Last month, Johnson & Johnson (J&J) announced that its Phase 1/2a in-human clinical trial of its potential COVID-19 vaccine was expected to begin in July – instead of September as initially scheduled. On Thursday, as reported by Fierce Pharma, J&J chief scientific officer Paul Stoffels confirmed the accelerated timeline, saying that the company has seen […]
U.S. Pfizer and Germany’s BioNTech announced Monday that they have received Fast Track designation from the FDA for two COVID-19 vaccine candidates – BNT162b1 and BNT162b2 – part of the companies’ “Project Lightspeed” program. The designation was issued based on promising preliminary data from Phase 1/2 clinical studies. The FDA’s Fast Track designation is intended […]
The MedTech Conference is proud to bring you unparalleled programming opportunities every year, and this year is no exception. We’re sharing just a few of our sessions and networking opportunities that will be offered virtually in 2020. See what’s in store for this year and make plans to participate! Learn more here.
The Johnson & Johnson Innovation (JLABS) Meet with… Series helps life sciences entrepreneurs, as well as the academic community, connect with potential partners including corporate venture, VC’s, Angels and other investment entities. Maha Katabi and Sarah Bhagat from Sofinnova will present an overview of the fund, it’s investment strategy, primary areas of interest, and a few investment […]
Outsourcing isn’t a trend in the life sciences – it’s the new way of doing business. Join MasterControl Executive Vice President of Product, Matt Lowe, in an exclusive webinar on July 15 as he discusses the challenges posed by modern business ecosystems and the criticality of extensible and flexible quality management systems. Lowe will examine […]
Today innovators across the Rocky Mountain Southwest Region are pioneering new ways to : Prevent disease and improve health. Provide more timely and accurate diagnostics Personalize therapies so that the right patient gets the right treatments at the right time and has the best possible outcome Engineer medical devices that improve the quality of life […]
Join youngStartup Ventures this August for the virtual 2020 Venture Summit. You can participate in one-on-one networking sessions, learn from 100 private company presentations, and virtually attend investor panels/startup bootcamp sessions with industry experts. Learn more and register here.
On June 16, Governor Herbert released Volume IV of the Utah Leads Together plan, which presents Utah’s economic recovery and revitalization plan, using a 100, 250, and 500-day time horizon. Volumes I, II, and III of the Utah Leads Together plan presented economic phases, color-coded health guidance, instructions for high-risk individuals, recommendations from Utah’s multi-cultural […]
Whether you are a solo entrepreneur, starting a company, or running an established corporation, you should be aware of issues such as IP ownership, freedom-to-operate, patentability, patent portfolio management and cost control. For more information, click here.
August 21, 2020 Update Thank you to everyone who submitted applications for the $2M of CARES Act funding appropriated by the Utah Legislature to support the response to COVID-19. Applicants were awarded grants through a multi-step review process. At this point, all $2M in CARES Act funding appropriated by the legislature has been distributed. Thank […]
The Senate Finance Committee held a hearing this week on the FDA’s oversight of foreign drug manufacturers, which also highlighted increased concerns about the U.S.’s dependence on foreign-made medicines. The committee heard testimony from FDA officials and generic drug manufacturers, including Salt Lake-based Civica. Founded in 2018, Civica, a non-profit social welfare organization, is committed to […]
By Brandon Allfrey, Partner, Squire, Brandona@squire.com Late Wednesday evening, the U.S Senate passed by unanimous consent the Paycheck Protection Program Flexibility Act of 2020 to ease some of the original rules of the PPP application and forgiveness rules from the CARES Act and the subsequent guidance from the Treasury Department. The details of the Act did not change from the […]
WEBINAR: IMAGING APPLICATIONS FOR R&D, SCREENING & QUALITY ASSURANCE – Thursday, June 24, 2020, 1:00 pm Eastern Collecting imaging data on the microscopic scale has become an essential part of any life sciences venture. Images not only provide striking visual insights into the microscopic world, they also contain a host of quantifiable, multi-dimensional information that can […]
ProLung, now IONIQ Sciences (IONIQ), has been on a roll! Last week, the company announced that they had fully subscribed a $3.3 million private placement. This week, the company unveiled its new name and also announced the initiation of an institutional private equity offering. The new corporate name – IONIQ Sciences – reflects the company’s mission […]
A letter from departing BIO president Jim Greenwood originally sent May 27, 2020 After more than fifteen years as President and CEO of BIO, I will pass the baton to Michelle McMurry-Heath on June 1st. It has been a fascinating period for me and for the biotechnology sector. I am proud of the unparalleled team […]
Multicenter ACTIVATE I Study to Enroll up to 15 Patients in the U.S. SALT LAKE CITY – May 27, 2020 – (Alucent Biomedical) Alucent Biomedical Inc. announced that it has enrolled the first two patients in ACTIVATE I, a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding […]
The House on Thursday passed legislation to make it easier for small businesses to have their PPP loans forgiven, including extending the timeframe during which businesses must use funds and easing requirements on how the funds can be used. The Paycheck Protection Program (PPP) Flexibility Act, authored by Rep. Dean Phillips (D-Minn.) and Rep. Chip […]
SALT LAKE CITY (May 27, 2020) – Gov. Gary R. Herbert has issued an Executive Order updating guidelines for areas in low health risk designation under Utah’s phased health guidance plan. The order specifically addresses updated guidelines pertaining to social gatherings, education, businesses, travel and events. “We are making progress and we can see that […]
On May 11, 2020, the Governor’s Office of Economic Development (GOED) began accepting applications for the Utah Commercial Real Estate Assistance Program, to provide rental relief to small businesses that have lost revenue as a result of COVID-19 mitigation efforts. The program, with $40 million in funds, has received 2,700 applications to date, totaling just […]
The U.S. House of Representatives is expected to vote next week on bipartisan legislation, the Paycheck Protection Flexibility Act, which would revamp the popular Paycheck Protection Program (PPP) to allow for more flexible terms. In Utah, for rounds one and two of funding, a total of 47,046 businesses have received PPP loans, amounting to nearly […]
On May 14, President Trump signed an executive order to encourage the domestic production of critical medical supplies. In the current pandemic, U.S. reliance on China for products such as personal protective equipment, ventilators, and antibiotics, has drawn increased interest in having critical drugs and medical devices manufactured in the homeland. The order would give […]
PPP loan forgiveness questions? Learn how to maximize your approval for loan forgiveness and understand the new Forgiveness Form Application. Your PPP loan has been submitted, accepted or received! Now what??? Many companies have worked with a SBA lender and have had their loan submitted, accepted or funded and wonder how to maximize the forgiveness […]
BioUtah and Utah’s life sciences community mourns the death of one our own, John “Brent” Hunt, age 59. He was founder and CEO of Soft Cell Biological Research (Soft Cell). Soft Cell issued a press release following his passing. According to a report by KSL, he was reported missing on Friday, May 4 after failing […]
On June 3-4, the Association of University Research Parks will be holding their Virtual Bio Health Caucus. BioUtah will be one of six cluster leaders presenting at the conference to discuss the growth of the life sciences sector in our area. That presentation will be at noon MDT on June 3. While this year’s event […]
How can we advance the utilization of innovations in healthcare? By lending them extra visibility to key stakeholders! Impactful Innovation Exchange Calling All Solutions! Cambia Grove is launching the Impactful Innovation Exchange – a free comprehensive platform where health care stakeholders can search for emerging and/or proven innovations to solve their high […]
Webinar In addition to evaluating data from adverse event reports, the bulk of FDA’s regulatory enforcement comes from its facility inspections and resulting 483 reports. This practical webinar will cover numerous aspects of preparing your drug or medical device establishment for a successful FDA facility inspection and responding to any post-inspection 483 letters. The key […]
On May 12, LabCorp announced that its COVID-19 at-home collection test kit is now available to individuals who have symptoms for COVID-19 as well as individuals without symptoms who may have been exposed to the virus. The diagnostic test, which uses a swab, is available through the company’s Pixel by LabCorp™ online platform. Last month, […]
House Democrats have proposed a new $3 trillion relief package, titled the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, which would increase funding for state and local governments, extend unemployment benefits, and designate special funding for frontline healthcare workers and first responders. Republicans have pushed back over the timing and priorities of the […]
Governor Herbert announced at a press conference on Thursday that most of Utah will move from the moderate-risk phase (orange), to low-risk phase (yellow) this weekend. Grand, Summit and Wasatch counties, as well as Salt Lake City and West Valley City, however, will remain under moderate-risk guidelines. Salt Lake City Airport will also remain in […]
Government to Growth Government to Growth (G2G) is led by Liz Powell, Esq., MPH, and includes a team of government affairs professionals who help startups, businesses and non-profits effectively navigate non-dilutive federal funding opportunities. With a specialty focus on life sciences, G2G tracks grants on a daily basis and produces a monthly GBG Report listing […]
Park City, Utah USA, May 12, 2020 /PRNewswire/ — Transit Scientific announced the FDA cleared the XO Cross Microcatheter platform for guidewire support, exchange, and contrast media injection in the peripheral vasculature. Microcatheters are small 0.70-1.30mm outer diameter (OD) catheters used to provide guidewire support, facilitate guidewire exchanges, access distal anatomy, cross lesions, deliver therapeutic […]
For Immediate Release: May 11, 2020 Statement From: Commissioner of Food and Drugs – Food and Drug Administran Stephen M. Hahn M.D. During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, […]
