virus vaccine candidate.

BRAINBox Solutions Enrolls 1000th Patient in Pivotal, HeadSMART II Clinical Study of BRAINBox TBI Concussion Diagnostic and Prognostic Test

RICHMOND, Va., Nov. 14, 2022 /PRNewswire/ -- BRAINBox Solutions today announced that the company has enrolled the 1,000th patient in the pivotal, HeadSMART II study of its concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site, trial is designed to support an application for regulatory clearance by the U.S. FDA.

"We are developing the BRAINBox TBI (Traumatic Brain Injury) test as the first objective test to aid in the diagnosis of concussion and to provide an assessment of the risk of post-concussive symptoms," said Donna Edmonds, BRAINBox Solutions' CEO. "We are now in the home stretch of this very important study for the field. We believe the test has great potential to change clinical practice in the diagnosis and management of concussion and will define for the first time, objective diagnostic criteria for this condition, termed Acute Traumatic Encephalopathy (ATE). As such, the trial has been rigorously designed in collaboration with leading experts in traumatic brain injury and emergency medicine. The study evaluates patients in multiple settings and includes state of the art expert adjudication panels."

Wizbiosolutions team is MEDICA in Dusseldorf.

Hello everybody, Wizbiosolutions team is MEDICA in Dusseldorf. We are in Hall 1, E18 now. Please come to visit our booth and discuss about new technology that we have. We are all welcomeing you.

Image: https://www.linkedin.com

Rockville Expansion | Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, invests more than € 290 million in its biosafety testing capacity at Rockville, Maryland, USA. This will significantly increase the company’s ability to conduct biosafety testing and analytical development services. Biosafety testing and analytical development are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines. Global demand for these services is growing at a double-digit rate.

Maryland's Governor Hogan Announces MilliporeSigma Expanding Biosafety Testing In Montgomery County, Adding 500 New Jobs

BALTIMORE, MD (November 16, 2022) — Governor Larry Hogan today announced that MilliporeSigma, an international biosciences company, is growing its presence in Montgomery County with a $286 million investment to expand its biosafety testing capacity.

The company, known locally as BioReliance Corporation, currently has five locations in Rockville and is planning to consolidate in a new 250,000-square-foot facility at 9820 Darnestown Road at the Alexandria Center® at Traville Gateway campus, which is being developed and operated by Alexandria Real Estate Equities, Inc. MilliporeSigma will maintain one additional facility at 9630 Medical Center Drive and will retain at least 600 full-time employees during the expansion, while creating more than 500 new jobs over the next four years.

NextCure and LegoChem Biosciences Enter into Collaboration and Co-Development Agreement to Develop Antibody Drug Conjugates

BELTSVILLE, Md. and DAEJEON, South Korea, Nov. 15, 2022 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC) and LegoChem Biosciences, Inc. (LCB, KOSDAQ: 141080) today announced a collaboration and co-development agreement focused on generating a B7-H4 antibody drug conjugate (ADC) and options for two additional targets. The B7-H4 ADC will utilize NextCure’s B7-H4 antibody and LCB’s ConjuAllTM ADC technology.

Under the terms of the agreement, both parties will equally share the costs to develop the molecules and profits on commercialized products. The parties will utilize their respective product development capabilities to generate the B7-H4 ADC and advance it to the clinic. In addition, there are options for the parties to nominate two additional targets for ADC development beyond B7-H4.

On the Road Montgomery County: Biotech boom not happening everwhere - Washington Business Journal

In Montgomery County, lab space has long been a prized get for biotechs, because there was so little of it. Shockingly little, actually, given the county is home to both the National Institutes of Health and the Food and Drug Administration.

That’s changing, and fast. There’s about 2 million square feet of the specialized space in the county’s pipeline, much of it taking the place of obsolete office buildings that are either being converted to labs, or demolished in favor of gleaming, state-of-the-art new construction.

BioHealth Capital Region 2022 Q3 News Recap – Keeping Up the Momentum · BioBuzz

A few of BioBuzz’s favorite stories from late summer/early fall Over the past several months, life sciences companies across the BioHealth Capital Region showcased their innovative capabilities and pipeline development program. BioBuzz takes a look back at five key events that took place in the third quarter.

BioFactura Moves Forward with Stelara Biosimilar

Frederick, Maryland-based BioFactura is beginning to see the fruits of its labors with the development of ustekinumab (BFI-751), its biosimilar for Janssen’s Stelara. In October, the company announced Phase 1 data that showed pharmacokinetic comparability to the comparison drug.

The company also reported there were no marked differences in the safety and tolerability profile for subjects receiving ustekinumab. BioFactura intends to conduct a confirmatory safety and efficacy study in patients to pave the way for global registration.

Image: https://biobuzz.io/

The Princeton Review & Entrepreneur Magazine Name the Top Undergrad & Grad Schools for Entrepreneurship Studies for 2023 - University of Maryland ranked in Top 10

NEW YORK, Nov. 15, 2022 /PRNewswire/ -- The Princeton Review® and Entrepreneur® today announced the results of The Princeton Review's 17th annual ranking of undergraduate and graduate schools for entrepreneurship studies.

Based on a summer 2022 survey The Princeton Review conducted of nearly 300 schools with entrepreneurship offerings, the rankings reported today took into account more than 40 data points about the school programs, faculties, students, and alumni.

The Princeton Review and Entrepreneur published the project's ranking lists on their respective websites at https://www.princetonreview.com/entrepreneur and https://www.entrepreneur.com/topcolleges.

Money Moves: Baltimore nanotech firm Pixelligent raised a sparkly new $38M - Technical.ly

Pixelligent, a nanotechnology firm that produces materials used in augmented reality displays and sensors, recently raised $38 million in IP-backed financing from a funding vehicle by MVolution Partners LLC. These funds brings the total raised this round of funding to $45 million, with the other $7 million coming from existing investors.

Image: Inside Pixelligent's manufacturing facility. (Courtesy photo)

Apply - virginia catalyst - Grant Round 14 Now Open!

October 6, 2022 – Now accepting Letters of Intent (LOI) for Grant Round 14

Dec 7, 2022 5:00 PM EDT Deadline to submit LOI for consideration in Grant Round 14

December 16, 2022 Invitation to submit a full application will be sent to Applicant Teams whose LOI meets funding criteria

February 2, 2023 5:00 PM Eastern Deadline to submit full application for Grant Round 14

February 24, 2023 Invitation to present proposal in person to our Project Management and Oversight Panel (PMOP) will be sent to the top 8 applicant teams as determined by scoring and ranking of applications

Week of March 13, 2023 Proposal Presentations

Week of March 20, 2023 Virginia Board of Directors final funding decision for Grant Round 14 March 2023 Grant Round 14 Awardees announced

Baltimore biotech Haystack Oncology raises $56M, plans move to City Garage

The Johns Hopkins University researchers behind two of Baltimore's most successful biotech firms have founded a new company that has now raised $56 million to create a new diagnostic tool for cancer.

Haystack Oncology plans to use the funding from its series A round to kickstart a move into a large lab inside of City Garage in Port Covington, which was recently renamed Baltimore Peninsula. The company also plans to invest in more clinical trials to get additional data to support the effectiveness of Haystack's cancer detection blood test. The 50-person company, currently based at Hopkins' FastForwardU, plans to have a commercial launch in 2023.

Deadline for Medtech Innovator Applications is January 31, 2023 - The LaunchPort

Apply Now for Our 2023 Programs!

Applications for our three different Innovator programs – MedTech Innovator US, MedTech Innovator Asia Pacific, and BioTools Innovator – are now open. Read below to learn which program is right for you and apply today.

Companies do not have to relocate, and there is no equity required or fee for participation. The application deadline for all programs is January 31, 2023.

Image: https://thelaunchport.com

Why the life sciences sector is heading for the city

From New York to Paris and London, life sciences companies are being drawn to parts of town often more synonymous with financial services. In London, the Canary Wharf Group and Kadans Science Partner are jointly developing Europe’s largest commercial laboratory building. Life science organization Genomics England will move in later this year, joined by a mix of startups, academics, clinicians and established pharmaceutical companies.

Chicago’s roadmap to becoming the next big life sciences city – REJournals

According to a recent report from CBRE, Chicago ranks No. 6 for job growth out of the Top 25 life sciences markets in the U.S. To establish itself as a prominent hub on par with the coastal life sciences clusters in Boston and San Francisco, Chicago needs to enhance its offering in the areas of funding, talent, real estate and infrastructure. While the city has made many positive strides toward becoming a life sciences destination, there are four key steps city and state leaders can take to accelerate this process.

Image: https://www.pexels.com/photo/architectural-photography-of-tunnel-2088233/