Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).

Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.

Roche AG’s Genentech unit landed another clinical victory with giredestrant that provided a major stock boost for competitor Olema Pharmaceuticals Inc. Made public were positive phase III data from the Lidera study testing selective estrogen receptor degrader and complete estrogen receptor antagonist (CERAN) as an adjuvant endocrine treatment for people with ER-positive, HER2-negative, early stage breast cancer (BC).

DNA damage response specialist Artios Ltd. has closed an oversubscribed $115 million series D after delivering positive phase I/IIa data for its two lead programs.

A potentially $1.76 billion oncology deal created a little more than three years ago between partners Jazz Pharmaceuticals plc and Zymeworks Inc. now has a more solid direction. New and positive top-line results for the phase III Herizon-GEA-01 study of the HER2-targeted bispecific antibody zanidatamab in locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) moved the stock and expectations for both companies.

About a month after rolling out positive phase I/II data with its candidate for metastatic, castrate-resistant prostate cancer (mCRPC), Halda Therapeutics Inc. disclosed the plan by Johnson & Johnson (J&J), which is paying to take over the company for $3.05 billion in cash.

In a deal worth up to $840 million, Third Arc Bio Inc. is licensing Adagene Inc.’s Safebody technology platform to generate two masked CD3 T-cell engagers against unique tumor associated antigens.

Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.

The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.

Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.