Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.

Acceleron-gained sotatercept comes through for Merck in PAH phase III 

Merck & Co. Inc. scored a phase III win in the pivotal phase III Stellar trial with sotatercept, an activin receptor type IIA-Fc fusion protein tested as an add-on to background therapy for the treatment of pulmonary arterial hypertension. The study met its primary efficacy outcome measure, showing a statistically significant and clinically meaningful improvement in six-minute walk distance test at 24 weeks from baseline. Merck brought aboard sotatercept in the $11.5 billion buyout about a year ago of Acceleron Pharma Inc. Shares of Merck (NYSE:MRK) were trading midday at $90.08, up $2.48.

NMPA nod gives Hua Medicine first GKA approval in diabetes

Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.

Makena’s fate is FDA adcom’s mission 

The U.S. FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee meets next week in a step to determine the fate of Makena (17-hydroxyprogesterone caproate), a grandfathered drug for preventing miscarriages. In October 2020, the FDA proposed withdrawing Makena from the U.S. market because a required postmarketing study failed to show a clinical benefit for the drug, which is for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The adcom will discuss whether to keep the drug available while a confirmatory study is designed and conducted while also considering if available evidence demonstrates the drug is actually effective. Covis Pharma BV markets the progesterone receptor agonist. The adcom convenes Oct. 17-19.

Andera closes Biodiscovery 6 fund at €456M

Andera Partners closed its Biodiscovery 6 fund at €456 million (US$442 million). The Paris-based venture capital firm will maintain its custom of allocating about two-thirds of the fund to biotechnology and one-third to medical devices and medical technology. The fund just edges past its target of €450 million. It is considerably larger than its immediate predecessor, Biodiscovery 5, which raised €345 million. “The idea here is to be able to deploy larger amounts if we need to,” Sofia Ioannidou, a partner at Andera, told BioWorld.

Evgen shares pop on autism med deal with Stalicla

Shares in Evgen Pharma plc more have more than doubled in value after the U.K. biotech signed a deal worth up to $160.5 million with Switzerland’s Stalicla SA, to develop sulforaphane-based drug SFX-01 for certain patients with autism spectrum disorder. Geneva-based Stalicla specializes in identification of specific phenotypes of autism spectrum disorder using its precision platform. Evgen, which is also developing sulforaphane-based medicines for several types of cancer, retains global rights in all other indications.

CSL’s Seqirus snags $30M contract with BARDA to develop pandemic avian flu vaccines

CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial. The first candidate will use a combination of cell-based and adjuvanted technologies that build on Seqirus’ combination platform technology used by Audenz (A H5N1c), a cell culture-based, MF59-adjuvanted, inactivated, monovalent vaccine for preventing H5N1 avian influenza A virus infection. The second candidate will use Seqirus’ next-generation self-amplifying mRNA (sa-mRNA) platform. Both cell-based and sa-mRNA technologies are steps forward in strengthening and diversifying vaccine development, manufacturing and supply chains and promoting new approaches to detect, prevent and respond to a potential influenza outbreak.

Also in the news

Allogene, Alnylam, Biontech, Bone Biologics, Clarity, CSL Seqirus, Diurnal, Evonik, Hugel, Icosavax, Immatics, Immune-Onc, Immunic, Knight, Lyell, Merck, Mersana, Prolynx, Ochre, Octapharma, Oravax, Pierre Fabre, Radiomedix, Revive, Ridgeback, Scpharmaceuticals, Teva, Xortx