IntellaTurn, LLC

• Inqovi (decitabine and cedazuridine tablets) with venetoclax is now approved by the FDA for treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are aged 75 and older or have comorbidities that preclude the use of intensive induction chemotherapy.

• The approval is notable for delivering the first all-oral treatment option in this setting.

• Until now, patients have relied on regimens built around parenteral hypomethylating agents—most commonly azacitidine plus venetoclax, the standard of care since the VIALE-A trial—requiring monthly, 7-day clinic visits for injections.

• The new all-oral regimen offers equivalent efficacy with significantly reduced treatment burden. (Pharmacy Times)

• The FDA granted accelerated approval to Beqalzi (sonrotoclax) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

• The approval specifically indicates the drug for patients who have received at least two lines of systemic therapy, which must include a Bruton's tyrosine kinase (BTK) inhibitor.

• Beqalzi is a next-generation BCL-2 inhibitor designed to target the aggressive B-cell malignancy. (Cure Today)

• Last Friday, two days after handing Partner a Commissioner's National Priority Voucher (CNPV), the FDA gave the all-clear to the company’s bispecific antibody Bizengri as a second-line treatment for adults with advanced, unresectable or metastatic cholangiocarcinoma with an NRG1 gene fusion. 

• The approval in the rare bile duct cancer marks the third indication for Bizengri, which scooped up class-first accelerated nods in NRG1+ pancreatic adenocarcinoma and non-small cell lung cancer in late 2024.

• Partner licensed US rights to the bispecific from its developer Merus in close conjunction with Bizengri’s first approval. 

• The new nod in cholangiocarcinoma, meanwhile, marks the latest in a series of swift approvals issued under the controversial CNPV pilot program, which the FDA debuted last June. (Fierce Pharma)

• But it won't solve the organizational upheaval and political jockeying that marked much of his 13-month tenure.

• The FDA itself is also facing other key internal vacancies, including for directors of the centers overseeing drugs and biologics.

• And there are questions about whether a successor will continue efforts to streamline clinical trials and other regulatory actions.

• "Marty is a great guy. He was having some difficulty," Trump told reporters, in response to questions about whether he resigned or was fired.

• Mid-sized European drugmakers have taken control of the M&A train. As April turned to May, a series of European pharma companies agreed to acquisitions of US biotechs worth billions of dollars.

• The flurry of activity raised a question: Does the succession of deals represent a trend or a coincidence?

• Kerem Can Alp, director of launch and commercial operations lead at Eversana, sees a trend. The deals reflect the “structural vice” that European mid-caps are caught in, Alp said.

• Most Favored Nation (MFN) drug pricing is eroding the economics of the companies’ home markets, “directly linking European reference prices to US negotiations and threatening the commercial logic of launches across the continent,” Alp said.

• The proposed MFN models could stop companies from charging higher prices in the US than in certain reference countries. Some companies have deferred launches in Europe to avoid tying their US prices to overseas markets, and experts have warned that the medicines available in the two markets could diverge. (Biospace)

• Bristol Myers Squibb is turning to one of China’s most prolific pharma companies for help finding new medicines, announcing Tuesday a multifaceted alliance with Hengrui Pharma that involves 13 early-stage drug prospects and could be worth more than $15 billion. 

• Over the last few years, large drugmakers have increasingly turned to China in search of drugs they can quickly advance through testing.

• Regulatory flexibility, low supply chain costs and an explosion of biotechnology investment have yielded a trove of drug candidates that can quickly get to human testing and, in many cases, are being designed to one-up medicines either in development or on the market. 

• The pact is at least the fifth cross-border alliance Hengrui has been involved in since the start of 2025. (Biopharma Dive)

• As the president lands in Beijing, one major industry is missing from his business delegation—pharma.

  • Medtech company Illumina’s CEO, Jacob Thaysen, is the sole representative from the life sciences industry.

• According to a list by The New York Times, the 17-member delegation is dominated by Wall Street and tech giants, including Apple’s Tim Cook, Nvidia’s Jensen Huang and Tesla’s Elon Musk, as well as the CEOs of Goldman Sachs, BlackRock and Blackstone. Brian Sikes of Cargill is the only one for agriculture and food. 

• But pharma isn’t the only absence from Trump’s side. No entities in wholesale, retail or culture were included. (Fierce Pharma)

• The largest biotech round ever belongs to Altos Labs, another AI-focused drug discovery engine, which emerged in 2022 with a massive $3 billion fundraising.

• Indeed, funding over at least the last year has shifted to later-stage assets as investors grow more risk-averse.

“Rounds like these give tech capital a place to go in biotech, while the rest of the industry stays focused on getting drugs to patients—and that’s probably a healthy split.”

• Rather than dedicating efforts to a specific disease target, machine learning models sit at the heart of Isomorphic’s engine, enabling work across different therapeutic areas and modalities, according to the biotech’s website.