BeiGene's BTK inhibitor latecomer Brukinsa posted another head-to-head win against AbbVie and Johnson & Johnson's blockbuster Imbruvica. China's Hua Medicines has won an industry-first approval for Bayer-partnered diabetes med dorzagliatin. Novavax pulled the plug on a Fujifilm contract manufacturing deal as uptake for its COVID-19 vaccine remains low. And more.
1. BeiGene heaps more pressure on AbbVie, J&J with new Brukinsa head-to-head win over Imbruvica
BeiGene’s Brukinsa topped AbbVie and Johnson & Johnson’s Imbruvica at staving off tumor progression or death in patients with previously treated chronic lymphocytic leukemia in the head-to-head ALPINE trial. The readout deals another blow to Imbruvica as the top-selling BTK inhibitor after Brukinsa had previously shown superiority on the tumor shrinkage endpoint.
Hua Medicine and commercial partner Bayer have won a Chinese go-ahead for dorzagliatin in Type 2 diabetes, making the drug the first glucokinase activator approved anywhere in the world. But the drug’s unimpressive efficacy data, China’s heavy price cuts on older diabetes meds and fierce competition from experienced players like Novo Nordisk have cast doubt on its commercial potential.
3. Amid low vaccine demand, Novavax pulls out of Fujifilm manufacturing deal and inks $185M settlement
Novavax is paying up to $185 million to terminate a COVID-19 vaccine manufacturing deal with Fujifilm Diosynth Biotechnologies. The final payment may be smaller as the Japanese CDMO will try to find other manufacturing business to try to offset the losses that it would incur from reserving the capacity for Novavax. The two are parting ways as Novavax’s shot suffers from low demand.
Siemens Healthineers has decided to separate China from its Asia-Pacific umbrella. The China branch will be led by its own director, Jerry Wang, who has headed up operations there since 2018. China accounts for nearly half of the Siemens unit’s Asia-Pacific haul, bringing in 2.35 billion euros in the 2021 fiscal year.
5. Sun, Camber join growing list of companies reporting Adderall supply problems
Sun Pharma and Hetero’s Camber Pharma are the latest to report Adderall supply problems, according to the University of Utah Pharmacy Services website. Before that, Teva, Amneal, Novartis’ Sandoz, Purdue Pharma’s Rhodes Pharma, Endo’s Par Pharma and Lannett have also reported shortages or difficulties in meeting demand.
6. Eisai cuts the ribbon on $69M injectable drug delivery facility
Eisai has completed construction of a $69 million facility that will serve as the Japanese pharma’s global base for formulation and modality research. The company will work on drug delivery methods, including liposomal and lipid nanoparticle formulations. The site will make investigational liquid drugs and offer space for collaboration with outside partners.
7. With China filing in its sights, ArkBio shares more phase 3 data on ex-Roche antiviral in RSV
Ark Biopharmaceutical has shared data for its RSV candidate ziresovir, which was discovered by Roche. In infants hospitalized with RSV infection, the drug reduced the duration of stays in intensive care units. The rate of wheezing was also significantly reduced in a group of children aged under 6 months who took ziresovir compared with those on placebo. The company had previously said it planned to file for approval in China midyear.