The new chairman of the Biotechnology Innovation Organization (BIO) is promising to crack down on “bad actors” that increase drug prices “dramatically”—in part by expelling member companies that carry out the sky-high hikes.

Health IT vendor Cerner has revealed a new challenge that asks developers to improve patients’ access to EHRs, according to a company news release.

Dubbed the 2019 code App Challenge, the contest encourages participants to build apps on Cerner’s platforms.

Whether you’re starting a business, relocating one, or just moving to live and work, there are endless reasons for why Maryland is the top state to relocate to. The BioHealth Capital Region continues to climb the GEN’s annual ranking of the nation’s top biopharma clusters, and was ranked fourth in 2018. There are many factors that make Maryland a great place to headquarter your BioHealth company. Biotech and life science companies are high-risk high expense ventures, and the location of your company is key to its success.

Governor Ralph Northam today announced $2.51 million in funding in support of 41 Commonwealth Research Commercialization Fund (CRCF) awards. The projects represent exciting advancements in five industries: clean energy, cybersecurity, data analytics, life sciences, and unmanned systems.

Johns Hopkins has ranked among the top 10 patent-earners since 2014.

Biotechnology venture capital firm Third Rock Ventures has raised $770m for its fifth fund, a sign that investor interest in funding early-stage science continues unabated despite volatile public markets.

The investment vehicle, the largest ever raised by Third Rock in its 12-year history, will support investments in 10 to 12 companies. The Boston-based firm's new fund came together quickly.

The Georgia Tech alum is the first Spanish-born president of an American university.

The U.S. Small Business Administration (SBA) has announced the fifth round of its Growth Accelerator Fund Competition to recognize innovative accelerators, including incubators, co-working startup communities or other similar models, to compete for prizes of $50,000 each for a total of $3 million.

Emergent BioSolutions CEO Robert Kramer Sr. sits down with Yahoo Finance's Dan Roberts, Melody Hahm and Myles Udland on "YFi AM" to discuss the fight over drug pricing and hear how the biopharmaceutical company is seeking to make Narcan, a life-saving drug that blocks the effects of an opioid overdose, more affordable and accessible.

Although the recent $110 million funding round for Thrive Earlier Detection Corp. was impressive — it is certainly not the biggest we've seen around Maryland to date.

The two health care organizations have been investing separately in health technology and companies for several years.

Altimmune, Inc. (ALT), a clinical-stage biotechnology company, today announced that it has received additional patent protection for its HepTcell and ALT-702 programs in the United States.

Johns Hopkins University is planning a bold new approach to career development for students and alumni that includes opening three new administrative offices, launching new initiatives, and better integrating career and life design into the academic and co-curricular experience of all Hopkins students and postdocs.

For augmenting readability, The Research Insights has added a fresh market study, titled Vaccines Market to its flared database. The report has been put together in a chapter-wise arrangement, by separating required illustrations transversely. This report is an expedient tool to get responses to some of the queries that hold significance for the growth of the Vaccines Market during the forecast period. The evidence in the report was congregated from qualified organizations & dependable sources and was further authenticated by industry specialists for increased integrity

The Biotechnology Innovation Organization (BIO) released “Transforming Ideas into Advances: Best Practices in State and Regional Bioscience Economic Development Initiatives” today at the 2019 BIO International Convention.

The fifth edition of the Best Practices Guide is the bioscience industry’s leading comprehensive analysis of state legislative and regulatory initiatives in support of economic development.

Whether you have a medical device, diagnostic, health IT app, or therapeutic, if you have to obtain FDA approval to commercialize your product, you should attend this event! Learn about the obstacles, opportunities, draft guidances and new pathways you must consider when creating a regulatory strategy. In this ever-changing environment, the key to success is both transparency and a keen understanding of the options available for your regulatory pathway. 

June 19, 2019 6:00pm-8:30pm

Hood College, 401 Rosemont Avenue, Frederick, MD 21701

The National Oceanic and Atmospheric Administration (NOAA) has awarded a five-year $175 million cooperative funding agreement to the University of Maryland for collaborative research in Earth system science.

Emergent BioSolutions Inc. (EBS) today announced approval by the U.S. Food and Drug Administration (FDA) of the Prior Approval Supplement (PAS) submitted by the company for its oral cholera vaccine, Vaxchora® (Cholera Vaccine, Live, Oral). The PAS supports the change in storage conditions of the vaccine from frozen to refrigerated at 2-8°C and the transfer of bulk drug substance manufacturing from Emergent’s product development facility in San Diego to its manufacturing facility in Bern, Switzerland. The PAS also covers changes in labeling regarding these developments. The company’s oral cholera vaccine is the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease.

MCEDC discovers how Jeff is using the availability of raw talent and novel technology unique to Montgomery County, MD to help cure HIV and cancers with gene and cell therapy research.

The great American political divide shows no sign of ending as the United States lurches toward the 2020 presidential election. However, one of the few areas where the parties have joined together in recent years has been where NIH funding is concerned.

Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $535 million over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.

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 the first U.S. Food and Drug Administration (FDA) approval of a gene therapy that leverages REGENXBIO's proprietary NAV Technology Platform, Novartis AG's ZOLGENSMA® (onasemnogene abeparvovec-xioi; AVXS-101). ZOLGENSMA was approved by the FDA as a one-time infusion for pediatric patients with spinal muscular atrophy (SMA) who are less than two years of age.

A newborn. A fatal diagnosis. And soon, a one-time gene replacement cure in the first weeks of life.

The cost? You don’t want to know.

Today, the Biotechnology Innovation Organization (BIO) released the 2019 Emerging Therapeutic Company Trend Report, highlighting ten years (2009-2018) of biotechnology funding and deal making across five areas: venture capital, Initial Public Offerings (IPOs), follow-on public offerings, licensing, and acquisitions. The report also contains a 2019 snapshot of the industry’s clinical pipeline to highlight the significant contribution of emerging companies.

For aspiring entrepreneurs, the thought of building a company from scratch can be daunting. What if no one wants to buy what you're selling? Where will the money come from to grow the business? And what will happen if you fail?

The BIO International Convention is being held in Philadelphia from June 3-6, with more than 16,000 attendees expected from around the world. The convention draws a list of who’s who in drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy, with more than 7,000 companies and 47,000 partnering meetings.

June 12, 2019! 

Register now for the 3rd annual Technology Showcase! The 2019 Technology Showcase will again highlight technologies being developed at the NCI and Frederick National Laboratory for Cancer Research (FNLCR) to encourage technology licensing and collaborations, startup company formation and the translation of NCI discoveries into solutions to benefit patients.

A Baltimore-based regenerative medicine firm called LifeSprout, which makes synthetic products used to restore soft tissue, has secured $6.5 million in financing.

A newly formed Baltimore company has raised $110 million to commercialize a cancer-detecting blood test, developed by Johns Hopkins researchers, that doctors would give patients during routine physicals.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices

Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed)

(NOT-OD-19-100)National Heart, Lung, and Blood Institute

Notice of Intent to Publish a Funding Opportunity Announcement for Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)

(NOT-OD-19-104)National Heart, Lung, and Blood Institute

Notice of Correction to Award Budget for RFA-HL-19-024 "Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25 Clinical Trial Not Allowed)"

(NOT-HL-19-698) National Heart, Lung, and Blood Institute

Notice of Change to Key Dates in RFA-RM-19-005 " NIH Directors Pioneer Award Program (DP1 Clinical Trial Optional)"

(NOT-RM-19-007) Office of Strategic Coordination (Common Fund)

Program Announcements

Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional)

(PAR-19-262) National Heart, Lung, and Blood Institute

It's the local company's first step toward establishing an international presence after it was spun out last year from MedImmune.

Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, today announced that it will voluntarily transfer its stock exchange listing to the Nasdaq Capital Market from its current listing on NYSE American.

The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region expects to add approximately 2,000 life science-related jobs in the near term with more on the way. Whether it’s Kite Pharma building a new manufacturing site in Frederick County, MD, the growth of cell and gene therapy companies such as Autolus, Inc., REGENEXBIO, and RoosterBIO, Inc. or recent acquisitions of companies like Paragon BioServices, Inc., it’s evident that the BHCR is thriving.