Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, defended the agency's rejection of Eli Lilly and Innovent Biologics' PD-1 inhibitor. The U.S. Senate has signed off on a bill focused on reducing the country's supply chain reliance on China. Insilico Medicine shows its artificial intelligence drug discovery engine works in age-related diseases. And more.
1. 'In the long-term interests': FDA oncology chief defends rejection of Lilly, Innovent cancer drug
In an interview with Fierce Pharma, FDA oncology chief Richard Pazdur, M.D., said the decision to reject Eli Lilly and Innovent Biologics’ PD-1 inhibitor sintilimab was a “future-directing approach to what drug development should be.” Conducting global trials is “in the long-term interest of all countries,” he said. And international data help the FDA understand the overall quality of results while the agency gets familiar with trial sites in China.
2. Senate blesses bill to wrest US supply chains from China's grasp, with pharma front and center
The U.S. Senate passed the U.S. Innovation and Competition Act of 2021, which is designed to restore the country’s manufacturing capabilities and reduce its reliance on China for critical supplies, especially drugs and medical devices. Instead, the bill encourages the U.S. and Europe to develop “joint strategies” to diversify supply chains. The House and the Senate will now attempt to agree on a final bill.
3. Insilico Medicine's AI zeroes in on new drug targets for aging, age-related diseases
New research shows Insilico Medicine’s artificial-intelligence-powered platform PandaOmics could predict molecular targets for new drugs to treat aging and age-associated diseases like Alzheimer’s, Parkinson’s, cirrhosis, rheumatoid arthritis and more. PandaOmics queries transcriptomics data to allow researchers to compare gene targets and narrow them done to those specific to age-related illnesses.
4. As Lilly, Innovent hit FDA rebuff, another China-made PD-1 cancer drug faces possible delay
The FDA’s rejection of Lilly and Innovent’s sintilimab has put a question mark on the next China-made PD-1 in line at the FDA, toripalimab by Coherus BioSciences and Junshi Biosciences. The drug’s target action date of April 30 now looks precarious as the FDA has yet to schedule an inspection of the manufacturing site in China because of COVID-19 travel restriction, Coherus said.
5. Ono pulls trigger on deal for multispecific antibody against 'very challenging' cancer target
Ono Pharmaceutical partnered with Numab Therapeutics on a multispecific antibody in 2017. Now, Ono has exercised its option to in-license the lead candidate, coded ND023, in a 258 million Swiss franc ($279 million) package, which includes upfront, milestone payments and research funds. The drug is for a “new and very challenging immuno-oncology target,” Ono said.
6. Roche's Chugai pays Halozyme $25M to access subcutaneous delivery tech
Roche’s Chugai Pharmaceutical has paid $25 million and committed up to $160 million in milestones for Halozyme Therapeutics’ Enhanze subcutaneous drug delivery technology. The tech is billed as a way to increase the volume of biologics that can be administered under the skin, thereby allowing drugs to switch from intravenous to more convenient subcutaneous delivery.
7. Aurobindo strikes branded generics buyout to build biosimilars 'launch pad' in India
Aurobindo is buying Indian compatriot Veritaz’s domestic formulations business for 171 crore rupees ($22.6 million). Veritaz holds about 180 trademarks and markets 40 products across anti-infective and pain management fields.
8. Bayer CEO Werner Baumann faces revolt from investor Temasek Holdings: report
Singapore’s state holding company Temasek plans to revolt against Bayer’s management team under CEO Werner Baumann at the German company’s upcoming annual meeting set for April 29, Bloomberg reports. Temasek, which holds 4% in Bayer, blames Baumann for the problems that have stemmed from the $63 billion Monsanto purchase in 2018.
In a global-first nod, Japan’s drug regulator has cleared Sanofi’s Xenpozyme for acid sphingomyelinase deficiency, making the drug the only approved treatment anywhere for the rare disease. The drug is also under priority review tracks in the U.S. and the EU, with decisions expected later this year.
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11. SK Bioscience eyes CDMO expansion, venture into cell and gene therapy (Yonhap)