Headquartered in Prague, Czech Republic, Neox is a CRO with over 150 employees who support biotechnology, pharmaceutical, and medical device customers. Neox has provided clinical research support for more than 1,000 studies and has built deep experience across multiple therapeutic areas. The company has operations primarily in central and eastern Europe, with a direct presence in the Czech Republic, Bulgaria, Germany, Hungary, Poland, Romania, Slovakia and Slovenia.  Neox operates in another 11 European countries, including a recently established entity in the United Kingdom.

Emergent BioSolutions  (EBS) - Get Report shares rose Wednesday after the life sciences company and Mount Sinai Health System announced a trial for Emergent’s coronavirus preventative with $34.6 million of support from the Pentagon.

Emergent recently traded at $92.70, up 2.84%, and has surged 71% year to date amid investor enthusiasm for companies involved with Covid treatments.

Washington, D.C.-based Children’s National Hospital is partnering with the National Institutes of Health and tech firm NVIDIA to launch a challenge in which participants will develop artificial intelligence tools to improve the detection of COVID-19 in the lungs, the hospital announced Jan. 7.

Participants in the COVID-19 Lung CT Lesion Segmentation Grand Challenge will use a multi-institutional, multinational NIH dataset that houses data on patients with a diverse range of age, gender and disease severity to create AI-powered imaging models to help clinicians better identify and treat COVID-19 infection in patients' lungs.

CAMBRIDGE, MA and GAITHERSBURG, MD, January 11, 2021 — Myeloid Therapeutics, Inc., a company harnessing and reprogramming  yeloid cells to treat cancers, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announce the signing of a clinical and commercial licensing agreement.

Myeloid Therapeutics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. This agreement enables Myeloid to advance its pipeline programs, including for engineered cell therapies targeting solid tumors, T cell lymphoma, and glioblastoma. In return, MaxCyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.

FREDERICK, Md – January 12, 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

Gov. Larry Hogan on Monday unveiled a state economic relief package designed to put money into the pockets of low-income Marylanders, help businesses stay afloat and forgive hundreds of millions of taxes on unemployment benefits and other aid.

The $1 billion legislative package, which Hogan is introducing as emergency legislation when the General Assembly session begins Wednesday, is called the Recovery for the Economy, Livelihoods, Industries and Families (RELIEF) Act. Its purpose is to provide “immediate financial relief and tax cuts for Maryland working families, small businesses and those who have lost their jobs” during what Hogan summarized as "one of the worst economic crises in our country’s history."

Image: Gov. Larry Hogan gives an update on the state's coronavirus response during a Dec. 1 press conference. JOE ANDRUCYK/MARYLAND GOVPICS/CC 2.0/FLIC.KR/P/2KCWGCT

COVID-19 vaccine research drove a lot of funding to biotechnology companies in Maryland’s Montgomery County last year, but it didn’t all come from coronavirus research.

Life sciences companies based in, or with a presence in, Maryland’s largest county received nearly $7.7 billion in research and development funding from the federal government, private investors and nonprofit organizations in 2020, according to the Montgomery County Economic Development Corp., a public/private partnership aimed at helping private companies connect with funding, permits and other resources.

Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that long-time employee, Dr. Paul VanVeldhuisen, has been named President of Emmes Public Sector.

Emmes is now organized into two business groups:  Emmes Public Sector and Emmes Biopharma.  The public sector group includes all the company's existing federal government clients and contracts, as well as work for foundations, public/private sector partnerships, and not-for-profit organizations.

Image: Paul VanVeldhuisen - PRNewsfoto/Emmes

The state is providing aid for startups that are struggling to survive this economic downturn.

As part of an economic relief package announced by the State of Maryland in December, TEDCO will be making $5 million available for technology businesses that were hit hardest by the COVID-19 pandemic.

The funding will be available for technology-based businesses that are socially or economically disadvantaged, or based in rural areas, according to TEDCO, which is the quasi-public state agency that supports early-stage tech companies. The funding is expected to be made available in early February.

Image: Les Williams, CRO of Risk Cooperative, speaks at a TEDCO Builder Fund event. (Photo courtesy of TEDCO)

The Johnson & Johnson Nurses Innovate QuickFire Challenge in Mental Health, together with the American Psychiatric Nurses Association (APNA), invites nurses and nursing students worldwide to submit their nurse-led novel concepts, education programs, protocols, prevention or treatment approaches, screening tools, and consumer product ideas with the power to potentially transform mental health care and well-being for their fellow healthcare professionals or the patients they serve amid the current pandemic environment and beyond.

Areas of interest

• Treatment protocols 
• Health technologies 
• Medical device 
• Preventive approach 
• Consumer product 
• Community health approach 
• Screening tools

The Johns Hopkins Coronavirus Resource Center, a site launched in the spring of 2020 to offer critical data and perspective during the pandemic, logged its billionth page view today.

Launched March 3, the Coronavirus Resource Center has become a trusted destination for data on the spread and reach of COVID-19. Its continuously updated data trackers and tools help the public, policymakers, and health care professionals worldwide respond to the pandemic. The site includes the latest numbers on cases, testing efforts, and the vaccine rollout as well as expert analysis.

Richmond, VA, Jan. 07, 2021 (GLOBE NEWSWIRE) -- The Center for Innovative Technology (CIT) announced today its Request for Proposals (RFP) for the first solicitation under the newly formed Commonwealth Commercialization Fund (CCF).

The CCF was launched on July 1, 2020 to foster innovative and collaborative commercialization efforts in Virginia, consolidating two legacy programs: the Commonwealth Research Commercialization Fund (CRCF) and the Virginia Research Investment Fund (VRIF). In FY2021, CIT is conducting a single CCF solicitation for young Virginia companies that have strong potential to drive economic growth in Virginia, including through revenue and job creation. Up to $7 million is available to award; a one-to-one match is required.

This competitive round will provide grants up to $100,000 to support companies' commercialization and market entry goals through product or service development, market research, intellectual property protection, marketing, pilots, and more. High-potential projects are sought in seven strategically important sectors: agricultural and environmental technologies, autonomous systems, clean energy, cybersecurity, data science and analytics, life and health sciences, and space and satellites. All Virginia companies that meet the eligibility criteria are invited to seek funding.

With more than $650 million in financing in place, vertical construction in excess of 1.1 million square feet of mixed-use space at Port Covington in Baltimore is set to begin at the 235-acre redevelopment site along the city’s waterfront.

This $500 million development phase, known as Chapter 1B, includes 440,000 square feet of office, 586,000 square feet of residential with 537 units, 116,000 square feet of retail, more than 1,000 parking spaces and 10 acres of parks and public space.  

Image: Port Covington. Image courtesy of Weller Development Co.

Ernesto Chanona joined Glen Burnie-based CSSi LifeSciences as its director of business development.

The organization works with companies to advance drugs and medical device technologies from discovery to commercialization.

“The onset of the COVID-19 pandemic has catalyzed business growth throughout the industry, and as such, CSSi LifeSciences is poised to expand in 2021,” Chanona said. “Initially, I’ll be focusing on managing the company’s early-stage clients, housed at incubators all over the world. Growing the pipeline through strategic partnerships with economic development agencies, incubators, universities and startups is also part of the plan.”

Last year, when GEN prepared an editorial titled Eight Biopharma Trends to Watch in 2020, who could have foreseen COVID-19 and the deaths, illnesses, and economic disruption that the disease would wreak? And who could have foreseen how armies of industry and academic researchers would race to develop hundreds of new and repositioned vaccines and drugs? (GEN tracks more than 300 on its COVID-19 Drug and Vaccine Tracker webpage).

While biopharma was dominated by COVID-19, which prompted a surge of research and business activity, the industry also saw developments that will position it for further growth even after the virus is brought under control.

Far from the medical labs and test tubes, a fisherman in old rubber boots walks across the docks of West Ocean City to inspect his catch.

He peers in a crate of spiny tails and grasping claws, hundreds of a common yet precious creature, among the oldest species on Earth: horseshoe crabs.

The scene on the docks is a glimpse into a strange and guarded Maryland fishery, one supporting a multimillion-dollar industry as surprising as the catch itself — a seemingly alien creature with 10 eyes, 12 legs and magical, milky blue blood.

The Trade and Cooperation Agreement and other agreements below are provided for information only. No rights may be derived from them until the date of application. The numbering of the articles is provisional.

US healthcare venture fundraising soared in 2020, totaling $17B, a 57% increase over 2019’s record.

Image: https://www.svb.com

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

ROCKVILLE, Md., Dec. 30, 2020 /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 Neox s.r.o., a European-based CRO.  Neox will add over 150 employees who support biotechnology, pharmaceutical, and medical device companies.

"This is an important and exciting step for Emmes, demonstrating significant progress on our strategic plans to grow our biopharmaceutical business," said Dr. Christine Dingivan, Chief Executive Officer of Emmes. "Neox adds a sizable, well-established biopharmaceutical research services business to Emmes and significantly expands our international presence."

Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate. 

Click here to schedule a time.

The National Institute of Allergy and Infectious Diseases (NIAID) announced the commencement of the Phase III trial (NCT04611802) of the Novavax investigational COVID-19 vaccine, in a press release issued on Monday, December 28, 2020. The trial will evaluate the effectiveness, immune response, and safety of a COVID-19 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland, called NVX-CoV2373, and is estimated to complete data collection by March 31, 2021.

LONDON — Britain on Wednesday became the first country to give emergency authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, clearing the path for a cheap and easy-to-store shot that much of the world will rely on to help end the pandemic.

Image: https://www.nytimes.com - From Video

RICHMOND, Va.--(BUSINESS WIRE)--Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).

At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.

SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

Maryland is home to one of the largest life science clusters in the United States with more than 500 biotech companies. In addition to several state-of-the-art labs, Maryland is home to the NIH in Bethesda. Research opportunities, as well as BS and MS degree programs, are offered at Johns Hopkins in Baltimore and the University of Maryland in College Park. Montgomery College in Germantown offers the AAS degree and certificate programs in biotech. World-class training by companies like BioTrac and Biotech Primer attracts an international audience of professionals.

Image: https://www.americangene.com

ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1^st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region.  This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.

The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET'S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

We are now only a few weeks out from Biotech Showcase and excited to launch the Spotlight Sessions on our on-demand hub on partneringONE.

We have also posted several Digital Medicine and Medtech Showcase sessions this week. Sponsor Insight content, on-demand public and private company presentations as well as Investor strategy videos are available for you to watch on demand.

Be sure to look at the sessions we have planned for the weeks of January 5 and 11.

Read more ...

I’ve been reluctant to write this blog post because historically I don’t like talking about weight. But I’ve been promising to publish how I lost 65 pounds in the past 18 months without any fad diets or gimmicks to try and be helpful to others. I have a plan,

I know it works and for the friends and family who have followed what I’ve done they’ve equally lost a lot of weight.