Over the past decade cancer immunotherapy has redefined standard care in many kinds of tumor, but low response rates remain a problem and there have been some shock trial failures where checkpoint inhibitors have failed to work as expected. To help, Neobe Therapeutics Ltd. is attempting to tackle an important constituent of the tumor microenvironment, the extracellular matrix.

Shares in Akero Therapeutics Inc. more than doubled in value after the company announced results from a phase IIb nonalcoholic steatohepatitis trial that it believes show lead candidate efruxifermin could challenge other candidates in development for the fatty liver disease targeted by so many biotechs and big pharmas.

It’s been five years since the first CAR T-cell therapy was approved, marking the beginning of a new era in cancer therapy, but it’s been a huge effort from pharma to turn them into commercial therapies. David Sourdive, co-founder and vice president for CMC and manufacturing at gene and cell therapy specialist Cellectis SA, is one of many in the field of advanced therapies who argue that CAR T cells are just the vanguard from a new army of cell therapies that could prove decisive in the war against cancer.

Ducentis Biotherapeutics Ltd. has been acquired by Arcutis Biotherapeutics Inc. for up to $400 million, representing a landmark moment for seed investor Lifearc Ventures, which aims to kick-start promising biotechs in the U.K. while giving any investment returns to its parent medical charity.

The U.S. FDA has become the first global regulator to approve Boehringer Ingelheim GmbH’s spesolimab, the first treatment specifically approved for generalized pustular psoriasis flares in adults, a rare and potentially fatal disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection. Ingelheim, Germany-based Boehringer Ingelheim is not giving away details about pricing but Carinne Brouillon, a member of the company’s board responsible for human pharma, said Spevigo is “priced similarly to the other biologic therapies used to treat rare dermatologic diseases.”

Regulation of advanced therapies has come under scrutiny at a conference in London, as activity in the sector heats up amid Europe’s root and branch review of pharmaceutical legislation.

Access to advanced therapies proved to be a major talking point at a conference in London, following the U.S. approval of Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) cell-based gene therapy for beta thalassemia and its $2.8 million price tag. Regulators in Europe backed Zynteglo in 2019 but Bluebird opted to withdraw the therapy in 2021 after deciding that the complex thicket of pricing bodies in Europe was too difficult to negotiate.

Nuvectis Pharma Inc. has been in business for barely two years, but thanks to a business model involving in-licensing promising late preclinical drug candidates, it has already begun a trial with a molecule targeting a little-known pathway that cancer cells depend on for protection. The firm is also close to the clinic with a drug that could give a new twist to tyrosine kinase inhibition after a $16 million financing round in early August.

The race to develop an oral selective estrogen receptor degrader (SERD) is under fresh scrutiny in light of Sanofi SA’s decision to axe development of its late-stage compound amcenestrant on Aug. 17, citing lack of efficacy in breast cancer trials. While there are concerns about the new class after Sanofi’s decision, a clear signal about its future could be growing nearer. The driver? Menarini Group and its development partner, Radius Health Inc., are advancing elacestrant, an oral SERD into regulatory reviews on both sides of the Atlantic.