Oncology December 28, 2023 Eli Lilly concludes POINT Biopharma acquisition for $1.4bn By PBR Staff Writer In October this year, Lilly signed a definitive agreement for POINT Biopharma acquisition. POINT Biopharma focuses on developing radioligand treatments for cancer and has a pipeline of such
Approvals December 22, 2023 SELLAS receives orphan drug designation for PTCL therapy By PBR Staff Writer Currently, SLS009 is under evaluation in a Phase Ib/II trial for patients with r/r PTCL. The study, which is open-label and single-arm, plans to enrol up to 95
Approvals December 21, 2023 Calliditas receives approval for Nefecon to treat IgAN By PBR Staff Writer This marks Nefecon as the first FDA-approved treatment for IgAN. Nefecon is an oral, delayed-release formulation of budesonide, a corticosteroid with potent anti-inflammatory properties. The enteric-coated capsule approval
Musculoskeletal Disorders December 19, 2023 Allay grants acute pain management drug license to Japan’s Maruishi Pharmaceutical By PBR Staff Writer ATX101 is designed for sustained, localised pain relief post total knee arthroplasty surgery. Under the agreement, Allay will receive an upfront payment and equity investment. It is also
News September 7, 2023 Maruho enters licence deal with Journey Medical for Qbrexza By PBR Staff Writer Under the agreement, Maruho will be responsible for the development and commercialisation of Qbrexza in South Korea, Brunei, Cambodia, Indonesia, Hong Kong, Macau, Vietnam, Malaysia, Philippines, Thailand, Myanmar,
RegulationApprovals July 28, 2023 EC approves AstraZeneca’s Soliris to treat refractory gMG in children, adolescents By PBR Staff Writer The first-in-class C5 complement inhibitor, Soliris has been indicated for anti-acetylcholine receptor antibody-positive children and adolescents aged six to 17 years. It is claimed to be the first
RegulationOphthalmology June 29, 2023 Regeneron receives FDA response letter for aflibercept’s BLA By PBR Staff Writer The letter is based on a continuing assessment of inspection data at a third-party filler. No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical
Infectious Disease June 26, 2023 MPP signs sublicence agreements for Shionogi’s Ensitrelvir By PBR Staff Writer Ensitrelvir is a COVID antiviral presently approved in Japan and being analysed in clinical trials outside of the country. The sublicence agreements were inked with three generic manufacturing
Immunology June 21, 2023 Eli Lilly and Company agrees to acquire DICE Therapeutics By PBR Staff Writer Under the deal terms, Lilly will begin a tender offer to purchase all outstanding shares of DICE for an acquisition price of $48 per share in cash, which translates to a total
Drug Manufacturing June 8, 2023 Samsung Biologics, Pfizer partner for biosimilars portfolio manufacturing By PBR Staff Writer Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more