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 intervention.
The trial achieved its primary... 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 unresectable or metastatic hormone... 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 determined by an FDA-approved test,... 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 previously untreated mantle cell lymphoma... 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 significant milestone follows... 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 pivotal clinical trial, marking a... 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 chemotherapy) for the treatment... 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: LLY) announced today that the U.S.... 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 Calmette-Guérin (BCG)-unresponsive... 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 BC Cancer, a part of PHSA that... 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 prior guidance and demonstrates... 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 expected 2024 revenue INDIANAPOLIS,... 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 of innovative therapies for use... 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 with diseases,... 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 NEWSWIRE) -- Emergent BioSolutions... 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 AI and proteomics technology... 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 National Medical Products... 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. Food and Drug Administration (FDA)... 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 EST / 9:15 am AEDT, 16 January).... 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 & Johnson’s robust lineup... 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 the Administration for Strategic... 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 Biolabs Group Limited (NASDAQ: VRAX)... 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 trispecific antibody that targets... 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) and Scorpion Therapeutics, Inc.... 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 in their baseline opioid use (+3.1%;... 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 updates to the ABBV-RGX-314 clinical... 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, positioning the Company at the... 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 announce that its natural psilocybin extract... 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 products SmoothLD®, SmoothHD®,... 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 immune-modulating assets designed... 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 the treatment of adult patients... 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, today announced that Bristol Myers... 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 period from September 16, 2024... 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 quarter (Q4 2023: US$97 million or AU$148... 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, 2025 / Business Wire / GSK plc... 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 non-Hodgkin lymphoma (NHL) cases, which... 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) -- Teva Pharmaceuticals International... 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 to enhance existing innovation... 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 Dermatology FOSTER CITY, Calif. &... 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 for over three decades NEW YORK... 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 Ltd. (NYSE: and TASE: TEVA) announced... 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 addition, the company reported preliminary... 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 Cencora shares
Adjusted earnings... 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. While the Company is aware... 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 designation from the U.S Food and... 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 day.
About AbbVie
AbbVie's mission... 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 enhance diagnostic accuracy, consistency,... 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 midpoint
Management to host a conference... 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 webcast, as with other selected presentations... 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, 2025 (GLOBE NEWSWIRE) -- Biofrontera... Read more
