NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services, today launched a partnership with ASCEND Therapeutics US, LLC, a subsidiary of Besins Healthcare and a specialty pharmaceutical company concentrating on women's health, to provide integrated telehealth services to improve access to EstroGel® 0.06% (estradiol gel). LifeMD’s telehealth services are now accessible on...Read more
Combined company will operate as Cyclo Therapeutics with primary focus on advancing Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1) At closing combined Company will have approximately $13.7 million cash on hand to fund operations into 2H 2024 Upcoming milestones include completion of enrollment in pivotal Phase 3 clinical trial in NPC1, reporting top line data and preparation for NDA submission GAINESVILLE,...Read more
Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival in these patients RAHWAY, N.J. / Sep 20, 2023 / 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 for priority review a new supplemental Biologics License...Read more
OSAKA, Japan & CAMBRIDGE, Mass. / Sep 20, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus.1 The...Read more
CHICAGO, IL / ACCESSWIRE / September 20, 2023 / 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 nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it has entered into a strategic collaboration with C.A.PAPAELLINAS...Read more
MONTREAL, Sept. 20, 2023 (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 Mr. Paul Lévesque, President and Chief Executive Officer, will participate in a panel presentation at the Cantor Fitzgerald Global Healthcare Conference 2023 being held September 26-28...Read more
Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies If approved, WELIREG would provide a new, novel mechanism of action for patients with advanced RCC in need of new options RAHWAY, N.J. / Sep 19, 2023 /...Read more
NEW YORK / Sep 19, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. LITFULO is also the...Read more
This Positive Opinion Reinforces Veklury’s Strong Safety Profile FOSTER CITY, Calif. / Sep 19, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury® (remdesivir) to treat people with COVID-19 with mild to severe hepatic impairment. The European Commission (EC)...Read more
Recruitment Accelerating and Full Patient Enrollment Anticipated to be Completed During Q3 2024, up to Six Months Ahead of Schedule Multi-Center, International, Double-blind, Placebo-controlled Trial Randomizing 100 Patients Toronto, Ontario--(Newsfile Corp. - September 19, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research...Read more
WOODCLIFF LAKE, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will participate in a panel presentation at the Cantor Global Healthcare Conference 2023 as follows: Date: Wednesday, September 27, 2023 Time: 2.25PM ET Webcast: Click here To schedule...Read more
HOLLISTER, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), a leading producer of critical reagents for the research, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, today announced the closing of its previously announced registered direct offering for the issuance and sale of an aggregate of 1,086,485 of its shares of common stock at a purchase price of...Read more
Investigational VVD-130037 is highly specific, potent Kelch-like ECH Associated Protein 1 (KEAP1) activator developed for treatment of advanced solid tumors Major milestone for Vividion’s chemoproteomics innovative technology platform First-in-class clinical candidate to target cancers with activation of KEAP1-NRF2 pathway Berlin, Germany, San Diego, CA, USA, September 18, 2023 – Vividion Therapeutics, Inc. (Vividion), announced...Read more
All primary and secondary endpoints were met for second Phase 3 study (M21-310) and results were consistent with findings from first Phase 3 study (M21-309). Results support onabotulinumtoxinA as a potential treatment option for moderate to severe platysma prominence. Data will be included as part of an upcoming U.S. Food and Drug Administration regulatory submission expected near the end of the year. If approved,...Read more
Yescarta Achieved a Complete Metabolic Response (CMR) of 71% at 3 Months Versus 12% Expected with Historical Standard of Care Controls Results Published in Nature Medicine SANTA MONICA, Calif. / Sep 18, 2023 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced results from the Phase 2 ALYCANTE study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of its chimeric antigen receptor...Read more
Concentrated form of Safety Shot may be effective as a rapid treatment for alcohol poising which causes 2,200 deaths each year from an estimated 20,000 cases annually in the U.S. Acute alcohol consumption leads to 52 million hospital emergency department visits annually JUPITER, FL, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Safety Shot, Inc. (Nasdaq: SHOT) today announced it intends to develop its Safety Shot functional beverage platform...Read more
BAUDETTE, Minn., Sept. 18, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will present at the Cantor Global Healthcare Conference 2023 in New York City as follows: Date: Tuesday, September 26, 2023 Time: 11:40am ET Webcast: Click here To...Read more
HOLLISTER, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), a leading producer of critical reagents for the research, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of up to 1,086,485 of its shares of common stock in a registered direct offering at a...Read more
SOMERSET, N.J. / Sep 18, 2023 / Business Wire / Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced that David McErlane has been named Group President of Catalent’s Biologics segment, effective September 25, 2023. Mr. McErlane joins Catalent from Lonza, where he served as senior vice president and business unit head for Lonza’s Bioscience business....Read more
VANCOUVER, British Columbia / Sep 18, 2023 / Business Wire / Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical Company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases announced today that Mathew Lee will join the organization as Chief Financial Officer, effective September 18, 2023. “Appointing Mathew is part of our overall long-term...Read more
Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, and over 30% will discontinue treatment due to anemia1,2,3 Ojjaara addresses key manifestations of myelofibrosis, namely anemia, constitutional symptoms and splenomegaly LONDON / Sep 15, 2023 / Business Wire / GSK plc...Read more
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial RAHWAY, N.J. / Sep 15, 2023 / 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 for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant...Read more
Conference call to be held at 8:45 am EDT SOUTH PLAINFIELD, N.J., Sept. 15, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna™ (ataluren) for the treatment of...Read more
Customers can now schedule appointments at Riteaid.com and Bartelldrugs.com PHILADELPHIA / Sep 15, 2023 / Business Wire / Following FDA authorization and CDC recommendation, Rite Aid (NYSE: RAD) today announced that scheduling is now available for eligible customers seeking the updated COVID-19 (2023-2024) vaccines at its locations and at Bartell Drugs locations in the Pacific Northwest. Appointments are available beginning on Friday,...Read more
JADA Rapidly and Effectively Controlled Bleeding Due to PPH,1 Reinforcing Pivotal Study Results1 PPH is a Significant Cause of Maternal Morbidities in the U.S.2,3,4,5 New Exploratory Post-Hoc Analysis Examined the Relationship Between Reported Severe Maternal Morbidity (SMM) Outcomes and Cumulative Blood Loss Prior to JADA Insertion1 JERSEY CITY, N.J. / Sep 14, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company...Read more
VANCOUVER, British Columbia, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian psychedelics drug research and formulation company, is pleased to see the positive and encouraging outcomes from the MAPS Phase 3 MDMA-Assisted Therapy (MDMA-AT) Clinical Trial published today on Nature Medicine. The Company considers the results to be a substantial step forward in the treatment of...Read more
Scilex Holding Company announced completion of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute LBP. The Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study evaluated the safety and efficacy of SP-103 (lidocaine topical system 5.4%) in subjects with moderate to severe acute LBP. The trial enrolled 75 patients at 10 sites across the U.S. SP-103 received Fast Track...Read more
ANN ARBOR, MI / ACCESSWIRE / September 14, 2023 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering diagnostic and therapeutic products for companion animals, today announced the commercial launch of its newest assay - endogenous ACTH (eACTH) for equine plasma - for the TRUFORMA In-Clinic Biosensor Testing Platform. Larry Heaton, Zomedica's Chief Executive Officer, commented, "For the...Read more
Voyageur Pharmaceuticals Ltd. (TSXV:VM) (USA: VYYRF) ("Voyageur" or the "Corporation"), a provider of innovative medical imaging solutions, is pleased to announce the completion of formulation and the engineering for production processing for the dry powdered barium contrast media product HDXBaTM. HDXBaTM is an oral contrast agent for suspension used as an oral drug for use in double-contrast radiographic examinations of the esophagus,...Read more
SOLANA BEACH, Calif., Sept. 14, 2023 (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, announced that it has been granted a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application No. 17/366,829 pertaining to GIMOTI, the first and...Read more
DEVON, Pa., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, announces an oral presentation at The Society for the Study of Behavioural Phenotypes (SSBP) 25th International Research Symposium, being held virtually September 14-15, 2023. Helen (Honey) Heussler, MBBS FRACP, DM, Associate...Read more
Registrational assets expected to double from six to 12 over next 18 months Cell Therapy and Targeted Protein Degradation platforms offer potential to expand treatment options across multiple therapeutic areas Enhanced approach to R&D expected to drive top-tier productivity PRINCETON, N.J. / Sep 14, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to...Read more
Applications for Investigational Subcutaneous Administrations for Both Crohn’s Disease and Ulcerative Colitis Are Now Under Review by the FDA OSAKA, Japan & CAMBRIDGE, Mass. / Sep 13, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of ENTYVIO®...Read more
Alopecia areata is the second autoimmune indication being evaluated for bempikibart WALTHAM, Mass. and DUBLIN, Sept. 13, 2023 /PRNewswire/ -- Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that the first patient has been dosed in a randomized, double-blind, placebo-controlled, Phase 2...Read more
PALO ALTO, Calif., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that on September 11, 2023, Scilex, Oramed...Read more
VANCOUVER, BC / ACCESSWIRE / September 12, 2023 / Lucy Scientific Discovery Inc. (NASDAQ:LSDI), a publicly traded company focused on the development, sale, delivery, and manufacturing of psychotropic products, recently announced its acquisition of all High Times IP and brand assets - has just announced the acquisition of BlueSky Wellness Inc., along with the full BlueSky portfolio of brands adding psychotropic products to its catalog,...Read more
Application based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58% TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic...Read more
BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP. ANI’s Estradiol Tablets USP are the generic version of the Reference Listed Drug (RLD) Estrace®. The According to IQVIA, a leading healthcare data and analytics provider,...Read more
SEQUENCE, a Phase 3 head-to-head study (study drug open-label and efficacy assessment blinded) compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs1 Risankizumab met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at...Read more
DEERFIELD, Ill. & NEW YORK / Sep 12, 2023 / Business Wire / Walgreens, a division of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), and Pearl Health, a leading provider enablement company, today announced a partnership to accelerate the expansion of value-based care in collaboration with community-based primary care physicians. Pearl Health offers technology and insight solutions that empower clinical teams to provide holistic,...Read more
LAVAL, QE / ACCESSWIRE / September 12, 2023 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) is pleased to announce that following its approval by Health Canada the new treatment PrUCERIS® (budesonide) aerosol foam is now available across Canada to treat mild to moderate distal ulcerative colitis in adults. UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients...Read more
VANCOUVER, British Columbia, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Lucy Scientific Discovery Inc. (NASDAQ: LSDI), the leader in the psychotropic industry, which recently celebrated the acquisition of High Times' Intellectual Property, the most iconic brand in the cannabis industry, is thrilled to announce an agreement to acquire BlueSky Wellness Inc. and its portfolio of brands. This transaction expands Lucy’s footprint into the growing...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that results from the confirmatory Phase IIIb clinical trial of savolitinib in patients with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration non-small cell lung cancer (“NSCLC”), were presented during the IASLC 2023 World Conference on Lung Cancer...Read more
PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual...Read more
BOSTON, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sensorium Therapeutics (Sensorium), a biotechnology company translating insights from nature and human experience to deliver transformational therapeutics, today announced the appointment of veteran life sciences executive David Southwell to its Board of Directors. “We are excited to welcome David to our Board,” said Dick Simon, Chief Executive Officer of Sensorium. “He is a seasoned life...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China. The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory...Read more
This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multiple circulating Omicron-related sublineages including XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris), which currently accounts for the largest portion of U.S. cases1 The...Read more
First head-to-head trial of biologics in EGPA, comparing a single monthly injection of FASENRA to three injections per month of mepolizumab WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s FASENRA (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic...Read more
Data from longest reported follow-up for a Phase 3 trial with immunotherapy in metastatic non-small cell lung cancer demonstrate consistent, durable benefits of Opdivo plus Yervoy vs. chemotherapy at six years, regardless of PD-L1 expression Opdivo plus Yervoy combination more than tripled overall survival rate at six years compared to chemotherapy in patients with PD-L1 expression <1% in an exploratory analysis Updated data to be...Read more
Combination reduced the risk of disease progression by 38% versus TAGRISSO monotherapy, the current 1st-line global standard of care WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to...Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU showed objective response rates of 49% and 56% with 5.4mg/kg and 6.4mg/kg doses respectively in primary analysis ENHERTU provided a median progression-free survival of 9.9 months at 5.4mg/kg dose and 15.4 months at 6.4mg/kg dose with a median duration of response of 16.8 months seen at the 5.4mg/kg dose and not reached at the 6.4mg/kg dose Favorable safety profile confirms 5.4mg/kg as optimal...Read more
Topline Results for TAK-279 Show that a Significantly Greater Proportion of Psoriatic Arthritis Patients Achieved at Least an ACR20 Response Compared to Placebo at Week 121 Based on the Positive Results, Takeda Intends to Initiate a Phase 3 Study of TAK-279 in Psoriatic Arthritis Full Clinical Results Will be Presented at an Upcoming Medical Meeting OSAKA, Japan & CAMBRIDGE, Mass. / Sep 11, 2023 / Business Wire / Takeda...Read more
Overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. On average, enobosarm or active control was given in the 4th line treatment in the metastatic setting which included a prior CDK 4/6 inhibitor combination Overall response rate was 20% for enobosarm monotherapy versus 0% for standard of care active control in patients who...Read more
Targeting to commence second part of Phase 3 clinical trial in mid-Q4 2023 Trial completion and results expected in mid-2024 TEL AVIV, Israel, Sept. 11, 2023 (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 plans to commence the second part of the Company’s phase 3 trial to...Read more
ROCKVILLE, Md., Sept. 11, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced the expansion of its patent portfolio following the issuance of a Canadian patent for its Histone Deacetylase (HDAC) inhibitor platform technology titled "Dual...Read more
THOUSAND OAKS, Calif., Sept. 11, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference at 11:40 a.m. BST on Thursday, Sept. 14, 2023. Peter H. Griffith, executive vice president and chief financial 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...Read more
Exploratory post-hoc analysis of STELLAR shows potential of sotatercept to improve cardiovascular function Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy Nine Merck-sponsored abstracts in PAH featured at European Respiratory Society...Read more
CAL02 is a unique therapeutic agent that is designed to work differently from antibiotics, aiming to disarm an infectious pathogen’s virulence factors to reduce damage and mitigate disease The first-in-human study showed positive safety and efficacy when added to standard of care in patients with severe community-acquired bacterial pneumonia WOODCLIFF LAKE, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals,...Read more
RANCHO CUCAMONGA, CA / ACCESSWIRE / September 11, 2023 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar") today announced that it intends to offer, subject to market conditions and other factors, $300.0 million aggregate principal amount of convertible senior notes due 2029 (the "notes") in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of...Read more
Appoints Experienced Consumer Packaged Goods Executive Catherine "Triona" Schmelter as EVP and President, Consumer Self-Care Americas (CSCA) and Global Portfolio Optimization DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced the appointment of Catherine "Triona" Schmelter as Executive Vice President and President, Consumer Self-Care Americas...Read more
PALO ALTO, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announces record revenue for the month of August 2023 and is providing certain preliminary...Read more
In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of 65% THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These...Read more
Results Show Encouraging Activity of Trodelvy in Combination with KEYTRUDA in 1L Metastatic NSCLC Across all PD-L1 Subgroups and Histologies Studied Results Support Further Investigation of Trodelvy in Combination with KEYTRUDA in 1L Metastatic NSCLC FOSTER CITY, Calif. / Sep 10, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced promising early data from the global, open-label, Phase 2 EVOKE-02 study...Read more
Topline results from Phase IV study demonstrate Qelbree is safe and well-tolerated, and significantly improved efficacy outcomes when added to a stimulant medication in pediatric patients with ADHD Final long-term data show Qelbree consistently improved symptoms and executive function in adults with ADHD, with safety and tolerability similar to the short-term pivotal adult Phase III trial ROCKVILLE, Md., Sept. 09, 2023 (GLOBE...Read more
Results show 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in percent predicted forced vital capacity versus placebo Treatment effect was consistent with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates These progressive pulmonary fibrosis findings, along with the...Read more
GREENFIELD, Ind. / Sep 07, 2023 / Business Wire / Today, Elanco Animal Health Incorporated (NYSE: ELAN) announced that the first shipments of Varenzin™-CA1 (molidustat oral suspension), conditionally approved by U.S. Food and Drug Administration (FDA) as the first and only treatment to control non-regenerative anemia in cats with chronic kidney disease (CKD), are shipping to veterinary clinics around the country. Anemia from CKD can...Read more
Milestone signifies ongoing effort to help prepare for outbreaks of Zaire ebolavirus RAHWAY, N.J. / Sep 07, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. The...Read more
Company on track to report topline data from AHFIRM in Q4 2023 CUPERTINO, Calif., Sept. 7, 2023 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions, including acute organ injury and cancer, today announced that the last patient has completed the study protocol in the...Read more
The Agreement Substantially Increases Procaps' Participation in the Oncology Market in the LatAm Region MIAMI & BARRANQUILLA, Columbia / Sep 07, 2023 / Business Wire / Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, announced today that it has entered into an agreement with BDR Pharmaceuticals International Pvt. Limited (“BDR...Read more
VANCOUVER, British Columbia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Lucy Scientific Discovery Inc. (“Lucy” or “the Company”) (NASDAQ: LSDI), a leading psychotropic innovator announces the acquisition of the intellectual property (IP) of High Times, the most recognizable and iconic brand in the cannabis industry. This acquisition provides a stream of high-margin licensing and royalty income from the well-regarded High Times, Cannabis Cup, and...Read more
VANCOUVER, British Columbia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian psychedelics drug research and formulation company, proudly announced today that Health Canada has approved an amendment to the Company’s Dealer's Licence. The amendment empowers Optimi to embark on the formal supply journey for Canada’s Special Access Program (SAP), operating within the provisions of the...Read more
SAN DIEGO and GAINESVILLE, Ga., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced new project expansion agreements with several existing customers. The six new scopes of work across four different current...Read more
THOUSAND OAKS, Calif., Sept. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley Global Healthcare Conference at 8:50 a.m. ET on Tuesday, Sept. 12, 2023. 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,...Read more
SOMERSET, N.J. / Sep 07, 2023 / Business Wire / Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced that members of its executive leadership team will participate at two upcoming investor conferences. On September 12, 2023, at 10:50 a.m. ET, the Company will present at the Morgan Stanley 21st Annual Global Healthcare Conference. On September 13, 2023,...Read more
WIXOM, Mich. / Sep 07, 2023 / 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 Company's President and CEO, Dr. Mark Strobeck, will present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023 at 11:00...Read more
CAMBRIDGE, Mass. and NESS ZIONA, Israel, Sept. 07, 2023 (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, today announced that the Company will present data from Part 1 of its ongoing Phase 1b/2a study evaluating the novel phage product candidate, BX004, for the treatment of chronic...Read more
TEL AVIV, Israel, Sept. 07, 2023 (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 that Company has been selected for a poster presentation, titled “Pharmacokinetics and Safety Profiles of PRF-110 in Subjects Following Bunionectomy Surgery,” at the upcoming 13th Congress of the...Read more
NORTHVALE, NJ / ACCESSWIRE / September 7, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing and manufacturing niche generic products, today announced the appointment of Carter Ward as its Chief Financial Officer (CFO), effective September 5, 2023. Mr. Ward previously served as the Company's Chief Financial Officer from July 2009 through May 2021, and the Company is...Read more
Key injectable currently on the U.S. FDA shortage list Received Competitive Generic Therapy approval designation BRIDGEWATER, N.J. / Sep 06, 2023 / Business Wire / Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for calcium gluconate in sodium chloride injection, 1000 mg/50...Read more
Key ADHD medicine on the U.S. FDA shortage product list Represents another high-value product approval for Amneal BRIDGEWATER, N.J. / Sep 06, 2023 / Business Wire / Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg,...Read more
Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal hemoglobinuria (PNH) If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting Filing applications have also been accepted in the EU, China and Japan, and submissions to...Read more
1st product approval in China represents Amneal’s entry in second largest pharmaceutical market Expects international expansion will be another key vector for long-term growth and impact BRIDGEWATER, N.J. / Sep 06, 2023 / Business Wire / Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China. Sevelamer carbonate was approved and is expected to...Read more
SCOTTSDALE, Ariz., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced it has entered into an exclusive license agreement (the...Read more
PARSIPPANY, N.J. / Sep 06, 2023 / Business Wire / Zoetis Inc. (NYSE:ZTS) will participate in the Morgan Stanley 21st Annual Global Healthcare Conference on Tuesday, Sept. 12, 2023. Wetteny Joseph, Executive Vice President and Chief Financial Officer, will represent the company and respond to questions from analysts. He is scheduled to present at 12:55 p.m. ET. Investors and other interested parties will be able to access a live audio...Read more
TEL AVIV, Israel / Sep 06, 2023 / Business Wire / Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, will present at the Morgan Stanley Global Healthcare Conference on Monday, September 11, 2023. The presentation will begin at 8:40 A.M. Eastern Time. To access a live webcast of the presentation, visit Teva’s Investor Relations website at...Read more
CAMBRIDGE, Mass. and NESS ZIONA, Israel, Sept. 06, 2023 (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, today announced that Jonathan Solomon, Chief Executive Officer of BiomX, will be presenting at the H.C. Wainwright 25th Annual Global Investment Conference, which is being held...Read more
NEW YORK, NY / ACCESSWIRE / September 6, 2023 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a pioneer in expanding consumer access to medication through over the counter (OTC) pathways, announces today that Fady Boctor, President and Chief Commercial Officer, will present a corporate overview at the H.C. Wainwright 25th Annual Global Investment Conference. The conference is being held on September 11 - 13, 2023 at the Lotte New York...Read more
Teva will share 16 data presentations across its neuroscience portfolio including AUSTEDO, once-daily AUSTEDO XR, UZEDY, TV-44749 (olanzapine) and AJOVY® (fremanezumab) injection Presentation highlights include data for AUSTEDO in the tardive dyskinesia (TD) START study on real-world effectiveness and adherence when initiating treatment with a 4-Week Patient Titration Kit and safety data for UZEDY along with results from the RISE (The...Read more
NORTH CHICAGO, Ill., Sept. 6, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Morgan Stanley 21st Annual Global Healthcare Conference on Wednesday, September 13, 2023. Robert A. Michael, president and chief operating officer, Scott Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, senior vice president, development and...Read more
TAMPA, Fla., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX) today announced its participation in an analyst-led fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference. The pre-recorded audio of the virtual event can be accessed beginning Monday, September 11th at 7:00AM ET by visiting the “Events” page of the company’s website at investor.pacira.com. A replay of the webcast will...Read more
| Company | Change | Last Trade |
|---|---|---|
| Phibro Animal Health | 0.64 5.10 | $13.20 |
| Roche | 0.55 1.55 | $35.93 |
| Guardion Health Sciences | 0.31 4.06 | $7.95 |
| Bristol-Myers Squibb | 0.31 0.53 | $59.09 |
| MIRA Pharmaceuticals | 0.31 7.42 | $4.49 |
| Journey Medical | 0.30 11.24 | $2.97 |
| Cosmos Health | 0.23 14.94 | $1.77 |
| Ironwood Pharmaceuticals | 0.23 2.51 | $9.41 |
| Harrow Health | 0.15 1.06 | $14.30 |
| HLS Therapeutics | 0.13 2.62 | $5.10 |
| Cumberland Pharmaceuticals | 0.06 2.68 | $2.30 |
| Scilex | 0.05 2.94 | $1.75 |
| Bausch Health | 0.05 0.60 | $8.40 |
| Crescita Therapeutics | 0.04 6.15 | $0.69 |
| Universe Pharmaceuticals | 0.03 2.44 | $1.37 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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