Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients. Read More
Taking its mission as looking at how cells function as opposed to looking at them anatomically, Kojin Therapeutics Inc. is launching with a $60 million series A to accelerate its ferroptosis-, or iron-dependent cell death-, based discovery platform for tackling hard-to-treat diseases, including drug-resistant cancers. Read More
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept). The news sent Remegen’s share price (HKEX:9995) up 12.8% in Hong Kong on June 9. Read More
Byondis BV is gearing up for a U.S. filing of an antibody-drug conjugate (ADCs) in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases. Read More
Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy. Read More
With Pharmabcine Inc.’s anti-angiogenic antibody TTAC-0001 (olinvacimab) already in testing against recurrent glioblastoma multiforme (GBM) and metastatic triple negative breast cancer, CEO Jin-San Yoo is now giving serious thought to starting trials to test it in children with brain tumors. Plans to begin four additional trials between the end of 2021 and the beginning of 2022 are also underway. Read More
For the second time, the biopharma industry’s largest event will be held virtually as BIO Digital 2021, with pandemic preparedness and infectious diseases a running theme throughout many of the scheduled sessions. Read More
Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries, including artificial intelligence, biotechnology and quantum computing. Read More
Recognizing that people with cancer want to know what symptoms they may experience and how a particular therapy may affect their quality of life, the FDA is issuing a draft guidance advising sponsors on incorporating a core set of patient-reported outcomes (PROs) into cancer clinical trials. Read More
New hires and promotions in the biopharma industry, including: Aeon, CDR-Life, Celsion, Chinook, IMV, Intercept, Karyopharm, Mind Medicine, PTC, Travecta. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology's annual meeting, including: Abbvie, Ascentage, Compugen, Hookipa, Osel, PDS, Seven and Eight. Read More
Biopharmas raising money in public or private financings, including: Aclaris, Alcyone, Cel-Sci, Lyell, Molecular, Ocuphire, Soligenix, Valeo, Viacyte. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ananda, Asklepios, Avadel, Bluerock, Chinook, Effector, Icosavax, Incarda, India Globalization, Nanology, Nascent, Noveome, Noxxon, Synaptogenix, Virios. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene. Read More
