Crinetics Pharmaceuticals Once Daily, Oral Treatment for Acromegaly Crinetics Pharmaceuticals (CRNX) announced that its oral and once daily investigational compound paltusotine achieved positive results by meeting the primary endpoint and all secondary endpoints of the Phase 3 PATHFNDR-1 study.   PATHFNDR-1 study enrolled participants with acromegaly who were biochemically controlled on octreotide or lanreotide depot monotherapy. PATHFNDR-1 is . . . This content is for …

Halozyme Therapeutics in the NEWS Halozyme Therapeutics (HALO) announced today that the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain has approved Roche's (

Arcus Biosciences Arcus Biosciences (RCUS) is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer and chronic inflammatory diseases, and other diseases. In partnership with firms and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways while studying novel, biology-driven . . . This content is for paid …

Regeneron Pharmaceuticals EYLEA HD Approved by the FDA Regeneron Pharmaceuticals (REGN) announced that the U.S. FDA has approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended dose for EYLEA HD is 8 mg . . . This content is for paid subscribers. Please click here to subscribe or …

CymaBay Therapeutics and Jazz Pharmaceuticals Conference Call Info CymaBay Therapeutics: Hosting a Conference Call and Live Audio Website at 4.30 PM  TODAY CymaBay Therapeutics, Inc. (CBAY) - a clinical-stage biopharmaceutical company developing therapies for liver and other chronic diseases with high unmet need, announced that it will host a conference call and live audio webcast Today, Thursday . . . This content is for paid …

ImmunoGen in the News WALTHAM, Mass.--(BUSINESS WIRE) --Jul. 31, 2023-- ImmunoGen (IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023. From ImmunoGen Mark Enyedy, ImmunoGen’s President and Chief Executive Officer said, “This quarter we achieved a . . . This content …

Merck and Moderna Inc Announcement Merck (MRK) and Moderna Inc (MRNA . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Syndax Pharmaceuticals and Incyte Syndax Pharmaceuticals (SNDX) and Incyte (INCY) announced positive data from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

AIM ImmunoTech Announcement AIM ImmunoTech (AIM) - an immuno-pharma company focused on the research and development of its TLR-3 agonist Ampligen (rintatolimod) as a novel and potentially powerful therapeutic in locally advanced pancreatic cancer (“LAPC”) and metastatic pancreatic cancer, announced the required approvals from the Netherlands for Erasmus Medical Center (“Erasmus MC”) to begin a . . . This content is for paid subscribers. Please …

Arbutus Biopharma Announcement Today, June 21, 2023, Arbutus Biopharma (ABUS) announced that the first patient has been dosed in the additional treatment arm of the AB-729 Phase 2a triple combination clinical trial, which has been expanded to include a PD-1 monoclonal antibody, nivolumab. Please note that . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

UT Southwestern Medical Center and RenovoRx RenovoRx Inc (RNXT) announced that the University of Texas (UT) Southwestern Medical Center is now enrolling pancreatic cancer patients in the open label, randomized Phase III TIGeR-PaC clinical trial. The study is investigating RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, Trans-Arterial Micro-Perfusion (TAMPä), to provide improved . . . This content is for paid subscribers. Please click here to subscribe …

Amylyx Pharmaceuticals  Amylyx Pharmaceuticals (AMLX) announced an update on the ongoing review of its Marketing Authorization Application (MAA) for AMX0035 (taurursodiol]) regarding the treatment of adults with amyotrophic lateral sclerosis (ALS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following an oral explanation held at the . . . This content is for paid subscribers. Please click here …

Prostate Cancer Prostate cancer is the most common type of cancer found in men, accounting for more than a quarter of all newly diagnosed cancer cases. Early detection is linked to improved survival rates, but typical screening recommendations — such as digital rectal exams or testing for the prostate specific antigen (PSA) biomarker — do not give the full picture. Halfway through 5-year study, ExoDx …

Celldex Therapeutics Announcement Celldex Therapeutics (CLDX) announced today preclinical data from its CDX-622 bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor (SCF), also known as KIT receptor ligand, developed from its bispecific antibody platform. TSLP and SCF demonstrated their contribution to the pathophysiology of various inflammatory, fibrotic and allergic disorders. The data . . . This content is for paid …

CureVac B.V. CureVac (CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology with more than 20 years of expertise in developing, optimizing and manufacturing this versatile biological molecule for medical purposes. CureVac’s proprietary technology uses optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable . . . This content is for paid …

Gilead Sciences CHMP Adopted Positive Opinion for Hepcludex® Today, May 4, 2023, Gilead Sciences (GILD) acknowledged that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex® (bulevirtide) for adults having chronic HDV and compensated liver disease,  recommended granting full Marketing Authorization (MA) that . . . This content is for paid subscribers. …

 ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results  On April 28, 2023, ImmunoGen (IMGN) reviewed recent progress in the business and reported financial results for the quarter ended March 31, 2023.  Immunogen's drug ELAHERE® (mirvetuximab soravtansine-gyn) is a first-in-class antibody drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid . . . This content is for paid subscribers. Please …

Vertex Pharmaceuticals ORKAMBI Receives Positive CHMP Opinion Today, April 27, Vertex Pharmaceuticals  (VRTX) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) embraced a positive opinion for the label extension of ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Apellis Pharmaceuticals Validation for Pegcetacoplan Apellis Pharmaceuticals (APLS) announced the receival of validation of its marketing applications by regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland for intravitreal pegcetacoplan regarding the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The decisions by the local regulatory authorities in these four countries are . . . This content is for paid subscribers. Please …

Important News from CymaBay Therapeutics Primary Biliary Cholangitis Today, April 21, 2023, CymaBay Therapeutics (CBAY) announced that results from the ENHANCE phase 3 global study evaluating seladelpar for Primary Biliary Cholangitis (PBC) have been published in Hepatology. The authors . . . This content is for paid subscribers. Please click here to subscribe or here to log in.