The marketing authorization for SKYRIZI® (risankizumab) marks its fourth approved indication in the European Union The approval is supported by data from two pivotal Phase 3 trials: The INSPIRE induction trial1 and COMMAND maintenance trial2 In both trials, SKYRIZI achieved the primary endpoint of clinical remission (per Adapted Mayo Score*) and key secondary endpoints, including mucosal healing** and histologic endoscopic mucosal...Read more
Opinion granted based on positive overall survival and progression-free survival results from the Phase 3 KEYNOTE-A39 trial Positive opinion marks step forward for a potential new first-line standard of care for the treatment of patients with this disease in Europe RAHWAY, N.J. / Jul 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s...Read more
Results Underscore Continued Progress on Commercial Execution, Driving the Growth Portfolio and Pipeline Advancement Second Quarter Revenues were $12.2 Billion, increasing 9% (+11% Adjusting for Foreign Exchange) Growth Portfolio Revenues were $5.6 Billion, increasing 18% (+21% Adjusting for Foreign Exchange) GAAP EPS was $0.83 and Non-GAAP EPS was $2.07; Includes Net Impact of $(0.04) Per Share for GAAP EPS and Non-GAAP EPS Due to...Read more
TOKYO and CAMBRIDGE, Mass., July 26, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval...Read more
Scienture, Inc., a private branded and specialty pharmaceutical company, entered into a business combination with TRxADE Health Inc., in an all-stock transaction valued at $103 million. TAMPA, FL and COMMACK, NY, July 26, 2024 (GLOBE NEWSWIRE) -- TRxADE HEALTH, INC. (“TRxADE”) (Nasdaq: MEDS) and Scienture, Inc. (“Scienture”) today announced the closing of TRxADE’s business combination with Scienture in an all-stock...Read more
Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart...Read more
Reports Second-Quarter Diluted EPS of $0.77 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.65, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $0.52 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $14.462 Billion, an Increase of 4.3 Percent on a Reported Basis and 5.6 Percent on an Operational Basis Second-Quarter...Read more
Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now expected to increase by a mid teens percentage at CER1 CAMBRIDGE, United Kingdom / Jul 25, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary H1 2024 % Change Q2 2024 % Change $m Actual CER $m Actual CER - Product...Read more
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9) after up to four years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients. NEW YORK / Jul 25, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission...Read more
New 5-Year Clinical and Real-World Data Reinforce Biktarvy® as a Long-Term Treatment Option for a Diverse Range of People with HIV, Including Those with Comorbidities Investigational, Once-Daily, Once-Weekly and Twice-Yearly Dosing Frequencies Across Administration Methods Aim to Expand Options, Advance Public Health and Help Address Unmet Needs in HIV Treatment FOSTER CITY, Calif. / Jul 25, 2024 / Business Wire / Gilead...Read more
Enrollment acceleration drives earlier-than-anticipated data availability for this potentially best-in-class IBD treatment Topline results for both UC and CD now anticipated in Q4 2024 Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug (anti-TL1A) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) patients PARSIPPANY, N.J. & PARIS / Jul 25, 2024 / Business Wire / Teva...Read more
Latest positive preclinical data provides another step in the path to potential IND submission this year for novel ketamine analog MIAMI, FL / ACCESSWIRE / July 25, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new insights garnered from additional, recently received preclinical study data regarding the mechanism of action and toxicology...Read more
CHICAGO, IL / ACCESSWIRE / July 25, 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 signed a distribution agreement (the "Agreement") with...Read more
CHICAGO, IL / ACCESSWIRE / July 25, 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 its wholly-owned subsidiary, Decahedron Ltd ("Decahedron"),...Read more
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis NEW YORK / Jul 24, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A. The AFFINE study...Read more
PURPOSE 1 Data Showed Zero Infections and 100% Efficacy and Superiority of Lenacapavir to Background HIV Incidence and Daily Truvada® for PrEP If Approved, Lenacapavir Would be the First and Only Twice-Yearly PrEP Choice and Could Address Critical Gaps in Uptake and Adherence for Individuals Who Need or Want PrEP Gilead Commits to Prioritizing Swift Access and Enabling Efficient Paths for Regulatory Approval of Lenacapavir...Read more
LAKE FOREST, Ill., July 24, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today announced that it will release second quarter 2024 financial results on Wednesday, August 7, 2024, after the market close. Following the release of its financial results, Assertio’s management will...Read more
CHICAGO, IL / ACCESSWIRE / July 24, 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 its wholly-owned subsidiary, Cana Laboratories ("Cana"), has...Read more
TEL AVIV, Israel, July 24, 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 it has filed a patent covering its new and highly scalable manufacturing process for PRF-110, its flagship product designed to revolutionize post-operative pain control. The patent filing follows...Read more
Time-limited reimbursement (TLR) recommendation is a new Canada's Drug Agency (CDA) review process whereby a temporary recommendation is issued based on a phase II clinical data assessment, and the final recommendation is contingent upon a future reassessment of additional evidence (i.e., phase III clinical data)1. The positive CDA TLR recommendation recognizes the clinical efficacy of EPKINLY based on phase II data (EPCORE NHL-1),...Read more
Clesrovimab met all primary safety and efficacy endpoints RAHWAY, N.J. / Jul 23, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease....Read more
This study aims to enhance U.S. public health preparedness through Walgreens community pharmacy network, improving access and diversity in clinical trials via a $25m award DEERFIELD, Ill. / Jul 23, 2024 / Business Wire / Walgreens today announced it received a project award valued up to $25 million through the Rapid Response Partnership Vehicle (RRPV) to conduct a Phase IV observational clinical study focused on assessing Correlates of...Read more
Observational studies to focus on patients with addiction and end-of-life distress pending formal approval and permitting from Thai health authorities Vancouver, British Columbia--(Newsfile Corp. - July 23, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a GMP-approved, Health Canada licensed psychedelics pharmaceutical manufacturer specializing in botanical psilocybin and MDMA, is...Read more
Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO® TITUSVILLE, N.J., July 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a...Read more
The extension to a four-year shelf-life helps improve naloxone access as communities continue to grapple with the growing opioid epidemic; product with the extended shelf life has officially begun shipping WINNIPEG, Manitoba, July 22, 2024 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions announced the shelf-life extension for NARCAN® Nasal Spray from three years (36 months) to four years (48 months) to all newly manufactured product....Read more
New findings highlight potential advantages of MIRA's novel oral ketamine analog for treating neurological and neuropsychiatric disorders MIAMI, FL / ACCESSWIRE / July 22, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new preclinical study results for its novel oral ketamine analog, Ketamir-2. The additional data announced today...Read more
LAVAL, Quebec / Jul 22, 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 with in-house R&D and manufacturing capabilities, today announced the signing of an amendment to its contract manufacturer supply agreement (the “Amended Agreement”) with its largest CMO client (the “Client”), a global skin care...Read more
The Application is based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population PRINCETON, N.J. / Jul 19, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy®...Read more
LAVAL, QC / ACCESSWIRE / July 19, 2024 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) today announced the appointment of two new members to its Executive Leadership Team (ELT). Jean-Jacques Charhon ("JJ") will join the Company as Chief Financial Officer on August 19, 2024. JJ has over 25 years of experience in financial leadership roles with public and private companies across healthcare, high tech and services, primarily at...Read more
LAVAL, Quebec / Jul 19, 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 with in-house R&D and manufacturing capabilities, today announced that it has signed an exclusive Manufacturing and Supply Agreement (the “Agreement”) with a leading Canadian diversified healthcare services provider (the...Read more
GAITHERSBURG, Md., July 19, 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), today announced the publication of a manuscript reporting on the ability of one of the Company’s HDAC inhibitor pre-clinical assets, SP-1-303, which exhibits...Read more
Two-year Phase III data presented at ASRS 2024 show Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR) Safety data were consistent with the known safety profile for Susvimo in people with DME and DR Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data Susvimo is a...Read more
SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo Efficacy is consistent with AJOVY (fremanezumab) pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed Full data to be presented at a medical meeting later in 2024 TEL AVIV, Israel / Jul 18, 2024 / Business Wire / Teva Pharmaceutical...Read more
CHICAGO, IL / ACCESSWIRE / July 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 that its wholly-owned subsidiary, Cana Laboratories ('Cana'), has...Read more
2024 Second-Quarter reported sales growth of 4.3% to $22.4 Billion with operational growth of 6.6%* and adjusted operational growth of 6.5%*. Adjusted operational growth excluding COVID-19 Vaccine of 7.1%* 2024 Second-Quarter Earnings per share (EPS) of $1.93 decreasing by 5.9% due to one-time special charges and adjusted EPS of $2.82 increasing by 10.2%* Significant new product pipeline progress including TREMFYA IBD and subcutaneous...Read more
More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis The study met all primary endpoints showing safety data were consistent with Vabysmo's known safety profile This is the largest long-term extension dataset...Read more
After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001)1 Pharmacokinetic data supports a once-daily oral dosing regimen for CT-9961 The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed1 SOUTH SAN FRANCISCO, Calif. / Jul 17, 2024 / Business Wire /...Read more
More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis The study met all primary endpoints, showing safety data were consistent with Vabysmo’s known safety profile This is the largest long-term extension...Read more
ACEA Therapeutics (“ACEA”) will serve as exclusive territories distributor in Greater China, including mainland China, Taiwan, Hong Kong and Macau, with potential minimum purchase commitment for ZTlido once approved locally in the region. ACEA to immediately start the process to explore potential commercialization of ZTlido®, with the opportunity to distribute with partners across Greater China and further expand the relationship to...Read more
LAVAL, Quebec / Jul 17, 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 has signed an exclusive distribution agreement (the “Agreement”) with NanoPass Technologies Ltd. (“NanoPass”), a pioneer in the development and commercialization of an advanced intradermal delivery device, to...Read more
Symposia will highlight work to overcome HIV-related stigma and discuss the evolving state of HIV treatment and prevention RAHWAY, N.J. / Jul 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced upcoming data presentations and programming at the 25th International AIDS Conference (AIDS 2024), taking place July 22-26, 2024, in Munich, Germany. Merck will share updates on new...Read more
- Late-Breaking Full Results from HIV Prevention Research of Twice-Yearly Injectable Lenacapavir - - Progress and Person-Centered Approaches Across HIV Treatment, Cure Research and Development Programs - - Key Initiatives Demonstrate Commitment to Collaboration to Help End the HIV Epidemic Worldwide - FOSTER CITY, Calif. / Jul 16, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced its program for the upcoming...Read more
Expansion adds more temperature-controlled storage and dedicated space for FastChain® demand-led supply service SOMERSET, N.J. / Jul 16, 2024 / Business Wire / Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced it has completed expansion of its clinical supply facility in Schorndorf, Germany. The Schorndorf site, Catalent’s flagship European...Read more
Vital study aligned with FDA guidelines shows encouraging performance as Petros continues close FDA contact for a potential technology-centered Rx-to-OTC switch NEW YORK, NY / ACCESSWIRE / July 16, 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, announces results of the first of a...Read more
PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI’s L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®. "The approval and launch of L-Glutamine...Read more
WIXOM, Mich. / Jul 15, 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, announced that the Company's President and Chief Executive Officer, Dr. Mark Strobeck, will present at the H.C. Wainwright 3rd Annual Kidney Conference, which is being held today virtually....Read more
Testing confirms MIRA's preliminary beliefs regarding potential treatment for neurological and neuropsychiatric disorders MIAMI, FL / ACCESSWIRE / July 15, 2024 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical development company, today announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being...Read more
Beijing, July 15, 2024 (GLOBE NEWSWIRE) -- Shineco, Inc. (“Shineco” or the “Company”) (NASDAQ: SISI), a provider of innovative diagnostic medical products and related medical devices, today announced the closing of its underwritten public offering of 1,869,160 shares of its common stock at a public offering price of $1.07 per share of common stock, for aggregate gross proceeds of approximately $2 million, prior to deducting underwriting...Read more
Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26-week steroid taper regimen achieved the primary endpoint of sustained remission from week 12 through week 521 The safety profile of upadacitinib in patients with GCA was generally consistent with that in approved indications1 NORTH CHICAGO, Ill., July 12, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has...Read more
HOLLISTER, Calif., July 12, 2024 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, today announced the closing of its previously announced private placement for the issuance and sale of an aggregate of 12,385,883 shares of its common stock at a purchase price of $1.24 per...Read more
HOLLISTER, Calif., July 11, 2024 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate 12,385,883 of its shares of common stock in a private placement at a purchase price...Read more
NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD) The Company is leveraging a multi-pathway approach to transform treatment in atopic dermatitis and other immune-mediated diseases NEW BRUNSWICK, N.J. / Jul 11, 2024 / Business Wire / Johnson & Johnson1 (NYSE: JNJ) announced today that it has successfully completed the acquisition of Yellow Jersey, a...Read more
Clinical evaluation of several modified release once-daily formulations of danuglipron resulted in encouraging pharmacokinetic data for several candidates with one showing the most favorable profile The company plans to conduct dose optimization studies with a focus on the preferred formulation to inform the registration enabling studies NEW YORK / Jul 11, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that based on...Read more
GSK supports annual flu immunization by getting FLULAVAL and FLUARIX to patients in advance of flu season PHILADELPHIA / Jul 11, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2024-25 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug...Read more
BRIDGEWATER, N.J. / Jul 11, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its second quarter 2024 financial results on Friday, August 9, 2024, prior to market open. The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time. The financial results and live webcast will be accessible through the Investor Relations section...Read more
Bagsværd, Denmark, 10 July 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus. In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed....Read more
Dr. Shrank brings extensive healthcare experience, business leadership and clinical expertise to WBA board as the company undergoes strategic turnaround DEERFIELD, Ill. / Jul 10, 2024 / Business Wire / Walgreens Boots Alliance, Inc. (Nasdaq: WBA) today announced the appointment of William H. Shrank, M.D., to the company’s board of directors. Dr. Shrank is globally recognized for his leadership and expertise in healthcare strategy,...Read more
Q2 revenue of $22 million represents +25% growth year-over-year Positive net income of $1 million realized with Adjusted EBITDA1 of $5.5 million Fiscal 2024 revenue guidance confirmed between $87 and $90 million and an Adjusted EBITDA in the range of $13 to $15 million MONTREAL, July 10, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company...Read more
CHICAGO, IL / ACCESSWIRE / July 10, 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 the successful completion of the pilot production and scale-up...Read more
Multi-year collaboration will initially focus on early discovery research for metabolic and infectious diseases HAMBURG, GERMANY / ACCESSWIRE / July 10, 2024 / Evotec SE (Frankfurt Stock Exchange:EVT) (NASDAQ:EVO) (MDAX/TecDAX , ISIN: DE0005664809) today announced it has entered into a multi-year master research collaboration and option and license agreement with Pfizer. Under the agreement, Evotec and Pfizer will initially focus...Read more
The Company believes that its Advanced Proprietary Production Technology Provides it with a Competitive Advantage in the Sector BEIJING, July 10, 2024 (GLOBE NEWSWIRE) -- Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a provider of innovative diagnostic medical products and related medical devices, announced today that its subsidiary, Fuzhou Meida Health Management Co., Ltd. (“Fuzhou Meida”), has entered into Distribution...Read more
Acquisition delivers industry-leading portfolio, scientific and research capabilities, for enhanced customer benefits RAHWAY, N.J. / Jul 09, 2024 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the completion of its acquisition of the aqua business of Elanco Animal Health Incorporated (NYSE:...Read more
FOCINVEZ (fosaprepitant) 150 mg/50 mL single dose vial is an anti-nausea agent for highly emetogenic and moderately emetogenic chemotherapy (HEC and MEC) Second injectable RTU product launched by Amneal in 2024 BRIDGEWATER, N.J. / Jul 09, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of...Read more
Contract Enhances Purchasing Power for 340B Prime Vendor Program (PVP) Participants; Aligns with Harrow’s Mission to Make Its Products Accessible and Affordable NASHVILLE, Tenn. / Jul 09, 2024 / Business Wire / Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that as of July 1, 2024, it has entered into an agreement with Apexus to make IHEEZO® (chloroprocaine hydrochloride ophthalmic gel)...Read more
Acquisition to expand Lilly's immunology pipeline with oral integrin therapies INDIANAPOLIS and WALTHAM, Mass., July 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Morphic Holding, Inc. (NASDAQ: MORF) today announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for treatment of serious chronic diseases. Morphic's lead program is a...Read more
The FDA has approved updates to Susvimo, which will be available to U.S. retina specialists and patients with wet AMD in the coming weeks Susvimo offers the first alternative to regular eye injections that are standard of care for wet AMD, which impacts 1.5 million people in the U.S. and 20 million people worldwide and can cause blindness if left untreated By continuously delivering medicine to the eye through a refillable implant,...Read more
Just - Evotec Biologics expands partnership with Sandoz for development and commercial manufacturing of biosimilars Additional biosimilars potentially to be added to Sandoz development pipeline Further guarantees for Sandoz long-term commercial supply security HAMBURG, GERMANY and SEATTLE, WA / ACCESSWIRE / July 8, 2024 / Evotec SE (Frankfurt Stock Exchange:EVT) (NASDAQ:EVO) (MDAX/TecDAX , ISIN: DE0005664809) today...Read more
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option Vabysmo PFS will be available for people living with wet AMD, DME and RVO SOUTH SAN FRANCISCO, Calif. / Jul 05, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG;...Read more
SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy compared to the comparator arm Safety was consistent with previous studies, however we intend to halt the trial due to reduced efficacy compared to the...Read more
Phase 3 PAPILLON study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival, reducing the risk of disease progression or death by 60 per cent versus carboplatin and pemetrexed alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations.1 TORONTO, July 3, 2024 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada,...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration...Read more
CHICAGO, IL / ACCESSWIRE / July 3, 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 its wholly-owned subsidiary, Cana Laboratories...Read more
Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39% Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment...Read more
CARVYKTI ® is the first and only BCMA-targeted CAR-T cell therapy approved by the U.S. FDA for the treatment of patients with multiple myeloma who have had at least one prior line of therapy RARITAN, N.J., July 2, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel;...Read more
CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs). “We are very excited about the addition of felzartamab into our pipeline, further strengthening our presence in immunology with a promising...Read more
PRINCETON, N.J., July 02, 2024 (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) and launched Naproxen Delayed-Release Tablets, USP. ANI’s Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®. "We are pleased to announce...Read more
GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received more than $250 million in contract modifications from the Administration for Strategic Preparedness and Response (ASPR) at the United States Department of Health and Human Services (HHS), to deliver millions of doses of four medical countermeasures (MCMs). These contract modifications will help ensure continued...Read more
Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly owned subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), and Denali Capital Acquisition Corp. (Nasdaq: DECA) (“SPAC”) announce signing of a letter of intent for a proposed business combination, which provides for a pre-transaction equity value of Semnur of up to $2.0 billion, subject to adjustment based on third-party fairness opinion, with expected cash on hand at closing of...Read more
Total consideration of up to $45.75 million, which consists of upfront cash, sales-based milestone payments and DRI Healthcare's assumption of future milestone payment obligations HLS will use the upfront cash proceeds to pay down debt 2024 revenue and Adjusted EBITDA guidance is updated to reflect effective sale date of June 28, 2024 TORONTO, July 2, 2024 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a...Read more
CHICAGO, IL / ACCESSWIRE / July 2, 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 enhanced and expanded its strategic collaboration with...Read more
As Previously Announced, Richard A. Gonzalez Retires as Chief Executive Officer to Become Executive Chairman Robert A. Michael Joins AbbVie Board of Directors NORTH CHICAGO, Ill., July 1, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that Robert A. Michael has assumed the role of chief executive officer (CEO) and has joined AbbVie's Board of Directors, effective today. As previously announced, Mr. Michael succeeds...Read more
RAHWAY, N.J. / Jul 01, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Orion Corporation (“Orion”) today announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an...Read more
NEW YORK / Jul 01, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the election of Cyrus Taraporevala to its Board of Directors, effective immediately. Mr. Taraporevala, age 57, was also appointed to and will join the Audit Committee and Compensation Committee of Pfizer’s Board. Mr. Taraporevala served as President and Chief Executive Officer at State Street Global Advisors from 2017 until his retirement in 2022. Prior to...Read more
Biotest, a Grifols Group company, is expected to launch its recently FDA-approved intravenous immunoglobulin in the U.S. in first quarter 2025 Yimmugo will be distributed by Kedrion in the U.S. as part of a broader Group channel strategy, with Grifols focusing on continued growth of its current portfolio for this market It adds to Grifols’ strong franchise of intravenous and subcutaneous immunoglobulins to meet growing patient...Read more
Builds on U.S. biosimilar portfolio of seven products with three commercial and four in pipeline 8th biosimilar expands portfolio into allergy treatments, a new therapeutic area BRIDGEWATER, N.J. / Jul 01, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the addition of omalizumab, referencing XOLAIR®, to its biosimilar pipeline. Omalizumab is a humanized monoclonal...Read more
NEWPORT BEACH, Calif. / Jul 01, 2024 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced the appointment of Albert G. White III, President and Chief Executive Officer of The Cooper Companies, Inc. to the Evolus Board of Directors, effective July 1. Mr. White will also serve as a member of Evolus’ Compensation Committee. “We are...Read more
Conference Call Scheduled for Tuesday, July 2 at 11:30 AM EDT Northvale, New Jersey--(Newsfile Corp. - July 1, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, announced results for the fiscal year ended March 31, 2024 ("Fiscal 2024"). Consolidated revenues for Fiscal 2024 were $56.6 million, an increase of $22.4 million or...Read more
PulseVet® Shock Wave Device Supports Equine Athletes Ahead of Major International Team Events ANN ARBOR, MI / ACCESSWIRE / July 1, 2024 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is honored to announce that the United States Equestrian Federation (USEF), which regularly competes in FEI...Read more
CHICAGO, IL / ACCESSWIRE / July 1, 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 signed a distribution agreement (the "Agreement") with...Read more
First-and-only FcRn blocker to demonstrate superiority in activities of daily living (MG-ADLa) over placebo when added to standard of care over 24 weeks in antibody positive patients: anti-AChR+, anti-MuSK+, anti-LRP4+ HELSINKI, June 28, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG)....Read more
| Company | Change | Last Trade |
|---|---|---|
| Bristol-Myers Squibb | 5.18 11.44 | $50.45 |
| Regencell Bioscience | 3.18 34.91 | $12.29 |
| AbbVie | 2.99 1.64 | $185.16 |
| ANI Pharmaceuticals | 1.22 1.97 | $63.25 |
| TRxADE Health | 1.16 9.97 | $12.79 |
| Roche | 1.12 2.82 | $40.77 |
| Johnson & Johnson | 1.00 0.63 | $160.64 |
| Agile Therapeutics | 0.84 139.12 | $1.44 |
| GSK | 0.79 2.02 | $39.86 |
| Collegium Pharmaceutical | 0.66 1.86 | $36.08 |
| Pfizer | 0.59 1.95 | $30.77 |
| Amgen | 0.55 0.16 | $334.85 |
| HUTCHMED | 0.55 3.05 | $18.56 |
| Alpha Teknova | 0.53 14.93 | $4.08 |
| PTC Therapeutics | 0.52 1.55 | $34.09 |
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. The company's lead cell therapy asset is NXC-201 in multiple myeloma...
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Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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