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IGM Biosciences Enters into Exclusive Licensing Agreement with Medivir for Birinapant

By Dr. Matthew Watson

- IGM to Develop Birinapant in Combination with IGM-8444 for the Treatment of Solid Tumors - - IGM to Develop Birinapant in Combination with IGM-8444 for the Treatment of Solid Tumors -

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T2 Biosystems T2SARS-CoV-2™ Panel Proves Effective Amid Global Rise in Variants of the SARS-CoV-2 Virus

By Dr. Matthew Watson

Panel can detect multiple variants of the SARS-CoV-2 virus, including those most recently identified in the United Kingdom, South Africa, and the U.S.

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Theratechnologies Announces US$40 Million Bought-Deal Public Offering of Units

By Dr. Matthew Watson

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Qilian International Holding Group Limited Announces Pricing of Initial Public Offering

By Dr. Matthew Watson

Jiuquan, China, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Qilian International Holding Group Limited (the “Company”), a China-based pharmaceutical and chemical products manufacturer, today announced the pricing of its initial public offering ("Offering") of 5,000,000 ordinary shares at a public offering price of US$5.00 per share. The ordinary shares have been approved for listing on the Nasdaq Global Market and are expected to commence trading on January 12, 2021 under the ticker symbol “QLI”.

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Adagene Announces Milestone of CAR-T Collaboration with the National Heart, Lung, and Blood Institute at the National Institutes of Health

By Dr. Matthew Watson

- Collaboration with Richard Childs, M.D., yields potential first-ever antibodies targeting human endogenous retrovirus associated with renal cell carcinoma

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Adagene Announces Milestone of CAR-T Collaboration with the National Heart, Lung, and Blood Institute at the National Institutes of Health

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Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common…

By Dr. Matthew Watson

Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

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Addex to Present at the Baader Helvea Swiss Equities Conference

By Dr. Matthew Watson

Geneva, Switzerland, January 12, 2021 -  Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that Tim Dyer, Chief Executive Officer, is scheduled to participate in the virtual Baader Helvea Swiss Equities Conference taking place on January 13 – January 15, 2021.

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Bone Therapeutics treats first patient in ALLOB Phase IIb tibial fracture study

By Dr. Matthew Watson

REGULATED INFORMATION

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iosBio signs exclusive worldwide licensing agreement granting ImmunityBio rights to OraPro™ oral vaccine platform technology for COVID-19  

By Dr. Matthew Watson

PRESS RELEASE

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BetterLife Provides Shareholder Update and 2021 Product Development Roadmap

By Dr. Matthew Watson

VANCOUVER, Jan. 11, 2021 (GLOBE NEWSWIRE) -- VANCOUVER, January 12, 2021 - BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, is pleased to provide an overview of the Company’s primary plans for this calendar year to develop 3 novel therapeutic products, each addressing significant unmet needs with multi-billion dollar market potential.

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Vir Biotechnology and GSK Announce NHS-Supported AGILE Study to Evaluate VIR-7832 in the Early Treatment of COVID-19

By Dr. Matthew Watson

SAN FRANCISCO and LONDON, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial. VIR-7832 is a neutralizing COVID-19 antibody that preclinical data suggests has two distinguishing properties: an enhanced ability to clear infected cells and the potential to enhance virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.

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Recommendation by the Nomination Committee concerning the Board of Directors to be elected by the 2021 AGM of Orion Corporation

By Dr. Matthew Watson

ORION CORPORATION  STOCK EXCHANGE RELEASE 12 JANUARY 2021 at 10.15 EET

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Recommendation by the Nomination Committee concerning the Board of Directors to be elected by the 2021 AGM of Orion Corporation

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Helsinn Announces First Patient Dosed in Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

By Dr. Matthew Watson

Helsinn Announces First Patient Dosed in Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

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Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate

By Dr. Matthew Watson

Saint-Herblain (France), January 12, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

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ProMIS Neurosciences Announces Strategic Priorities for 2021

By Dr. Matthew Watson

TORONTO and CAMBRIDGE, Mass., Jan. 12, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, announced today an outline of its strategic priorities and action plan for 2021.

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Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and…

By daniellenierenberg

CARLSBAD, Calif., Jan. 12, 2021 /PRNewswire/ Today Callaway Golf Company (NYSE: ELY), an industry leader in golf equipment and innovation, announced its new family of Apex Irons and Apex Hybrids. These irons provide exceptional forged performance and A.I.-designed ball speed technologies for a wide range of players. And the hybrids feature new Jailbreak A.I. Velocity Blades for fast ball speeds in versatile, high performance offerings.

Apex 21, Apex Pro 21, and Apex DCB Irons

Apex is widely recognized for establishing the forged distance category, and the Apex 21 Irons deliver an exceptional level of performance and craftsmanship. They're the first forged Apex irons with an A.I-designed Flash Face Cup, for high ball speeds and increased spin robustness across the face. Increased forgiveness comes from a massive Tungsten Energy Core, while the 100% forged body and proprietary urethane microspheres deliver remarkable sound and feel at impact. Callaway has also enhanced the shaping for even better turf interaction.

In the players category, new Apex Pro 21 Irons promote Tour distance and performance for scratch or single-digit handicap golfers. They also utilize an A.I.-designed Flash Face in each iron for high COR's and fast ball speeds, along with extremely soft feel from an all-new forged 1025 hollow body construction and urethane microspheres. There are up to 90 grams of tungsten in the longer irons, the most ever for any Apex model, to improve launch characteristics while simultaneously improving forgiveness.

In the game-improvement category, new Apex DCB Irons extend the forged Apex offering to a wider group of golfers than ever before. They combine the look, feel and performance of a forged players club with the forgiveness of a deep cavity back. The deep cavity back design and enhanced sole width promote easy launch and solid turf interaction out of a variety of lies. The irons are engineered with an A.I.-designed Flash Face Cup, up to 50 grams of tungsten per iron for outstanding launch and forgiveness on off-center hits, and forged feel.

All of these Apex Irons will be available for online pre-order on January 26, and at retail on February 11, at a price of $1,480 for a standard 8-piece steel set ($185 per individual steel iron), and $1,600 for a standard 8-piece graphite set ($200 per individual graphite iron). Combo sets are also available.

Apex 21 and Apex Pro 21 Hybrids

The Apex 21 Hybrids are suited to help a wide range of players. They feature new Jailbreak A.I. Velocity Blades designed to increase vertical stiffness near the sole of the club, promoting more speed low on the face where players often mishit their hybrids. The blades allow the Face Cup to flex on the crown to create better spin rate consistency, and the bars are spread to enhance torsional stiffness, to provide more forgiveness across the face.

Every model and every face in the Apex Hybrids are uniquely designed using advanced A.I. This proven ball speed technology puts an even greater emphasis on center and off-center ball speeds. To create high launch and forgiveness. Callaway has implemented a massive amount of tungsten, and the adjustable hosel helps to optimize loft, trajectory and control.

Apex Pro Hybrids also incorporate Jailbreak A.I. Velocity Blades and an A.I-designed Flash Face. The Forged 455 steel provides strength and flexibility, while the iron-like design and fixed hosel create a look at address that highly skilled players prefer.

These new hybrids will all be available for online pre-order on January 26, and at retail on February 11, at a price of $269.99 each.

The Apex Family

Apex is synonymous with legendary performance and we've created a truly special offering with our new 2021 lineup, said Callaway Sr. VP of R&D, Dr. Alan Hocknell. Now we've implemented A.I.-designed ball speeds, enhanced launch characteristics, and reliable forgiveness to advance this iconic name. There's nothing like our best, and that's Apex.

About Callaway Golf Company Callaway Golf Company (NYSE: ELY) is a premium golf equipment and active lifestyle company with a portfolio of global brands, including Callaway Golf, Odyssey, OGIO, TravisMathew and Jack Wolfskin. Through an unwavering commitment to innovation, Callaway manufactures and sells premium golf clubs, golf balls, golf and lifestyle bags, golf and lifestyle apparel and other accessories. For more information please visitwww.callawaygolf.com, http://www.odysseygolf.com,www.ogio.com, http://www.travismathew.com,andwww.jack-wolfskin.com.

MEDIA CONTACTS: Jeff NewtonCallaway Golf Company[emailprotected]

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Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and...

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Bone Marrow Processing Systems Market Recent developments in the competitive landscape forecast 2018 2025 – SoccerNurds

By daniellenierenberg

Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.

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Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.

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Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy. Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.

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Four promising COVID-19 therapies being tested at nearby UVA – Rappahannock News

By daniellenierenberg

Over the past nine months, clinical trials conducted at the University of Virginia have led to new treatments for patients fighting COVID-19 and new tools for health care workers saving lives around the commonwealth and world.

We have been able to learn very quickly, and try new things that have changed the way we approach treatment for this virus, said Dr. Kyle Enfield, a professor and physician in pulmonary and critical care medicine who has helped to coordinate clinical trials at UVA Health.

We are seeing clinical research happen at a speed that has never been seen before, both for drug therapies and vaccine development, Dr. Linda Duska, associate dean for clinical research in the School of Medicine, added. Weve also seen funding and the regulatory apparatus really adapt to this pandemic, while maintaining rigorous standards.

Four clinical trials of COVID-19 drug therapies either underway or completed at UVA, and their implications for patients and for the ongoing pandemic, are summarized below.

A single-site trial based at UVA, the study examines the use of convalescent plasma derived from blood donated by recovered COVID-19 patients to treat patients hospitalized with the virus, but not yet in intensive care. In theory, the antibodies in the plasma will bind to virus cells, blocking them from harming healthy cells.

Convalescent plasma therapy has been around for more than 100 years, and there has been a lot of interest in it since COVID-19 appeared, said Dr. Jeff Sturek, who specializes in pulmonary and critical care medicine and is the principal investigator for the trial. We wanted to bring this therapy to UVA, to contribute to the development of the field and to offer our patients as many options as possible.

The trial was approved in April and patients were enrolled at UVA from May to August. Researchers are now in the process of analyzing results, which look promising.

UVA is part of a multisite Adaptive COVID-19 Treatment Trial, or ACTT, testing the antiviral drug remdesivir in adults hospitalized with COVID-19.

Results from the first part of the trial found that the drug sped recovery time in patients with advanced cases of COVID-19, prompting the U.S. Food and Drug Administration to issue an emergency use authorization for remdesivir. It was the first drug authorized to treat COVID-19.

The trial is now in its third phase; it began with comparing remdesivir to a placebo drug, and then progressed to pairing different drugs with remdesivir, to see which combination was most effective.

The trial was designed to be iterative, to allow us to continue to adapt the study as we learn more about the drug, Duska said. That lets us continually improve treatment without having to go through a complete restart.

Another multisite trial that includes UVA is investigating if infusion of the mesenchymal stromal cell remestemcel-L, a type of stem cell derived from bone marrow, can increase survival rates among COVID-19 patients experiencing acute respiratory distress syndrome.

The cells have been shown to migrate to the lungs when inflammation occurs and release anti-inflammatory factors that can reduce cytokines secreted by the immune systems. High levels of cytokine production have been associated with severe illness and death among COVID-19 patients.

These adult bone marrow stem cells have been used to treat a variety of inflammatory diseases, which means they have already been through early safety trials and we could move more quickly into a larger trial, said Sturek, also the principal investigator for this trial. We hope that the cells can turn down inflammation in the lungs and help the lungs repair themselves, especially for critical ill patients on ventilators.

The trial is halfway through its enrollment process, with a target of enrolling 300 patients. It has already passed initial safety checks with the National Institutes of Healths Data Safety Monitoring Board.

In this multisite trial, researchers are working to determine if monoclonal antibodies made by the drug company Regeneron Pharmaceuticals can prevent COVID-19 infection among people who have been exposed by someone in their household, but have not yet developed the disease. The trial is testing the same antibody cocktail given to President Trump when he was hospitalized with COVID-19, though with a different use.

In this case, the antibodies are intended to prevent people from getting sick if they have a household member with COVID, Enfield said. So far, UVA has done a good job with recruitment, which is particularly tricky in this case as you have to find people who have been exposed to COVID in their household, but who do not yet have COVID.

UVA is recruiting 40 participants for the study, each of whom will receive four injections of either the antibodies or a placebo. Participants must have been exposed to COVID-19 by someone in their household within the previous 96 hours and continue to live with that person for a month.

Its been a rapid process, and a testament to the multidisciplinary team involved, from infectious disease clinicians and researchers to cell therapy, pulmonary critical care and several other departments, Sturek said. Its been all-hands-on-deck.

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Orchard Therapeutics Announces 2021 Corporate Priorities Supporting the Build-out of its Commercial Business in Hematopoietic Stem Cell (HSC) Gene…

By daniellenierenberg

Preparations on Track for First Half 2021 Commercial Launch of Libmeldy (OTL-200), the First Approved Product for Metachromatic Leukodystrophy (MLD) in the EU

Filing Strategy for OTL-200 Biologics License Application (BLA) in MLD in the U.S. to be Communicated by Mid-2021 Following Additional Regulatory Interactions

Marketing Authorization Application (MAA) Filing for OTL-103 in Wiskott-Aldrich Syndrome (WAS) on Track for Year End 2021 in the EU; Followed by BLA Filing in 2022 in the U.S.

New Clinical Data for OTL-203 (for MPS-I) and OTL-201 (for MPS-IIIA) Accepted for Oral Presentation at February 2021 WORLD Symposium; Preclinical Data from Research Programs in Larger Indications Expected in 2021

$192M in Cash and Investments to Support Strategic Execution into the First Half of 2022

BOSTONandLONDON, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today outlined the companys 2021 strategic priorities in advance of its attendance at the virtual 39thAnnual J.P. Morgan Healthcare Conference. These priorities support the companys plan of building a successful commercial business in HSC gene therapy and advancing its portfolio of investigational medicines for high-value, high-need indications.

In a year that challenged how we live and work, Im extremely proud of Orchards achievements in 2020, said Bobby Gaspar, M.D., Ph.D., chief executive officer, Orchard Therapeutics. Our accomplishments were a direct result of the drive and innovation that fuels our commitment to bring our potentially life-saving HSC therapies to patients, including Libmeldy, which is the first product approved for the treatment of eligible patients with early-onset MLD in the EU. With the HSC approach to gene therapy as our scientific foundation, we are focused on the capabilities that can deliver our therapies on a global commercial scale and support our ability to also treat larger indications over time. It has been a privilege to be a pioneer in changing the way medicine is practiced in these conditions, and we look forward to another year of continued execution and scientific progress.

2021 Corporate PrioritiesOrchard has outlined the following key corporate objectives and expected milestones for 2021:

In preparation for a European launch, Orchard has put in place the commercial infrastructure to support Libmeldy as well as future product launches. The company is qualifying five treatment centers in the UK, Germany, Italy, France and the Netherlands with specialized expertise in transplant and disease area knowledge. In addition, the company expects to leverage cross-border and treatment abroad reimbursement pathways in both Europe and markets such as the Middle East and Turkey. Activities are also underway to drive timely MLD patient identification and access, including disease awareness, genetic testing and newborn screening studies, which have started or are on track to initiate in five countries in 2021.

The company also provided an update concerning the impact of the COVID-19 pandemic on certain development activities. These include restrictions to laboratory access at Orchard and third-party service providers, which is impacting the timeline to develop a specific functional potency assay for OTL-103 in WAS, as requested by the FDA. As a result, the company now expects to file a BLA for OTL-103 in the U.S. in 2022. Orchard is utilizing the benefits provided under OTL-103s RMAT designation and plans to continue interacting with the FDA in 2021 to confirm the data package for the BLA filing. In addition, with several of the follow-up visits associated with the companys active clinical trials impacted by COVID-19 travel restrictions and other trial site limitations, Orchard is using alternative data collection approaches to capture the necessary data to support future regulatory filings.

Frank Thomas, president and chief operating officer continued, Starting 2021 with a clear set of strategic priorities is crucial to our ability to effectively manage the business while fueling Orchards continued growth. Our launch preparations for Libmeldy not only mark our evolution towards a fully integrated company but establish a common manufacturing, commercial and operational infrastructure to support multiple future potential products. This work is complemented by our exciting proof-of-concept and research pipeline that we look forward to advancing internally or in partnership.

Key 2020 AchievementsOrchards key 2020 achievements are highlighted below.

Cash GuidanceThe company ended 2020 with approximately $192 million of cash and investments. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2020 will enable the funding of its currently anticipated operating expenses and capital expenditure requirements into the first half of 2022. This excludes the $50 million expected to be available under the companys credit facility and any non-dilutive capital received from potential future partnerships or priority review vouchers.

About Libmeldy / OTL-200

Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene), also known as OTL-200, has been approved by the European Commission for the treatment of MLD in eligible early-onset patients characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.

The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies. In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.

For more information about Libmeldy, please see the Summary of Product Characteristics (SmPC) available on the EMA website.

Libmeldy is not approved outside of the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy in the US.

Libmeldy was developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.

About Orchard

Orchard Therapeuticsis a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Ourex vivoautologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy inMilan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters inLondonandU.S.headquarters inBoston. For more information, please visitwww.orchard-tx.com, and follow us on TwitterandLinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (TwitterandLinkedIn), including but not limited to investor presentations and investor fact sheets,U.S. Securities and Exchange Commissionfilings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, including its plans and expectations for the commercialization of Libmeldy, the therapeutic potential of Libmeldy (OTL-200) and Orchards product candidates, including the product candidates referred to in this release, Orchards expectations regarding its ongoing preclinical and clinical trials, including the timing of enrollment for clinical trials and release of additional preclinical and clinical data, the likelihood that data from clinical trials will be positive and support further clinical development and regulatory approval of Orchard's product candidates, and Orchards financial condition and cash runway into the first half of 2022. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that prior results, such as signals of safety, activity or durability of effect, observed from clinical trials of Libmeldy will not continue or be repeated in our ongoing or planned clinical trials of Libmeldy, will be insufficient to support regulatory submissions or marketing approval in the US or to maintain marketing approval in the EU, or that long-term adverse safety findings may be discovered; the risk that any one or more of Orchards product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates or the receipt of restricted marketing approvals; the inability or risk of delays in Orchards ability to commercialize its product candidates, if approved, or Libmeldy, including the risk that Orchard may not secure adequate pricing or reimbursement to support continued development or commercialization of Libmeldy; the risk that the market opportunity for Libmeldy, or any of Orchards product candidates, may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter endedSeptember 30, 2020, as filed with theU.S. Securities and Exchange Commission(SEC), as well as subsequent filings and reports filed with theSEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaChristine HarrisonVice President, Corporate Affairs+1 202-415-0137media@orchard-tx.com

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Orchard Therapeutics Announces 2021 Corporate Priorities Supporting the Build-out of its Commercial Business in Hematopoietic Stem Cell (HSC) Gene...

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Brave West Lothian women discovers back pain is actually deadly blood cancer – Daily Record

By daniellenierenberg

A brave West Lothian mum was floored after doctors found her sciatica pain was actually a symptom of a deadly blood cancer which had hollowed out her bones.

Judith Green had suffered from back pain on several occasions over the last 10 years but was repeatedly told it was likely due to a trapped nerve and would resolve itself.

The 42-year-olds pain became too much in June 2019 when she woke screaming in the middle of the night before repeatedly vomiting blood over the next two days.

She took herself to St Johns Hospital in Livingston where doctors soon made the shock diagnosis of myeloma cancer which had left her kidneys functioning at only 15 per cent.

The mum-of-two was told that the condition - which normally affects men over the age of 60 - was incurable but doctors hoped to extend her life through various treatments.

She underwent a stem cell transplant with her own cells in January 2019 but was heartbroken when medics revealed the cancer had returned just seven months later.

The former waitress has vowed to keep fighting so she can meet her future grandchildren and is urging people to register as stem cell donors in a bid to save more lives.

She explained: I remember thinking but its just a sore back. I had never heard of myeloma before I got diagnosed with it.

I 100 per cent thought I was going to hospital that day because I had sciatica. With myeloma, it eats away at your bone marrow.

My ribs were sore but I brushed it off thinking it was my new bra digging in. When my back hurt, I thought it was the new car seat causing it.

But in reality, I had almost no bone marrow. It was 90 per cent cancerous cells. I just made excuse after excuse but looking back I now realise that it was all part of it.

My kidneys were only working at 15 per cent, which explained why I was so thirsty.

Doctors immediately started Judith on a course of chemotherapy and steroids before attempting to harvest some of her remaining bone marrow.

The first attempt was unsuccessful but the next managed to gather enough cells to provide at least three more transplants.

The cells were then deep frozen before being transplanted back into the mum-of-two in January this year - a move which they hoped would buy her at least 18 more months.

But a blood test in August revealed that the myeloma had returned a lot quicker than expected meaning she now has to undergo a second transplant from a mystery donor.

They then discovered Judith had sepsis and MRSA and having no immune system and blood cancer, Judith said she was the sickest she had ever been.

She continued: They were hoping I would make it 18 months post transplant but they discovered in August that the cancer had returned and it had only worked for seven months.

Thats when we found out that they wouldnt be able to use my own cells again because it wasnt worth putting me through all that again.

So now Ill be going back on chemo in January and getting a transplant from a worldwide donor. Thankfully the transplant team has already found a match for me on the system.

Judith continued: Im really lucky that theres a match out there for me. But there are so many others, who are a lot sicker than I am, that dont have theirs yet.

The reason I wanted to speak out is to raise awareness of myeloma and stem cell donation.

You really could be giving someone a second chance at life by spitting into a tube. Back in the day it was a bone marrow transplant but now its stem cells.

Its no different from giving blood. I would just ask everyone to go have a look into it and see if they want to or are able to register.

Judith, who lives with her two sons and partner Steven (46), added: I may not be able to do some of the things I did before like go to the cinema with the boys but Im still here.

And I hope to be here long enough to see my grandkids. I know Ill keep fighting after that to see them grow up then. But for now, its just taking each day as it comes.

To find out more about stem cell donation for those aged under 30 visit https://www.anthonynolan.org/.

Those over 30 can visit https://www.dkms.org.uk/en.

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Brave West Lothian women discovers back pain is actually deadly blood cancer - Daily Record

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