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Andy

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FDA establishes CDER Center for Clinical Trial Innovation (C3TI)

By News

FDA logo[4/15/2024] Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

“CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, M.D., director of CDER. “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”

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UShasVCs

Pitchbook: 3 charts: The US has more startups than VCs can support

By News

UShasVCs2024 may well become the year of the bootstrapped founder.

The startup “mass extinction event” that doomsayers have predicted for two years is likely to ramp up in 2024. New founders facing a brutal funding environment may instead opt to bootstrap their growth.

Over 55,000 VC-backed companies are operating in the US right now, according to the latest PitchBook-NVCA Venture Monitor. Many of them are aggressively competing for funding in a slow dealmaking landscape.

At the same time, over 2,000 VC firms effectively halted making new investments in startups in the first nine months of 2023. Approximately 3,200 startups failed in 2023, and there’s even a burgeoning industry dedicated to helping founders wind down their companies.

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Adventist HealthCare

Adventist HealthCare Earns Spot on Newsweek’s Most Trustworthy Companies in America 2024 List

By News

Adventist HealthCareGAITHERSBURG, Md. – Adventist HealthCare has been named one of Newsweek’s Most Trustworthy Companies in America 2024. The list of 700 U.S. companies was announced March 27 after an analysis by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider.

Adventist HealthCare was among only 10 hospitals and healthcare systems in the U.S. to receive this prestigious recognition.

Adventist HealthCare ranked 18th among 37 public and private organizations in the Healthcare and Life Sciences category, which included a broad range of care providers, device manufacturers, pharmaceutical companies, and online health and wellness firms.

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STAT: NCI director expresses optimism about next era of cancer research, despite shrinking budget and brain drain

By News

Rathmell photo final JPEGSAN DIEGO — Kimryn Rathmell, director of the National Cancer Institute, gestured toward the screen and asked an audience of clinicians, researchers, and patient advocates what they thought they were looking at. Projected behind her was a patchwork of purple, red, pink, and blue squares.

Moments later, a larger-than-life image of Taylor Swift flashed in the middle of the pattern, and laughter rippled through the room here at the American Association for Cancer Research annual meeting as attendees realized they were staring at a poster of the singer’s “Eras Tour.”

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Collins2

WaPo: Former NIH director Collins on his prostate cancer, medical research

By News

Collins2Over my 40 years as a physician-scientist, I’ve had the privilege of advising many patients facing serious medical diagnoses. I’ve seen them go through the excruciating experience of waiting for the results of a critical blood test, biopsy or scan that could dramatically affect their future hopes and dreams.

But this time, I was the one lying in the PET scanner as it searched for possible evidence of spread of my aggressive prostate cancer. I spent those 30 minutes in quiet prayer. If that cancer had already spread to my lymph nodes, bones, lungs or brain, it could still be treated — but it would no longer be curable.

Why am I going public about this cancer that many men are uncomfortable talking about? Because I want to lift the veil and share lifesaving information, and I want all men to benefit from the medical research to which I’ve devoted my career and that is now guiding my care.

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TedcoAstek

TEDCO Invests in Astek Diagnostics

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TedcoAstekMaryland biotech company continuing mission to provide antibiotic sensitivity precision diagnostics

COLUMBIA, Md. (April 15, 2024) – fdfsTEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Seed Funds investment in Astek Diagnostics, a biomedical company.

“From the early days in my basement during the pandemic, TEDCO saw potential in our idea and supported us with our very first check,” said Mustafa Al-Adhami, CEO of Astek Diagnostics. “Today, our team stands strong at nine, having achieved the milestone of our first version of the product and partnerships with urology practices and hospitals across the globe.”

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TEDCO

TEDCO Announces Federal Lab Leveraging Innovation to Products Pilot Program

By News

TEDCOSenators Cardin and Van Hollen requested more than $1 million to fund this new program

COLUMBIA, Md., (April 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, has received $1,150,000 in Congressionally Directed Spending to advance its Federal Lab Leveraging Innovation to Products (FLLIP) Pilot Program. The direct spending request was sponsored by U.S. Senators Ben Cardin and Chris Van Hollen (D-Md.) and included in the Fiscal Year 2024 Financial Services and General Government funding bill, which was signed into law last month as part of a FY24 appropriations package.

“Maryland is home to more than 70 federal labs, from the NIH in Silver Spring to the Frederick National Lab for Cancer Research and the Army Medical Research and Development Command,” said Senator Cardin. “With this federal investment, we’re making it easier for traditionally underserved businesses in the healthcare industry to take full advantage of the resources right in their backyard. Community partnerships like the FLLIP Program drive innovation in the state and help build a more equitable, prepared and developed health care system.”

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TEDCOAloe

TEDCO Invests in Aloe Therapeutics

By News

TEDCOAloeCOLUMBIA, Md. (April 8, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Aloe Therapeutics, a company working to deliver cancer cures. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“At Aloe Therapeutics, we are working to increase efficacy and expand eligibility for patients with hard-to-treat solid tumors and limited treatment options,” said Martha Sklavos, founder and CEO of Aloe Therapeutics. “Thanks to TEDCO’s investment we can continue to develop our lead therapy to the clinic to ‘wake up the immune system’ with our cell-based therapeutic vaccine, Allo-Immunotherapy (AIM).

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BmoreEDA2

Technical.ly: How Baltimore plans to spend $70M in EDA Tech Hubs Funding

By News

BmoreEDA2Anticipation is building for the pending decision on Baltimore’s Phase 2 Tech Hubs application to the US Economic Development Administration (EDA).

That energy was most recently demonstrated during a roundtable discussion on the region’s tech hub designation at Coppin State University (CSU) on Monday. The HBCU’s president Anthony L. Jenkins kicked off the Greater Baltimore Committee’s (GBC) event by welcoming dignitaries and leaders in Maryland’s public and private sector to CSU’s sprawling 38-acre campus along North Avenue in West Baltimore.

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Medcura

Medcura Closes $22.4 Million Financing to Accelerate Development of Surgical Hemostatic Gel and Surgical Hemostasis Portfolio

By News

MedcuraRIVERDALE, Md.April 3, 2024 /PRNewswire/ — Medcura, Inc., a developer of hemostatic products for use in surgery, today announced that it has closed a private placement with aggregate gross proceeds of US $22.4 million (the “Offering”) in Convertible Debt. The Company intends to use the proceeds from this Offering to accelerate the development of its lead surgical product, LifeGel™ Absorbable Hemostatic Gel.  Medcura will complete its pre-clinical testing and file an Investigational Device Exemption for LifeGel with the U.S. FDA to support a global investigational study focused on stopping bleeding in spinal surgery. Current hemostatic agents swell and can cause neurological issues, including paralysis, when used in confined spaces routinely addressed in spinal surgery.

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