The CDC’s Advisory Committee on Immunization Practices again took up the matter of risk vs. benefit with the COVID-19 vaccine made by Johnson & Johnson, and proved significantly less skeptical at its second meeting. The FDA and CDC swiftly determined that the recommended pause should be lifted and use of the vaccine should resume. Read More
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product. Read More
While biopharma deals are not showing any drastic changes over last year, three areas that continue to dominate the landscape include the pandemic, oncology and cell and gene therapies. The lack of mega-mergers so far this year, specifically those above $10 billion, is also holding M&A values down by about 61% compared to this point in 2020, even though the number of mergers has climbed. Read More
LONDON – A large scale U.K. study looking at the impact of COVID-19 vaccinations on antibody responses and new infections in 373,402 people in the general population has shown a single dose of vaccine cut infections by 65%. Symptomatic infections fell by 74% and infections with no reported symptoms by 57%, 21 days after receiving the first dose of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s vaccine. Read More
DUBLIN – The European Medicines Agency (EMA) has reiterated its support for Astrazeneca plc’s Vaxzervia COVID-19 vaccine, following an interim analysis of a data review, which the agency’s Committee on Human Medicinal Products (CHMP) has conducted over the past two weeks. Read More
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children. Read More
Shares of Inovio Inc. (NASDAQ:INO) fell 25% to $6.85 on April 23 after the company said the U.S. Department of Defense scratched funding for the phase III portion of an ongoing trial of its COVID-19 vaccine candidate, INO-4800, in light of the broad availability of other COVID-19 vaccines in the U.S. The news followed recent phase I data showing '4800 performed about in line with already available competitors against SARS-CoV-2 variants now dominant in the U.S. Read More
Twenty years after the first, exclusively white human genomes were fully sequenced, science finds itself in the same position as the rest of society: with the uncomfortable realization that old inequalities are often morphing, rather than disappearing. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Arena, Avillion, Boehringer Ingelheim, Brickell, Bristol Myers Squibb, Eli Lilly, EMD Serona, Incyte, Janssen, Nicox, Novartis, Novavax, UCB, Verona. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Courage, E-therapeutics, Ethypharm, Galapagos, Inovio, Life. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ADC, Biogen, BMS, Calliditas, Eisai, Gilead, Glaxosmithkline, Hua, Leo, Medicago, Merck, Protara, Roche, Shanghai Henlius, Shorla. Read More
