Radiopharmaceuticals have been used for a long time for diagnostics, but radiopharma therapies are entering a new era in which they are becoming widely accepted as a key tool in the oncology armamentarium potentially providing patients with a big bump in efficacy with fewer side effects and less damage to healthy tissue. In this eight-part series, BioWorld takes a deep dive into this new treatment modality to explore what the new uses or alternatives are and what the future of radiopharmaceutical therapy might look like. Part one sets the stage and outlines the beginnings of the industry and some of the challenges drugmakers will need to overcome. The series takes a closer look at the different radiopharmaceutical moieties, the science behind them, the patient journey, the therapies in the pipeline, the regulatory landscape, and the supply chain vulnerabilities. Read More
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader. Read More
The big idea behind radiopharmaceuticals is taking the hallmarks of two cancer therapies – radiology and chemotherapy – and merging them, and this is what makes the technology a disrupter. Read More
A frustrating lack of detail left analysts with little to do but speculate on the odds for a 2023 U.S. FDA approval of Ascendis Pharma A/S’s Transcon PTH (palopegteriparatide), a parathyroid hormone prodrug for hypoparathyroidism, after the company disclosed a letter from the agency citing unspecified deficiencies that preclude further discussions about labeling and postmarketing requirements. Read More
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more. Read More
For European biotech, the first quarter (Q1) of 2023 could hardly be described as the best of times – but the period did not represent the worst of times either. European firms engaged in drug discovery and development collectively raised $1.88 billion during this period. The tally is 4% less than the total raised in the comparable period last year, and it represents just 32% of the total raised during the COVID-19-fueled biotech boom during 2021. But it’s still the third highest Q1 raise during the last six years. Read More
More than four years after it was given the authority to do so, the FDA is requiring manufacturers of opioid painkillers dispensed in outpatient settings to make prepaid mail-back envelopes available to pharmacies and other dispensers as part of their risk evaluation and mitigation strategy (REMS). Read More
Cancer treatment developer Apollomics Inc. merged with special purpose acquisition company (SPAC) Maxpro Capital Acquisition Corp., gaining a listing on Nasdaq under the ticker APLM and raising $23.65 million of private investment in public equity (PIPE). Read More
New hires and promotions in the biopharma industry, including: Anheart, Appili, Arvinas, Bicycle, Biosenic, Cancervax, Heron, Mitsubishi Tanabe, Newamsterdam, Qnovia, Relief. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Almirall, Anavex Life Sciences, Curasen, Cytokinetics, Eisai, Eledon, Eli Lilly, Hansa, Immutep, Insmed, Invivyd. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Alligator, Ascendis, BMS, Cabaletta, Chiesi Global Rare Diseases, Citius, Fennec, Huidagene, Hutchmed, Inmune, Kiromic, Neurobo, Novartis, Samsung Bioepis, Sandoz, Sequana Medical, Soligenix, Tango, TG, Vertex. Read More
