NORTH CHICAGO, Ill., Sept. 20, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (ELAHERE®) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant and high-grade serous epithelial ovarian,...Read more
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy, based on the Phase 3 NRG-GY018 trial, also known as KEYNOTE-868 Positive opinion also granted for KEYTRUDA plus chemoradiotherapy for the treatment of FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received...Read more
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older Data demonstrate that the Omicron KP.2-adapted COVID-19 vaccine generates a substantially improved response against multiple circulating Omicron JN.1 sublineages as did the Omicron JN.1-adapted COVID-19 vaccine authorized by the European Commission in July 2024 Doses will be ready to...Read more
OPUVIZ™, a biosimilar referencing Eylea1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency INCHEON, South Korea and CAMBRIDGE, Mass., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human...Read more
MISSISSAUGA, Ontario, Sept. 20, 2024 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) is pleased to announce that its wholly-owned subsidiary, BioSyent Pharma Inc., has entered into an agreement to acquire certain assets enabling it to supply Tibelia®, a tibolone-based hormone replacement therapy drug, to distributors worldwide. Under an Asset Purchase Agreement entered into with the trustees of Novalon SA...Read more
Wegovy® recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function Wegovy® (semaglutide 2.4 mg) is the first obesity medication to receive a positive opinion recommending a label update that reflects reduced symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection...Read more
Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall RARITAN, N.J., Sept. 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed)...Read more
Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members This is the first time that any antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global Phase III study Reducing the spread of infection in the household could help limit transmission within communities and societies,...Read more
Presentations Include New Data from the TAK-861-2001 Phase 2b Trial in Narcolepsy Type 1 Highlighting Impact on Daily Functioning Including Cognition and Sleep Quality Data from Long-Term Extension Study will also be Presented Phase 3 Trial of an Orexin Agonist for Narcolepsy Type 1 Now Enrolling Patients Globally OSAKA, Japan & CAMBRIDGE, Mass. / Sep 19, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) will present additional...Read more
U.S. Food and Drug Administration approves Zenrelia, a once-daily oral JAK inhibitor for dogs with allergic and atopic dermatitis Elanco enters the estimated $1.7 billion global canine dermatology market, highly accretive to existing portfolio In a head-to-head study, Zenrelia was shown to be at least as effective as the market incumbent JAK inhibitor at the primary end point, with an additional endpoint at which Zenrelia got 77% of...Read more
NEW YORK, Sept. 19, 2024 (GLOBE NEWSWIRE) -- LifeMD, Inc.® (Nasdaq: LFMD), a leading provider of virtual primary care services, today announced significant enhancements to its weight management program, underscoring the company’s commitment to expanding patient access and improving the quality and comprehensiveness of care available on its virtual care platform. The investments include a new and improved platform and partnership for...Read more
Installation and Qualification Successfully Completed for Closed-System Filler for Pre-Filled Syringes, Vials, and Cartridges Offers State-of-the-Art Speed and Aseptic Isolation Required for Fill/Finish of Latest Sterile Injectable Pharmaceutical and Biopharmaceutical Products Current Capacity More than Doubles with New Filler CHASKA, Minn., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a...Read more
CHICAGO, IL / ACCESSWIRE / September 19, 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 the development phase for CCDL24, an...Read more
SOLANA BEACH, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, reaffirms its commitment to improving the lives of patients suffering from diabetic gastroparesis in light of the recent decision by the U.S. Food and Drug Administration (FDA) to...Read more
Approval based on results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone Approval marks the first indication for KEYTRUDA in MPM in the U.S. RAHWAY, N.J. / Sep 18, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug...Read more
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids WILMINGTON, Del. / Sep 18, 2024 / Business Wire / AstraZeneca’s FASENRA® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).1 EGPA is a rare, immune-mediated vasculitis that can result in...Read more
Final results from the DAYBREAK long-term extension study showed brain volume loss decreased during Phase 3 studies and was sustained with continuous Zeposia treatment for up to 5 years More than eight years of DAYBREAK data confirm established safety profile of Zeposia, with rates of treatment-emergent adverse events declining or stable over time PRINCETON, N.J. / Sep 18, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more
Trial met primary endpoint, non-inferior immune response for both vaccines when co-administered compared with separate administration Co-administration of the RSV and shingles adjuvanted vaccines was well tolerated, with acceptable reactogenicity and safety profiles These data advance the science of co-administration of recommended adult vaccines PHILADELPHIA / Sep 18, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced...Read more
PALO ALTO, Calif., Sept. 18, 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 the continuing support from Endeavor Distribution LLC (“Endeavor”) on Scilex’s commercial products and the satisfaction of the FSF...Read more
CHICAGO, IL / ACCESSWIRE / September 18, 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 its updated guidance for the 2024-2027 period. Key highlights...Read more
GAITHERSBURG, Md., Sept. 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, announces the Company will present further data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary...Read more
MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, today announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy,...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...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...Read more
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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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)...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...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...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...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...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...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...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/ --...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...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...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...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...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,...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...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...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,...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,...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...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...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)....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...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)...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...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...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...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...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...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...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...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)...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...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...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...Read more
Detailed results were published in The Lancet and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024 INDIANAPOLIS, Sept. 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the QWINT-5 phase 3 trial evaluating once-weekly insulin efsitora alfa (efsitora) compared to once-daily insulin degludec in adults with type 1 diabetes who...Read more
In QWINT-2, efsitora helped adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists achieve an A1C below 7% Detailed results were published in The New England Journal of Medicine and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024 INDIANAPOLIS, Sept. 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results...Read more
Pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous RYBREVANT®, a three-fold reduction from 67.4 percent historically seen with standard IRR management SAN DIEGO, Sept. 10, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related...Read more
CONSTELLA is the first and only Health Canada-approved prescription therapy for functional constipation in this patient population Submission is based on positive Phase 3 study data demonstrating linaclotide (72mcg) resulted in increases in frequency of spontaneous bowel movements (SBM) in children and adolescents aged 6 to 17 years MONTREAL, Sept. 10, 2024 /CNW/ - AbbVie (NYSE: ABBV), today announced that Health Canada has approved...Read more
Gilead and Genesis Will Leverage the GEMS AI Platform to Generate and Jointly Optimize Molecules Against Selected Targets Gilead Receives Exclusive Rights to Develop and Commercialize Products from the Collaboration FOSTER CITY, Calif. & BURLINGAME, Calif. / Sep 10, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic...Read more
Full clinical data will be reported in an oral presentation at the premier global event for advancements in cardiovascular science and medicine on November 18, 2024 Toronto, Ontario--(Newsfile Corp. - September 10, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic...Read more
NEW YORK and MELBOURNE, Australia, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (the “Company” or “Incannex”), a clinical-stage biopharmaceutical company developing life-changing medicines for people with chronic diseases and significant unmet medical needs, today announced it has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, LP (Arena) and its...Read more
TEL AVIV, Israel, Sept. 10, 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 the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 989,300 ordinary shares of the Company originally issued in December...Read more
INDIANAPOLIS, Sept. 9, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the appointment of Lucas Montarce as executive vice president and chief financial officer (CFO) and member of the company's Executive Committee, effective immediately. Since joining Lilly in 2001, Montarce has held a range of finance leadership roles, including serving as group vice president, corporate controller and chief financial...Read more
Full data from the primary analysis of the positive, single-arm Phase 2 PICCOLO trial, evaluating mirvetuximab soravtansine (ELAHERE®), for high folate receptor-alpha (FRα) expressing platinum-sensitive ovarian cancer (PSOC) (mini-oral presentation). Exploratory patient reported outcomes (PROs) from the Phase 2 LUMINOSITY trial, evaluating telisotuzumab vedotin (Teliso-V), a potential first-in-class c-Met directed antibody-drug...Read more
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population Presidential Symposium for NeoCOAST-2 demonstrates potential for datopotamab deruxtecan plus IMFINZI® (durvalumab) and chemotherapy in neoadjuvant early-stage non-small cell lung cancer WILMINGTON, Del. / Sep 09, 2024 / Business...Read more
The Roche Digital Pathology Open Environment brings together a wide array of innovative AI-based pathology tools to help clinicians improve patient care and expand personalised healthcare. Roche is now integrating more than 20 artificial intelligence (AI) algorithms from eight new collaborators into its digital pathology open environment. AI technology helps enhance pathology with high value insights, which can benefit cancer patients...Read more
DeLLphi-303 Study Results Show Potential for IMDELLTRA in Combination with a PD-L1 Inhibitor as First-Line Maintenance Therapy in ES-SCLC DeLLphi-301 Long-Term Follow-up Data Demonstrate Sustained Safety and Efficacy for IMDELLTRA THOUSAND OAKS, Calif., Sept. 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data showcasing IMDELLTRATM (tarlatamab-dlle), a first-in-class delta-like ligand 3...Read more
Data from proof-of-concept, randomized, Phase 2 RELATIVITY-104 trial exploring the combination of nivolumab, relatlimab (1:1) and chemotherapy as first-line treatment for stage IV or recurrent NSCLC; BMS initiating Phase 3 RELATIVITY-1093 trial Ten-year follow-up data from CheckMate -067 showed continued durable, long-term survival benefit of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) in patients with advanced or metastatic...Read more
PALO ALTO, Calif., Sept. 09, 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 Jaisim Shah, Chief Executive Officer and President of Scilex will present at the 26th Annual H.C. Wainwright Global Investment...Read more
Provides Customer with the only hemodialysis concentrates convenience pack in the dialysis marketplace to support its at-home and acute care patient populations WIXOM, Mich. / Sep 09, 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 a product...Read more
MONTREAL, Sept. 09, 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’s President and CEO, Paul Lévesque will be presenting at two investor conferences in September. Members of the Theratechnologies management team will also be available for...Read more
New longer-term data from the MARIPOSA study confirm superior outcomes of chemotherapy-free RYBREVANT® plus LAZCLUZE™ regimen compared to osimertinib monotherapy as first-line therapy Results from an interim analysis featured in late-breaker oral presentation at WCLC SAN DIEGO, Sept. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced longer follow-up data from the landmark Phase 3 MARIPOSA study which...Read more
| Company | Change | Last Trade |
|---|---|---|
| Eli Lilly | 1.69 0.18 | $916.73 |
| Novartis | 0.70 0.60 | $116.68 |
| HUTCHMED | 0.65 3.87 | $17.46 |
| Guardion Health Sciences | 0.38 3.50 | $11.23 |
| Amphastar Pharmaceuticals | 0.37 0.74 | $50.46 |
| Bristol-Myers Squibb | 0.22 0.45 | $49.24 |
| Phibro Animal Health | 0.19 0.85 | $22.60 |
| Evolus | 0.13 0.79 | $16.57 |
| ANI Pharmaceuticals | 0.08 0.13 | $60.46 |
| Procaps | 0.07 3.89 | $1.87 |
| Rockwell Medical | 0.06 1.33 | $4.20 |
| ProPhase Labs | 0.05 1.99 | $2.56 |
| BioSyent | 0.05 0.47 | $10.75 |
| Avadel Pharmaceuticals | 0.04 0.29 | $13.64 |
| PetIQ | 0.03 0.10 | $30.79 |
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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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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