One year after spinning out from AstraZeneca’s MedImmune, Viela Bio is already anticipating filing a Biologics License Application with the U.S. Food and Drug Administration (FDA) for its lead asset, inebilizumab.
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One year after spinning out from AstraZeneca’s MedImmune, Viela Bio is already anticipating filing a Biologics License Application with the U.S. Food and Drug Administration (FDA) for its lead asset, inebilizumab.
Vixiar, a Johns Hopkins spinout marketing a tablet-based point of care system for assessing cardiac filling pressure, has raised $1.5 million in Series A funding. This brings the company’s total funding to $3 million.
GlaxoSmithKline’s experimental drug GSK095 is designed to work in tandem with checkpoint inhibiting medicines in the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a preclinical trial of a related GSK drug suggest that the combo holds promise in treating pancreatic cancer—so much so that the company is launching a phase 1 study of the drug in combination with Merck’s blockbuster PD1 checkpoint inhibitor Keytruda.
Emergent BioSolutions said on Tuesday it will begin a Phase 3 trial of a new anthrax vaccine it is developing.
The Phase 3 trial will evaluate the lot consistency, immunogenicity, and safety of the vaccine, called AV7909. AV7909 is designed to elicit a faster immune response than other anthrax vaccines that are currently available.
There's new hope for patients who have blood diseases. Johns Hopkins Kimmel Cancer Center researchers say a new protocol offers the possibility of a cure. One patient who tried the treatment says it didn't just change her life, it saved it.
2018 was undoubtedly one of the most important years ever for biopharma, setting records for valuations and dealmaking. But a paper published in January called some of that exuberance into question, noting that many startups over the years have managed to become unicorns – with valuations of $1 billion or more – despite having little or no published, peer-reviewed data.
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced additional positive data from a Phase 2 extension study of its NasoVAX intranasal influenza vaccine candidate. Data from this study demonstrated that 100% of the evaluated subjects remained seroprotected, and the seroconversion rate was unchanged more than one year after vaccination.
It didn’t take long for the Trump administration to tap Ned Sharpless, now director of the National Cancer Institute, to take the reins at FDA for now—or for biopharma to hail the news. In fact, one team of analysts said the industry would “breathe a collective sigh of relief.”
Sonavex is first targeting the reconstructive surgery market with its new medical technology, which just earned its final FDA clearance.
Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, today announced that it has applied the CE mark to PGDx elio™ plasma resolve. It is the first kitted plasma-based NGS oncology test to have that certification, enabling greater access to genomic testing for cancer patients in Europe.
A pair of Baltimore healthcare leaders are partnering to reach digital health startups.
Hospital network LifeBridge Health and health insurance provider CareFirst BlueCross Blue Shield will be hosting an innovation challenge that includes a chance to pitch and win funding for companies.
When Kevin Tran ‘12, chemical engineering, was a student at UMBC, he took a course on sensors that made him realize the best high tech solution is sometimes a low tech solution.
Innovation is a principal driver of U.S. economic growth. In 2019, the U.S. will spend an estimated $581 billion on research and development — more than any other country in the world and about 25% of the world’s total — helping the nation rank No. 6 on the Global Innovation Index. According to the results of the ranking, knowledge and technology outputs are America’s particular strengths.
MCEDC discovers how Greg’s clinical-stage company in Montgomery County, MD is using bacteria phage to combat the worldwide crisis in multi-drug resistant bacterial infections.
It all begins at birth. That’s the starting point for Kurt Newman as he shares his poignant journey as a pediatric surgeon. Newman offers a new perspective for approaching the most chronic and debilitating health conditions. Against a backdrop of personal challenges and patients who overcame impossible odds, we learn to appreciate the importance of treating every child with early customized care, and an eye for the future.
The part of your brain responsible for ASMR catalogs music, and appears to be a stronghold against Alzheimer's and dementia.
The already much-heralded University of Texas MD Anderson Cancer Center has just scored global bragging rights. James Allison, Ph.D., a scientist at MD Anderson Cancer Center, has been awarded the 2018 Nobel Prize in Physiology or Medicine, it was announced on October 1.
Eargo, a direct-to-consumer health technology company that is destigmatizing hearing loss through innovation, announced it raised $52 million in Series D funding from existing investors New Enterprise Associates (NEA), the Charles and Helen Schwab Foundation, Nan Fung Life Sciences, and Maveron. And new investor Future Fund also participated in this round.
The Universities at Shady Grove (USG) will hold a Undergraduate Expo Saturday, Apr. 6 from 9 a.m. to noon. USG is part of the University System of Maryland and offers approximately 80 undergraduate and graduate degree programs from nine different state universities on the Rockville campus.
In 1942, Austrian economist Joseph Schumpeter wrote, “ …industrial mutation—if I may use that biological term—that incessantly revolutionizes the economic structure from within, incessantly destroying the old one, incessantly creating a new one. This process of Creative Destruction is the essential fact about capitalism.”
The joint health-care venture between Amazon AMZN , J.P. Morgan JPM and Berkshire Hathaway BRK.A finally has a name: "Haven."
Alexandria Real Estate Equities, Inc. ("Alexandria" or the "Company") (NYSE: ARE) today announced that it has priced a public offering of $200,000,000 aggregate principal amount of 4.000% senior notes due 2024, $350,000,000 aggregate principal amount of 3.800% senior notes due 2026 and $300,000,000 aggregate principal amount of 4.850% senior notes due 2049. Goldman Sachs & Co. LLC, Citigroup Global Markets Inc., J.P. Morgan Securities LLC and SMBC Nikko Securities America, Inc. are acting as joint book-running managers in connection with the public offering and Barclays Capital Inc., BB&T Capital Markets, a division of BB&T Securities, LLC, BBVA Securities Inc., BNP Paribas Securities Corp., Capital One Securities, Inc., Evercore Group L.L.C., Fifth Third Securities, Inc., Mizuho Securities USA LLC, PNC Capital Markets LLC, RBC Capital Markets, LLC, Regions Securities LLC, Samuel A. Ramirez & Company, Inc., Scotia Capital (USA) Inc., SunTrust Robinson Humphrey, Inc., TD Securities (USA) LLC, U.S. Bancorp Investments, Inc. and Wells Fargo Securities, LLC are acting as co‑managers in connection with the public offering.
Columbia-based Osiris is coming off a tumultuous three-year period in which four CEOs left the company and several former executives faced criminal charges for fraud.
For American patients aching for relief from the sky-high price of drugs, the news has been decidedly mixed recently.
Just as the drug pricing debate on Capitol Hill is heating up, an important new study, “The Bayh-Dole Act’s Vital Importance to the U.S. Life-Sciences Innovation System,” published by the Information Technology & Innovation Foundation (ITIF), underscores the law’s contribution to the United States’ lead in the life sciences. The report warns that attempts to misuse the march-in rights provision of the law to control drug prices would have serious consequences to our competitiveness and our health.
Learn the answers to these questions and more through the April 4th PathFinder Innovation Program. (There is no charge to attend in person or by videoconference, however, pre-registration by NOON, 4/2 is required).
8:15 a.m. Networking and Coffee
8:30 a.m. – Issues Overview and Discussion (in person/by videoconference)
9:45 a.m. – 1:1 Office Hours (in person/by videoconference)*
This program is cosponsored by BioHealth Innovation, Launch Workplaces, and TEDCO. It is open to anyone in the BioHealth Capital Region.
To register/for more information, email: BHI@BioHealthInnovation. (Please include in your RSVP: Your company name, your title and contact information, the type of product(s) services you are promoting, and your interest in a 1:1 meeting following the overview session.)
*Attendance at Overview in person/by videoconference is required to participate in 1:1 sessions.
Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced today that on March 8, 2019 it received 510(k) clearance from the U.S. Food and Drug Administration for its EchoSure device to deliver definitive blood flow data on demand.
Four Johns Hopkins professors received grants through a fund created to help faculty put their research on a path to commercialization.
The professors received grants between $25,000 and $100,000 from the Bisciotti Foundation Translational Fund.
One woman is making her mark at the highest level of U.S. local politics.
She was born in China and successfully carved her path all the way to the state capitol.
CGTN’s Frances Kuo has her story.
On Wednesday, MACo Legislative Committee members Craig Rice (Montgomery), Jan Gardner (Frederick), and Laura Price (Talbot) joined Executive Director Michael Sanderson in support of SB 1030 The Blueprint for Maryland’s Future.
UMB has long been one of the state’s most powerful economic drivers, stimulating $3 billion in economic activity in 2018, up from $2.8 billion in 2016. A significant factor in that growth is the UM BioPark, which occupies 14 acres in West Baltimore providing laboratory and office space to 41 biotechnology companies and over 1,000 employees.
The National Capital Consortium for Pediatric Device Innovation is accepting applications for its Make Your Medical Device Pitch for Kids competition.
Cell therapy is emerging, cell by cell, into the repertoire of medical therapies. However, it still has not broken into mainstream use. For instance, there are only two FDA-approved chimeric antigen receptor (CAR) T-cell treatments in the United States: Kymirah, Novartis’s treatment for acute lymphoblastic leukemia, and Yescarta, Kite Pharma’s treatment for non-Hodgkin’s lymphoma.
The Maryland Technology Development Corporation (TEDCO), Maryland’s economic engine for technology companies, announced today the findings of an independent economic impact study detailing the economic development contributions of TEDCO’s five core programs to the state of Maryland.
Visibility, speaking out, courage and organization. Forty years ago, these were the things that brought the Orphan Drug Act to life. On Sunday, February 24, across the U.S. and India, over 7,000 supporters gathered in the same passion: speaking out and bringing visibility to the more than 7,000 disorders collectively known as rare diseases, organized under the banner of Racefor7USA and its parent organizations, the Organization for Rare Disease India (ORDI) and Organization for Rare Diseases India in the U.S. (ORDIUSA).