AbbVie announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of risankizumab (SKYRIZI®) for treating adults with moderately to severely active ulcerative colitis (UC) who…
Be Biopharma Announces FDA Clearance for BE-101 IND Application in Hemophilia B Be Biopharma, Inc. (“Be Bio”), a pioneer in Engineered B Cell Medicines (BCMs), has announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug…
A Journey from Curiosity About Life on Earth to Transformative Therapies at Novartis When I was young, my fascination with science began with the natural world and animals. A BBC Nature presenter and biologist, David Attenborough, was a significant idol…
Roche announced today that James Sabry (born 1958), Head of Roche Pharma Partnering, will be retiring after fourteen years with the company. James Sabry joined Genentech in 2010 as Head of Genentech Partnering. In 2018, he became Head of Pharma…
Today, it was announced that new subgroup analyses from Ionis and AstraZeneca’s Phase 3 NEURO-TTRansform study of WAINUA™ (eplontersen) will be presented at the 2024 International Symposium on Amyloidosis (ISA) in Rochester, Minnesota, taking place from May 26 to May…
First-in-human data for the potential first-in-class anti-CEACAM5 ADC with topoisomerase 1 inhibitor payload, M9140, in the treatment of metastatic colorectal cancer to be featured in an oral presentation. Phase I data for tuvusertib, the lead asset from the company’s unique…
Eli Lilly and Company announced today a significant increase in investment for its Lebanon, Indiana, manufacturing site. The company has committed an additional $5.3 billion, bringing the total investment to $9 billion. This expansion will boost Lilly’s capacity to produce…
CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) have announced the publication of groundbreaking findings in Nature Communications, revealing the results from a comprehensive phase 1/2/3a/3b study investigating the safety, immune response, and effectiveness of ARCT-154, a pioneering self-amplifying (sa-mRNA)…
Today, AstraZeneca unveiled its ambitious target to achieve $80 billion in Total Revenue by 2030, a significant increase from the $45.8 billion reported in 2023. This expansion will be fueled by substantial growth in its existing oncology, biopharmaceuticals, and rare…
AstraZeneca to Establish $1.5 Billion Antibody Drug Conjugates (ADCs) Manufacturing Facility in Singapore AstraZeneca plans to build a $1.5 billion manufacturing facility in Singapore, aimed at enhancing the global supply of its Antibody Drug Conjugates (ADCs). ADCs represent next-generation cancer…
Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. This treatment is for adult patients with PIK3CA-mutated, hormone receptor-positive, human…
Eli Lilly’s Mirikizumab Shows Promise in Phase 3 Study for Crohn’s Disease In Eli Lilly and Company’s pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn’s disease, regardless of previous biologic failure, showed significant and meaningful improvements…