Astrazeneca plc’s Tagrisso (osimertinib) seems poised to become standard of care in the adjuvant setting for early stage (IB, II and IIIA) EGFR-mutated non-small-cell lung cancer (NSCLC), thanks to phase III data from the study called Adaura, made public at the American Society of Clinical Oncology (ASCO) meeting. Read More
Positive preclinical data from Phio Pharmaceuticals Inc., of Marlborough, Mass., propelled the company stock (NASDAQ:PHIO) dramatically upward, about 86%, at midday Friday only to see it finally settle at a more modest 36.16% increase to close May 29 at $3.05. Read More
A phase III test of roluperidone, a drug developed by Minerva Neurosciences Inc. with a goal of treating negative symptoms in schizophrenia, found that the experimental medicine failed to deliver statistically significant differences vs. placebo in improving both the trial's primary endpoint, a common measure of symptom severity, and its secondary endpoint, a score measuring social function. Read More
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo). Read More
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing. Read More
SUZHOU, China – Chinese CAR T therapy developers from early to IPO-ready-stage are confident that they can create a strong presence in the global scene with their innovations, and they are also making strategies that will work best for their home market. Read More
HONG KONG – South Korea’s Qurient Co. Ltd., located in Gyeonggi-do, is preparing to send its novel drug, Q-702, into the clinic after receiving clearance from the U.S. FDA, roughly a month after submitting the application on April 24. Read More
The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner. Read More
Biopharmas raising money in public or private financings, including: Arcus, Genetic Technologies, Iovance, Legend Biotech, Marinus, Mersana, Palvella. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achilles, Adverum, Aveo, Bio-Path, BMS, Chiesi, Corvus, Eloxx, Galera, Janssen, Minerva, Molecular Partners, Myovant. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Boehringer, Chi-Med, Immune-Onc, J&J, Lilly, Menlo, Nabriva, Novartis, Onxeo, Orphazyme, Roche, Santhera, Takeda. Read More
Few would dispute that the best way to find innovative solutions to the COVID-19 pandemic is through industry, academia and government working together. BioWorld data indicate that more than 45% of the biopharma deals with nonprofit entities (bio/nonprofit) in 2020 are indeed focused on fighting the globally-disruptive SARS-CoV-2 virus. Read More
