Fierce Pharma Asia—Eisai and Biogen's Leqembi progress; AZ and Daiichi's Enhertu data; Samsung Biologics' manufacturing deal

The FDA appears to support a full approval for Biogen and Eisai’s Leqembi, a briefing document ahead of an advisory committee meeting suggests. AstraZeneca and Daiichi Sankyo’s Enhertu could break into other tumor types, according to early data experts call “very compelling.” Samsung Biologics will manufacture biosimilars for Pfizer in a long-term, $411 million deal. And more.

1. FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

Eisai and Biogen’s Alzheimer’s disease drug Leqembi could be on its way to full approval, but first an advisory committee will have its say on the medicine. In a briefing document ahead of Friday's adcomm meeting, the FDA said that Leqembi’s treatment effect in its pivotal study is supported by “consistently favorable” results. Now, it will be up to the advisory committee to vote on whether the study results verify the treatment benefits. The FDA is due to decide on the drug by July 6.

2. ASCO: AstraZeneca, Daiichi's Enhertu delivers 'very compelling' pan-tumor activity, experts say

AstraZeneca and Daiichi Sankyo’s Enhertu has posted early pan-tumor data experts called “very compelling." The trial showed that the HER2 antibody-drug conjugate shrank tumors in 37.1% of patients with various types of HER2-expressing solid tumors through a median of 11.8 months. The results could eventually enable Enhertu to win a tumor-agnostic FDA approval.

3. Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics is set to manufacture biosimilars for Pfizer under a new $411 million contract. Samsung called the deal a “long-term” arrangement and committed to providing “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio." Pfizer’s biosimilar portfolio includes copycats to Roche’s Rituxan, Avastin and Herceptin, Johnson & Johnson’s Remicade and Amgen’s Neupogen.

4. Astellas takes another punt at tricky muscular condition despite past patient deaths

Despite patient deaths taking a major toll on Astellas’ previous attempt at a gene therapy for rare neuromuscular disease X-linked myotubular myopathy, the Japanese pharma company is taking another go at it with a new preclinical asset called KT430. Astellas scooped up rights to the therapy from Kate Therapeutics for an undisclosed sum.

5. FDA to allow temporary overseas production to shore up supplies of chemo drug

As the U.S. navigates a major shortage of cancer meds, the FDA is allowing temporary importation of chemotherapy cisplatin from Chinese manufacturer Qilu Pharmaceutical. The 50-mg vials will be distributed in the U.S. by Canadian-based Apotex Corp. The FDA also told India’s Intas Pharmaceuticals that it could resume shipping cisplatin and chemotherapy carboplatin, along with 14 other injectables, despite manufacturing deficiencies found at the company's site during an inspection last year. 

6. Coherus, Junshi eye FDA finish line after agency finally conducts plant inspection

After a May 2022 FDA rejection for Coherus BioSciences and Junshi Biosciences’ cancer med toripalimab, the companies are gearing up for another try. The FDA has now completed its pre-licensing inspection of Junshi’s China manufacturing site and made three observations that Coherus believes are “readily addressable,” it said in a Securities and Exchange Commission filing.

7.  Eisai hit with ransomware attack, launches investigation into possible data leaks

After being hit with a ransomware attack, Eisai quickly set up a companywide task force to respond to the incident and is now working with external experts and law enforcement. The Japanese company is still investigating the possibility of data leaks and expects it will “take some time” to determine the full scope of the cyberattack, Eisai said in a statement.