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Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated locally adv...

Merck (MSD) announced that the European Commission approved Keytruda® (pembrolizumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC).  The ...

On 27 March 2024, Korea Biomedical Review reported that Korean biologics manufacturer Rophibio (affiliate of  healthcare company Amicogen) entered into an agreement with US biotech Avantor to supply raw materials and provide support for the development of a biosimilar to MS...

On 27 March 2024, Biocon announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) approved its liraglutide in the UK, which is the first approved biosimilar to Novo Nordisk’s Victoza® (liraglutide).  Biocon’s liraglutide, a drug-device combination (6mg/...

On 26 March 2024, MSD announced that its WINREVAIR™ (sotatercept-csrk) has been approved by the FDA for treating adults with pulmonary arterial hypertension (PAH).  FDA classified WINREVAIR™ as a breakthrough therapy due to it representing a new class of therapy which funct...

The perils of prioritising commercial strategies over patenting strategies
Pearce IP’s Founder Naomi Pearce discusses this topic on prime time radio with ABC Law Report Host Damian Carrick, in light of the recent decision of the Federal Court in Allied Pumps Pty...

The Korea Biomedical Review reports that South Korean company, Sam Chun Dang Pharm Co Ltd (SCD), has entered an exclusive distribution agreement with an unnamed distributor to supply its Eylea® (aflibercept) biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, ...

On 25 Mar 2024, Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for (up to) € 1.025B comprised of an initial payment and milestone payments.
Cardior Pharmaceuticals specialises in RNA-targeted therapies aimed at preventing, repairing, and reversing h...

On 24 March 2024, the Korea Economic Daily (KED) reported Samsung Bioepis entered pre-clinical stage, with multiple undisclosed gene therapy candidates, for the treatment of rare diseases.
According to KED, Samsung Bioepis is committed to advancing drug development th...