TEL AVIV, Israel, Nov. 20, 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 receipt of partial topline data from its contract research organization (CRO), Lotus Clinical Research ("Lotus"), for the Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionect... Read more
MISSISSAUGA, Ontario, Nov. 20, 2024 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q3) and nine months (YTD) ended September 30, 2024. Key highlights include: (CAD)
Q3 2024
% Change vs. Q3 2023
YTD 2024
% Change vs. YTD 2023
Trailing Twelve Months (TTM) Sept 30, 2024
% Change vs. TTM Sept 30, 2023
Canadian Pharma Sales
8,303... Read more
Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment MIAMI, FL / ACCESSWIRE / November 20, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine... Read more
MELT-300 Demonstrates Statistically Superior Compared to Both Sublingual Midazolam (P=0.009) and Placebo (P<0.001) for Providing Successful Procedural Sedation
Proportion of Patients Requiring Rescue Sedation Was Nearly Two-Fold Higher for Sublingual Midazolam Compared with MELT-300 (P=0.003)
MELT-300 Had a Favorable Safety Profile That Was Generally Comparable to Placebo NASHVILLE, Tenn. / Nov 20, 2024 / Business Wire / Melt Pharmaceuticals, Inc. (“Melt”),... Read more
Lilly to Develop Two Targets Identified and Validated Using Verge Genomics’ AI-Enabled, All-in-Human CONVERGE® Platform
Demonstration of the Robust Predictive Power of CONVERGE® - 83% of Prioritized Targets were Validated in Disease-Relevant Models, a Rate Significantly Higher than Industry Standards SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Verge Genomics, a clinical-stage biotechnology company pioneering the use of artificial intelligence... Read more
In the EU, HYMPAVZI is the first once-weekly subcutaneous treatment approved for eligible people living with severe hemophilia B and the first to be administered via a pre-filled pen or syringe for people living with severe hemophilia A or B
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors NEW YORK / Nov 20, 2024 / Business... Read more
Howard Chang, M.D., Ph.D., Joins as Senior Vice President of Research and Chief Scientific Officer THOUSAND OAKS, Calif., Nov. 20, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Howard Chang, M.D., Ph.D., will join the company as senior vice president of Research, effective Dec. 16, 2024. Chang will also assume the title and responsibility of serving as Amgen's chief scientific officer, reporting to Jay Bradner, M.D., executive vice president of... Read more
Chris Boshoff to lead all Research and Development functions including Oncology
Oncology Unit end-to-end structure to remain intact, reporting to Boshoff
Roger Dansey to become Interim Chief Oncology Officer and Johanna Bendell to join Pfizer as Oncology Chief Development Officer NEW YORK / Nov 20, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that after a comprehensive internal and external selection process, the company is appointing Chris Boshoff,... Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that Dr Chaohong Hu (Dr Mary Hu) is appointed as an Independent Non-executive Director and a member of the Technical Committee of the Company with effect from November 21, 2024.
Dr Hu has over 20 years of experience in the development of therapeutic antibodies, antibody-drug conjugates,... Read more
More than 90 presentations of clinical trial and real-world data highlight potentially practice-changing evidence and commitment to pioneer the next wave of therapies for patients with hematologic malignancies RARITAN, N.J., Nov. 19, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today more than 90 abstracts featuring data from the Company's differentiated blood cancer portfolio and pipeline will be presented at the 66th American Society of Hematology... Read more
SAN CARLOS, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, and a subsidiary of Grifols, announced today that the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for the treatment of hepatitis B virus (HBV) infec... Read more
Data from more than 20 programs, including new research from cell therapy and targeted protein degradation platforms, showcase the depth and breadth of BMS’ diverse portfolio and ongoing leadership in blood diseases and beyond PRINCETON, N.J. / Nov 19, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the presentation of more than 90 data disclosures, including 18 oral presentations, across company-sponsored studies, investigator-sponsored studies... Read more
WIXOM, Mich. / Nov 19, 2024 / Business Wire / Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company entered into a distribution agreement with Nephro Group Dialysis Centers ("Nephro Group"), the largest dialysis provider in the Philippines. Under the terms of the agreement, Rockwell Medical... Read more
INDIANAPOLIS, Nov. 19, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that it has elected Jon Moeller as a new member of its board of directors, effective Dec. 1, 2024. In addition, the company announced that Karen Walker will transition her role with Lilly, resigning as a member of Lilly's board of directors effective Dec. 31, 2024. In 2025, Ms. Walker will collaborate with Lilly on certain digital commercial activities.
Mr. Moeller is the... Read more
Dapirolizumab pegol (DZP) met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity
A greater response was observed across multiple clinical endpoints among participants treated with DZP including 50% less severe disease flares compared to participants on standard of care alone
Systemic Lupus Erythematosus is a chronic, debilitating autoimmune disease... Read more
U.S. Patent Office issues notice of allowance for a second patent for Conjugated Psilocin™
Once issued, this patent will provide additional coverage for psilocin mucate compositions VANCOUVER, British Columbia & STUART, Fla. / Nov 18, 2024 / Business Wire / Lobe Sciences, Ltd. ("Lobe Sciences" or the "Company") (CSE: LOBE), (OTCQB: LOBEF) and Alera Pharma, Inc. (“Alera” or “Alera Pharma”), biopharmaceutical companies focused on developing products to treat... Read more
MELBOURNE, Australia, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces it will expand its theranostic pipeline with new assets targeting Fibroblast Activation Protein (FAP), one of the most promising pan-cancer targets in nuclear medicine. Telix’s development program will initially focus on the treatment of bladder cancer, rounding out its urology franchise, which includes late-stage therapeutic... Read more
Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis
74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24
Comprehensive results are being prepared for presentation at upcoming medical congresses SPRING HOUSE, Pa., Nov. 18, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive... Read more
Muvalaplin, an oral, once-daily treatment that inhibits lipoprotein(a) formation via a novel mechanism, achieved positive results in a 12-week Phase 2 study
These data were published in the Journal of the American Medical Association (JAMA) and simultaneously presented today at the American Heart Association (AHA) Scientific Sessions 2024 INDIANAPOLIS, Nov. 18, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive Phase 2 results... Read more
Marked and rapid reductions in both pericarditis pain and inflammation maintained throughout the 26-week study
Episodes of pericarditis per year substantially reduced MAvERIC-Pilot results support advancing CardiolRx™ into the Phase II/III MAVERIC-2 and the Phase III MAVERIC-3 clinical trials Toronto, Ontario--(Newsfile Corp. - November 18, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage... Read more
Next generation product may increase gastrointestinal luminal concentration while limiting system exposure LAVAL, QC / ACCESSWIRE / November 18, 2024 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced the first look at its late-stage RED-C clinical trial program which will be presented at the American Association for the Study of Liver Disease (AASLD), The Liver Meeting® in San... Read more
LAVAL, QC / ACCESSWIRE / November 18, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE/TSX:BHC), today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older,1 has received positive reimbursement recommendations from Canada's Drug Agency (CDA, formerly the Canadian Agency... Read more
Ratio to receive upfront, and potential milestones and tiered royalty payments BOSTON, Nov. 18, 2024 /PRNewswire/ -- Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, entered today into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration leverages Ratio's... Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - November 18, 2024) - Earlier in November 2024, Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) successfully completed a negotiation process with the pan-Canadian Pharmaceutical Alliance seeking to make Trecondyv® (treosulfan for injection) accessible to publicly funded drug programs and patients in Canada. The pCPA is an independent organization whose membership includes the provincial, territorial, and federal... Read more
OPUVIZ™ is one of the first wave aflibercept biosimilars in Europe
OPUVIZ is the second European Commission (EC)-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership
EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq:... Read more
Northvale, New Jersey--(Newsfile Corp. - November 18, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse® (Lisdexamfetamine Dimesylate) with strengths of 10... Read more
ELAHERE is the first and only novel therapy approved in the European Union specifically for patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer
ELAHERE represents the first treatment to demonstrate an overall survival benefit in a Phase 3 trial in platinum-resistant ovarian cancer compared with chemotherapy
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the companion diagnostic to identify ovarian cancer patients eligible for ELAHERE,... Read more
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers.
The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE.
This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year. TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:... Read more
In a first-of-its-kind study, tirzepatide also alleviated heart failure symptoms and physical limitations
Patients on tirzepatide experienced improved exercise capacity, greater weight loss and reduced systemic inflammation
Lilly has initiated submissions for tirzepatide for the treatment of HFpEF and obesity to global regulatory agencies INDIANAPOLIS, Nov. 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the... Read more
GREENFIELD, Ind., Nov. 15, 2024 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today acquired a contract manufacturing facility and related assets in Speke, UK. The facility, previously owned by TriRx Speke Ltd., was under trading administration, a formal insolvency process in the United Kingdom.
As previously shared on the Company's third quarter 2024 earnings call, the Speke facility plays a vital role for Elanco in producing a number of farm... Read more
New Findings Demonstrate 81% of Participants Achieve Durable Biochemical Response by Month 30 with Livdelzi
Nearly Half of Participants with Primary Biliary Cholangitis (PBC) Achieve Alkaline Phosphatase (ALP) Normalization with Livdelzi
Livdelzi Reduced Pruritus Severity in PBC Participants and Led to Near Resolution of Itch in 27% of Participants with Moderate to Severe Itch FOSTER CITY, Calif. / Nov 15, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD)... Read more
Stable revenue and gross profit despite cost-cutting initiatives, indicating the strength of underlying segments and brands. Solid liquidity position, with cash and cash equivalents exceeding $3.3 million. Hard assets, mainly comprised of debt-free properties, valued at over $12 million; exceeding total debt and providing financing flexibility. Liquid inventory position and accounts receivable that are collected at an accelerated pace provide additional... Read more
PALO ALTO, Calif. , Nov. 15, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced presentation of data at the 2024 American College of Rheumatology Convergence conference to be held at the Walter E. Washington Convention Center in Washington,... Read more
Opinion based on results from the Phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo and Yervoy demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to investigator’s choice of chemotherapy PRINCETON, N.J. / Nov 15, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines... Read more
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial RAHWAY, N.J. / Nov 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum... Read more
Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity with repotrectinib in these patient populations
If approved, repotrectinib has the potential to be a best-in-class treatment for patients with advanced ROS1-positive non-small cell lung cancer in the European Union PRINCETON, N.J. / Nov 15, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal... Read more
Conference Call Scheduled for Friday, November 15 at 11:30 AM EST Northvale, New Jersey--(Newsfile Corp. - November 14, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, announced results for the three months ended September 30, 2024, which is the second quarter of the Company's fiscal year ending on March 31, 2025 ("Second... Read more
MONTREAL, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM™, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children.
JORNAY PM™ is the first and only evening-dosed methylphenidate product commercially available in Canada... Read more
MITIGATE Phase 3 Study Results Reinforce Promise of UPLIZNA® as the First Potential Treatment tor IgG4-RD
Phase 4 AGILE Data Support Shortening KRYSTEXXA® Infusion Time THOUSAND OAKS, Calif., Nov. 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheumatology (ACR) Convergence 2024 conference in Washington, D.C., Nov. 14-19, 2024. New data... Read more
TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody... Read more
PARSIPPANY, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new data demonstrating its gene therapy for osteoarthritis candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function to 104 weeks following local administration, with a well-tolerated safety profile.... Read more
Adults with moderately-to-severely active Sjögren's disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels
Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease based on results from the Phase 2 DAHLIAS study WASHINGTON, Nov. 14, 2024... Read more
RAHWAY, N.J. / Nov 14, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and LaNova Medicines Ltd. (LaNova), a privately held clinical-stage biotechnology company, today announced that Merck has entered into an exclusive global license to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova.
“At Merck, we continue to assemble a strong and diversified oncology pipeline... Read more
Combined with Zomedica's eACTH assay, equine veterinarians get same day answers for their PPID and EMS patients ANN ARBOR, MI / ACCESSWIRE / November 14, 2024 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced the launch of its third equine-focused assay - Insulin for equine plasma - for the TRUFORMA In-Clinic Biosensor... Read more
NEW YORK and MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today reported fiscal first quarter financial results and provided business highlights for the quarter ended September 30, 2024.
“The first quarter reflects ongoing progress for Incannex, building on the... Read more
Strategic merger with Rafael Holdings to combine two companies and advance Trappsol® Cyclo™ for NPC1 patients expected to close Q4 2024
Company on track for topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ in H1 2025
Submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to European Medicines Agency (EMA) targeted for H2 2025
Qualification for Priority... Read more
BX211 Phase 2 for treatment of Diabetic Foot Osteomyelitis (DFO) patient enrollment completed and on track to report topline results in Q1 2025
BX004 Phase 2b study in Cystic Fibrosis (CF) is now expected to report topline results in H1 2026 following resolved manufacturing delays
Company to host conference call and webcast today at 8:00AM ET NESS ZIONA, Israel, Nov. 14, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE, the “Company” or “BiomX”),... Read more
First-ever FDA approval for gene therapy directly administered to the brain
Priority review voucher granted
Broad label including children and adults
PTC pioneers new approach for CNS drug delivery WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the... Read more
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Total revenues for the third quarter 2024 were $9.0 million, an increase of 1.5% from Q3 2023. Revenue increase would have been 19% if shipments were not delayed due to Hurricane Milton.
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Total revenues for the first 9 months were $24.8 million, an increase of $1.3 million, or 5.6% as compared to the same period last year. Without the impact of Hurricane Milton delaying shipments, the increase would have been 12%.
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Ameluz®... Read more
SURMOUNT-1 results show a 94% reduction in risk of progression to type 2 diabetes across all pooled doses of tirzepatide compared to placebo over three years
Results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide
Participants treated with tirzepatide had an average weight reduction of 22.9% (15 mg dose) INDIANAPOLIS, Nov. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today detailed results... Read more
