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House of Reps

Bio: House passes bill restoring full R&D expensing

By News

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

By News

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

By News

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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VAState

BioBuzz: Virginia Bio-Connect – The Success of Virginia’s First Statewide Collaborative Life Sciences Initiative

By News

VAStateBy Jelena Ivanjac | January 30, 2024 – The end of 2023 marked the completion of Virginia’s first statewide life sciences initiative, Virginia Bio-Connect, which started in April 2021. This comprehensive industry cluster strengthening project, supported by Virginia Growth and Opportunity Foundation funding and led by the Virginia Biotechnology Association, engaged thousands of life sciences professionals and hundreds of organizations and companies within the sector with the overarching goal of fostering a more connected life sciences ecosystem, providing support for early-stage companies, and driving workforce development throughout the state.

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Baltimore’s LifeSprout Enters into Licensing Agreement with Boyang Trading to Develop and Commercialize Next-Generation Lumina™ Dermal Filler in Greater China

By News

LifeSprout LogoBALTIMORE, Jan. 31, 2024 /PRNewswire/ — LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has entered into a definitive agreement with Boyang Trading Co., Ltd. to exclusively develop and commercialize the Lumina™ dermal filler in mainland China, Hong Kong, Macau, and Taiwan.

Lumina is the first product from LifeSprout’s proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.

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Takeovers

GEN: Top 10 Biopharma Takeover Targets of 2024

By News
BioMaryland

Deadline Approaching: Apply to Be Part of the Maryland Delegation at BIO 2024

By News

BioMarylandThe Maryland Department of Commerce invites companies to seize the opportunity to join the Maryland delegation at the BIO International Convention in San Diego, CA, this June 3-6, 2024. This event offers unparalleled networking, learning, and visibility for companies in the biotech sector.

Benefit from a complimentary Premier Access pass, which includes access to key partnering sessions, exhibitor booths, educational content, and exclusive networking receptions. Your company will also gain promotional exposure as part of the delegation.

To be eligible, companies must be registered and in good standing in Maryland. Selected companies are expected to actively participate in pre-conference and event activities, and share insights post-event.

Applications are due by February 21, 2024. Click here to apply now. For queries, contact life.sciences@maryland.gov. This is a valuable opportunity to showcase your company on a global stage. Apply now to join the Maryland delegation at BIO 2024.

NeoImmuneTech

FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech’s NT-I7 for Advanced Pancreatic Cancer Treatment

By News

NeoImmuneTechROCKVILLE, Md.Jan. 30, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a “silent killer” because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.2

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Infinity Bio

Infinity Bio Launches Next-Generation Antibody Profiling Platform Utilizing MIPSA Technology

By News

Infinity BioBALTIMORE–()–Infinity Bio, Inc. announces its new antibody profiling platform, leveraging Molecular Indexing of Proteins by Self-Assembly (MIPSA) technology. This platform offers unparalleled depth in immune system analysis, advancing immunology, virology, autoimmunity, and allergy research, providing new disease insights, and discovering new biomarkers and treatments. The MIPSA technology exploits recent advances in high throughput DNA sequencing and DNA synthesis, to create and analyze the most complete panels of immune targets available.

The immune system crafts antibodies from approximately one quadrillion options, enabling it to identify and neutralize any infectious threat. However, flaws in the immune system can result in excessive inflammation, autoimmunity, or allergies. Infinity Bio’s scientists have developed a novel technique, MIPSA, to examine the extensive array of antibodies present in blood or other fluid, providing comprehensive understanding of individual immune responses.

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Revolo

Revolo Biotherapeutics Receives Orphan Drug Designation from the U.S. FDA for its First-in-Class Peptide as a Potential Treatment for Eosinophilic Esophagitis

By News

RevoloGAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) — Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.

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