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WASHINGTON, Sept. 20, 2023 /PRNewswire/ -- VerImmune Inc. ("VerImmune"), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP™) technology platform, announced today the securing of an additional $3.125 million from follow-on Seed financing and a partnership milestone payment.

The follow-on financing was led by previous investor, Proxima VC, a specialist seed-to-growth healthcare venture capital firm with participation from other previous investors such as Gaingels, Mana Ventures and others. In addition to this financing, a milestone payment from Fosun Pharma USA was triggered by  the successful completion of a process development milestone.

Childrens

Federal funding fosters development and commercialization of medical devices designed for children

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital. The nonprofit group, which is one of five in the FDA’s Pediatric Device Consortia (PDC) program, will utilize the five-year grant to provide a platform of services, expertise and funding that supports pediatric innovators in bringing medical devices to the market that specifically address the needs of children. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

Forum Website

We're just ONE DAY away from the FREE 9th Annual BioHealth Capital Region Forum, and there's still time to register! Don't miss out on this incredible opportunity to join nearly 500 other registrants on September 19th and 20th. 🗓️

📍 Location: US Pharmacopeia (USP), 12601 Twinbrook Pkwy, Rockville, MD 20850
👔 Attire: Business/Business Casual
🚗 Parking: Paid-parking garage across the street or metered-street parking
🚇 Metro: Twinbrook Metro stop on the Red Line (8-minute walk)

🔬 Why Attend?

  • Network with esteemed government officials, academic leaders, and industry executives.
  • Explore new avenues for growth within the BioHealth Capital Region.
  • Engage in thought-provoking discussions and knowledge sharing.
  • Discover investment and partnership opportunities in the vibrant biohealth industry.

📈 The BioHealth Capital Region is a thriving hub of innovation and opportunity, boasting over 2,300 life science companies, 78 federal labs, and renowned academic institutions.

👉 Register now to be a part of this prestigious event and help shape the future of the BioHealth Capital Region!

Visit https://bit.ly/BHCRForum2023 to register now. 

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PQE Group is excited to announce the opening of its newest office in Montreal, Quebec, Canada, marking a significant expansion for the company. The expansion aims to provide enhanced services to both existing and potential clients across various regions in Canada. The Greater Montreal area, located along North America's east coast, is renowned for its vibrant life sciences community, featuring prestigious universities, leading hospitals, and innovative life sciences companies. Notably, Quebec serves as a hub for the development and acceleration of artificial intelligence (AI), reflecting its forward-thinking approach to shaping the future. Canada's expertise in AI, characterized by its high-quality research, skilled workforce, and contributions to AI innovation on a global scale, has been a key source of inspiration for PQE Group.

Crabby


Rockville, Maryland – September 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading regional innovation intermediary, is thrilled to announce the five outstanding finalists for the 8th Annual BioHealth Capital Region Crab Trap competition. The Crab Trap is a competition designed to identify and showcase promising life sciences and biotechnology startups from around the world. These finalists have demonstrated exceptional innovation, vision, and potential to significantly impact the healthcare industry.

 

 

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ARLINGTON, Va.--()--The Accelerate Investor Conference is back for its third year at George Mason University’s Arlington Campus, November 1-2, 2023. Spurring the region’s innovation and entrepreneurship engagement to a new level, the conference will showcase the Virginia, Maryland, and metropolitan DC region as a destination for business development, venture investment, and job creation.

Top venture firms from across North America participate to attend top keynotes and industry panels and watch 40+ high growth tech and life science companies pitch for their next round of capital. These cutting-edge startups compete for top prizes and are joined by 25 regional student teams presenting business concepts.

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BETHESDA, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the Company has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical study of its lead drug candidate GT-02287 in development for GBA1-Parkinson’s disease (GBA1-PD). Dosing in healthy volunteers to assess the safety and pharmacokinetics of GT-02287 is expected to begin in the near term.

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GAITHERSBURG, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of dosing (last subject last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the efficacy and safety of pemvidutide 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).

oneweekbhcr

One week away from the 9th Annual BioHealth Capital Region Forum (https://bit.ly/BHCRForum2023), a cornerstone event for anyone involved in the biopharma sector. Scheduled for September 19th and 20th at the US Pharmacopeia in Rockville, Maryland, this year's forum promises to be an enriching experience for all attendees. Even better, thanks to the generosity of our sponsors, attendance is entirely free of cost!

A Gathering of Minds

The forum is a unique confluence of thought leaders, industry executives, academic pioneers, and government officials. This year, the keynote addresses promise to be particularly illuminating. Rachel King, the CEO of BIO, will speak on biotechnology's accomplishments and challenges in her talk titled "Biotechnology: What We've Accomplished and the Challenges Before Us." On the other end of the spectrum, Lance Liotta, Co-Director of the Center for Applied Proteomics and Molecular Medicine at George Mason University, will explore the cutting-edge intersection of AI and BioHealth in his keynote, "Hijacking Cellular Communications using AI Tools: A New Frontier in BioHealth."

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ROCKVILLE, Md., Sept. 09, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announces the presentation of two posters at Psych Congress 2023 with new data showing improved efficacy in children ages 6 years and older with ADHD when Qelbree is added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with Qelbree.

“While ADHD is recognized as one of the most common psychiatric diagnoses, affecting approximately 16.1 million individuals in the United States, patients are in need of alternative or additional options to stimulants that allow them to manage their symptoms with a safe and tolerable treatment option,” says Jonathan Rubin, Chief Medical Officer and Senior Vice President of Research & Development. “The new Qelbree data presented during Psych Congress 2023 reinforce the efficacy and safety of our novel nonstimulant treatment in addition to existing stimulant therapy in children ages 6 and older with ADHD and in a long-term setting in adults with ADHD.”

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BELTSVILLE, Md., Sept. 07, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of a review article in the online journal Frontiers in Immunology, highlighting the need for targeting tumor collagen in the extracellular matrix (ECM) in the tumor microenvironment to enhance anti-tumor immunity.

“Emerging data on the effects of dysregulated collagen in the ECM show that it modulates accessibility and activity of immune cells within the TME, leading to suboptimal oncology treatment outcomes,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer. “A key aspect of what we highlighted in this review is that an expanded understanding and cross-fertilization within the fields of tumor matrix biology, cancer biology, and immunology will contribute to improving the efficacy of cancer therapeutics. Importantly, it will enable the development of new classes of therapeutics to address the unmet needs of cancer patients who do not benefit from current therapies. This is a key focus of our ongoing NC410 clinical trial.”

Resistance

The documentary-style film addresses the urgent global health crisis of antimicrobial resistance, which is causing widespread concern in the scientific and medical fields. The film highlights the dire consequences of this growing issue and showcases the relentless efforts of doctors, scientists, and experts who are working on innovative research and solutions to protect future generations.

https://www.youtube.com/watch?v=5U3k9ruszxI

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Your Invitation to apply to a Key Investment Event in Rockville, Maryland Awaits

There's still time if you haven't yet marked your calendar for the 6th Annual BioHealth Capital Region Investment Conference. The one-day event will also be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors. Applications to attend are due by September 12th!

A Unique Investment Opportunity: September 21st

The Investment Conference brings together investors and companies seeking funding. With a strong track record of fostering successful financial engagements, this conference is an unparalleled opportunity for those eyeing transformative funding.

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Your Invitation to a Pivotal BioHealth Event in Rockville, Maryland Awaits

If you haven't yet marked your calendar for the 9th Annual BioHealth Capital Region Forum, it's not too late. The event will be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors.

Two Days of In-Person BioHealth Exploration: September 19th and 20th

The Forum is just weeks away and promises an in-person experience under the theme "Global Breakthroughs for a Healthier Future." This cornerstone event offers industry experts, academic trailblazers, and government representatives a unique opportunity to reconnect in this “Top 3” BioPharma cluster.

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GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium.

The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy.

Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix.

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US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on September 5 the second closing of its financing round, which secured investments from two existing investors: MUFG Bank, Ltd., and Miyako Kyoto University Innovation II L.P., as well as two new investors: FFG Venture Business Partners Co., Ltd. and toberu Fund run by Phoenixi Co., Ltd.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

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ROCKVILLE, MD, Sept. 05, 2023 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that its partner, Gilead Sciences, Inc. (NASDAQ: GILD), nominated the first of two research programs, leveraging MacroGenics’ DART® and TRIDENT® platforms for generating bispecific antibodies. This nomination grants Gilead an exclusive option, upon achievement of a pre-defined preclinical milestone, to license worldwide rights to the research program.

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Join us for an insightful episode of BioTalk as host Rich Bendis welcomes back Rachel King, the visionary CEO of the Biotechnology Innovation Organization (BIO), bringing with her a remarkable journey spanning roles as an entrepreneur, board member, and advocate for the biotech industry.

In this engaging installment, Rachel offers a glimpse into her evolution from consulting to industry, including her role as co-founder and former CEO of GlycoMimetics, Inc. (GMI). Discover the essence of BIO, its mission, and the global perspective it brings to the biotech landscape. Delve into Rachel's advocacy role and the critical issues facing the industry today, including pricing, congressional relations, and investment challenges. Gain insights into the state of the biotech industry and Rachel's projections for both the near and long term.

Listen as we unravel the dynamic journey of Rachel King, a trailblazing leader in biotechnology, and gain a comprehensive perspective on the industry's present and future. Available now on all major podcasting platforms.

 

Listen now via your favorite podcasting platform:

AmgenHorizon

THOUSAND OAKS, Calif. and DUBLINSept. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.

Narcan

GAITHERSBURG, Md., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced NARCAN® Naloxone HCl Nasal Spray 4 mg will be available on shelves nationwide and online beginning in September. Over-the-counter (OTC) access to NARCAN® Nasal Spray offers more people the ability to respond in an opioid emergency, helping to save lives and keep loved ones and communities safe. Expanding access and awareness is critical given the staggering toll of the epidemic mainly driven by synthetic opioids, like fentanyl.1 Last year, approximately every seven minutes one life was lost due to an opioid overdose, and today it is the leading cause of accidental death in the U.S.2,3 The average response time for emergency services to arrive is approximately 10 minutes.4 Having NARCAN® Nasal Spray in a first-aid kit, or carrying it on the go in case of an opioid emergency, can make a difference and help reverse the effects of opioids while waiting for emergency personnel to arrive.

Emerald

Los Angeles, CA; September - CellKey, a leading provider of innovative bioanalytical solutions, is thrilled to announce the signing of a Memorandum of Understanding (MOU) with Emerald Cloud Lab (ECL), a pioneer in cloud-based laboratory facilities, to collaborate on the development of a cutting-edge glycoprotein analysis platform. This strategic partnership aims to revolutionize glycosylation studies, essential for diagnosing and treating cancer and various other diseases, as evidenced by the groundbreaking work of the recent Nobel laureate in Chemistry at Stanford University.

tech showcase

The Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD, is set to host the 2023 Technology Showcase on September 6, 2023. This annual event serves as a platform for potential industry partners to engage with the National Cancer Institute (NCI) and Frederick National Laboratory (FNL).

Registration and Attendance

Interested parties can register to attend the showcase either in person or online. Each mode of attendance has its own unique registration link, offering flexibility for participants.

What to Expect

The Technology Showcase is a free hybrid event featuring a variety of activities and opportunities:

  • Inventor Highlights: NCI and FNL inventors will present technologies ripe for commercialization and collaboration.

  • Programmatic Insights: Leaders from NCI and FNL will share avenues for potential collaboration.

  • Partnership Perspectives: The event will provide insights into what partnering with NCI and FNL entails, including viewpoints from companies that have successfully collaborated.

  • Panel Sessions: These will feature success stories and topics relevant to the commercialization of biomedical technology.

  • Lightning Pitch Competition and Poster Session: These segments will spotlight NIH technologies available for co-development or licensing, presented by the NCI Technology Transfer Ambassadors Program.

polaris

Maryland-based veteran-owned biotech company is working to transform mental health care

COLUMBIA, Md. (August 28, 2023) – Charles Cathlin, CEO of Polaris Genomics (TEDCO Portfolio company)TEDCO, Maryland’s economic engine for technology companies, announced its Venture Funds invested $500,000 State Small Business Credit Initiative (SSBCI) funds in Polaris Genomics, a Maryland-based biotech company.

Fierce15

It’s been a tough year for biotech, so how about a little good news? In between all the layoffs, restructurings and last-ditch strategic option hunting, we wanted to take a moment to shine a spotlight on 15 innovative and truly fierce biotechs.

That didn't surprise us, because everyone we talk to in the Fierce Biotech universe tells us that science doesn't stop for the markets. Financing might be a little tough right now, but innovation, breakthroughs and discoveries are all still being made. 

The latest crop of Fierce 15 honorees consists of companies pushing the envelope not only in the lab, in the clinic or on the conference circuit: They are also defining what it means to be a modern biotech company, with modalities ranging from radiopharmaceuticals to cell therapy. Indications as diverse as oncology, neurodegenerative disorders, Pompe disease and even pregnancy complications made the list this year.

Danaher

Danaher’s wide-ranging offerings for the life sciences sector will get broader and deeper with the $5.7 billion acquisition of Abcam, a company that makes reagents and tools used in scientific research, drug discovery, and diagnostics.

According to deal terms announced Monday, Washington, D.C.-based Danaher agreed to pay $24 cash for each Abcam share, which is a modest 2.7% premium to that company’s $23.36 closing stock price on Friday. However, shares had already spiked sharply in June after Abcam announced it would pursue a strategy to increase shareholder value as it fended off attempts by company’s founder and former CEO to wrest control of the business. Abcam also said in June it would explore strategic alternatives, including the potential sale of the company. Abcam said Monday that its process engaged with more than 30 entities, a list that narrowed to 20 potential acquirers before leading to the Danaher acquisition agreement.

LUPUS

WASHINGTONAug. 28, 2023 /PRNewswire/ -- The Lupus Foundation of America and Lupus Canada are pleased to announce Joan Wither, MD, PhD, FRCPC has been awarded the 2023 Lupus Canada Catalyst Award for her study "Interferon and Prediction of Treatment Responses in Lupus Nephritis," focused on interferon (IFN)-induced genes (an inflammatory marker) to predict treatment response in lupus nephritis with a new technique that could be incorporated into routine analysis of kidney biopsies.

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Explore the world of scientific mentorship and education with Dr. Judy Staveley, an accomplished Chief Biotechnologist and STEM advocate. In this episode of BioTalk, Dr. Staveley discusses her journey in supporting young scientists and her roles in organizations like the National Association of Academies of Science (NAAS) and the American Junior Academy of Science (AJAS).  

Discover the upcoming NAAS/AJAS STEM EDUCATION CONFERENCE/FUNDRAISER on September 16th and its impact on inspiring the next generation of innovators. Learn about AJAS's life science support programs that encourage young talents to pursue careers in STEM.  

Dr. Staveley shares insights into STEM education in the BioHealth Capital Region and her personal goals for nurturing young scientists. Join us to uncover the pivotal role of mentorship in shaping the future of STEM.

Listen now via your favorite podcasting platform:

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Rockville, MD – BioHealth Innovation (BHI), a founding member of the BioHealth Capital Region (BHCR), announces its strategic partnership with Big4Bio, an national aggregator of news and developments in the life sciences sector. This collaboration aims to share pivotal news and information from the BHCR, which has recently achieved a significant milestone by ranking as a Top 3 BioPharma Cluster in the Genetic Engineering & Biotechnology News “Top 10 US Biopharma Clusters” rankings, to a larger audience beyond the region.

In an era where the life sciences sector is experiencing unparalleled innovation and investment, staying updated with key information is paramount. Big4Bio, focused on its comprehensive coverage of the cornerstone “Big 4” in biosciences and health - drugs, devices, diagnostics, and digital (the “four D’s”), offers daily email newsletters that provide readers with easy-to-scan headlines sourced from hundreds of credible industry sources across eight US Biotech markets. Their commitment to producing individual summaries for the world’s most significant life sciences markets aligns with BHI’s and the BHCR’s vision of fostering growth and innovation in the biotech and life sciences industries.

Bloomberg Business School

The new 250,000-square-foot facility will support the Bloomberg School's mission through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces.

The Johns Hopkins Bloomberg School of Public Health shared the latest updates on their planned new building at the Baltimore City Urban Design & Architecture Advisory Panel (UDAAP) meeting this morning.

The new building will be located on existing Johns Hopkins property at the corner of McElderry and Washington streets—adjacent to the division's main Wolfe Street building and at the heart of the East Baltimore campus. The school has been working with award-winning, London-based architectural firm Hopkins Architects as design architect and Baltimore-based Hord Coplan Macht Inc. as architect of record to design a facility that will meet the demands of public health education, research, and practice well into the future.

Totaling approximately 250,000 gross square feet across seven floors, the new facility will support the school's mission of inspiring and educating the next generation of public health leaders through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces, including for events and meetings with community groups.

Currently, the school's academic departments have outgrown their existing spaces, primarily comprised of two separate buildings on North Wolfe Street and North Broadway. The new facility will connect to the Wolfe Street building, bring the core activities of all 10 departments together in one location, and accommodate the Bloomberg School's growth. The new building will also add much-needed green space to the campus, including an expansion of the existing School of Nursing courtyard that will provide a shared collegial space for rest and relaxation between the two schools.

"We are thrilled to be able to move this building to the next phase of planning, with a thoughtful design for a modern facility that connects to our current Wolfe Street building, in order to foster interdisciplinary collaboration, enhance our teaching and learning experience, and provide new opportunities for community engagement and convening," said Bloomberg School of Public Health Dean Ellen J. MacKenzie. "Our goal is to create a vibrant space where researchers, practitioners, policymakers, and students collaborate seamlessly to address the most pressing challenges facing us today. We are excited to create an environment that nurtures innovation and incubates ideas that can advance public health globally."

Click here to read more via JHU's HUB.

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ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

“Dosing of the first patient in the Phase 1 clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” stated Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”

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Horizon Therapeutics and Roche rank among the top pharma companies in terms of reputation among rare disease patient groups, according to a recent report compiled by U.K. consultancy PatientView. 

Published Tuesday, the 2022 Corporate Reputation of Pharma survey asked 426 rare disease patient groups representing some 3.3 million patients to assess the performance of 34 drugmakers in the space.

The report noted that pharma has steadily improved its reputation among rare disease patient groups over the past five years. Most respondents praised drugmakers’ abilities to provide products that are beneficial to patients and innovating on breakthrough treatments.

Still, the industry scored lower in 2022 for key activities that are meaningful to these patient populations, including fair pricing policies and access to medicines.

Out of the 34 companies, Horizon was ranked first among rare disease patient groups familiar with the brand, followed by Roche and Takeda Pharmaceuticals. Out of 31 companies, Roche was assessed as the top company by rare disease patient groups working with the company.

Click here to continue reading.

Gillian Henker

We’re excited to introduce you to the always interesting and insightful Gillian Henker. We hope you’ll enjoy our conversation with Gillian below.

Hi Gillian, thanks for joining us today. So let’s jump to your mission – what’s the backstory behind how you developed the mission that drives your brand?

At Sisu Global, we set our vision for a world where medical technology enables access to healthcare in every community. In 2010 at Komfo Anokye Teaching Hospital (KATH), I set out to create medical devices to fit the unmet needs of those in resource-limited settings — medical devices that are simple in nature yet impactful in design, serve as a lifesaving intervention for patients, and directly influence the entire healthcare ecosystem.

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COLUMBIA, Md., August 23, 2023 — Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar® . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.

Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes. Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin.

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Funding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies

Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), awarded more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.

The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.

“Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” said HHS Secretary Xavier Becerra. “These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”