The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
With the next big wave of biologic patent expirations soon to wash over the U.S. market, companies developing biosimilars are optimistic about the future. “We’re at a place where we’re seeing really strong uptake of biosimilars, which has resulted in cost savings,” Chad Pettit, executive director of marketing for Amgen Inc.’s biosimilars unit, told BioWorld.
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis.
HONG KONG – Chinese biotech companies, long in-licensors of innovative biopharma assets for the region, have started to reverse the flow by out-licensing domestically generated candidates to global players. The changing tide signals China’s innovation in the life sciences is bearing fruit. But the country’s efforts isn’t without complication, shadowed now by tense relations with the U.S.
HONG KONG – Chinese biotech companies, long in-licensors of innovative biopharma assets for the region, have started to reverse the flow by out-licensing domestically generated candidates to global players.
A nearly $2 billion global development and commercialization deal with Abbvie Inc. and a $418 million private placement have bolstered I-Mab Biopharma Co. Ltd.’s position globally. I-Mab framed the deal as being the largest out-licensing and global partnership transaction ever executed by a China-based biotech. Abbvie and I-Mab plan to develop and commercialize the anti-CD47 monoclonal antibody lemzoparlimab for treating multiple cancers globally, with the exception of China. Lemzoparlimab, also called TJC-4, is Shanghai-based I-Mab’s discovery and its lead cancer therapy. The company will get an up-front $180 million by licensing the highly differentiated antibody to Abbvie, along with a $20 million milestone payment based on phase I results.
A nearly $2 billion global development and commercialization deal with Abbvie Inc. and a $418 million private placement have bolstered I-Mab Biopharma Co. Ltd.’s position globally. I-Mab framed the deal as being the largest out-licensing and global partnership transaction ever executed by a China-based biotech.
Investigators at Weill Cornell Medical College have demonstrated that mitochondrial DNA drives the abscopal antitumor response to radiation, which can be boosted by autophagy inhibition.
Bold up-fronts and even bigger milestones defined ambitious neurology deals Abbvie Inc. struck with Voyager Therapeutics Inc. in 2018 and 2019. With vectorized antibodies, they planned to target multiple indications tied to excess aggregations of tau and tragic synucleinopathies. Considerable progress was made, said Omar Khwaja, Voyager's chief medical officer. But despite millions of dollars invested in the programs, Abbvie has now decided to quit the venture, leaving Voyager to either go it alone or find a new partner in its work on the challenging indications.
