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Isabella Casillas Guzman SBA Administrator

Administrator Guzman Applauds Passage of Small Business Innovation Research (SBIR) Program Reauthorization, Committing to Scientific and Technology Innovation

By News Archive

Isabella Casillas Guzman SBA AdministratorWASHINGTON – Administrator Isabella Casillas Guzman, head of the U.S. Small Business Administration and voice for America’s 33 million small businesses in President Biden’s Cabinet, released the following statement today after the House voted to reauthorize funding for the Small Business Innovation Research (SBIR) program:

“Today’s Congressional vote demonstrates overwhelming bipartisan support for the Small Business Innovation Research program which is vital to our nation’s capacity to innovate and improve the lives of all Americans.  When President Biden signs this bill, America’s innovators, scientists and entrepreneurs will have another three years of certainty as they continue to create opportunities which lead to jobs and equity in our nation’s innovation economy.  If past performance of the SBIR program is any guide, new generations of entrepreneurs will be breaking barriers in science, medicine, and technology, while ensuring that the United States maintains its position as an innovation leader at the forefront of science and technology in a rapidly evolving global market.  A new three-year reauthorization for SBIR is a significant win for our nation’s small businesses and the American jobs it supports.”

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Commerce secretary, local experts project how recession would affect life sciences

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Balance 2022 08 01 01 48 57 utcSome economists say yes — and predict it’s going to be bad — while others say the United States will avoid one altogether. Still others forecast that one will linger for a while, but be relatively shallow.

But even if the country can’t dodge what many fear will follow record levels of inflation, a panel of experts in the life sciences field said on Tuesday they’re optimistic that the Frederick County biohealth sector may be spared from the worst effects of an economic downturn.

 

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Additional Information on New NIH MedTech Program: Incubator hubs will provide subawards to technology innovation teams and aim to accelerate medical devices to treat, diagnose nervous system disorders – The LaunchPort

By News Archive

NIH NIBIB logoNewswise — The National Institutes of Health, through its Blueprint MedTech program, has established two incubator hubs and launched a funding solicitation in support of commercially viable, clinically focused neurotechnology solutions to diagnose and treat disorders of the nervous system. Blueprint MedTech relies on the collaborative framework of the NIH Blueprint for Neuroscience Research, which includes the NIH Office of the Director and 12 NIH institutes and centers that support research on the nervous system.

 

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Maxcyte

MaxCyte Signs Strategic Platform License with Vertex Pharmaceuticals to Advance CRISPR/Cas9-based Gene-editing Program

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MaxcyteVertex Pharmaceuticals will continue to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support gene-edited cell therapy exa-cel, formerly known as CTX001™ for hemoglobinopathies

ROCKVILLE, Md., Sept. 28, 2022 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with Vertex Pharmaceuticals Incorporated, a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

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Altimmune Announces First Dosing of All Subjects in Phase 2 MOMENTUM Trial of Pemvidutide in Subjects with Obesity or Overweight

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altimmune logoTwenty-four week interim analysis on approximately 160 subjects planned for Q1 2023 September 28, 2022 07:30 ET | Source: Altimmune, Inc

GAITHERSBURG, Md., Sept. 28, 2022 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of first dosing of all subjects in its Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH).

MOMENTUM is a multicenter, randomized, placebo-controlled trial that is ongoing at approximately 30 sites in the United States, with Dr. Louis J. Aronne, Founder and Director of the Center for Weight Management at Weill-Cornell Medical Center, and a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator. Approximately 320 subjects with obesity or overweight and without diabetes are being randomized 1:1:1:1 to either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. The primary endpoint of the trial is the relative (percent) change in body weight at 48-weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.

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Emmes Acquires Clinical Edge

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Emmes-LogoThe Company’s Fifth Acquisition Deepens Ophthalmology Credentials and Enhances Global Reach

ROCKVILLE, Md., Sept. 28, 2022 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Clinical Edge. Clinical Edge trains and certifies visual function examiners at investigator sites conducting Phase I to IV ophthalmic clinical trials.

The combination of Optym, Emmes’ ophthalmology certification unit, and Clinical Edge will make the organization a leader in ophthalmic certification and training services.

Emmes officially rolled out the new name – OptymEdge – and branding ahead of the American Academy of Ophthalmology annual meeting, which takes place in Chicago from September 30 to October 3.

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Emergent BioSolutions Completes Acquisition of Exclusive Worldwide Rights to TEMBEXA® (brincidofovir), the First FDA-Approved Smallpox Oral Antiviral for All Ages

By News Archive

Emergent LogoGAITHERSBURG, Md., Sept. 26, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® (brincidofovir), the first oral antiviral approved by the U.S. Food and Drug Administration (FDA) for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent.

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Washington dc at the white house 2021 09 03 03 07 35 utc

President Biden Announces Intent to Appoint Dr. Renee Wegrzyn as Inaugural Director of Advanced Research Projects Agency for Health (ARPA-H) – The White House

By News Archive

Washington dc at the white house 2021 09 03 03 07 35 utcToday, President Joe Biden announced his intent to appoint Dr. Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans.  On the 60th anniversary of President John F. Kennedy’s Moonshot speech, Dr. Wegrzyn will join President Biden today at the John F. Kennedy Presidential Library in Boston as he discusses his bold vision for another American Moonshot: ending cancer as we know it.

 

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Neuroene Therapeutics Wins 7th Annual BioHealth Capital Region Crab Trap Competition

By News Archive

Neuroene Therapeutics LogoROCKVILLE, MARYLAND, September 26, 2022 – When it was announced that the winner of the 7th Annual BioHealth Capital Region Crab Trap would be the recipients of a larger than ever prize pool, organizers didn’t expect that two companies would benefit thanks to unique circumstances. The main winner, Neuroene Therapeutics, a biotech company focused on discovering, developing, and commercializing novel therapeutics for difficult-to-treat neurological disorders, was selected from five finalists as the company with the most commercial potential at the 7th Annual Crab Trap Competition.

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BioBuzz: Neuroene Therapeutics Wins 7th Annual Crab Trap Competition

By News Archive

CrabTrapHeaderGaithersburg-based Neuroene Therapeutics and its approach to treating a rare form of epilepsy were crowned the winner of the seventh annual Crab Trap Competition, which highlights the commercialization potential of biohealth technologies throughout the BioHealth Capital Region.

The company was largely recognized for its lead asset, NT102, a Vitamin K analog demonstrating broad seizure protection in preclinical animal models. In particular, the asset showed protection against seizures in Dravet syndrome, a rare genetic disease marked by severe encephalopathy and epilepsy that doesn’t respond well to current medications.

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