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...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,...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...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...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,...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...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,...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...Read more
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...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...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...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...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...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...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...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...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 &...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...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)....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/...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.,...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...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...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...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"...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...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...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...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...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...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...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...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 /...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...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...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...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...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...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,...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...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...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...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...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...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...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...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...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:...Read more
Newly Presented Results, to be Published in The New England Journal of Medicine, Include Adherence and Pharmacokinetics Data; Data Underscore High Efficacy and Safety Profile of Lenacapavir Among Broad and Geographically Diverse Range of Individuals FDA Recently Granted Breakthrough Therapy Designation for Lenacapavir for PrEP; Gilead to Begin Regulatory Filings by End of 2024 Gilead Spearheading Lenacapavir Access...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...Read more
RANCHO CUCAMONGA, CA / ACCESSWIRE / November 13, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Jacob Liawatidewi, EVP of Corporate Administration, will participate in an Analyst-Moderated fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024 at 3:30 pm GMT. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com. This webcast...Read more
Third Quarter 2024 and Recent Selected Highlights: Revenues increased 44% from $34.3 million in the prior-year quarter to $49.3 million GAAP net loss of $(4.2) million Adjusted EBITDA of $8.8 million Operating cash flow of $3 million Cash and cash equivalents of $72.6 million as of September 30, 2024 VEVYE® total prescriptions up 55% over the second quarter of 2024 IHEEZO® customer unit demand volume up 15% over the second quarter...Read more
DUBLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 20 at 7:30 a.m. GMT / 2:30 a.m. ET. A live webcast of the fireside chat, as well as an archived recording, will be available...Read more
Revenues for Third Quarter of 2024 were $41.7 Million, up 10% Year-over-Year; Nine Month 2024 Total Revenues were $121.9 Million, up 15% Year-over-Year Third Quarter 2024 Adjusted EBITDA of $8.8 Million, Representing an 11% Increase Year-over-Year; Nine Month 2024 Adjusted EBITDA of $25.4 Million, up 43% Year-over-Year Robust Third Quarter and Nine Month Results and Positive Outlook for Remainder of 2024 Support Increased Adjusted...Read more
Seeking to initiate Phase 3 registrational trial for larsucosterol with topline results expected within two years of initiation Webcast of Earnings Call Today, November 13 at 4:30 p.m. ET CUPERTINO, Calif., Nov. 13, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended September 30, 2024 and provided a business update. "We remain focused on preparations for the Phase 3...Read more
Highlights Q4 2024 and Q1 2025 with multiple potential liquidity events, growth in multiple subsidiaries as well as potentially significant reduction in overhead and expenses Company to hold a virtual conference call Wednesday, November 13, 2024, at 11:00 AM ET GARDEN CITY, NY, Nov. 13, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase” or the “Company”), a next-generation biotech, genomics, and diagnostics...Read more
Five sites actively screening with multiple patients having completed the study; two additional institutions expected to begin screening in the fourth quarter totaling seven active sites Cash and investments at September 30, 2024 of $11.1 million Conference call and webcast to be held Wednesday, November 13, 2024 at 4:30 pm ET SAN MATEO, Calif., Nov. 13, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a...Read more
● 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. ● 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...Read more
GAITHERSBURG, Md., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the third quarter ended September 30,...Read more
MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) announces that its American Depository Shares (ADSs) have commenced trading on the Nasdaq Global Select Market (Nasdaq) under the ticker symbol ‘TLX’. The Company continues to have its primary listing on ASX, with the Nasdaq listing of ADSs expected to complement the Company’s ASX listing. Each ADS represents...Read more
MELBOURNE, Australia and BERLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into a technology collaboration and licence agreement with Berlin-based Eckert & Ziegler SE (EZAG) for the use of EZAG’s cyclotron-based systems to produce the alpha-emitting isotope, actinium-225 (225Ac). This provides Telix with both an additional commercial source of...Read more
RAHWAY, N.J. / Nov 12, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new clinical and real-world data for the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), evaluating the burden and incidence of certain HPV-related cancers and diseases, will be presented at the International Papillomavirus...Read more
These results showed reduction in tumor volume, building on the established safety and efficacy profile of KOSELUGO in certain children and has the potential to support expanded use in certain adults RAHWAY, N.J. / Nov 12, 2024 / Business Wire / Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KOMET trial, which is...Read more
Upgrade to full year 2024 guidance underpinned by strong underlying growth momentum CAMBRIDGE, United Kingdom / Nov 12, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary 9M 2024 % Change Q3 2024 % Change $m Actual CER1 $m Actual CER - Product...Read more
Collaboration will leverage Flare Therapeutics' proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncology Flare Therapeutics to receive US$70 million upfront, and potential milestone payments exceeding US$1.8 billion, as well as royalties CAMBRIDGE, Mass., Nov. 12, 2024 /PRNewswire/...Read more
Four-Year Outcomes from the BICSTaR Study Further Demonstrate the Long-Term Efficacy and Safety Profile of Biktarvy®, Providing Insights for HIV Clinical Care New Data on HIV Treatment Patterns Reinforce the High Barrier to Resistance of Biktarvy Investigational Regimens with Once-Daily, Once-Weekly and Twice-Yearly Dosing Frequencies Across Administration Methods Aim to Expand Options, Help Address Unmet Needs in HIV...Read more
Ma brings deep manufacturing and innovation expertise GREENFIELD, Ind., Nov. 12, 2024 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced the appointment of Dr. Stacey Ma to its Board of Directors, effective immediately. Dr. Ma brings extensive global leadership experience in biopharmaceutical development and manufacturing, further strengthening Elanco's expertise in these critical areas. "We are...Read more
NASHVILLE, Tenn. / Nov 12, 2024 / Business Wire / Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced its first major market access wins in the 2025 Medicare Part D Prescription Drug Program. Starting January 1, 2025, VEVYE will be included in key formularies managed by major plan sponsors such as Express Scripts, Cigna, Kaiser Permanente, and CVS Caremark. In the aggregate, these sponsors...Read more
Generated $50.0 million in net revenue from sales of LUMRYZ™ 2,300 patients on LUMRYZ as of September 30th, including 700 patients that initiated therapy in the quarter Received FDA approval for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy, granted ODE through October 16, 2031 LUMRYZ approval upheld by court in suit brought by Jazz regarding FDA’s determination that...Read more
CANTON, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that it has entered into a Subscription Agreement with affiliates of Avista Healthcare Partners (“Investors”) for the sale of its Series...Read more
CANTON, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the third quarter ended September 30, 2024. Third Quarter 2024 Financial Results Summary: Net revenue of $115.2...Read more
CHASKA, Minn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that Paul Josephs, the company’s president and chief executive officer, will be a featured speaker in a fireside chat at the upcoming Stephens Annual Investment Conference. The conference is being held November 19-21, 2024, in Nashville,...Read more
U.S. FDA approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the treatment of inflammatory lesions of rosacea in adults; launch expected in late Q1 or early Q2 of 2025 Total revenues for the third quarter ended September 30, 2024 were $14.6 million SCOTTSDALE, Ariz., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a...Read more
Reports net product sales of $28.3 million for the third quarter of 2024, an increase of 31% over net product sales for the same period in 2023. Net product sales for the third quarter of 2024 included a special large order of premium-priced products by our largest customer. Reports gross profit of $6.2 million for the third quarter of 2024, an increase of 183% over the same period in 2023. Achieves gross margin of 22% for the third...Read more
Company reports Q3 2024 XHANCE net revenue of $20.4 million, an increase of 3% compared to Q3 2023 Company reports positive inflection in new prescriptions of XHANCE starting in September Company decreases full year 2024 XHANCE net revenue guidance to be between $75.0 to $79.0 million and increases expected average net revenue per prescription guidance to be approximately $270 Company decreases full year 2024 operating expenses...Read more
BOCA RATON, Fla. / Nov 12, 2024 / Business Wire / TherapeuticsMD, Inc. (“TherapeuticsMD” or the “Company”) (NASDAQ: TXMD), a company that owns rights to pharmaceutical royalties, today reported financial results for the third quarter ended September 30, 2024. Third Quarter 2024 Financial Results Net Income (Loss) from Continuing Operations Net loss from continuing operations was $(567) thousand, or $(0.05) per basic and diluted common...Read more
GARDEN CITY, NY, Nov. 12, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase” or the “Company”), a next-generation biotech, genomics and diagnostics company, today announced the closing of its previously announced underwritten public offering of 4,795,500 shares of its common stock, including 625,500 shares sold upon full exercise of the underwriter's option to purchase additional shares. Each share of common stock was...Read more
VANCOUVER, November 12, 2024 – TheNewswire – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing, and promoting differentiated products, today reports financial results for the quarter ended September 30, 2024 (“Third Quarter 2024”) and associated Company developments. Unless otherwise noted, all figures are in Canadian currency. Doug...Read more
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received...Read more
EMPOWER-1 and EMPOWER-2 Phase 2 clinical trials did not meet their primary endpoint Emraclidine was well-tolerated with an adverse event profile consistent with Phase 1b trial NORTH CHICAGO, Ill., Nov. 11, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute...Read more
Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS® (mavacamten) PRINCETON, N.J. / Nov 11, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data across its cardiovascular portfolio at the American Heart Association (AHA) Annual Scientific Sessions,...Read more
New Commercial Organizational Structure to Accelerate Long-Term Growth Strategy in Key Markets and Optimize Global Commercial Operations PARSIPPANY, N. J. / Nov 11, 2024 / Business Wire / Zoetis Inc. (NYSE:ZTS) today announced the appointment of Jamie Brannan to a newly created role of Chief Commercial Officer, overseeing all commercial markets across the globe for the world’s leading animal health company. In this new role, Mr....Read more
CANTON, Mass., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension...Read more
Third Quarter Total Net Product Sales of $28.7 Million Rolvedon Net Product Sales of $15.0 Million Cash and Short-Term Investments of $88.6 Million LAKE FOREST, Ill., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today reported financial results for the...Read more
BOULDER, CO / ACCESSWIRE / November 11, 2024 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and...Read more
KIRKLAND, QC, Nov. 8, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that Canada's Drug Agency (CDA) has recommended WINREVAIR® (sotatercept) for reimbursement in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III. Sotatercept is the first activin...Read more
TEZSPIRE demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size and reduced nasal congestion compared to placebo WILMINGTON, Del. / Nov 08, 2024 / Business Wire / Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) demonstrated a statistically...Read more
THOUSAND OAKS, Calif., Nov. 8, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2024 UBS Global Healthcare Conference at 10:15 a.m. PT on Wednesday, Nov. 13, 2024. Peter Griffith, executive vice president and chief financial officer at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The...Read more
Statistically Significant Reduction in Nasal Polyp Size, Nasal Congestion Compared to Placebo THOUSAND OAKS, Calif., Nov. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). The trial demonstrated patients treated with TEZSPIRE® (tezepelumab-ekko) had a statistically...Read more
| Company | Change | Last Trade |
|---|---|---|
| Eli Lilly | 23.68 3.25 | $753.41 |
| Amgen | 8.13 2.90 | $288.08 |
| Novo Nordisk | 2.65 2.58 | $105.28 |
| PTC Therapeutics | 2.60 6.61 | $41.96 |
| Alpha Teknova | 1.79 28.82 | $8.00 |
| AbbVie | 1.38 0.83 | $167.95 |
| HUTCHMED | 1.23 7.34 | $17.98 |
| Merck | 0.90 0.93 | $97.44 |
| Gilead Sciences | 0.88 1.00 | $88.63 |
| Harrow | 0.62 1.56 | $40.32 |
| Emergent BioSolutions | 0.61 7.38 | $8.88 |
| Supernus Pharmaceuticals | 0.59 1.66 | $36.12 |
| Biogen | 0.57 0.37 | $156.00 |
| Amphastar Pharmaceuticals | 0.47 1.08 | $44.09 |
| BioSyent | 0.39 3.57 | $11.30 |
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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