Fierce Pharma Asia—Daiichi AML med's 2nd FDA shot?; BeiGene's Brukinsa delay; Kyowa Kirin mulls asset sale

Daiichi Sankyo's once FDA-rejected quizartinib could have a second chance at a U.S. approval with its phase 3 win in newly diagnosed acute myeloid leukemia. BeiGene's application for Brukinsa in chronic lymphocytic leukemia hit a three-month FDA extension. Kyowa Kirin is reportedly weighing the sale of some international assets. And more.

1. Daiichi Sankyo's survival data mean it may finally be ready to compete with Novartis', Astellas' marketed AML meds

The FDA had rejected Daiichi Sankyo’s quizartinib in previously treated acute myeloid leukemia (AML). But the drug may find a second chance with U.S. regulators. In newly diagnosed AML with the FLT3-ITD mutation, a regimen of quizartinib and chemotherapy showed it could help patients live longer than chemo alone, according to phase 3 data presented at the European Hematology Association congress.

2. In short reprieve for AbbVie and J&J, FDA extends BeiGene's Brukinsa review in blockbuster leukemia realm

The FDA extended its decision date for BeiGene’s Brukinsa in chronic lymphocytic leukemia to Jan. 20, 2023. The agency needs more time to review new data from a phase 3 trial in previously treated patients after BeiGene submitted an updated analysis by an independent review showing Brukinsa topped AbbVie and Johnson & Johnson’s market-leading Imbruvica at shrinking tumors. The application also includes data on newly diagnosed patients.

3. Kyowa Kirin weighing $1 billion asset sale: Bloomberg

Kyowa Kirin is considering selling some assets outside of Japan, sources close to the matter told Bloomberg. The sale would include “established and mature products” that could fetch about $1 billion, but nothing has been determined, according to the news organization.

4. Boston Scientific offers $230M for Korean maker of gastrointestinal and airway stents

Boston Scientific has offered to buy out Korea’s Synergy Innovation's 64% stake in M.I.Tech, a maker and distributor of non-vascular metal stents. For 14,500 Korean won (about $11) apiece, Boston Sci is paying about $230 million in total. M.I.Tech’s Hanarostent technology offers self-expanding metal stents for endoscopic and urologic procedures.

5. Pfizer lays off sales staffers in India amid marketing model revamp

Pfizer has reportedly abruptly terminated over 200 of its Indian sales reps. The layoffs come two months after the unit rolled out a voluntary retirement scheme for the field staffers there. Pfizer is changing its “go-to-market model” in India and is instead creating new roles focusing on digital engagement, a spokesperson said.

6. Pfizer's blockbuster rare disease med Vyndaqel hits supply snag in Korea thanks to quality problem: report

Pfizer halted the supply of rare disease med Vyndaqel in Korea, Korea Biomedical Review reports. A Pfizer spokesperson pointed to an internal inspection, which uncovered “a minor packaging issue with one batch of the medicine.” The problematic drugs were discarded, and the issue is considered closed, the spokesperson told Fierce Pharma.

7. Sanofi union members set strike date in Korea as wage negotiations stall: report

Unionized Sanofi workers in South Korea threatened to go on strike next month after failing to reach an agreement on a pay raise, Korea Biomedical Review reports. Sanofi Aventis Korea and the union had held eight rounds of negotiations plus a mediation and still couldn’t find common ground. The union lowered its demand to a 4% increase, while Sanofi stuck to 1.5%.

8. Teva, after Lupin deal, holds another Austedo generic challenger to a 2033 launch

9. Shionogi quests to slay antibiotic resistance with cefiderocol licensing and collaboration troika

10. SK Biotek earmarks $35M for first expansion phase at Irish API plant

11. Organon pays Fosun's Henlius for biosimilars to Roche's Perjeta, Amgen's Prolia (release)