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 transaction (the “Business... 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 (MAA) for the humanized anti-soluble... 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 Acquired IPRD Charges and Licensing... 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 Committee for Medicinal Products... Read more
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 healing†,1,2 NORTH CHICAGO, Ill.,... 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"), has successfully submitted its tender... 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 ProMed Trading Company ("ProMed")... 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 attack (myocardial infarction)... 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 (EC) has granted conditional marketing... 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 Sciences, Inc. (Nasdaq: GILD) today... 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 Global Net Revenues from the Immunology... 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 Sales 24,629... 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 data for its novel oral ketamine... 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 Pharmaceuticals, a U.S. affiliate of Teva... 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 host a live webcast of... 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 completed the first phase ("Phase... 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 successful completion and testing of the... 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 achieved its primary objective of non-... 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 for PrEP in High-Incidence, Res... 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 pleased to announce a strategic supply... 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 Protection (CoP), known as responses... 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), and benefits of subcutaneous administration... 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. In the trial, clesrovimab met... 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 continues a string of promising preclinical... 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 supplemental New Drug Application (sNDA)... 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. The update makes NARCAN® Nasal... 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 company. The Amended... 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 ataxia-telangiectasia mutated... 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 General Electric, Hewlett Packard,... 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 “Client”) to supply various... 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® (ipilimumab) as a potential first-line... 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 secured additional contract manufacturing... 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 Industries Ltd. (NYSE and TASE: TEVA)... 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 unique therapeutic approach that... 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 include other products in Scilex’s... 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 launch and distribute... 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 filings, RYBREVANT subcutaneous filing,... 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 in DME to-date, demonstrating... 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 in DME to-date, demonstrating consistent... 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 / Genentech, a member of the Roche Group... 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 series of pivotal studies aimed at... 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 25th International AIDS Conference... 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 scientific findings from its HIV... 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 facility, provides comprehensive clinical... 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 studied as a potential treatment for... 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 Oral Powder, the first AA-rated... 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. For more information, visit hcwe... 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 discounts and other offering... 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 share. The private placement... 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 submitted applications for a new indication... Read more
