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
Averaging up to 20% of weight loss, adults taking Zepbound had at least 25 fewer breathing interruptions each hour as they slept Up to 50% of adults taking Zepbound no longer had symptoms associated with OSA after one year INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription...Read more
Bagsværd, Denmark, 20 December 2024 – Novo Nordisk today announced headline results from REDEFINE 1, a phase 3 trial in the global REDEFINE programme. REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo, all administered once-weekly. The...Read more
RAHWAY, N.J. / Dec 20, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the closing of the exclusive global license agreement for LM-299, a novel investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd. As previously announced, Merck will develop, manufacture and commercialize LM-299. Merck will record a pre-tax charge relating to the upfront payment of $588...Read more
BRAFTOVI in combination with cetuximab and mFOLFOX6 is the first and only combination regimen with targeted therapy approved for use as early as first-line for patients with metastatic colorectal cancer with a BRAF V600E mutation Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the Phase 3 BREAKWATER trial NEW YORK / Dec 20, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that...Read more
FOSTER CITY, Calif. / Dec 20, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conference: J.P. Morgan Healthcare Conference on Monday, January 13, 2025 beginning at 11:15 a.m. Pacific Time The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation. About Gilead...Read more
MIAMI and BARRANQUILLA, Colombia, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, today announced significant outcomes from its recent Shareholders Meeting and subsequent Board of Directors meeting. These include changes to the Board composition, restructuring of Board committees, and updates to its executive...Read more
LOI Agreement is steppingstone to formal agreement, The Multinational Pharmaceutical company is ranked in the top five contrast agent suppliers in the world, signaling and solidifying Voyageur’s importance in the global contrast agent market Calgary, Alberta, Canada – TheNewswire - December 20, 2024 - Voyageur Pharmaceuticals Ltd. (TSXV:VM) (OTC Pink:VYYRF) ("Voyageur" or the "Company") a vertically integrated...Read more
Trials met efficacy success criteria for non-inferiority of DOR/ISL to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 Safety profiles were generally comparable between DOR/ISL and other therapies in these trials RAHWAY, N.J. / Dec 19, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from two pivotal Phase 3 trials of the...Read more
PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints Prasinezumab continues to be well tolerated and no new safety signals were observed Genentech is further evaluating the data and will work together with health authorities to determine next steps SOUTH SAN FRANCISCO, Calif. / Dec 19, 2024 / Business Wire / Genentech, a member of the Roche...Read more
MELBOURNE, Australia, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has completed the installation of two new cyclotrons at Telix Manufacturing Solutions (TMS) in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 20251. The installation of cyclotrons from GE HealthCare and IBA (Ion Beam Applications...Read more
JERSEY CITY, N.J. / Dec 19, 2024 / Business Wire / Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13th, 2025, at 3:45 p.m. PT. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the...Read more
If approved, vatiquinone would be the first and only authorized therapy for children with FA PTC's fourth approval application submitted to FDA in 2024 WARREN, N.J., Dec. 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the vatiquinone New Drug Application (NDA) for the treatment of children and adults living with Friedreich ataxia (FA) to the U.S. Food and Drug...Read more
Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum’s NIH-Funded NRS-033 Development Program CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and...Read more
MIAMI, FLORIDA / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND...Read more
RAHWAY, N.J. / Dec 18, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, today announced that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. “We continue to leverage science-driven business development to augment and complement our robust...Read more
The agreement is a critical step in ensuring paediatric patients living with NF1 PN have public access to Koselugo, the only approved therapy in Canada for this rare disease MISSISSAUGA, ON, Dec. 18, 2024 /CNW/ - Alexion Pharma Canada Corp., AstraZeneca's Rare Disease group, has entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for Koselugo for the treatment of paediatric...Read more
Biomarker data from CARE study characterizing cenerimod's mechanism of action in systemic lupus erythematosus also published in the Annals of the Rheumatic Diseases PITTSBURGH, Dec. 18, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today announced the publication of Phase 2b CARE study results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE). The...Read more
MONTREAL, Dec. 18, 2024 (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 the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility...Read more
JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal...Read more
China is the fourth major market where Kisunla has received approval Kisunla was first approved in the United States in July 2024, approved in Japan in September 2024 and then in Great Britain in October 2024 INDIANAPOLIS, Dec. 17, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the National Medical Products Administration (NMPA) in China has approved Kisunla™...Read more
This milestone stems from the companies' collaboration to expand access to affordable insulin to one million people living with diabetes in low- to middle-income countries annually by 2030 INDIANAPOLIS and CAIRO, Dec. 17, 2024 /PRNewswire/ -- The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022,...Read more
If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the U.S. in time for the 2025-26 season RAHWAY, N.J. / Dec 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational...Read more
Full-Year 2025 Revenue Guidance(1) Range of $61.0 to $64.0 Billion Full-Year 2025 Adjusted(2) Diluted EPS Guidance Range of $2.80 to $3.00 Expect Full-Year 2025 Adjusted(2) Diluted EPS Operational(3) Growth of 10% to 18% from the Midpoint of 2024 Guidance After Adjusting for 2024 Non-Recurring Items(4) Achieved Goal of $4.0 Billion in Net Cost Savings Through 2024 and Anticipate an Additional $500 Million in Savings in 2025 from...Read more
Gilead and Terray Will Leverage Terray’s tNova Drug Discovery Platform to Identify Small Molecule Therapeutics Against Targets of Interest Gilead Has Exclusive Option to Develop and Commercialize Products from the Collaboration FOSTER CITY, Calif. & LOS ANGELES / Dec 17, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Terray Therapeutics, Inc. announced today that the companies have entered into a...Read more
FOSTER CITY, Calif. / Dec 17, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. The Breakthrough Therapy Designation is...Read more
Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibody Sanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions PARSIPPANY, N.J. and PARIS, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S....Read more
LAKE FOREST, Ill., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced today that Mark Reisenauer has been appointed as an independent director to the Company’s Board of Directors. Mr. Reisenauer will serve as a member of the Compensation Committee. “Mark is a...Read more
Partnership is expected to generate upwards of $10 million in net sales for the Company in 2025, with incremental price increases each subsequent year and an effective term of up to five years WIXOM, Mich. / Dec 17, 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...Read more
Agreement Supports Phase IIb and Future Phase III Trial Development, Addressing Critical Needs in Palliative Care Using Optimi's Natural Psilocybin Extract Vancouver, British Columbia--(Newsfile Corp. - December 17, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP-certified, naturally-derived psilocybin and MDMA, has entered into binding agreements with...Read more
Bagsværd, Denmark, 16 December 2024 – Today, Novo Nordisk announced plans to invest 8.5 billion Danish kroner to establish a completely new production facility in Odense, Denmark. The investment marks the first time in this century that Novo Nordisk breaks ground in Denmark by establishing a new production site. The new site will feature a state-of-the-art finished production facility and warehouse spanning over 40,000 m2....Read more
RAHWAY, N.J. / Dec 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. Vibostolimab is being evaluated as an investigational fixed-dose combination with pembrolizumab (KEYTRUDA®) in the KeyVibe program. Favezelimab is being evaluated as an...Read more
This approval marks the fourth non-small cell lung cancer (NSCLC) indication and the first indication in earlier stages of NSCLC for KEYTRUDA in China RAHWAY, N.J. / Dec 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with...Read more
EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-AD™ treatment success at Week 8 versus 18% of patients on vehicle. POWERFUL SKIN CLEARANCE: The majority of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week open-label ADORING long-term extension (LTE) study and remained treatment-free (remittive effect) for an average of ~80...Read more
GAITHERSBURG, Md., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services has awarded a $50 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of CYFENDUS® (Anthrax Vaccine...Read more
MONTREAL, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Knight's New Drug Submission (NDS) for Qelbree® (viloxazine extended-release capsules) has been accepted for review by Health Canada. Qelbree® is a novel nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Knight entered into an...Read more
Transaction Expected to Close in the Coming Days SOMERSET, N.J. & COPENHAGEN, Denmark / Dec 14, 2024 / Business Wire / Catalent, Inc. (“Catalent,” NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings A/S (“Novo Holdings”), a global life sciences investment firm, today announced that the companies have fulfilled all regulatory closing conditions for their pending...Read more
The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without prior biologic failure and was the basis for the positive opinion VIVID-1 was the first pivotal Crohn's disease trial to show benefits in hard-to-treat symptom of bowel urgency using a patient-centric scale Omvoh will be the first treatment for Crohn's disease with results demonstrating improvements of histologic measures of...Read more
Proposed acquisition adds Nimble's lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for psoriasis, and a pipeline of other novel oral peptide assets across autoimmune diseases where significant unmet needs remain Acquisition also allows AbbVie to utilize Nimble's proprietary peptide synthesis platform to enable the discovery and optimization of oral peptide therapeutics NORTH CHICAGO, Ill. and...Read more
If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor available for these patients in the European Union Positive opinion granted based on data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial RAHWAY, N.J. / Dec 13, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines...Read more
Recommendation Based on the RESPONSE Study Which Demonstrated ALP Normalization in 25% of Participants at 12 Months and Statistically Significant Reduction of Pruritus Versus Placebo If Approved by the European Commission, Seladelpar Would Provide an Important Treatment Option for People Living with the Rare Liver Disease in the EU FOSTER CITY, Calif. / Dec 13, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today...Read more
The Walgreens Patient Advisory Board will collaborate with the Walgreens Clinical Trials team to provide insights aimed at increasing representation in clinical trials. DEERFIELD, Ill. / Dec 13, 2024 / Business Wire / With a history of more than 120 years serving communities across the country, Walgreens prides itself in being a trusted retail pharmacy partner for more than 9 million patients and customers it serves each day. Walgreens...Read more
PALO ALTO, Calif., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing the treatment for neurodegenerative and cardiometabolic disease, and non-opioid pain management products for the treatment of acute and chronic pain, today announced the closing of its previously announced registered direct...Read more
LAKE FOREST, Ill., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced yesterday results of a clinical trial investigating the utility of Rolvedon® (eflapegrastim-xnst) injection when dosed the same day of chemotherapy for patients with early stage breast cancer...Read more
Bagsværd, Denmark, 12 December 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events,...Read more
IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy NEW YORK / Dec 12, 2024 / Business Wire / Pfizer Inc. (NYSE:PFE) and Alliance Foundation Trials, LLC (AFT) today announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE® (palbociclib) to current standard-of-care first-line...Read more
FOSTER CITY, Calif. / Dec 12, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Dietmar Berger, MD, PhD, will join the company on January 2, 2025, as Chief Medical Officer and will become a member of Gilead’s senior leadership team. Dr. Berger succeeds Merdad Parsey, MD, PhD. Dr. Berger is a board-certified internist, hematologist and oncologist who brings more than 25 years of extensive experience in...Read more
Six Late-Stage Programs with Peak Revenue Potential of $10B - $20B1 Poised to Deliver Sustainable Growth Expected Phase 3 Data Readouts in 2025 for Oveporexton (TAK-861), Zasocitinib (TAK-279) and Rusfertide (TAK-121) Regulatory Filings for Oveporexton (Narcolepsy Type 1), Zasocitinib (Psoriasis) and Rusfertide (Polycythemia Vera) on Track for Fiscal Years 2025 - 2026 Five Additional Filings Anticipated in Fiscal Years 2027 - 2029...Read more
US$10 million milestone payment to HUTCHMED follows first national reimbursement in Europe Follows June 2024 European approval of FRUZAQLA® (fruquintinib), the first novel oral targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 12, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today...Read more
MONTREAL, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., received regulatory approval from COFEPRIS for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have...Read more
PALO ALTO, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing the treatment for neurodegenerative and cardiometabolic disease, and non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has entered into a definitive agreement with certain...Read more
LAKE FOREST, Ill., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced today the creation of a new Transformation Office and the appointment of Paul Schwichtenberg as Chief Transformation Officer (CTO). Mr. Schwichtenberg currently serves as the company’s Chief...Read more
As monotherapy, imlunestrant significantly reduced the risk of progression or death by 38% compared to standard endocrine therapy (ET) in patients with ESR1 mutations As combination therapy, imlunestrant plus Verzenio significantly reduced the risk of progression or death by 43%, compared to imlunestrant alone, in all patients, regardless of ESR1 mutation status These data were published simultaneously in the New...Read more
Acquisition adds potential best-in-class disease-modifying therapy for Alzheimer's disease, ALIA-1758, and novel blood-brain barrier (BBB)-crossing technology to strengthen neuroscience pipeline and R&D capabilities NORTH CHICAGO, Ill., Dec. 11, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that it has completed its acquisition of Aliada Therapeutics. With the completion of the acquisition, Aliada is now a part of...Read more
87.5% of patients treated with LYNPARZA were alive at six years vs. 83.2% in the comparator arm First and only PARP inhibitor to improve survival in early breast cancer WILMINGTON, Del. / Dec 11, 2024 / Business Wire / Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA® (olaparib) demonstrated sustained, clinically meaningful improvements...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or...Read more
Currently enrolling randomized, double-blind, placebo-controlled, dose-finding, Phase 2 clinical trial to evaluate the safety and efficacy of KDS2010 in patients with Alzheimer’s disease with mild cognitive impairment and mild dementia is currently recruiting in South Korea in 114 patients and U.S. cohort will be added in 2025. KDS2010 (Tisolagiline) is a new reversible selective monoamine oxidase B (MAO-B) inhibitor being studied for...Read more
The ongoing obesity Phase 2 trial is a randomized, double-blind, placebo-controlled, dose finding, clinical trial to evaluate the safety and efficacy of KDS2010 in approximately 75 overweight or obese patients currently enrolling in South Korea with a cohort in U.S. to be added in 2025. KDS2010 has shown promising preclinical results with a novel mechanism of blocking MAO-B-dependent aberrant GABA (gamma-aminobutyric acid) production...Read more
NEWARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL), today reported its financial results for the first quarter of fiscal year 2025 ended October 31, 2024. “We anticipate proceeding to a shareholder vote on our pending merger agreement with Cyclo Therapeutics, Inc. (Nasdaq: CYTH) in the first calendar quarter of 2025 and closing promptly post shareholder approvals. Upon closing of the merger, the Company...Read more
Novo Nordisk and Evotec select three projects from Boston University, Harvard University in collaboration with Mass General Brigham, and Joslin Diabetes Center to be developed within LAB eN² focusing on cardiometabolic diseases LAB eN² is also expanding, adding Boston Children's Hospital, Boston University, Johns Hopkins University, Joslin Diabetes Center, and the Icahn School of Medicine at Mount Sinai as new participating...Read more
MONTREAL, Dec. 10, 2024 (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 the United States Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company’s recently submitted supplemental...Read more
Collaboration leverages NeuroBiogen’s research and development of novel oral tablet KDS2010 and Scilex’s commercial and development expertise in central nervous system (CNS) and primary care diseases. Novel oral tablet KDS2010, a recently synthesized potent, selective, and reversible MAO-B inhibitor will be the collaboration’s lead product candidate, targeting the fast growing $150 billion weight loss and Alzheimer’s disease...Read more
The joint venture, Scilex Bio (“Scilex Bio JV”), will have global development and commercialization rights for a Phase 2 clinical stage, potential best-in-class novel oral tablet, KDS2010, for the treatment of obesity and neurodegenerative diseases including Alzheimer’s disease. KDS2010 has shown promising preclinical results with a novel mechanism (controls GABA levels in astrocytes) that acts reversibly and selectively inhibits MAO-B...Read more
Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, proudly announces the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results confirm no adverse...Read more
New York, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Univest Securities, LLC (“Univest”), a member of FINRA and SIPC, and a full-service investment bank and securities broker-dealer firm based in New York, today announced the closing of registered direct offering (the “Offering”) of its client Universe Pharmaceuticals INC (NASDAQ: UPC) (the “Company”), a pharmaceutical producer and distributor in China. Under the terms of the securities...Read more
COMMACK, NY and TAMPA, FL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- SCIENTURE, LLC (“the “Company”), a wholly owned subsidiary of SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), focused on developing and commercializing novel branded, specialty pharma products, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent, No. 12,156,869 (the ‘869 patent), further strengthening the intellectual property position and coverage...Read more
Results from BRUIN CLL-321 show Lilly's pirtobrutinib reduced the risk of disease progression or death by 46% compared to idelalisib plus rituximab or bendamustine plus rituximab Pirtobrutinib prolonged the time to next treatment or death by a median of 23.9 months compared to 10.9 months in the control arm BRUIN CLL-321 is the first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK...Read more
89 percent of patients evaluable for MRD assessment were MRD negative, with the majority reaching MRD negativity in less than 2 months Results add to the overall survival (OS) benefits recently presented, as the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma SAN DIEGO, Dec. 9, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today new results from the...Read more
Abstracts presented at ASH 2024 provide insight into the patient experience given the unpredictable nature of wAIHA, a rare autoantibody disease, and the uncertainty of current treatment approaches used to manage the condition There are no FDA-approved therapies indicated for wAIHA, and patients living with this condition need targeted treatment options with a proven safety and efficacy profile Johnson & Johnson is evaluating...Read more
| Company | Change | Last Trade |
|---|---|---|
| Zoetis | 2.59 1.59 | $165.90 |
| Ipsen | 1.76 6.23 | $30.00 |
| Biogen | 1.06 0.70 | $153.27 |
| Sanofi | 1.04 2.16 | $49.19 |
| AbbVie | 0.90 0.50 | $180.10 |
| HUTCHMED | 0.82 5.47 | $15.81 |
| Telix Pharmaceuticals | 0.68 4.55 | $15.61 |
| AstraZeneca | 0.59 0.89 | $66.84 |
| Merck | 0.58 0.59 | $99.72 |
| GSK | 0.49 1.46 | $33.96 |
| Embecta | 0.42 2.05 | $20.93 |
| China Jo-Jo Drugstores | 0.40 21.98 | $2.22 |
| Alpha Teknova | 0.35 4.02 | $9.06 |
| Roche | 0.34 0.97 | $35.56 |
| Pfizer | 0.30 1.13 | $26.89 |
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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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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