Bagsværd, Denmark, 17 January 2025 – Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle...Read more
First approval in the US for AstraZeneca and Daiichi Sankyo’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death vs. chemotherapy DATROWAY is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030 WILMINGTON, Del. / Jan 17, 2025 / Business Wire / DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with...Read more
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone First and only BTK inhibitor approved for the 1st-line treatment of MCL in the US WILMINGTON, Del. / Jan 17, 2025 / Business Wire / AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with...Read more
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as...Read more
Phase 3 MARIPOSA-2 study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival compared to carboplatin and pemetrexed alone.1 TORONTO, Jan. 16, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab for injection) in combination with carboplatin and pemetrexed (platinum-based...Read more
MELBOURNE, Australia and LIÈGE, Belgium, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection), which was submitted in Europe via a decentralized procedure (DCP). This...Read more
ADDIS ABABA, Ethiopia and KINSHASA, Democratic Republic of the Congo and WASHINGTON and PARIS, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Africa CDC’s support for the MOSA, a pan-African randomized platform adaptive trial for the MpOx Study, adding to the initial EU funding, has enabled the enrollment of the first patients at Mbandaka Hospital in Equateur Province, Democratic Republic of Congo (DRC). These patients have been randomized in this...Read more
In the pivotal Phase 3 VIVID-1 trial, patients treated with Omvoh experienced significant improvement in clinical remission and endoscopic response at one year Among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in open-label extension INDIANAPOLIS, Jan. 15, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1 RARITAN, N.J., Jan. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus...Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - January 15, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) recently completed a listing agreement with British Columbia's Provincial Health Services Authority (PHSA), a publicly funded health service provider in the Canadian province, for a new approved indication for Trecondyv® (treosulfan for injection) to be listed on the BC Cancer Benefit Drug List and funded through...Read more
YARDLEY, Pa., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced preliminary unaudited XHANCE® (fluticasone propionate) net product revenue of $22.4 million for the three months ended December 31, 2024. “Our preliminary unaudited fourth quarter net product revenue of $22.4 million is in line with our...Read more
2024 revenue is expected to be approximately $45.0 billion for the full year, $4.0 billion above the midpoint of first-time 2024 financial guidance Q4 2024 revenue is expected to be approximately $13.5 billion, approximately $400 million below the low end of recently issued financial guidance The company anticipates 2025 revenue to be in the range of $58.0 billion to $61.0 billion, growth of 32% at the midpoint compared to...Read more
‘Chronos-PD’ is looking for biological signals that could indicate increased chance of developing Parkinson’s disease (PD) years before symptoms appear, leading to new diagnostic tools and disease-modifying therapies Part of broad Grifols program to find disease-revealing clues in more than 100 million proprietary plasma samples connected to real-world data on thousands of disease states in many therapeutic areas Cutting-edge use of...Read more
Alongside over-the-counter NARCAN® Nasal Spray 4 mg, prescription KLOXXADO® (naloxone HCl) Nasal Spray 8 mg will expand Emergent’s ability to distribute multiple life-saving opioid overdose emergency treatments to patients, customers and communities in need Focus remains on increasing access, raising awareness and ensuring strong supply to meet the ongoing demand of naloxone nasal spray GAITHERSBURG, Md., Jan. 14, 2025 (GLOBE...Read more
Pivotal Phase 3 global study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (“NPC1”) to be highlighted in an oral presentation GAINESVILLE, Fla. / Jan 14, 2025 / Business Wire / Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living...Read more
Submission of a Prior Approval Supplement for a reduction in the number of patients in the NEPHRO CRRT study is expected within the coming week The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study SAN MATEO, Calif., Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization...Read more
The acquisition will expand Lilly's oncology pipeline with STX-478, the differentiated and potentially best-in-class, mutant-selective PI3Kα inhibitor currently in a Phase 1/2 clinical trial STX-478 could potentially address 30-40% of people with hormone-positive breast cancer, building on Lilly's advancements against this disease INDIANAPOLIS and BOSTON, Mass., Jan. 13, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)...Read more
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson...Read more
Pivotal data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet age-related macular degeneration (wet AMD) are expected in 2026 AbbVie and REGENXBIO will plan the Phase 3 clinical program of investigational ABBV-RGX-314 in diabetic retinopathy (DR) NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced...Read more
NORTH CHICAGO, Ill. and SHANGHAI, Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096) today announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S. SIM0500 is a humanized...Read more
Application based on TROPION-Lung05 trial and supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials Approval would mark the first for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in lung cancer WILMINGTON, Del. / Jan 13, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for...Read more
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of...Read more
Bristol Myers Squibb exercises an exclusive license option for ArsenalBio’s AB-4000 series programs ArsenalBio is eligible for additional milestone payments and royalties as the programs advance SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage programmable cell therapy company focused on engineering advanced CAR T cell therapies for solid tumors,...Read more
Acquisition includes IDRX-42, a highly selective KIT tyrosine kinase inhibitor (TKI) designed to treat gastrointestinal stromal tumours (GIST) IDRX-42 offers potential to address all key KIT mutations in GIST that drive tumour growth and progression and improve tolerability, gaps in current therapies Acquisition adds to GSK’s growing portfolio in gastrointestinal (GI) cancers GSK to pay up to $1.15 billion PLYMOUTH, Mass. / Jan 13,...Read more
Klinge Biopharma GmbH (Klinge) holds the exclusive global commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®1 Agreement builds on the proven and successful collaboration of commercialization of FYB201, Formycon's biosimilar to Lucentis®2 (ranibizumab) in Europe The partnership broadens Teva's biosimilars portfolio, in line with its Pivot to Growth strategy TEL AVIV, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE)...Read more
LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 /PRNewswire/ -- 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 that the U.S....Read more
MELBOURNE, Australia and INDIANAPOLIS, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today advises that Dr. Christian Behrenbruch, Managing Director and Group CEO, will be presenting this week at the 43rd Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.A.). The presentation will take place this Wednesday, 15 January at 2:15 pm PST (5:15 pm...Read more
MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024). Sustained revenue growth Q4 2024 unaudited revenue of approximately US$142 million (AU$218 million)1, represents an increase of 46% over the prior year corresponding...Read more
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 14, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted approval by the China...Read more
For full year 2024, the Company expects total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS to be at or above the guidance ranges provided on November 8, 2024 Rare Disease Segment performed in line with expectations, with Purified Cortrophin Gel net revenues of $197.8 million to $198.4 million for the full year 2024 and ILUVIEN and YUTIQ net revenues of $30.4 million to $31.0 million for the post-acquisition...Read more
ARCALYST® (rilonacept) 2024 net product revenue of $416.4 million (unaudited), representing ~79% year-over-year growth ARCALYST 2025 net product revenue expected to be $560 - $580 million Kiniksa expects to remain cash flow positive on an annual basis LONDON, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of...Read more
This option is part of Emergent’s existing 10-year contract with BARDA for advanced development and procurement of Ebanga™, with a maximum value of $704 million Program progress and performance triggers $16.7 million contract option GAITHERSBURG, Md., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of...Read more
More patients treated with ZTlido® saw either a decrease or discontinuation of opioid use compared with those treated with the 5% patch (51.9% vs. 45.5%). Of all study patients reporting a decrease in opioid use, significantly more in the ZTlido® group experienced a 20% or greater reduction in opioid use, compared with those treated with 5% lidocaine patch (21.3% vs. 13.4%; P=0.0008). Patients on ZTlido® had a non-significant change...Read more
The Company's natural psilocybin extract powers a culturally transformative study to address methamphetamine addiction through indigenous frameworks. Vancouver, British Columbia--(Newsfile Corp. - January 13, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in natural psilocybin and MDMA, is proud to...Read more
Calgary, Alberta, Canada – TheNewswire - January 13, 2025 - Voyageur Pharmaceuticals Ltd. (TSX.V:VM) (OTC Pink:VYYRF) ("Voyageur" or the "Company") is pleased to announce that it has begun human testing on its latest barium contrast suite of products (as outlined below). This is a necessary and critical step for the Company, as it marks another milestone in the Company’s path forward towards market launch. Five of the Company’s innovative...Read more
CHICAGO, IL / ACCESSWIRE / January 13, 2025 / Cosmos Health Inc. ("Cosmos Health" or the "Company") (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it has entered into a distribution agreement with Virax...Read more
Jupiter, Florida, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the “Company”), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based platform, today announced a strategic focus on targeting the NLRP3 inflammasome in all upcoming clinical trials. This shift aims to unlock new therapeutic potential for neurodegenerative diseases, longevity, and aging,...Read more
MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has entered into an asset purchase agreement with antibody engineering company ImaginAb, Inc. (ImaginAb) to acquire a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility...Read more
Strategic Partnership Strengthens Gilead’s Inflammation Research Portfolio with the Addition of LEO Pharma’s Preclinical Oral STAT6 Program, Including Targeted Protein Degraders Gilead Will Have Exclusive Global Rights to the STAT6 Program, and LEO Pharma Will Have the Option to Co-Commercialize for Dermatology Indications Outside the U.S. LEO Pharma to Maintain Global Rights to Topical Formulations of the STAT6 Program in...Read more
Clinically meaningful and statistically significant results are the first pivotal Phase 3 data for sasanlimab, a subcutaneously administered PD-1 inhibitor If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population Treatment naïve high-risk NMIBC is an area of significant unmet need, where therapeutic options have largely remained unchanged...Read more
Marks a step forward in broadening treatment options for patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in the U.S. Partnership supports Teva's Pivot to Growth strategy and adds to its broad biosimilar portfolio INCHEON, Korea and TEL AVIV, Israel, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries...Read more
Delivering Progress on Strategic Priorities; Maintaining Full Year Adjusted EPS Guidance First quarter financial results First quarter loss per share1 was $0.31 versus loss per share of $0.08 in the year-ago quarter. Loss per share in the current quarter includes costs related to the Footprint Optimization Program and an after-tax charge for fair value adjustments on variable prepaid forward derivatives related to the monetization of...Read more
PARSIPPANY, N.J., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced its five-year growth-oriented plan to accelerate its ongoing transition into an innovative biopharmaceutical organization and become a therapeutic area leader in musculoskeletal pain and adjacencies. In...Read more
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad population of antibody positive adult patients: anti-AChR, anti-MuSK, anti-LRP4 SPRING HOUSE, Pa., Jan. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics License Application (BLA) received Priority Review...Read more
NORTH CHICAGO, Ill., Jan. 9, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025. Management will participate in a fireside chat at 10:15 a.m. Central time. A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that...Read more
The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. Primary diagnosis in digital pathology helps...Read more
MONTREAL, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that a shortage of EGRIFTA SV® (tesamorelin for injection) will occur at the patient level in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024....Read more
Building on decades of the Company's Alzheimer's research, two differentiated investigational therapies aim to slow pathological tau in distinct populations Fast Track designations reinforce J&J's commitment to Alzheimer's disease development and the potential of its precision approach TITUSVILLE, N.J., Jan. 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA)...Read more
Scope of collaboration originally signed in 2023 will significantly expand to enable the discovery and development of up to 20 novel drug programmes in obesity, type 2 diabetes, and cardiovascular disease Expanded collaboration includes near-term payments totalling up to 190 million US dollars, while Valo is eligible to receive milestone payments of approximately 4.6 billion dollars, plus R&D funding and potential royalty...Read more
GARDASIL is the first HPV vaccine approved for the prevention of certain HPV-related cancers and diseases in Chinese males RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26...Read more
Basel, 8 January 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche’s wholly owned subsidiary Blue Giant Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX) at a price of $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) to...Read more
THOUSAND OAKS, Calif., Jan. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2025 J.P. Morgan Healthcare Conference at 3:00 p.m. PT on Monday, January 13, 2025. Robert A. Bradway, chairman and chief executive 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
Product Revenues, Net Expected in the Range of $735 Million to $750 Million Jornay PM® Net Revenue Expected to be in Excess of $135 Million Adjusted EBITDA* Expected in the Range of $435 Million to $450 Million Adjusted Operating Expenses* Expected in the Range of $220 Million to $230 Million STOUGHTON, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced...Read more
Approximately $50.0 million of net revenue from sales of LUMRYZ™ estimated for the fourth quarter, a greater than 150% increase over $19.5 million for the comparable period in 2023 2,500 patients on LUMRYZ as of December 31, 2024, including 600 patients that initiated therapy in the fourth quarter LUMRYZ net product revenue of $240 – $260 million in 2025, representing 50% year-over-year growth at the...Read more
GAITHERSBURG, Md., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS), a leading public health company that delivers protective and life-saving solutions to communities across the world, today announced that Joe C. Papa, president and chief executive officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 1:30 PM PST. The audio link for Emergent's session may be...Read more
GAITHERSBURG, Md., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced the exercise of contract option and modification valued at approximately $20 million to supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense (DoD). The first delivery, which was valued at approximately $7 million began in December 2024, and remaining deliveries are expected in 2025. “We’re pleased to...Read more
Provides 2025 Annual Guidance of $178 - $182 Million in Revenue and $38 - $42 Million of Adjusted EBITDA, Representing Year-Over-Year Increase of 13% in Revenues and 19% in Adjusted EBITDA Based on Mid-Point of 2024 Annual Guidance Expects to Achieve 2024 Guidance of $158 - $162 Million in Revenue and $32 - $35 Million of Adjusted EBITDA; 2024 Year-End Cash of $78 Millio Aiming to Secure New Business Development and M&A...Read more
Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024. Data from follow-up will be included in FDA submission, expected in Q3 2025. Biofrontera announced highly statistically significant results for all primary and secondary endpoints (p <0.0001) in October 2024. BCC, of which sBCC is a subgroup, is the most common skin cancer in the US with more than 3 million cases each year1. WOBURN, Mass., Jan. 08,...Read more
Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer RARITAN, N.J., Jan. 7, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating...Read more
PITTSBURGH, Jan. 7, 2025 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced that the company will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 14, 2025. The company's presentation and fireside chat will begin at 8:15 a.m. PT / 11:15 a.m. ET. A live webcast of the event can be found at investor.viatris.com. An archived version of the...Read more
PARSIPPANY, N.J., Jan. 07, 2025 (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, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain. The ioveraº system is an...Read more
Company Believes it is Well Positioned for Mid-Term and Long-Term Growth as Current Capacity Continues to Support up to $300 Million in Annual Revenue CHASKA, Minn., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has entered into a sales agreement with a non-competitive buyer for...Read more
IMDYLLTRA® is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy1 Lung cancer is the third most common cancer in the UK, with more than 49,000 cases diagnosed in the UK between 2017 and 20192 Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancers3 In...Read more
Expanded Scientific Office Unifies Scientific-Focused Teams, Facilitating Seamless Collaboration Across Product Portfolio Lennox Most Recently Led Regulatory, Medical Affairs, Safety and Quality Teams, Plus Drove Product Innovation, at Bayer Consumer Health Previous Chief Scientific Officer, Alison Ives, to Lead Newly Formed Disruptive Growth Team DUBLIN, Jan. 6, 2025 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading...Read more
LONDON, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that it will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). A live webcast of Kiniksa’s presentation will be accessible through the Investors section of the company’s website at www.kiniksa.com. A replay of...Read more
Vancouver, British Columbia--(Newsfile Corp. - January 6, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in natural psilocybin and MDMA, is pleased to announce the completion of its second shipment of GMP-certified MDMA capsules to Australia. Optimi has also increased its 2025 production forecast to supply...Read more
PRINCETON, N.J. / Jan 03, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the company will present at J.P. Morgan’s 43rd Annual Healthcare Conference on Monday, January 13, 2025. The company’s presentation and participation in a fireside chat will begin at 7:30 a.m. PT/10:30 a.m. ET. The event will be webcast simultaneously at http://investor.bms.com, with materials related to the presentation available at the...Read more
PRINCETON, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride Tablets. ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity®. "We are delighted to build momentum...Read more
PARSIPPANY, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX) today announced that it will present at the 43rd Annual J.P. Morgan Healthcare Conference at 10:30 AM PT (1:30 PM EST) on Wednesday, January 15, 2025. Live audio of the event can be accessed by visiting the “Events” page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the...Read more
Recorded Revenues of $32.6 Million for Q2 Fiscal 2025 Signed Multiple Development Agreements with New Customers Strengthened Balance Sheet with Financing Raising Approximately $24.3 Million, and Favorable Restructuring of Credit Facility with BMO Conference Call Today at 4:30pm ET CHASKA, Minn., Jan. 02, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer...Read more
HUTCHMED continues to deliver on its strategy outlined in November 2022 to create value, prioritize its portfolio and bring innovative medicines to patients globally Divestment proceeds to advance HUTCHMED’s pipeline and core innovative medicines business Focused R&D investment includes HUTCHMED’s proprietary antibody-targeted therapy conjugate platform, with first candidates expected to enter clinical trials in the second...Read more
MELBOURNE, Australia and BRUSSELS, Dec. 31, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) and the Brussels-based Oncidium foundation today announce that results for the NOBLE Registry of TLX599-CDx (99mTc-iPSMA) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Reports. The NOBLE (Nobody Left Behind) Registry (NOBLE) is a global...Read more
PRINCETON, N.J., Dec. 30, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that Nikhil Lalwani, President and Chief Executive Officer; Stephen Carey, Chief Financial Officer; and Dr. Mary Pao, Chief Medical Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 2:15pm PST/5:15pm EST, in San Francisco. The live and archived...Read more
MELBOURNE, Australia and INDIANAPOLIS, Dec. 30, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2. TLX250-CDx is an investigational PET3 drug product for the non-invasive diagnosis...Read more
Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor1 Given over three- to five-minutes, Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to intravenous Opdivo in the Phase 3 CheckMate-67T trial1,3 PRINCETON, N.J. / Dec 27, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo...Read more
HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is the First and Only Facilitated Subcutaneous Immunoglobulin (fSCIG) Approved in Japan for Agammaglobulinemia and Hypogammaglobulinemia Administration of Recombinant Human Hyaluronidase Prior to Immunoglobulin Facilitates Subcutaneous Infusion of Larger Volumes, Potentially Reducing Frequency and Giving Patients More Flexibility Approval Expands Takeda’s...Read more
TEL AVIV, Israel, Dec. 27, 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 an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy. PainReform previously disclosed initial topline data from its...Read more
Northvale, New Jersey--(Newsfile Corp. - December 26, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that the company has launched Elite's generic version of Vyvanse® (Lisdexamfetamine Disylate) with strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules. The product is indicated for the treatment of...Read more
CHICAGO, IL / ACCESSWIRE / December 26, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today the appointment of Professor Dimitrios Trafalis, MD, as Head of...Read more
POETYK PsA-1 and POETYK PsA-2 trials met primary endpoint, with significantly greater proportion of Sotyktu-treated patients achieving ACR20 response compared with placebo at Week 16 Sotyktu was well-tolerated and demonstrated safety consistent with established profile PRINCETON, N.J. / Dec 23, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055),...Read more
TEL AVIV, Israel, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025. The presentation will begin at 8:15 A.M. Pacific Time (11:15 A.M. Eastern Time). To access a live webcast of the presentation, visit Teva’s Investor Relations website at...Read more
WARREN, N.J., Dec. 23, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that CEO Matthew B. Klein, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 11:15 a.m. PST / 2:15 p.m. EST. The presentation will be webcast live on the Events and Presentations page under the Investors section of PTC Therapeutics' website at...Read more
With the addition of these two new assay launches, Zomedica has added 8 new assays in the past 18 months to the rapidly growing TRUFORMA Platform ANN ARBOR, MI / ACCESSWIRE / December 23, 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 two new canine assays...Read more
| Company | Change | Last Trade |
|---|---|---|
| Amgen | 2.68 0.99 | $272.11 |
| ANI Pharmaceuticals | 0.96 1.67 | $58.46 |
| HUTCHMED | 0.88 6.61 | $14.20 |
| Telix Pharmaceuticals | 0.78 4.88 | $16.78 |
| PTC Therapeutics | 0.76 1.76 | $43.84 |
| Alpha Teknova | 0.54 7.17 | $8.07 |
| Cipher Pharmaceuticals | 0.48 3.55 | $14.01 |
| Harrow | 0.39 1.17 | $33.85 |
| OptiNose | 0.33 5.47 | $6.36 |
| Pacira BioSciences | 0.30 1.36 | $22.36 |
| Teva Pharmaceutical | 0.24 1.11 | $21.92 |
| Gilead Sciences | 0.19 0.21 | $91.84 |
| Kiniksa Pharmaceuticals | 0.15 0.82 | $18.54 |
| Veru | 0.13 15.56 | $0.98 |
| Incannex Healthcare | 0.08 4.32 | $1.93 |
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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