Approval is based on the Phase 3 KEYNOTE-859 Trial KIRKLAND, QC, April 19, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced...Read more
Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to the U.S. market the newly FDA approved high-concentration interchangeable biosimilar to Humira® The agreement broadens patient access and further commitment to availability of vital biologics in the U.S. and globally REYKJAVIK, Iceland, April 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company...Read more
MALVERN, Pa., April 19, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an...Read more
BERKELEY HEIGHTS, N.J., April 19, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® meets the criteria for a Transitional Drug Add-On Payment (TDAPA) in the anti-infective functional category,...Read more
NEW YORK, NY / ACCESSWIRE / April 19, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals, is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product. Nora Pharma has received approval from Health Canada for the...Read more
GAITHERSBURG, Md., April 19, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced its unaudited consolidated financial results for the first nine months of the fiscal year ended March 31,...Read more
Intranasal foralumab attenuated microglial activation in patients with non-active secondary progressive multiple sclerosis and progression independent of relapse (PIRA) Data presented in a platform session at the Annual Meeting of the American Academy of Neurology in Denver, Colorado NEW YORK, April 19, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company...Read more
Nutriband is targeting a 505(b)(2) NDA to the FDA for marketing approval of AVERSA™ Fentanyl in Q1 2025 ORLANDO, FL / ACCESSWIRE / April 19, 2024 / Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW), a company engaged in the development of abuse deterrent pharmaceutical products announced that it has entered into definitive securities purchase agreements for the purchase and sale of an aggregate of 2,100,000 shares of common stock (the...Read more
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 19, 2024 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (DBA Lifeward™) (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global market lead delivering life-changing solutions to revolutionize what is possible in rehabilitation, recovery, and the pursuit of life’s passions in the face of physical limitation or disability, announced that the Board has approved the appointment...Read more
Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1 The safety profile in GCA was generally consistent with that in approved indications, and no new...Read more
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC) This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy The National Comprehensive...Read more
SUNNYVALE, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- Intuitive (the “Company”) (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced financial results for the quarter ended March 31, 2024. Q1 Highlights Worldwide da Vinci procedures grew approximately 16% compared with the first quarter of 2023. The Company placed 313 da Vinci surgical systems,...Read more
1Q 2024 operating revenue of $42.3 billion, up 0.9% from 1Q 2023 1Q 2024 diluted EPS1 of $9.59, up 15.5% from 1Q 2023 and adjusted diluted EPS2 of $10.64, up 12.5% FY 2024 diluted EPS and adjusted diluted EPS guidance raised to greater than $34.05 and $37.20, respectively Launching strategic partnership to advance primary care and physician enablement INDIANAPOLIS / Apr 18, 2024 / Business Wire / Elevance Health, Inc. (NYSE: ELV)...Read more
Rolling submission for suzetrigine moderate-to-severe acute pain NDA granted by FDA; first module submitted and on track to complete filing this quarter Successful completion of end-of-phase 2 FDA meeting for pain associated with diabetic peripheral neuropathy (DPN); Phase 3 program to initiate in 2H 2024 Breakthrough Therapy designation for pain associated with DPN granted by FDA Enrollment of Phase 2 study in...Read more
ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease OSAKA, Japan & CAMBRIDGE, Mass. / Apr 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance...Read more
Integrated artificial intelligence (AI) and advanced tools improve image quality and exam speed to help providers make accurate diagnoses and tailor precision care for women Latest Voluson Signature ultrasound technology offers an intuitive and ergonomic design allowing clinicians to focus on patient care CHICAGO / Apr 18, 2024 / Business Wire / GE HealthCare (Nasdaq: GEHC) today announced the launch of the Voluson Signature 20 and 18...Read more
Advanced technology and support to enable the development of GenAI solutions PLEASANTON, Calif., April 18, 2024 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced the Veeva AI Partner Program to provide partners with the advanced technology and support needed to integrate Generative AI (GenAI) solutions seamlessly with Veeva Vault applications. "Our customers are exploring GenAI solutions across many use cases...Read more
Smith+Nephew (NYSE:SNN; LSE:SN), the global medical technology company is pleased to announce exciting data for its ALLEVYN LIFE Dressing in a recent study by Professor Amit Gefen and his research group published in the International Wound Journal,1 that shows a novel mechanism of action relating to pressure injury prevention (PIP). The study found that due to the independent and non-bonded internal layers of ALLEVYN LIFE Dressing, a...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial, demonstrating a statistically significant increase in total “on” time without troublesome dyskinesia compared with placebo over 27 weeks Results demonstrate tavapadon’s potential to provide the right balance of motor control, safety and tolerability for people living with Parkinson’s disease Additional data from the trial will be presented at a future...Read more
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced two additional data presentations from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 American Academy of Neurology (AAN) annual meeting, being held in Denver, Colorado. Links to the data presented yesterday are included...Read more
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis (RMS). Michael S. Weiss, Chief Executive Officer and Chairman of TG...Read more
FT. MYERS, Fla. / Apr 18, 2024 / Business Wire / NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, today announced two promotions within its senior leadership team, effective immediately. Warren Stone has been promoted to Chief Commercial Officer and will lead NeoGenomics’ clinical and pharma services commercial teams. Stone will be responsible for sales, marketing, pharma project management, commercial...Read more
MASON, Ohio / Apr 18, 2024 / Business Wire / AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that it has launched the cryoSPHERE®+ cryoablation probe, leveraging new insulation technology to reduce freeze times by 25% versus AtriCure’s legacy cryoSHPERE® device. The product is...Read more
cGMP Facility Streamlines Clinical & Commercial mRNA Drug Substance Development; Built by mRNA & Industry Experts to Meet Demand for mRNA-based Medicine SAN DIEGO / Apr 18, 2024 / Business Wire / TriLink BioTechnologies (TriLink®), a Maravai LifeSciences company (NASDAQ: MRVI) and global provider of life science reagents and services, has announced the grand opening of its new cGMP mRNA manufacturing facility. The...Read more
46.2% of patients demonstrated a 1- or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks in the AXPAXLI arm, compared to 0% in the control arm No patients in the AXPAXLI group experienced worsening in DRSS compared to 12.5% in the control arm at 40 weeks AXPAXLI was generally well tolerated with no inflammation observed Ocular intends to present the Phase 1 HELIOS study at an upcoming...Read more
Financing led by Deep Track Capital with participation from other leading healthcare investors Pro-forma cash and cash equivalents of approximately $236 million before fees and expenses On track for regulatory filing for First-in-Human (FIH) study of KRRO-110 in Alpha-1 Antitrypsin Deficiency (AATD) patients anticipated in the second half of 2024 Proceeds fund interim readout in the second half of 2025 and FIH study completion in...Read more
STOCKHOLM, April 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina on April 13-16, 2024. "We...Read more
LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL. The details of the oral presentation are below: Session: Oral...Read more
LOS ANGELES and AMSTERDAM, April 18, 2024 (GLOBE NEWSWIRE) -- Renovaro Inc. (Nasdaq: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, announces the distinguished Professor Geert Kazemier, MD, PhD, as the new Chairman of its Scientific Advisory Board. This pivotal move signifies a major leap forward in Renovaro’s quest to redefine cancer diagnosis and treatment through cutting-edge AI and...Read more
- Publication explores structure-activity relationships (“SAR”) of a broad range of 2C-X analogs - - Innovative research led to the discovery of CYB210010, a potent and long-acting serotonin 5-HT2 receptor agonist with favorable pharmacokinetic properties - TORONTO / Apr 18, 2024 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to...Read more
Media Release Centre for Human Drug Research (CHDR) will conduct Phase I trial to evaluate IMP761, a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system and address the underlying cause of autoimmune diseases CHDR will utilize its unique challenge model that enables insights into IMP761’s pharmacological activity early in clinical development Trial expected to begin mid-CY2024 SYDNEY, AUSTRALIA,...Read more
Dr. Hayslip to lead development programs for avutometinib, including Verastem Oncology’s international confirmatory Phase 3 RAMP 301 clinical trial, and advance pipeline assets BOSTON / Apr 18, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the appointment of John Hayslip, M.D., an accomplished oncologist with deep...Read more
Iomab-B led bone marrow transplant produced high rates of complete remission and durable complete remission regardless of TP53 mutation status in patients age 55 and above with high-risk active relapsed or refractory acute myeloid leukemia Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not...Read more
Company to deliver three oral and three poster presentations highlighting its portfolio of non-viral genetic medicines Presentations to include new pre-clinical data on lead non-viral candidates P-KLKB1-101 and P-FVIII-101 SAN DIEGO, April 18, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell therapy and genetic medicines company advancing a new class of treatments for patients with cancer and...Read more
Financing includes new and existing leading life sciences institutional investors Strengthened balance sheet expected to fund operations through 2027 HENDERSON, Nev. / Apr 18, 2024 / Business Wire / Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that it has entered into subscription...Read more
GAITHERSBURG, Md., April 18, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (Nasdaq: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B...Read more
Primary safety endpoint met; VTP-200 was generally well-tolerated, with no treatment-related grade 3 or higher adverse events (AEs) or serious AEs (SAEs). Positive trends in clearance rate for both high-risk (hr)HPV (60%, Group 2) and cervical lesions (67%,Groups 2 and 5), were observed in the groups receiving the highest ChAdOx dose. Pooled data from the five different active dose groups demonstrated no statistically significant...Read more
SAN JOSE, Calif., April 18, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced the appointment of Sanjay Juneja, MD to its Cancer Business Advisory Board. Anixa Chairman and CEO Dr. Amit Kumar stated, "Dr. Juneja is an accomplished medical oncologist who has earned status...Read more
FLORHAM PARK, N.J., April 18, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, today announced that its abstract entitled “Emerging Technologies for the Management and Protection of Tendon Injuries: Decellularized Placental Biomaterials” was accepted by the Orthopedic Research Society (ORS)...Read more
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces a platform presentation titled, “Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS” at the Annual...Read more
Scheduling U.S. site initiation visits April and May 2024 On track to dose relapsed/refractory AL Amyloidosis patients with CAR-T NXC-201 at New York City lead site and other leading U.S. sites mid-2024 No change in patient enrollment timing LOS ANGELES, April 18, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company trailblazing...Read more
Catherine Miller Collis was instrumental in bringing about Jaguar's recent in-license agreement for FDA-approved Gelclair®, a protective gel for management of oral mucositis, a common, painful, and debilitating cancer treatment-related side effect SAN FRANCISCO, CA / ACCESSWIRE / April 18, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it has appointed biopharmaceutical industry veteran Catherine Miller...Read more
CARSON CITY, Nev., April 18, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (Nasdaq: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that an oral presentation and poster presentation will be shared at the 12th Annual Alzheimer's & Parkinson's Drug Development Summit to be held in Boston,...Read more
SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors...Read more
Presentation by Massachusetts General Chair of Neurology Merit Cudkowicz, MD, shows both positive clinical effects and consistent trend toward impact on Neurofilament biomarker levels CAMBRIDGE, Mass., April 18, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces the presentation of data from the Company's PARADIGM...Read more
AUSTIN, Texas, April 18, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, announced today that abstracts reviewing data from its Phase 2 OraGrowtH210 and OraGrowtH212 Trials will be presented at several upcoming medical meetings in the US and Europe. Pediatric Endocrine Society...Read more
Collaboration leverages variant bio's cutting-edge genomic discovery platform and evotec's integrated end-to-end R&D platform and disease area expertise to address unmet medical need in fibrotic indications Commercial terms include research funding and milestones and/or royalty payments to evotec based on the overall success of the program HAMBURG, Germany and SEATTLE, April 18, 2024 /PRNewswire/ -- Evotec SE...Read more
SANTA ANA, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details around its NK cell therapy in...Read more
TORONTO, April 18, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced receipt of a Complete Response Letter (“CRL”) for its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022...Read more
First efficacy signals demonstrated for a gene therapy under development for Oculopharyngeal Muscular Dystrophy (OPMD) which affects ~15,000 patients worldwide BB-301 facilitated improvements across multiple measures of swallowing function in the first Phase 1b/2a clinical study subject as compared to pretreatment assessments conducted during the observational natural history portion of the study Virtual R&D Day being held today...Read more
HAYWARD, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced a $40.0 million private investment in public equity (PIPE) financing from the sale of 5,749,152...Read more
CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the appointment of Susan Blum to its Board of Directors. Ms. Blum was also appointed to serve as a member and chair of the audit committee of the Board. “We are...Read more
LANGHORNE, Pa., April 18, 2024 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: “NXGL”), a leading provider of medical and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels for healthcare and consumer applications, today announced that Adam Levy, Chief Executive Officer, will be presenting at the Planet MicroCap Showcase: VEGAS 2024, taking place at the Paris Hotel and Casino, Las...Read more
REDWOOD CITY, CA / ACCESSWIRE / April 18, 2024 / Biotricity Inc. (NASDAQ:BTCY) a leading Technology-as-a-Service (TaaS) company at the forefront of medical diagnostics and consumer healthcare, announces a groundbreaking cardiac monitoring pilot program with a prestigious hospital group spanning 9 hospitals and 10 clinics. Biotricity will work closely with healthcare professionals to optimize patient interaction protocols and streamline...Read more
WILMETTE, Ill., April 18, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced that its abstract on the preclinical data for its radiopharmaceutical program MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) submitted to the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting...Read more
TORONTO, April 18, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today that the U.S. Food & Drug Administration (“FDA”) has accepted the Company’s meeting request for the...Read more
Company expects enrollment in Phase 1 proof-of-concept study of DNA-based vaccine technology to begin in the second quarter LAWRENCEVILLE, N.J., April 18, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces receipt of clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase...Read more
Longitudinal Study of a 200+ Real-World Patient Cohort Further Validates CCL24 as a Novel Target for Systemic Sclerosis (SSc), Showing that It is Associated with Disease Severity Across the Fibrotic and Vascular Manifestations of SSc TEL AVIV, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare...Read more
Next-generation non-cardiotoxic anthracycline Annamycin with notable signs of clinical efficacy in AML in combination with Cytarabine achieves preliminary CRc rate of 60% in 2nd line AML subjects in a European clinical trial There are approximately 160,000 people with AML worldwide Annamycin continues to show no signs of cardiotoxicity (N=82 across multiple studies); Lower toxicity profile than traditional intensive...Read more
MELBOURNE, Australia, April 19, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE, "Company", "GTG", or "Genetic Technologies"), a global leader in guideline-driven genomics-based tests in health, wellness and serious diseases, today announced that it has entered into a definitive agreement for the purchase and sale in a registered direct offering of 1,000,000 American Depositary Shares ("ADSs") (or ADS...Read more
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced preliminary unaudited revenue results for the fiscal third quarter and nine months ended March 31, 2024. The Company expects approximate unaudited revenue of $0.82 million for the three months ended March 31,...Read more
ASGCT (American Society of Gene and Cell Therapy) Baltimore, MD, May 7-11, 2024 SID (Society of Investigative Dermatology) Dallas, TX, May 15-18, 2024 ASCO (American Society of Clinical Oncology) Chicago, IL, May 31 – June 4, 2024 BRANFORD, Conn. / Apr 18, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today...Read more
IND to be filed with the FDA in the coming weeks PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / April 18, 2024 / Biophytis SA (NASDAQ:BPTS) (Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announces the formation of a new Scientific Advisory Board to support the advancement of its phase 2 OBA clinical...Read more
MIAMI, April 18, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announced the closing of its previously announced exercise of certain existing warrants to purchase an...Read more
HOUSTON, April 18, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute...Read more
HOUSTON, April 18, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (Nasdaq: BPTH) (the “Company” or “Bio-Path”), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that it has entered into a definitive agreement with certain institutional investors for the issuance and sale of 375,000 shares of its common stock...Read more
Vancouver, British Columbia--(Newsfile Corp. - April 18, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a leader in the research, development, manufacturing, and commercialization of rare cannabinoids and proprietary cannabinoid analogs, today announced the addition of Dr. David G. Morgan, a renowned leader in neurodegenerative disease to its Scientific Advisory Board ("SAB") reinforcing the Company's...Read more
TEL AVIV, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) (“PainReform” or the “Company”), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced the closing of its previously announced public offering of an aggregate of 5,000,000 of the Company’s ordinary shares (or ordinary share equivalents) and warrants to purchase up to 5,000,000...Read more
Tirzepatide achieved a mean apnea-hypopnea index reduction of up to 63% (about 30 fewer events per hour), meeting all primary and key secondary endpoints in two phase 3 clinical trials Tirzepatide meaningfully improved sleep apnea symptoms in those with moderate-to-severe OSA and obesity with and without PAP therapy, and based on these results Lilly plans to submit these data for global regulatory reviews INDIANAPOLIS, April 17,...Read more
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations U.S. FDA and EMA accepted filings based on...Read more
Sales of $10.0 billion driven by strong underlying base business performance Reported sales increased 2.2 percent, which includes the impact from the anticipated decline in COVID-19 testing-related sales versus prior year Organic sales growth for underlying base business of 10.8 percent, which represents the fifth consecutive quarter of double-digit growth1 ABBOTT PARK, Ill., April 17, 2024 /PRNewswire/ -- Abbott (NYSE: ABT)...Read more
Marketing automation with seamless integration to sales drives customer centricity PLEASANTON, Calif., April 17, 2024 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced Veeva Vault CRM Campaign Manager, a new industry-specific marketing application that simplifies and speeds non-personal promotion to healthcare professionals. Vault CRM Campaign Manager lives in the same Vault as Veeva Vault CRM and shares the same customer...Read more
Keynote speakers include leaders from Bayer, Genentech, Novo Nordisk, and Takeda sharing strategies for effective commercialization and engagement PLEASANTON, Calif., April 17, 2024 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that leaders from Bayer, Genentech, Novo Nordisk, Takeda, and others will be among the keynote speakers at the 2024 Veeva Commercial Summit, May 7-8 in Boston. Commercial and medical affairs...Read more
NEW HAVEN, Conn., April 17, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience and oncology, today announced that it has commenced an underwritten public offering of $200 million of its common shares. All of the common shares to be sold in the offering will be...Read more
SAN DIEGO / Apr 17, 2024 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that two oral presentations featuring DAYBUE™ (trofinetide) findings in Rett syndrome will be presented at the American Academy of Neurology (AAN) 2024 annual meeting, being held this week in Denver, CO. The presentations include outcomes from the DAFFODIL™, a Phase 2/3 open-label study evaluating the safety, tolerability and exploratory...Read more
HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable...Read more
PLYMOUTH MEETING, Pa. / Apr 17, 2024 / Business Wire / AdaptHealth Corp. (NASDAQ: AHCO) (“AdaptHealth” or the “Company”), a national leader in providing patient-centered, healthcare-at-home solutions including home medical equipment, medical supplies, and related services, announced today that its Board of Directors has named Suzanne Foster as its Chief Executive Officer. Ms. Foster will assume leadership of the Company from interim CEO and...Read more
RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older. “We are excited to announce that ORLADEYO is now approved in the...Read more
SAN FRANCISCO, April 17, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the appointment of Martin Babler to its Board of Directors, effective April 13, 2024. Mr. Babler, a highly successful executive who brings valuable industry experience to...Read more
In the Phase 2 PRECEDENT Study, dalzanemdor (SAGE-718) did not show statistically significant differences versus placebo on the primary endpoint in patients with mild cognitive impairment in Parkinson’s disease Dalzanemdor (SAGE-718) was generally well-tolerated and there were no new safety signals observed Topline data readouts from the Phase 2 studies in Huntington’s disease and Alzheimer’s disease are expected later this...Read more
The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale NEWPORT BEACH, Calif. / Apr 17, 2024...Read more
PONTE VEDRA, Fla., April 17, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced that John T. Treace, Chief Executive Officer, and Mark L. Hair, Chief Financial Officer, will participate...Read more
Mr. Hoitt brings more than two decades of successful commercial experience with an emphasis on rare diseases BEDFORD, Mass. / Apr 17, 2024 / Business Wire / Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced the appointment of Jason Hoitt as Chief Commercial Officer. Mr. Hoitt...Read more
Subgroup analysis of the UGN-102 ATLAS Trial in patients with new versus recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Three independent long-term real-world analyses of JELMYTO® (mitomycin) for pyelocalyceal solution exploring its use in broad patient types and method of administration PRINCETON, N.J. / Apr 17, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company...Read more
BPL-003 is Beckley Psytech’s novel patent-protected benzoate salt formulation of 5-MeO-DMT that is administered intranasally. BPL-003 was shown to be safe and well-tolerated with a predictable pharmacokinetic profile and a reliable induction of subjective psychedelic effects with single doses of up to 12 mg in healthy participants. Subjective psychedelic effects correlated with 5-MeO-DMT exposure and had a rapid onset and short...Read more
European-based Unilabs has deployed the SOPHiA DDM™ Platform across its network in Switzerland to support cancer diagnostics and treatment BOSTON and ROLLE, Switzerland, April 17, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and a leader in data-driven medicine, today announced that Unilabs, one of the largest diagnostic providers in Europe, and the only provider to offer laboratory,...Read more
WATERTOWN, Mass. / Apr 17, 2024 / Business Wire / Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for indications in virology and immunology, today announced that data from the company’s SPRINT (SARS-Cov-2 PRotease INhibitor Treatment) study of EDP-235 has been accepted for a poster presentation at ESCMID Global 2024 (formerly ECCMID) being held April 27–30 in...Read more
SYDNEY, AUSTRALIA, April 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of...Read more
MOUNTAIN VIEW, Calif., April 17, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced that the Company’s exclusive worldwide collaboration agreement with Sanofi to create and develop IgM agonist antibodies will now focus exclusively on immunology/inflammation targets. IGM will retain global rights to its proprietary...Read more
Fully non-viral approach to genetic medicine employs differentiated gene delivery, gene editing and gene insertion technology Progressing two fully non-viral programs in rare disease with significant unmet patient need Virtual R&D Day featuring academic experts and Poseida's leadership and scientific teams to be held today at 10:00am ET / 7:00am PT SAN DIEGO, April 17, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc....Read more
Anticipated completion of enrollment of the chronic cohort in the Phase 1b/2a clinical trial in Q2 2024 CA$23 million bought deal financing completed in March 2024 provides expected cash runway through Q3 2025 Fast Track designation granted by U.S. Food and Drug Administration (FDA) for NVG-291 in spinal cord injury Vancouver, British Columbia--(Newsfile Corp. - April 17, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF) a...Read more
Agreement designed to provide patients and caregivers access to innovative home dialysis with the Tablo® Hemodialysis System SAN JOSE, Calif. / Apr 17, 2024 / Business Wire / Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, and U.S. Renal Care, the largest privately held kidney care provider in the United States, announced...Read more
Findings from ILLUMINATE Natural History Study show that MRI and fluid biomarkers are emerging as key measures of ALSP pathophysiology - Positive interim IGNITE Phase 2 data demonstrating iluzanebart (VGL101) as potential disease-modifying therapy for ALSP WATERTOWN, Mass., April 17, 2024 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of...Read more
Simplifies capital structure through prepayment of existing term loan Reduces annual interest expense, providing increased near-term cash flow and operational flexibility Extends expected cash runway in advance of AUDACITY FDA trial read-out Strengthens long-term partnership with RTW Investments NATICK, Mass. / Apr 17, 2024 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated...Read more
MINNEAPOLIS / Apr 17, 2024 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today announced the first patient being dosed in DiaMedica’s relaunch of its pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the treatment of acute ischemic stroke. The company continues to work closely with its contract...Read more
TEL AVIV, Israel & ZURICH & NEW YORK / Apr 17, 2024 / Business Wire / SHL Telemedicine Ltd. (NASDAQ: SHLT; SIX Swiss Exchange: SHLTN) ("SHL" or the "Company"), a leading provider and developer of advanced personal telemedicine solutions, announced today its results for the full-year 2023, highlighting fiscally responsible growth across all regions and a strategic focus on expansion and innovation. In 2023, SHL Telemedicine achieved...Read more
MONTREAL and CHARLOTTE, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present data on etripamil at the 30th Annual Cardiovascular Nursing Symposium held by the Preventive Cardiovascular Nurses Association on April 18-20th in Orlando, FL. The posters...Read more
Data Support HPA-1a Negative Frequency of More than 2% in Nearly 200,000 Screened Pregnant Women Among HPA-1a Negative Pregnant Women, Approximately 33% are at Higher Risk for Alloimmunization NEW HAVEN, Conn. / Apr 17, 2024 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with...Read more
TEL AVIV, Israel, April 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma. The poster will be presented at the American Society for...Read more
Study will assess the clinical utility and workflow benefits of physicians using images acquired by the Swoop® Portable MR Imaging® system to identify ARIA events in Alzheimer’s patients treated with amyloid-targeting therapy GUILFORD, Conn. / Apr 17, 2024 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance...Read more
Bionano, a global leader in the transformation of the cytogenetic workflow with optical genome mapping (OGM), has entered into a strategic partnership with Hangzhou Diagens Biotechnology Co., Ltd. (Diagens), the pioneering leader in artificial intelligence (AI) chromosome karyotype analysis technology. Their joint endeavor aims to commercialize the first ever cytogenetic workflow that integrates OGM plus AI chromosome karyotype...Read more
PRINCETON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today announced that topline results from its pivotal U.S. and Canadian Safe and Timely Antithrombotic Removal of Ticagrelor (STAR-T) randomized controlled trial will be...Read more
RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- Science 37 Holdings, Inc., the clinical research industry’s leading MetasiteTM, today announced the launch of a stand-alone Patient Recruitment Solution to deliver patients to sites that are eligible, medically reviewed, and fully consented. While traditional central patient recruitment campaigns have proven to be effective in accelerating enrollment, they are fraught with...Read more
DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update. “It was exceptionally exciting to receive our first FDA approval for...Read more
New data demonstrates no impact of NRX-101 on gut or vaginal flora – considered primary causes of pseudomembranous colitis due to C difficile and vaginal yeast infections NRX-101 previously demonstrated potent activity against resistant urinary pathogens and has been shown to be fully excreted, unmetabolized, in the urine NRX-101 has received FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation in...Read more
RADNOR, Pa., April 17, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it intends to offer to sell shares of its common stock in an underwritten public offering. All of the shares of common stock are to be sold by the Company. The offering is subject to market conditions and there can be no assurance as to whether...Read more
Significant Phase 2 clinical trial progress obtained with first patient finalizing EVX-01 vaccine dosing Favorable safety profile confirmed Trial on track for one-year clinical efficacy readout in Q3 2024 COPENHAGEN, Denmark, April 17, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces that...Read more
HAMBURG, GERMANY / ACCESSWIRE / April 17, 2024 / Evotec SE (Frankfurt Stock Exchange:EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:EVO) today announced the appointment of Aurélie Dalbiez as the Company's new Chief People Officer ("CPO"), effective 15 June 2024. Aurélie will be joining Evotec's Management Board, bringing with her a wealth of experience and expertise in Human Resources leadership. In her role as CPO, Aurélie will oversee...Read more
SOMERSET, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- CareCloud, Inc. (Nasdaq: CCLD, CCLDP, CCLDO), a leader in healthcare technology solutions for medical practices and health systems nationwide, is pleased to announce its participation in the 2024 Kansas MGMA Annual Conference, taking place from April 17-19 at the Wichita Marriott, Kansas. CareCloud will seize this opportunity to showcase its innovative solutions aimed at transforming...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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