While Servier Pharmaceuticals LLC awaits this summer’s PDUFA date for the IDH-mutant glioma drug vorasidenib, acquired in the buyout of oncology assets from Agios Pharmaceuticals Inc., the latter unveiled positive data from a global phase III study with oral mitapivat in adults with transfusion-dependent alpha- or beta-thalassemia. Read More
Unblinding, zealous therapists, severity of harms, abuse potential and actual benefit could all be part of the conversation June 4 when the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee meets in person for the first time since the COVID-19 lockdowns to consider the use of a psychedelic drug, guided by psychotherapy, to treat post-traumatic stress disorder, or PTSD. Read More
With its hands full developing QRL-101 and QRL-201, both in clinical trials for amyotrophic lateral sclerosis with plans to expand into other neurodegenerative diseases such as frontotemporal dementia, Quralis Corp. has decided to out-license its preclinical ALS and FTD drug, QRL-204. Read More
Shares of Structure Therapeutics Inc. (NASDAQ:GPCR) were trading up more than 54%, gaining $18.54 to close June 3 at $52.74, on the back of data for GSBR-1290, an oral, GLP-1 receptor agonist it hopes to position in the highly competitive obesity market. The latest readout sees the company regaining ground lost late in 2023 when earlier phase IIa data prompted unflattering comparisons to more advanced oral GLP-1 candidates. Read More
Astrazeneca plc’s blockbuster Enhertu continued to garner attention as new data released at the American Society of Clinical Oncology (ASCO) annual meeting show the antibody-drug conjugate demonstrated strong progression-free survival in metastatic breast cancer patients. Puma Biotechnology Inc. had advances of its own at ASCO with new biomarker findings from a phase II study of alisertib, an aurora protein kinase 2 inhibitor, in endocrine-resistant metastatic breast cancer. Read More
Cambridge, Mass.-headquartered Flagship Pioneering Inc. opened its Asia-Pacific (APAC) headquarters in Singapore on June 1, BioWorldlearned from APAC chair and strategic adviser André Andonian in a May 30 interview. Read More
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn. Read More
South Korea’s Genome & Co. Ltd. (KOSDAQ:314130) shares rose nearly 30% June 3 after it disclosed a potential ₩586.38 billion (US$426 million) licensing deal for its novel antibody-drug conjugate candidate with Switzerland’s Debiopharm International SA. Read More
While there was much talk about the vast potential of artificial intelligence (AI) during one of the world’s largest research cancer conferences, antibody-drug conjugates (ADCs) continued to grab the lion’s share of attention as Corbus Pharmaceuticals Holdings Inc. and Takeda Pharmaceutical Co. Ltd. released new and positive data. Read More
Eli Lilly and Co.’s updated phase I/II study of olomorasib as a monotherapy in patients with KRAS G12C-mutant advanced solid tumors yielded more promise in data released over the weekend at the American Society of Clinical Oncology (ASCO) annual meeting. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Blueprint, Gilead, Ionis, Medicenna, Nextcure, Novartis, Pfizer, Summit, Telix., Ultragenyx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Biogen, Bristol Myers Squibb, Calliditas, Catalyst, Larimar, Invivyd, Minoryx, Pharming, Regeneron, Sanofi, Sifi, SN. Read More
Chris Bardon, a co-managing partner at MPM Bioimpact, shares her insights into the American Society of Clinical Oncology (ASCO) conference. She talks about the major trends in oncology, including development of antibody drug conjugates, which is currently the hottest area in cancer treatment. Read More
