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The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Adakveo® (crizanlizumab) should no longer be used to prevent painful crises in patients aged 16 years and older with sickle cell disease.  This follows a review by the CHMP, which concluded...

Alnylam commenced  proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer alleging patent infringement over Alnylam’s RNA Lipid Particle Technology encompassed in United States Patent Nos. 11,590,229, 11,633,479, 11,633,480 and 11,61...

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory recognition routes for medicines, utilising approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore, and the US to expedite new product approvals.  T...

Korea Biomed has reported that Celltrion filed a marketing authorisatn application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab).  Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy, pharmaco...

The Pharma Letter has reported that the STADA-controlled Norbitec biologics facility in Uetersen, Germany, has been approved by the FDA to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx), biosimilar to Amgen’s Epogen®/Procrit®.  The approval followed a six-day ...

Astrazeneca announced that it has received approval in Japan for Ultomiris® (ravulizumab).  Ultomiris is  the first and only long-acting C5 complement inhibitor approved for preventing relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis o...

Bristol Myers Squibb announced that the EMA CHMP recommended the approval of Opdivo® (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) with a high risk of recurrence in adult patients w...

AstraZeneca announced that its Ultomiris® (ravulizumab) has a new indication approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQ...