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 https://ir.tevapharm.com/Events... 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 https://ir.ptcbio.com/events-presentations and will be archived for 30 days... 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), the pivotal Phase 3 trials evaluating... Read more
Approval based on results of the Phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful reduction in the risk of disease progression or death compared to investigator’s choice of chemotherapy
With this approval, Opdivo plus Yervoy is the first dual checkpoint inhibitor treatment approved in the European Union for the first-line treatment of MSI-H/dMMR mCRC PRINCETON,... 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 for the TRUFORMA In-Clinic Biosensor... 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 the U.S. Food and Drug Administration... 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 trial included 3,417 randomised... 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 leadership team.
The Shareholders... 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 medicine for adults with moder... 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 Sciences
Gilead Sciences, Inc. is a... 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 radiology drug company, that is... 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 million, or approximately $0.18 per... 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 submission marks a major step in advancing... 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 Administration (FDA).
"We are excited to have... 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 presentation by clicking here.
About... 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 S.A.), along with proprietary solid... 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 manufacturing organization (“CDMO”),... 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 investigational, once-daily, oral,... 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 Group (SIX: RO, ROG; OTCQX: RHHBY) announced... 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 pipeline,” said Dr. Dean Y.... 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 where EGRIFTA SV® is produced.... 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 patients aged two years and above with... 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 infections.
“We... 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 results, published in Lancet Rheumatologyi,... 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 Ongoing Cost Realignment Program
First... 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™ (donanemab-azbt, 350 mg/20 mL every four... 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 based on results from the global... 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 Psyence Biomedical Ltd. (Nasdaq: PBM)... 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. affiliate of Teva Pharmaceutical... 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 strategic collaboration to discover... 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 prophylactic long-acting monoclonal... 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 worldwide, today announced that the... 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, the collaboration aims to deliver... 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 highly accomplished commercial... 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 investigational fixed-dose combination... 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 agreement in December 2023 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. Designed to be modular and flexible,... 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 Adsorbed, Adjuvanted).
Deliveries... 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 consecutive days.
RAPID ITCH RELIEF:... 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 platinum-containing chemotherapy as neoadjuvant... 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 transaction. The companies... 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 offering of an aggregate of 26,355,347... 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 MADISON, Wis., Dec. 13, 2024 /PRNewswire/... 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 is amplifying its commitment to... 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 inflammation included in its label, if... 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 (ESBC). The results were presented... 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 Agency’s Committee for Medicinal Products... 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 announced that the Committee for Medicinal... 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 announces that it will receive... 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 Including First Indication Submissions... Read more
