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Children’s National Event: Navigating from Research to Market Approval: The AGAMREE Journey

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ChildrensJoin Children’s National Hospital for a pivotal symposium on the journey of AGAMREE® from academic research to market approval for DMD treatment in children. This event highlights the critical role of academic entrepreneurship and collaboration with industry in advancing treatments for rare diseases. Featuring insights from experts on the Vamorolone drug development program, regulatory pathways, and the venture philanthropy business model, this symposium is for those committed to making a difference in the biotech and healthcare sectors. Don’t miss this opportunity to engage, learn, and network with leaders in the field.

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BISNOW: In Nation’s Tightest Life Sciences Market, There Is Little Appetite To Build More Space

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DCBmoreFebruary 1, 2024 Emily Wishingrad – The life sciences real estate train, which just a few years ago was reaching top speeds, is now pressing down firmly on the brakes.  

The D.C.-Baltimore region is one of the largest life sciences clusters in the U.S., and like its peers, it’s dealing with a slowdown. Biotech companies that were previously growing rapidly were hit last year by rising interest rates, slowing venture capital funding and the collapse of industry backer Silicon Valley Bank, leading to a dramatic pullback in their real estate demand. 

But the D.C. region has an advantage over other top markets during this slowdown, experts say: Developers pursued far less speculative construction during the pandemic-era demand boom. This helped the region maintain the lowest vacancy rate of all U.S. life sciences hubs, according to CBRE, but it has left developers with shovel-ready sites waiting for large tenants that have become few and far between.

“We’re a very healthy market in comparison to other regions, because we did not overbuild,” JLL Executive Managing Director Pete Briskman told Bisnow. “Other top clusters are overbuilt and don’t have enough demand to fill their space. We’re not overbuilt.” 

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Baltimore Banner: One biotech company is leaving, one is staying. What does that say about Baltimore?

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Baltimore3Meredith Cohn – Thrive Earlier Detection Corp., a startup company based on early cancer testing technology developed at the Johns Hopkins University, was snatched up three years ago and is now planning to move out of Baltimore.

Another startup spun from the same revered Hopkins team called Haystack Oncology was bought last year by New Jersey-based giant Quest Diagnostics but plans to stay long term in the city.

There are dollars and jobs on the line with both, not to mention the dose of prestige from homegrown companies transforming patient care. So what does a city need to tip the scales in favor of more Haystacks and fewer Thrives?

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WBJ: AstraZeneca doubles down on Montgomery County with $300M investment

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az newfacility 2024 900xx2000 1125 0 0By Sara Gilgore – Staff Reporter, Washington Business Journal – AstraZeneca PLC (NYSE: AZN) is leaving no doubt about its commitment to Montgomery County, pouring $300 million into a new U.S. manufacturing hub it’s establishing in Rockville just a couple months after taking over another building nearby.

The British pharmaceutical giant said Tuesday the facility at 9950 Medical Center Drive will start out as a space to make T-cell therapies for clinical trials in cancer, and could support other disease areas and commercial work going forward. The company also said it expects to create more than 150 new jobs at the site.

 
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NovoCatalent

GEN: Novo Holdings Buys Catalent for $16.5B; Sells Three Sites to Novo Nordisk for $11B

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NovoCatalentBy Alex Philippidis -February 5, 2024 – Novo Holdings, the asset manager of the foundation that controls Novo Nordisk, has agreed to acquire contract development and manufacturing organization (CDMO) Catalent for $16.5 billion—with the buyer standing to recoup two-thirds of that expense by selling three of Catalent’s fill-finish sites to Novo Nordisk for $11 billion upfront so it can meet booming demand for its blockbuster obesity drugs Wegovy® and diabetes drug Ozempic®, the companies said today.

The three sites—consisting of facilities in Bloomington, IN; Brussels, Belgium; and Anagni, Italy—employ more than 3,000 people combined, about one sixth of Catalent’s total global workforce of more than 18,000 people, including 3,000 scientists and technicians.

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JPM

J.P. Morgan Releases 2024 Innovation Economy Outlook: What’s Next for Venture Capital?

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JPMJ.P. Morgan has released its 2024 Innovation Economy Outlook, offering valuable insights for those interested in the future of venture capital, investment trends, and the landscape of startup exits. This report provides an in-depth analysis of the venture fundraising environment and the challenges and opportunities that lie ahead.

The outlook delves into key areas such as the interplay between public markets and venture capital, the direction of venture capital flow, and how valuation trends are shaping the industry. It also addresses the challenges business leaders face in this evolving market and evaluates the state of the exit environment, posing the question of whether it will facilitate a rejuvenated venture capital cycle.

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BioHealth Innovation, Inc. (BHI) Welcomes Yaminah Leggett-Wells, Senior Director, Alliance Management at Amgen as Newest Member of the Board of Directors

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Yaminah2ROCKVILLE, MARYLAND, February 5, 2024 – BioHealth Innovation, Inc. (BHI), a leading public-private nonprofit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, proudly announces the appointment of Yaminah Leggett-Wells to its esteemed Board of Directors.

Yaminah Leggett-Wells serves as the Senior Director of Alliance Management at Amgen, overseeing global partnerships spanning all stages of drug development. With over 20 years of experience in the pharmaceutical industry, her expertise includes strategic leadership, clinical operations, business development, and project and alliance management.

Yaminah Leggett-Wells’ appointment to the BHI Board of Directors is a significant addition who brings valuable skills and experience to our organization,” remarked Richard Bendis, President and CEO of BHI. “Her extensive pharmaceutical industry background and commitment to our region make her an outstanding asset to our Board and our mission in the BioHealth Capital Region.”

Yaminah joined Amgen in 2023 following Amgen’s acquisition of Horizon Therapeutics. Prior to this, she played instrumental roles in the development of medicines for asthma and neuromyelitis optica spectrum disorder at AstraZeneca and Viela Bio, demonstrating her in-depth knowledge of drug development and regulatory affairs.

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House of Reps

Bio: House passes bill restoring full R&D expensing

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House of RepsOn January 31, the House passed legislation to restore the immediate expensing of R&D expenses. The Biotechnology Innovation Organization (BIO) has long advocated for this change.

Until 2022, research and development expenses were 100% tax deductible each year. However, the Tax Cuts and Jobs Act of 2017 required companies to amortize domestic expenditures over five years, and international expenditures over 15 years.

The $78 billion Tax Relief for American Families and Workers Act, passed yesterday, would reverse the change and reinstate R&D expensing. R&D expenses would be 100% deductible through 2025.

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Maxim Biomedical, Inc. Secures Second NIH RADx Tech High Performance Award for Continued Development of At-Home FiarFly™ Reader and COVID-19 & Flu A/B Rapid Test

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maximbio logo LogoROCKVILLE, Md.Feb. 1, 2024 /PRNewswire/ — MaximBio, a leading innovator in next-generation healthcare diagnostic technologies, is pleased to announce that it has been granted a second follow-on award from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program for the continued development of its revolutionary FiarFly™ reader and COVID-19 & Flu A/B multiplex test. This additional Phase 2 award, totaling approximately $4.4 million, will be used to accelerate the development of the FiarFly™ reader and COVID-19 & Flu A/B multiplex test and quickly prepare for clinical trials targeting this influenza season.

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Theradaptive

U.S. FDA Grants Theradaptive IDE Approval For Phase I/II Clinical Trials

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TheradaptiveGlobal study will assess the safety and efficacy of the company’s lead spinal fusion product, OsteoAdapt SP

FREDERICK, Md.Feb. 1, 2024 /PRNewswire/ — Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.

With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain.

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