AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA approved Lokelma sodium zirconium cyclosilicate (ZS-9) to treat hyperkalemia in adults. AZ had received two CRLs for Lokelma following manufacturing concerns (see BioCentury Extra, March 17, 2017).

Enthusiasm for the biopharmaceutical sector in Asia has been flat, due in part to China’s market-access blockade, Japan’s spending controls, and deceleration in India and Southeast Asia. Recent changes have reignited interest in the region, with important implications for pharma executives.

A nonprofit organization, Knowledge Ecology International (KEI), recently filed a lawsuit against the National Institutes of Health (NIH) over Gilead Sciences’ patents for a new chimeric antigen receptor T-cell (CAR-T) therapy.

KEI calls itself a “not for profit non government organization that searches for better outcomes, including new solutions, to the management of knowledge resources. KEI is focused on social justice, particularly for the most vulnerable populations, including low-income persons and marginalized groups.”

The U.S. Small Business Administration, under its Federal and State Technology (FAST) Partnership Program, is soliciting grant applications from New York organizations to help boost the development of technology from small businesses.

Today the President of Iceland awarded Kerecis the Industry Award for Entrepreneurship. Kerecis is the creator, manufacturer and patent holder of revolutionary, fish-skin-based therapeutic products that speed up the healing process of human wounds and repair tissue damage. 

The Maryland Tech Council (MTC), Maryland’s largest technology trade association, announced the winners of its 30th Annual Industry Awards during a celebration and ceremony at The Hotel at the University of Maryland attended by more than 550 business leaders from around the state.

A complication from surgery can cost tens of thousands of dollars and require more surgery to correct — but a young Maryland startup is cooking up a more affordable and less invasive solution.

Maryland Technology Development Corp. has doled out $7.1 million to 25 companies and researchers working on stem cell products and medical therapies.

Venture development organizations (VDO), nonprofit organizations across the country investing in innovation startups to help grow their regional economies as well as earn a respectable return, saw at least 20 exits in the first quarter of 2018, based on data entered on Pitchbook.com. Here are some examples from the quarter:

Join the FLC on Tuesday, May 22 at 1:00 p.m. EDT for an inside look into these new regulations with NIST’s Courtney Silverthorn. To register for this webinar, visit http://connect.federallabs.org/new-t2-regulations-what-you-need-to-know. 

The Icahn School of Medicine at Mount Sinai has created a $10 million accelerator fund to speed up the commercialization of research at the school. It's starting with two investments in drug-development ventures.

The Small Business Innovation Research (SBIR) Program is an important funding mechanism that the National Institutes of Health (NIH) uses to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. This Funding Opportunity Announcement (FOA) invites SBIR grant applications from SBCs to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR Phase II awards and will require eventual Federal regulatory approval/clearance. The goal of this FOA and the resulting Phase IIB awards is to assist applicants in pursuing the milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners.

The Small Business Innovation Research (SBIR) Program is an important National Institutes of Health (NIH) funding mechanism used to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. This gap is increased by the barriers associated with technologies under development for small commercial markets, such as those focused on rare diseases or young pediatric populations. This Funding Opportunity Announcement (FOA) invites small businesses to submit SBIR grant applications to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR (Small Business Technology Transfer) Phase II awards that address rare diseases or young pediatric populations (aged 0-12 years and defined in Section IV, part 7), and will require eventual Federal regulatory approval/clearance. The goal of this FOA and the resulting Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between small business awardees and third-party investors and/or strategic partners, including patient advocacy organizations.

Kite, a Gilead Company (Nasdaq: GILD), today announced it has leased a new facility in the Netherlands to engineer cell therapies in Europe. The 117,000 square-foot site in Hoofddorp (SEGRO Park Amsterdam Airport) will enable Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe and will provide more than 300 new jobs when fully operational in 2020.

Founders can become myopic during the long, stressful process of fundraising. Many focus solely on the amount of money they’re going to raise, their valuation, and the brand name of the investors they are pitching.

Tufts University has joined the biotech incubator craze, launching a coworking space in Boston earlier this year that organizers hope will foster another life sciences cluster in the heart of the city.

The MdBio Foundation, a non-profit that provides STEM education and workforce development to underserved communities, today announced that Katy Wnuk-Fink – a senior from Laurel who attends Reservoir High School – was named winner of the 2018 Maryland BioGENEius Challenge, the premier competition for high school students that recognizes outstanding original research in biotechnology for healthcare, sustainability, and the environment. As the Maryland BioGENEius finalist, Wnuk-Fink will represent the state in the International BioGENEius Challenge at the BIO International Convention in Boston in June.

Boston Children’s Hospital has teamed up with open-source solution provider Red Hat to create a web-based medical image platform that will speed the time it takes to share and analyze life-saving images.

Trying to build on Arizona’s significant investments in the life science discovery and healthcare delivery infrastructure, the state’s leaders are focused on bridging the funding gap that slows the growth of Arizona-based life science companies. Leaders of Arizona’s life science sector share a drive to accomplish a common goal: accelerate the growth of local companies that are developing and delivering innovative treatments that truly change lives.

This white paper takes an in depth look at trends in the pharmaceutical industry that are anticipated to make a significant impact on the sector in 2018. Industry professionals can leverage this information to make the course adjustments that will give their companies a competitive edge in the market.

A company that works to turn intellectual property into businesses is backing a new Johns Hopkins startup developing therapeutics to treat cancer.

New Enterprise Associates, one of Silicon Valley’s largest venture-capital firms, plans to sell off a big chunk of its startup investments in response to a dearth of initial public offerings, according to people familiar with the discussions.

Rexahn Pharmaceuticals, Inc. (NYSE American:RNN), a clinical-stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, advances its ongoing Phase 2a study of RX-3117 in combination with Abraxane® in first-line patients with metastatic pancreatic cancer following a recently completed routine Safety Monitoring Committee (SMC) review.

MockV Solutions, Inc. (MockV or the Company), a company developing innovative products to analyze virus clearance during process development, announced today that it will be collaborating with the Vaccine Production Program of the Vaccine Research Center/National Institute of Allergy and Infectious Diseases/National Institutes of Health (VRC, NIAID, NIH) to evaluate its lead product candidate, the MVM-MVP Kit. The MVM-MVP Kit contains a non-infectious “Mock Virus Particle” (MVP) spiking surrogate that mimics the physicochemical characteristics of Minute Virus of Mice (MVM), a small and physiochemically resistant parvovirus, used as a universal standard for assessing viral clearance during process validation studies. The intention of this collaboration is to determine if the non-infectious MVP could be used as an accurate and economic indicator of MVM clearance during small scale bioprocess development studies.

The Iowa AgriTech Accelerator is a mentor-led accelerator focused on AgTech innovations. The Accelerator is led by innovators and leaders in several areas of agriculture, and seeks startups ready to change the status quo.

Intralytix, Inc., announced today that it has closed on the acquisition of a 33,000 sq. ft. building in Columbia, Maryland. The facility, located in the Columbia Gateway Community, will serve as the Company's new headquarters. Plans are underway to house expanded research and laboratory space, executive offices, and substantially increased manufacturing capacity.

The University of Maryland announced its goal Friday to fundraise $1.5 billion by the end of 2021 for numerous construction projects, scholarship funds and program upgrades, according to a news release.

The government said Friday it would spend 7.5 trillion won ($7 billion) to support the biohealth sector by 2022 aggressively.

The Ministry of Trade, Industry and Energy launched “Industrial Innovation 2020 Platform” with private companies and experts to discuss cooperative measures to accelerate private sector-driven industrial innovation and growth.

More than half of all venture capital dollars invested in small businesses and startups during the first three months of 2018 went straight into the state of California, according to a recent investment report from PwC and CB Insights suggesting the vast majority of business investment in the U.S. is concentrated in only a few states.

You’ve heard the cliché about wearing your heart on your sleeve. But a group of Army doctors did one better: They grew a new ear on a soldier’s forearm, using cartilage harvested from her ribs.

It pays to be a business in Baltimore. That's the message that Johns Hopkins wants proprietors and their patrons to know as part of the institution's HopkinsLocal initiative to support and invest in local enterprises.

Famous local inventor Robert E. Fischell is gifting $20 million to the University of Maryland School of Medicine in support of biomedical research.

The gift will be used to establish the Robert E. Fischell Center for Biomedical Innovation at the medical school, and provide funding for a planned new 450,000 square foot research building on the school's Baltimore campus. It will also support research funds and endowed professorships for the new Fischell Center.

Takeda Pharmaceutical agreed to buy London-listed Shire for 45.3 billion pounds ($62 billion) on Tuesday, the biggest yet in a wave of deals sweeping the drugs industry.

The Emmes Corporation today announced that scientists and health professionals from the company, LDS Hospital in Salt Lake City, Utah, Lovelace Biomedical Environmental Research Institute in Albuquerque, New Mexico, and the U.S. Army Medical and Materiel Development Activity at Fort Detrick, Maryland, have completed a multi-year clinical trial testing hyperbaric oxygen as an intervention for U.S. military service members who have suffered mild traumatic brain injuries with persistent symptoms.

The first-quarter numbers for Emergent BioSolutions (NYSE:EBS) didn't look too great. In fact, they were arguably ugly.