DUBLIN, Sept. 17, 2024 /PRNewswire/ -- Perrigo Company plc ("Perrigo" or the "Company") (NYSE: PRGO) today announced the closing of a registered public offering by Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), of $715 million aggregate principal amount of the Issuer's 6.125% Senior Notes due 2032 (the "USD Notes") and €350 million aggregate principal amount of the Issuer's 5.375% Senior Notes due... Read more
Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2
Kisqali® (ribociclib) significantly reduced the risk of recurrence by 25% vs. endocrine therapy (ET) alone; consistent benefit and a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial, including patients with node-negative disease3-6
Late-breaking... Read more
BOULDER, CO / ACCESSWIRE / September 17, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for... Read more
Daiichi Sankyo and Merck’s patritumab deruxtecan demonstrates a statistically significant progression-free survival improvement in this EGFR-mutated non-small cell lung cancer population with high unmet need following prior EGFR TKI treatment
Discussions with global regulatory authorities to be initiated BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 17, 2024 / Business Wire / The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally... Read more
GAITHERSBURG, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma.... Read more
Strengthens Rare Disease segment as largest driver of future growth, adding approximately $105 million in 2024 revenue on a pro forma basis
Adds two durable commercial assets ILUVIEN® and YUTIQ® with significant growth potential, expanding ANI’s foothold in strategic therapeutic area of ophthalmology
Anticipated to drive high single-digit to low double-digit accretion in adjusted non-GAAP EPS in 2025 and to be substantially accretive thereafter
New capital structure... Read more
CHICAGO, IL / ACCESSWIRE / September 16, 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 that it has entered into an extension of its existing exclusive distribution agreement with Virax... Read more
Company planning for every eligible baby in the US to have access to BEYFORTUS
New BEYFORTUS filling line approved by the U.S. Food and Drug Administration (FDA) to expand manufacturing capacity and help meet demand
2 out of 3 babies get respiratory syncytial virus (RSV) disease1 BRIDGEWATER, N.J., Sept. 16, 2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers... Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - September 16, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has been informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has extended the review period for the New Drug Application for treosulfan by three months. The FDA has set a new PDUFA target action date of January 30, 2025.
The FDA notified medac that the Agency requires additional... Read more
Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, Del. / Sep 16, 2024 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy... Read more
TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate... Read more
Vatroslav Mateljic's innovative approach and commitment to transforming the lives of patients will strengthen Takeda's leadership position in the Canadian biopharmaceutical sector TORONTO, Sept. 16, 2024 /CNW/ - Takeda Canada Inc. ("Takeda Canada") is pleased to announce the appointment of Vatroslav (Vatro) Mateljic as its new General Manager to lead the Canadian operations of Japan's largest pharmaceutical company. Mr. Mateljic has held a number of... Read more
Late-breaking results selected for presentation during a Presidential Symposium session and an official Press Briefing at the European Society for Medical Oncology Congress 2024 and simultaneous publication in the New England Journal of Medicine
KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival as pre-operative (neoadjuvant) treatment with chemotherapy and then as a single... Read more
First immunotherapy regimen before and after surgery to demonstrate statistically significant and clinically meaningful overall survival improvement in this setting WILMINGTON, Del. / Sep 15, 2024 / Business Wire / Positive results from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS)... Read more
These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial; data selected for official ESMO press conference
At ten years, more than 40% (43%) of patients treated with Opdivo plus Yervoy were alive; a decade ago, this patient population faced a survival rate of around 25% after only one year
Data to be presented today as a mini oral and simultaneously published in The New England Journal of Medicine PRINCETON, N.J. / Sep... Read more
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab RAHWAY, N.J. / Sep 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with... Read more
Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive BARCELONA, Spain, Sept. 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with... Read more
Study met primary endpoint of change from baseline in body weight for ponsegromab compared to placebo across all ponsegromab doses tested, reaching 5.6% mean increase at the highest dose evaluated at 12 weeks; ponsegromab was generally considered safe and well-tolerated at all dose levelsi
At the highest dose evaluated, improvements were seen from baseline in appetite and cachexia symptoms, physical activity, and muscle massi
Based on positive Phase 2 results, regist... Read more
In the Phase 3 LEAP-012 trial, KEYTRUDA plus LENVIMA in combination with TACE reduced the risk of disease progression or death by 34% compared to TACE alone
Late-breaking first interim analysis results are being presented during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 RAHWAY, N.J. & NUTLEY, N.J. / Sep 14, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today... Read more
KEYNOTE-A18 is the first Phase 3 study of an immunotherapy in combination with CRT to demonstrate a statistically significant and clinically meaningful improvement in overall survival versus CRT alone in these patients
Results were selected for the official press briefing and presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 and published simultaneously in The Lancet RAHWAY, N.J. / Sep 14, 2024 / Business... Read more
KEYTRUDA is the first anti-PD-1/L1 therapy in combination with trastuzumab and chemotherapy to demonstrate a statistically significant improvement in OS in this patient population
Results from the final analysis of KEYNOTE-811 are being presented during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2024 and published simultaneously in the New England Journal of Medicine
In the U.S., KEYTRUDA, in combination with trastuzumab and... Read more
Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease
New results show potential of RYBREVANT® beyond lung cancer BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI) demonstrated promising rapid and durable... Read more
Post-progression outcomes showed significant and sustained improvement for RYBREVANT® plus standard of care versus chemotherapy alone BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with previously treated non-small cell... Read more
BRAFTOVI + MEKTOVI continued to show substantial antitumor activity after a minimum follow up of approximately three years, corresponding to the longest duration of response and progression-free survival in treatment-naïve patients compared to historical outcomes
Results support BRAFTOVI + MEKTOVI as a standard of care option for this population NEW YORK / Sep 14, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the... Read more
EBGLYSS provides a new first-line biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topicals
Patients treated with EBGLYSS experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks
EBGLYSS delivers long-lasting efficacy for patients through one year of treatment with a monthly maintenance dose INDIANAPOLIS, Sept. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)... Read more
Ocrevus Zunovo™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor's office
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Ocrevus Zunovo™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs SOUTH SAN FRANCISCO, Calif. / Sep 13, 2024 / Business Wire / Genentech,... Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU achieved 61.6% progression-free survival rate at one year in patients with active or stable brain metastases in DESTINY-Breast12
Largest prospective trial of ENHERTU in this patient population WILMINGTON, Del. / Sep 13, 2024 / Business Wire / Results from the DESTINY-Breast12 Phase IIIb/IV trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated substantial overall and intracranial clinical activity in a large... Read more
Results Illustrate Depth and Diversity of Amgen's Targeted Therapies Across Tumor Types THOUSAND OAKS, Calif., Sept. 13, 2024 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the presentation of new data across its broad oncology pipeline and portfolio at the European Society for Medical Oncology (ESMO) Congress 2024, taking place Sept. 13-17 in Barcelona. The abstracts showcase data from Amgen-sponsored and investigator-sponsored studies for colorectal,... Read more
PRINCETON, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, 6.25 mg/15 mg per 5 mL.
"The launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution just prior to the onset of cough and cold season is especially timely. With our 14th new product launch this year, we continue to drive... Read more
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq
New subcutaneous (SC) option reduces treatment time to approximately 7 minutes, compared with 30-60 minutes for IV infusion SOUTH SAN FRANCISCO, Calif. / Sep 12, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug... Read more
PALO ALTO, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®). Scilex has satisfied all the drug distributor... Read more
99.9% of Participants Did Not Acquire HIV Infection in the Lenacapavir Group, with 2 Incident Cases Among 2,180 Participants
PURPOSE 2 Trial Results for Cisgender Men and Gender-Diverse People Add to the Body of Evidence for the Investigational Use of Lenacapavir for HIV Prevention
Gilead Stopped the Blinded Phase of the Trial at Interim Analysis and Will Offer Open-Label Lenacapavir to All Participants FOSTER CITY, Calif. / Sep 12, 2024 / Business... Read more
GAITHERSBURG, Md., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a contract modification executing an option period by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at $41.9 million, for drug substance engineering and scale-up... Read more
LAVAL, Quebec / Sep 12, 2024 / Business Wire / Crescita Therapeutics Inc. (TSX: CTX and OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company, today announced that it will be presenting and participating in 1x1 meetings at the Planet MicroCap Showcase: VANCOUVER 2024 in association with Small Cap Discoveries on Thursday, September 26, 2024 at 1:00 PM (Local Time – PST). Serge Verreault, Chief Executive... Read more
KIRKLAND, QC, Sept. 12, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a validated test, that have progressed... Read more
Company ups manufacturing investment in Limerick by $1 billion; unveils new $800 million Kinsale facility
New investment will enhance global medicine production, benefiting millions of patients worldwide INDIANAPOLIS, Sept. 12, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced a $1 billion expansion of its Limerick, Ireland, manufacturing site to increase production of biologic active ingredients, including those for its recently approved... Read more
CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- The Biogen Inc. (Nasdaq: BIIB) Board of Directors (the “Board”) today announced the appointments of two new independent directors, Lloyd B. Minor, M.D., effective October 1, 2024, and Sir Menelas (Mene) Pangalos, Ph.D., effective January 1, 2025. Dr. Minor is currently the Dean of the Stanford University School of Medicine and Vice President for Medical Affairs at Stanford University, and Prof Sir Pangalos was most... Read more
Q3-24 revenues of $12.6 million, down 11% from Q3-23, excluding XIIDRA, growth trend from continued business remains healthy at +9%, Q3-24 vs Q3-23
Q3-24 adjusted EBITDA loss of $1.5 million compared to $2.5 million for Q3-23, down 40% MONTREAL, Sept. 12, 2024 /CNW/ - Valeo Pharma Inc. (TSX: VPH) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, today reported its financial... Read more
The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5
TREMFYA® is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis HORSHAM, Pa., Sept. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food... Read more
TEL AVIV, Israel, Sept. 11, 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 Bank of America 2024 Global Healthcare Conference on Thursday, September 19, 2024. The presentation will begin at 8.15 A.M. British summer time (3.15 A.M. Eastern Time).
To access a live webcast of the presentation, visit Teva’s Investor Relations website at https://ir.tevap... Read more
Company is currently conducting larger scale comprehension test to confirm results in compliance with FDA discussions NEW YORK, NY / ACCESSWIRE / September 11, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over-the-counter ("OTC") drug development programs, today announced results of an initial study to determine consumer comprehension of the messaging in its App Technology... Read more
BOULDER, CO / ACCESSWIRE / September 11, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, in partnership with EMC Pharma, LLC, today announced they have entered into a co-marketing agreement to launch... Read more
BOTOX® Cosmetic is the first neurotoxin approved in China for the treatment of masseter muscle prominence (MMP), the largest global market for MMP.
Approval supported by well-established safety profile and robust clinical trials demonstrating BOTOX® Cosmetic is effective in reducing the prominence of the masseter muscle.
Allergan Aesthetics intends to develop onabotulinumtoxinA treatment for MMP in additional global markets and expand the use of BOTOX® Cosmetic in... Read more
MIAMI, FL, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, will present a corporate update with a focus on the progress of Veru’s Phase 2b clinical... Read more
TEL AVIV, Israel, Sept. 11, 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 positive findings regarding the compatibility of sutures in human clinical trials of its lead product, PRF-110. PRF-110 is designed to provide extended, non-opiate, post-surgical pain relief.
The Company conducted comprehensive in vitro... Read more
MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, announced today that it has selected neuropathic pain as the initial and primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a request for a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug... Read more
LAVAL, QC / ACCESSWIRE / September 11, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced the approval by Health Canada of PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older.1
CABTREO is the first and only triple-combination topical treatment for acne approved... Read more
More than 10 oral and mini-oral presentations span Pfizer’s extensive Oncology portfolio of approved and investigational therapies
Two late-breaking presentations include longer-term results from BRAFTOVI® + MEKTOVI® PHAROS study in BRAF V600E-mutant metastatic NSCLC and new Phase 2 ponsegromab data in cancer cachexia
Encouraging early results for PD-L1 vedotin ADC, disitamab vedotin and the novel combination of CDK4 + CDK2 inhibitors highlight rapidly advancing... Read more
RAHWAY, N.J. / Sep 11, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Joseph Romanelli, president, Human Health International, is scheduled to participate in a fireside chat at the Bank of America 2024 Global Healthcare Conference on Wednesday, Sept. 18, 2024, at 6:40 a.m. EDT / 11:40 a.m. BST.
Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast... Read more
RAHWAY, N.J. / Sep 11, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years. The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen... Read more
