Celsion and Medidata Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial at 2022 AACR Annual Meeting
By Dr. Matthew Watson
Phase Ib dose-escalating OVATION I Study with GEN-1 in advanced ovarian cancer patients was well received at 2022 AACR Annual Meeting
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Celsion and Medidata Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial at 2022 AACR Annual Meeting
Junshi Biosciences and Coherus Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States
By Dr. Matthew Watson
SHANGHAI, China and REDWOOD CITY, Calif., April 14, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation (“ODD”) for toripalimab, a PD-1 inhibitor, for the treatment of small cell lung cancer (“SCLC”). ODD is granted to drugs intended to treat rare diseases with a patient population less than 200,000 in the United States. The designation provides incentives to advance development and commercialization of drugs that have the potential to provide benefit to patients with rare diseases.
Agios Announces Publication of Phase 3 ACTIVATE Study in New England Journal of Medicine Demonstrating Benefits of PYRUKYND® (mitapivat) for Adults…
By Dr. Matthew Watson
– In Adults with Pyruvate Kinase (PK) Deficiency Who Are Not Regularly Transfused, PYRUKYND® Significantly Increased Hemoglobin Level, Decreased Hemolysis and Improved Patient-Reported Outcomes –
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Agios Announces Publication of Phase 3 ACTIVATE Study in New England Journal of Medicine Demonstrating Benefits of PYRUKYND® (mitapivat) for Adults...
Biomerica Reports 111% Increase in Q3 Fiscal 2022 Revenues to $7.6 million vs. Q3 Fiscal 2021
By Dr. Matthew Watson
IRVINE, Calif., April 14, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic and therapeutic products, today announced its fiscal third quarter and nine month results ended February 28, 2022.
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Biomerica Reports 111% Increase in Q3 Fiscal 2022 Revenues to $7.6 million vs. Q3 Fiscal 2021
Longeveron to Present at Longevity Leaders World Congress; Latinos and Alzheimer’s Symposium; International Frailty and Sarcopenia Research…
By Dr. Matthew Watson
April events to highlight Longeveron’s commitment to developing cell therapeutics for chronic aging related diseases. April events to highlight Longeveron’s commitment to developing cell therapeutics for chronic aging related diseases.
BeyondSpring Files 2021 Annual Report on Form 20-F
By Dr. Matthew Watson
NEW YORK, April 14, 2022 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs, today announced that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2021 with the U.S. Securities and Exchange Commission (“SEC”) on April 14, 2022. The annual report on Form 20-F, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at www.sec.gov and on the Company’s website at www.beyondspringpharma.com under “Financials & Filings” in the Investors section.
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BeyondSpring Files 2021 Annual Report on Form 20-F
Immunicum AB: Immunicum to Participate in the New Cancer Research Consortium Oncode-PACT
By Dr. Matthew Watson
Immunicum AB (“Immunicum” publ; IMMU.ST), a biopharmaceutical company focused on therapies addressing tumor recurrence and hard-to-treat established tumors, today announced that the company will participate in the public-private partnership Oncode-PACT, which will be supported by the National Growth Fund, an initiative of the Dutch Ministry of Economic Affairs and Climate Policy and the Ministry of Finance.
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Immunicum AB: Immunicum to Participate in the New Cancer Research Consortium Oncode-PACT
Virbac : Very strong growth in revenue in the first quarter of 2022 of +16.2% at comparable exchange rates (+19.3% at real rates), driven by good…
By Dr. Matthew Watson
1 Growth at constant exchange rates and scope corresponds to organic growth of sales, excluding exchange rate variations, by calculating the indicator for the financial year in question and the indicator for the previous financial year on the basis of identical exchange rates (the exchange rate used is the previous financial year), and excluding change in scope, by calculating the indicator for the financial year in question on the basis of the scope of consolidation for the previous financial year.
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Virbac : Very strong growth in revenue in the first quarter of 2022 of +16.2% at comparable exchange rates (+19.3% at real rates), driven by good...
Heat Biologics’ Announces Planned Investor and Media Livestream Event to Discuss Latest Developments
By Dr. Matthew Watson
DURHAM, N.C., April 14, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system and novel biodefense assets, today announced it plans to host an investor and media livestream event on Tuesday, April 19, 2022 at 10:30 AM Eastern Time to discuss the latest developments. The event will be broadcast at: https://vimeo.com/event/2027558/fc6de52c31
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Heat Biologics’ Announces Planned Investor and Media Livestream Event to Discuss Latest Developments
Idorsia holds its Annual General Meeting of Shareholders
By Dr. Matthew Watson
Ad hoc announcement pursuant to Art. 53 LR
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Idorsia holds its Annual General Meeting of Shareholders
Terranueva: Results of the Shareholders Meeting
By Dr. Matthew Watson
L’ASSOMPTION, Quebec, April 14, 2022 (GLOBE NEWSWIRE) -- Terranueva Corporation (CSE: TEQ) ("Terranueva" or the "Company") is pleased to announce the results of its annual and special meeting of shareholders held on April 14, 2022. The shareholders approved, by a majority of votes, a resolution to elect the following directors: Sylvain Aird, Marc-André Aubé, Marianne Fortier-Landry, Gérard Landry, Jean-Luc Landry, Peter Polatos and Sylvain Tremblay. Also, the shareholders, by a majority of votes, proceeded with the appointment of PricewaterhouseCoopers LLP as auditors of the Corporation, as well as approved the Corporation’s Fixed Stock Option Plan in order to increase at 4,596,996 the maximum of common shares to be issued upon exercise of options, which represents 10% of the number of common share in the capital stock of Terranueva as of the record date of March 14, 2022.
NexImmune Promotes Mathias Oelke, Ph.D., To Chief Scientific Officer
By Dr. Matthew Watson
Dr. Oelke is a scientific co-founder of NexImmune and a pioneer in the field of artificial antigen presenting cell (aAPC) technology Dr. Oelke is a scientific co-founder of NexImmune and a pioneer in the field of artificial antigen presenting cell (aAPC) technology
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NexImmune Promotes Mathias Oelke, Ph.D., To Chief Scientific Officer
Eledon to Host Virtual R&D Day on Thursday, April 28, 2022
By Dr. Matthew Watson
IRVINE, Calif., April 14, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today announced that it will host its first R&D Day on Thursday, April 28, 2022, from 10 a.m. to 12 p.m. ET (7 a.m. to 9 a.m. PT). Members of Eledon’s senior management team will be joined by four leading experts for a deep dive on the company’s investigational drug, tegoprubart, and the promise of CD40 Ligand targeted immunotherapy for the treatment of amyotrophic lateral sclerosis, kidney transplantation, islet cell transplantation, and IgA nephropathy.
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Eledon to Host Virtual R&D Day on Thursday, April 28, 2022
Angion Announces Participation in Upcoming Investment Conference
By Dr. Matthew Watson
UNIONDALE, N.Y., April 14, 2022 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases, today announced participation in an upcoming investment conference.
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Angion Announces Participation in Upcoming Investment Conference
LianBio Announces Formation of Scientific Advisory Board
By Dr. Matthew Watson
Scientific Advisory Board strengthens LianBio’s mission of bringing novel therapeutics to Greater China and Asia Scientific Advisory Board strengthens LianBio’s mission of bringing novel therapeutics to Greater China and Asia
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LianBio Announces Formation of Scientific Advisory Board
Vor Bio Announces Retirement of Chief Medical Officer
By Dr. Matthew Watson
CAMBRIDGE, Mass., April 14, 2022 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced that Dr. Christopher Slapak, Chief Medical Officer for Vor Bio plans to retire. The Vor Bio clinical team is fully resourced and continues to actively recruit patients into VBP101, the Company’s Phase 1/2a first-in-human study of VOR33 in patients with AML who are at high risk of relapse. An executive search to replace Dr. Slapak is underway.
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Vor Bio Announces Retirement of Chief Medical Officer
CytomX Therapeutics Announces Retirement of John A. Scarlett, M.D. from Board of Directors
By Dr. Matthew Watson
SOUTH SAN FRANCISCO, Calif., April 14, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that John A. Scarlett, M.D. is retiring from its board of directors, effective when his current term expires at the company’s next annual meeting of stockholders, which is currently scheduled to be held on June 15, 2022.
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CytomX Therapeutics Announces Retirement of John A. Scarlett, M.D. from Board of Directors
Monthly information regarding the total number of voting rights and total number of shares of the Company as of March 31, 2022
By Dr. Matthew Watson
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Monthly information regarding the total number of voting rights and total number of shares of the Company as of March 31, 2022
BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress…
By daniellenierenberg
SUNNYVALE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). This allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.
The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19. "This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies," said Ian McNiece, Ph.D., BioCardias Chief Scientific Officer. "After IV delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs. Our goal is to help recovering patients with ARDS due to COVID-19 recover faster and more fully, while avoiding longer term respiratory issues."
"In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system," said Peter Altman, Ph.D., Chief Executive Officer. "Our off the shelf MSC platform may have significant advantages over others in clinical development for multiple indications because the MSCs express the biologically important NK1 receptor which binds Substance P. Our in-house clinical cell manufacturing is also expected to be an important strategic asset that enables rapid and cost-effective development."
About ARDS
Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid keeps the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS typically occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath the main symptom of ARDS usually develops within a few hours to a few days after the precipitating injury or infection. Many people who develop ARDS don't survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs1. Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.2 Despite multiple clinical studies, no pharmacological treatments have proven effective for ARDS.3, 4
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in clinical development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS reimbursement. For more information visit:www.BioCardia.com.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, initiation of our BCDA-04 clinical trial, and the mechanism of action and ease of administration of our NK1R+ MSC therapy.
We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2022, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
_________________________________________________________________________________________________________
Media Contact:Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120
Investor Contact:David McClung, Chief Financial OfficerEmail:dmcclung@BioCardia.comPhone: 650-226-0120
(1)MayoClinic.Org
(2)Rajagopal K, Keller SP, Akkanti B, et al. Advanced pulmonary and cardiac support of COVID-19 patients, emerging recommendations from ASAIOa living working document. Circ Heart Fail. 2020 May;13(5).
(3)Thompson BT, Chambers RC, Liu KD (2017) Acute respiratory distress syndrome. N Engl J Med 377(19):19041905.
(4)3. Group RC, Horby P, Lim WS et al (2020) Dexamethasone in hospitalized patients with Covid-19preliminary report. N Engl J Med.
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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress...
Space station’s first all-private astronaut team welcomed aboard orbiting platform – Reuters
By daniellenierenberg
April 9 (Reuters) - The first all-private team of astronauts ever launched to the International Space Station (ISS) were welcomed aboard the orbiting research platform on Saturday to begin a weeklong science mission hailed as a milestone in commercial spaceflight.
Their arrival came about 21 hours after the four-man team representing Houston-based startup company Axiom Space Inc lifted off on Friday from NASA's Kennedy Space Center, riding atop a SpaceX-launched Falcon 9 rocket.
The Crew Dragon capsule lofted into orbit by the rocket docked with the ISS at about 8:30 a.m. EDT (1230 GMT) on Saturday as the two space vehicles were flying roughly 250 miles (420 km) above the central Atlantic Ocean, a live webcast of the coupling from the National Aeronautics and Space Administration showed.
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The final approach was delayed for about 45 minutes by a technical glitch with a video feed used to monitor the capsule's rendezvous with the ISS, but it otherwise proceeded smoothly.
The multinational Axiom team, planning to spend eight days in orbit, was led by retired Spanish-born NASA astronaut Michael Lopez-Alegria, 63, the company's vice president for business development.
His second-in-command was Larry Connor, a real estate and technology entrepreneur and aerobatics aviator from Ohio designated as the mission pilot. Connor is in his 70s, but the company did not provide his precise age.
Rounding out the Ax-1 crew were investor-philanthropist and former Israeli fighter pilot Eytan Stibbe, 64, and Canadian businessman and philanthropist Mark Pathy, 52, both serving as mission specialists.
With docking achieved, it took nearly two hours for the sealed passageway between the space station and crew capsule to be pressurized and checked for leaks before hatches were opened to allow the newly arrived astronauts to come aboard the ISS.
The Ax-1 team was welcomed by all seven of the regular, government-paid crew members already occupying the space station: three American astronauts, a German astronaut from the European Space Agency and three Russian cosmonauts.
The NASA webcast showed the four smiling Axiom astronauts, dressed in navy blue flight suits, floating headfirst, one by one, through the portal into the space station, warmly greeted with hugs and handshakes by the ISS crew.
Lopez-Alegria later pinned astronaut wings onto the uniforms of the three spaceflight rookies of his Axiom team -- Connor, Stibbe and Pathy -- during a brief welcome ceremony.
Stibbe is now the second Israeli to fly to space, after Ilan Ramon, who perished with six NASA crewmates in the 2003 space shuttle Columbia disaster.
SCIENCE FOCUSED
The new arrivals brought with them two dozen science and biomedical experiments to conduct aboard ISS, including research on brain health, cardiac stem cells, cancer and aging, as well as a technology demonstration to produce optics using the surface tension of fluids in microgravity.
The mission, a collaboration among Axiom, Elon Musk's rocket company SpaceX and NASA, has been touted by all three as a major step in the expansion of space-based commercial activities collectively referred to by insiders as the low-Earth orbit economy, or "LEO economy" for short. read more
NASA officials say the trend will help the U.S. space agency focus more of its resources on big-science exploration, including its Artemis program to send humans back to the moon and ultimately to Mars.
While the space station has hosted civilian visitors from time to time, the Ax-1 mission marks the first all-commercial team of astronauts sent to ISS for its intended purpose as an orbiting research laboratory.
The Axiom mission also stands as SpaceX's sixth human spaceflight in nearly two years, following four NASA astronaut missions to the space station and the Inspiration 4 launch in September that sent an all-civilian crew into orbit for the first time. That flight did not dock with the ISS.
Axiom executives say their astronaut ventures and plans to build a private space station in Earth orbit go far beyond the astro-tourism services offered to wealthy thrill-seekers by such companies as Blue Origin and Virgin Galactic (SPCE.N), owned respectively by billionaire entrepreneurs Jeff Bezos and Richard Branson.
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Reporting by Steve Gorman in Los Angeles; Editing by Angus MacSwan, Daniel Wallis and Jonathan Oatis
Our Standards: The Thomson Reuters Trust Principles.
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Space station's first all-private astronaut team welcomed aboard orbiting platform - Reuters