Ronald T. Piervincenzi, Ph.D., Chief Executive Officer, United States Pharmacopeia virtually sits down with Rich Bendis to discuss the over 200 year old Organization, the services they offer, and their goals for the future.

Listen now on Google http://bit.ly/2NjX8As, Apple http://apple.co/3irukRQ, Spotify http://spoti.fi/35UfM8B, and TuneIn http://bit.ly/2XRFEgD.

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Amalgam Rx, Inc., a leading Digital Therapeutics and Patient Support company, announces the acquisition of Avhana Health, a privately held clinical decision support (CDS) company, which has deep integrations with the leading electronic health records (EHR). Amalgam Rx will expand Avhana’s CDS tools to multiple therapeutic areas and combine them with other digital solutions to simplify doctors’ workflows.

Avhana Health is a CDS company used by doctors to support real-time adoption of and adherence to clinical quality guidelines. Avhana’s SaaS-based CDS tool has been implemented in more than 150 provider groups and identifies over $120 million a year in cost savings. Enabling real-time two-way interactions within the EHR, Avhana optimizes provider workflow beyond simple data integration.

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The latest funding comes on top of $61.3 million in new funding the local biotech raised in April.

Image: Bill Hearl is CEO and founder of Immunomic Therapeutics in Rockville. COURTESY IMMUNOMIC THERAPEUTICS

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Wednesday, January 27, 2021

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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More often than not, girls in developing countries either cannot afford or do not have access to menstrual products. This makes it extremely difficult for them to go about their day, particularly if they are in school. Flo is a menstrual product that allows the user to wash, dry and carry a reusable menstrual pad with dignity. The concept was developed by Mariko Higaki Iwai. The Flo menstrual kit was designed with the following issues in mind:

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GAITHERSBURG, MD – January 18, 2021 – NexImmune today announced the appointment of Dr. Robert (Bob) Knight as Chief Medical Officer (CMO). Dr. Knight is a seasoned executive with extensive experience leading early- and late-stage immunotherapy product development teams. Prior to joining NexImmune, Dr. Knight led the Yescarta® clinical program at Kite Pharmaceuticals (a Gilead Company) and, prior to that, spent 16 years at Celgene Corporation as a Vice President in Clinical Research. During his tenure at Celgene, he helped lead the development of the company’s IMiD and targeted therapy programs, including thalidomide, lenalidomide, and enasidenib. In addition to his roles at Kite and Celgene, Dr. Knight also led the cancer immunotherapy development program at Sorrento Therapeutics as the company’s Senior Vice President and Head of Clinical Research.

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After a bitter battle with Democratic lawmakers last year, the Department of Commerce is looking to alter the biotech, cybersecurity and research and development tax credits.

Image: Maryland Commerce Secretary Kelly Schulz wants the legislature to pass four bills that would alter tax credit programs including the cybersecurity and biotechnology tax credits. ERIC STOCKLIN

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GAITHERSBURG, MD - January 19, 2021 – NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology, today announced the appointment of Grant Verstandig to its Board of Directors.

“We are delighted to welcome Grant to the NexImmune Board,” said Sol Barer, PhD, Chairman of NexImmune’s Board of Directors. “Grant is a recognized innovator and leader in the evolving fields of digital health and artificial intelligence (AI). We believe that better understanding the intersections of biology, big data and artificial intelligence is a clear trend in our industry and will greatly help the Company design, implement and collect outcomes on clinical trials that may truly transform the way we develop novel therapeutics. We look forward to working with him as we continue the development of our product candidates and technology platform.”

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With a phase 3 data readout on its COVID-19 vaccine looming, Novavax has already started stockpiling doses ahead of an authorization. Now, thanks to a fresh manufacturing tie-up, the company’s ex-U.S. supplies just got a little more secure.

Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets, the companies said.

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SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Jan. 13, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced that results from the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) have been published online in the New England Journal of Medicine. Results from INCREASE, the largest and most comprehensive completed study of adult patients with PH-ILD, showed that treatment with inhaled Tyvaso was well tolerated and improved the exercise capacity measure of six-minute walk distance (6MWD) by 31 meters relative to placebo at Week 16 (p

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A key lesson we can learn from Warren Buffett, is about how to think about a potential stock investment in the context of a long-term time horizon. Every investor in a stock has a choice: bite our fingernails over the short-term ups and downs that are inevitable with the stock market, or, zero in on stocks we are comfortable to simply buy and hold for the long haul — maybe even a twenty year holding period. Heck, investors can even choose to completely ignore the stock market’s short-run quotations and instead go into their initial investment planning to hold on for years and years regardless of the fluctuations in price that might occur next.

Image: Photo credit: commons.wikimedia.org

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The pandemic changed everything. We live differently, behave differently, and have come to appreciate the little things we might have taken for granted before COVID-19 took hold in the BioHealth Capital Region (BHCR).

We saw a move to nearly 100% remote work within the life sciences industry, companies pivoting to join the fight against SARS-CoV-2, and telemedicine finally earning more widespread acceptance and usage. The region became an epicenter for COVID-19 vaccine development and funding, requiring a host of companies to recruit and hire new talent to support the fight against the pandemic while also advancing their own pipelines.

Image: https://biobuzz.io

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Join MCEDC and the FLC for a free virtual seminar. Learn about proposed policies for obtaining federal R&D funding, licensing federal technologies and accessing federal resources. The Department of Commerce has proposed new rules and legislation to provide extended protection for proprietary information, allow the licensing of government produced software, authorized more flexible grant terms - and more.

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Venture capitalists invested $1.159 billion into Maryland companies, according to data from the MoneyTree Report by PwC/CB Insights. It marks the third-highest VC dollar total in a year since 2000, and the highest since 2001.

The funding was invested over 79 deals that included a pair of megadeals over $100 million, which typically drive yearly totals up.

“Maryland not only had a good year in 2020 but the upward trend in funding over the last 20 years in Maryland is quite encouraging as well,” said Brad Phillips, a director in PwC’s emerging company services practice.

Image: (Photo by Flickr user Austin Kirk, used under a Creative Commons license)

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The Foundation for Advanced Education in the Sciences (FAES) at the NIH will host a Virtual Open House on Monday, March 1 for its online Spring 2021 Academic Programs, including the several courses for its "Advanced Studies in Technology Transfer Program". The Advanced Studies in Technology Transfer is a low-cost, open enrollment program with class credits transferable into various university graduate degree programs. Online registration for these classes is now open:

Online Courses

• TECH 514 | Technology Transfer: Transitions, Processes, and Players (Starts March 22)
• TECH 540 | Introduction to Life Sciences Licensing (Starts March 22)
• TECH 566 | Building a Biotech Company: Business Leadership and Management Strategies (Starts March 22)
• TECH 582 | Intellectual Property and Patent Prosecution for Scientists (Starts March 22)
• TECH 607 | Capstone Course in Technology Transfer (Starts February 1 and March 22)

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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” 

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Maryland's growing companies raised a record $1.16 billion in VC dollars last year.

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The Pulmonary Fibrosis Foundation (PFF) announced that United Therapeutics will sponsor the PFF Registry.

The Registry is a research resource that tracks clinical data, samples, and patient-reported outcomes from people living with pulmonary fibrosis in the U.S.

According to the PFF, United Therapeutics’ sponsorship of the Registry will aid researchers who are working to develop better treatments for people with pulmonary fibrosis and secondary pulmonary hypertension (PH, when the blood pressure in the lungs is abnormally high).

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The days are long, but the years are short.” This bittersweet saying, which is often shared with new parents, may apply to everyone who has been living through the COVID-19 pandemic—although what we’re experiencing is almost entirely bitter and not at all sweet. Over the past 12 months, SARS-CoV-2, an RNA virus that carries a mere 29,903 nucleotides, has devastated our communities, disabling economies and taking far too many lives. However, as we hit the grim one-year anniversary of COVID-19, we may anticipate a measure of relief.

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A significant volume of new M&A deals during 2021 are expected to involve cell and gene therapy developers as in recent years—but with an emerging twist resulting from some recent clinical disappointments for autologous treatments . . .

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The Department of Health and Human Services (HHS) has extended the public health emergency surrounding the COVID-19 pandemic until April, extending key waivers for regulations on a variety of topics such as telehealth.

The public health emergency declaration was originally scheduled to expire Jan. 21. HHS Secretary Alex Azar extended the emergency Thursday, according to a notice.

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In this article, we are going to list the 15 largest vaccine companies in the world. Click to skip ahead and jump to the 5 largest vaccine companies in the world. Vaccination is the most simple and effective way of prevention of many diseases. It provides immunity to infectious diseases and it is the most cost-effective method to protect the world population. The first-ever vaccine was introduced for smallpox to treat the deadly cowpox virus in 1796. This virus killed many people and developing a vaccine for it saved many lives. But the concept of vaccines existed even before 1796. Pharmaceutical companies around the globe have worked to develop vaccines for diseases such as Malaria, HIV, cholera, influenza and tuberculosis.

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Alexandria Real Estate Equities has announced it has entered into an agreement to purchase 401 Park Drive and 201 Brookline Ave. from Samuels & Associates for $1.5 billion. The office and research campus is located in Boston’s Fenway neighborhood and will include 1.8 million square feet of rentable space.

The 401 Park property was built in 1928 as a Sears, Roebuck and Co. distribution center and is home to a number of office and life science tenants. It is 93% occupied across 973,000 rentable square feet. The property is on the National Register of Historic Places and is also a retail and restaurant hub. The property at 201 Brookline is a 510,000-square-foot, 14-story office and lab development currently under construction with an estimated completion date of next year.

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Harvard University and the Massachusetts Institute of Technology's joint biological innovation center has secured $76 million and signed a lease for a new facility in Watertown, Mass., according to a Jan. 14 news release.

Harvard and MIT partnered with several Harvard-affiliated teaching hospitals including Massachusetts General and Brigham and Women's in November 2019 to launch the Center for Advanced Biological Innovation and Manufacturing.

The new funding will go toward building the 40,000-square-foot facility and support 40 full-time employees. The center expects to begin operations in early 2022.

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Biotech companies on London stock markets delivered market-beating returns in 2020 and attracted new investors looking for growth in a turbulent year, according to new analysis published today by the UK BioIndustry Association (BIA) and Radnor Capital Partners.

The study reveals 24 new American and 16 new European finance houses invested in the UK biotech sector for the first time, showing global recognition for UK innovation. 20 new UK institutional investors also entered the sector as other sectors of the economy were hit by the impacts of the pandemic. The findings show the importance of including biotech and healthcare in investment portfolios as part of both risk management and growth strategies.

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2020 INVESTMENTS HIT NEW ANNUAL RECORD DESPITE THE PANDEMIC

US-based, VC-backed companies raise nearly $130B in 2020, up 14% year-over-year (YoY) from 2019, despite the impacts of Covid-19 around the world.

However, annual deal activity is down YoY, falling to 6,022 deals, a 9% decline from 6,599 in 2019.

Image: https://www.cbinsights.com

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Washington, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Today, the U.S. Small Business Administration announced 38 companies, seven organizations and 14 individuals as the winners of the prestigious Tibbetts Award for their accomplishments in creating cutting-edge technologies. The Tibbetts Awards, named after Roland Tibbetts, the founder of the SBIR Program, honors these awardees for the exceptional successes they achieved through SBA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

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