As the first targeted C3 therapy for treating paroxysmal nocturnal hemoglobinuria, the FDA’s approval of Apellis Pharmaceuticals Inc.’s Empaveli (pegcetacoplan) now means it will compete against C5 inhibitors from Alexion Pharmaceuticals Inc. Empaveli’s wholesale acquisition cost, $458,000 annually per patient, is set at parity to Alexion’s Ultomiris (ravulizumab) and at a discount to Soliris, the company said. Empaveli is approved for treatment-naïve adults with the rare, chronic and potentially life-threatening blood disorder characterized by red blood cell destruction via extravascular and intravascular hemolysis. Patients suffer persistently low hemoglobin levels, which the therapy is designed to increase. The Waltham, Mass.-based company’s stock (NASDAQ:APLS) surged in midday trading as share value swelled 19%.

Soteria raises $42M series A to develop switchable bispecific T-cell engagers

Soteria Biotherapeutics Inc., a company developing switchable bispecific T-cell engagers to treat patients with solid tumors, has raised $42 million in series A financing to fund early development of a pipeline of candidates with potential in validated cancer targets, it said. Roche Venture Fund and 5AM Ventures led the round with further investments from M Ventures, Novartis Venture Fund and Alexandria Venture Investments.

Lianbio licenses Landos’ LANCL2- and NLRX1-targeted candidates in $218M deal for UC and CD

Shanghai and New Jersey-based Lianbio Co. Ltd. has made its second in-licensing deal in a week. This time, it obtained rights for omilancor and NX-13, both under development by Landos Biopharma Inc. for the potential treatment of ulcerative colitis (UC) and Crohn’s disease (CD) – plus eosinophilic esophagitis, for omilancor – in greater China, South Korea and seven ASEAN countries as part of a $218 million deal.

Sinopharm vaccine draws questions after Seychelles COVID-19 case spike

Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of the COVID-19 vaccines used by the island nation. Among the fully vaccinated population, nearly 57% received China National Pharmaceutical Group (Sinopharm)’s inactivated vaccine, BBIBP-CorV , according to the island country’s health ministry, while 43% received the Oxford University-Astrazeneca plc vaccine Covishield. Despite mass vaccination efforts, Seychelles has seen a surge in the number of COVID-19 cases, despite 37% of the patients being fully vaccinated.

Supreme Court: Enbrel biosimilars will have to wait out U.S. patents

It looks like the two biosimilars referencing Amgen Inc.’s Enbrel (etanercept) will have to wait most of the decade before they can launch in the U.S. The U.S. Supreme Court declined to hear Sandoz Inc.’s appeal of last year’s split Federal Circuit ruling affirming the validity of two patents protecting etanercept and its manufacturing methods. Thanks to a tortuous route through the U.S. Patent and Trademark Office, the patents won’t expire until 2028 and 2029, even though Enbrel was approved in 1998. Sandoz’s biosimilar, Erelzi, has been sidelined in the U.S. since its approval in 2016. A second U.S. biosimilar, Samsung Bioepis Co. Ltd.’s Eticovo, joined Erelzi on the U.S. bench when it was approved in 2019.

TIGIT space grows more crowded as Arcus, Iteos, others march on

The field of anti-TIGIT drugs continues to bubble. Interim phase II data are coming soon from the likes of Arcus Biosciences Inc. (partnered with Gilead Sciences Inc.), as Iteos Therapeutics Inc. prepares to enter the combination-cohorts portion of the phase I/IIa study with its prospect in the class. Among a raft of other players, Merck & Co. Inc. has vibostolimab in the works.

Abbvie CEO faces House grilling on Humira, Imbruvica price hikes

As part of its ongoing investigation into what it considers excessive prescription drug price increases, the U.S. House Oversight Committee plans to put Abbvie Inc. CEO and Chairman Richard Gonzalez on the hot seat May 18 for a grilling on the company’s pricing of Humira and Imbruvica. Today’s $77,586 annual price tag for Humira (adalimumab), a mega-blockbuster immunosuppressive drug, is 470% higher than it was when the biologic entered the market in 2003, thanks to 27 price increases. Imbruvica (ibrutinib), a cancer drug partnered with Johnson & Johnson, now has an annual price tag, based on three pills a day, of $181,529 as compared with $99,776 per year at its 2013 launch.

FDA COVID-19 guidance lays out best practices for master protocols

To accelerate drug development targeting the pandemic, the FDA issued final guidance on master protocols for drugs intended to prevent or treat COVID-19 infections. The guidance primarily focuses on umbrella trials, which evaluate multiple therapies simultaneously for a single disease, and platform trials, which evaluate multiple therapies for a single disease in a perpetual manner, with therapies entering or leaving the platform based on a decision algorithm. The master protocols accelerate drug development by maximizing the information from the trials and reduce administrative costs and time, according to the FDA. They also can be updated to incorporate new scientific information.

CMS punts on MCIT rule, argues coverage already available for most breakthrough devices

Despite support from a wide range of stakeholders and bipartisan congressional support, the U.S. Centers for Medicare & Medicaid Services has suspended implementation of the Medicare Coverage of Innovative Technology (MCIT) rule through Dec. 15, 2021. The CMS argued that most of the approved or cleared breakthrough devices are already covered through existing payment mechanisms, but the delay opens the door to any one of multiple possible legislative solutions, such as follow-on legislation to the 21st Century Cures Act.

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