Novartis' sale of some troubled U.S. generics and dermatology products to Aurobindo helps the Indian company become the second-largest generics play by U.S. prescriptions. A former GlaxoSmithKline scientist has pleaded guilty to conspiring to steal trade secrets for her Chinese startup. Eli Lilly and Chi-Med's Elunate has become the first Chinese-made drug cleared for a major cancer treatment. And more.
1. Novartis finally unloads 300 troubled U.S. generics to India’s Aurobindo for $1B
India’s Aurobindo Pharma is buying part of Novartis’ Sandoz U.S. business for $1 billion. The deal includes about 300 products and several development projects in generic oral solids and dermatology, as well as three manufacturing facilities and about 750 employees. While the deal relieves Novartis of a troubled franchise, it boosts Aurobindo to become the second-largest generics player by prescriptions in the U.S.
2. Former GSK cancer scientist admits attempt to steal trade secrets
Yu Xue, a former GlaxoSmithKline scientist at its R&D unit in Philadelphia, has pleaded guilty to a Department of Justice charge that she stole confidential research and funneled it to conspirators and co-founders of biotech Renopharma in China. Xue insists she did not know that the material was considered secret, but Judge Joel Slomsky agreed with prosecutors.
3. Eli Lilly, Chi-Med’s Elunate becomes first China-made cancer drug to win a key nod
China’s drug regulator has approved Chi-Med and Eli Lilly’s Elunate (fruquintinib) for patients with colorectal cancer who have failed at least two treatments. The drug is the first Chinese-made medicine for a major cancer type to clear the full span of discovery, development and now commercialization completely in China. Chi-Med is now also eyeing the U.S. market.
4. Valsartan probe teaches FDA lesson about impurities in manufacturing
The FDA said U.S. company Prinston Pharmaceutical had contacted the agency to report detection of possible carcinogen NDMA in the API made by Zhejiang Huahai Pharmaceutical. Since the Huahai impurity was identified, more than half of all valsartan products on the market are being recalled. The FDA also believes that the impurity resulted from changes made to the manufacturing process.
5. Cipla, Zydus Cadila and more eye $1B deal for Bharat Serums: report
Several Indian biopharma companies, including Cipla, Zydus Cadila and Dr Reddy’s laboratories, are eyeing a potential buy of Bharat Serums and Vaccines in a deal that could be worth $1 billion, according to The Economic Times.
6. Fosun Pharma ‘massively’ fakes API production data and bribes regulators, whistleblower says
Self-claimed employees of Chongqing Pharma Research Institute, a Fosun Pharma unit, alleged that the company illegally changed production processes of almost all its APIs and fabricated data and manipulated testing readouts to achieve passing results. A local drug regulator has started an investigation, and the national agency also sent a supervisory team.
7. Qiming, Hillhouse lead Jacobio’s $55M series C
Beijing-based Jacobio Pharmaceuticals has raised $55 million in a series C led by Qiming Capital and Hillhouse Capital. The company is working on drugs for cancer, autoimmune diseases and infectious diseases. The money will help advance a cancer drug dubbed JAB-3000 into the clinic.
8. Otsuka's dose-tracking digital pill charts its first course to market with Magellan
In its first wave of use, Otsuka's Abilify MyCite, the only FDA-approved digital pill, will be distributed through Magellan Health’s network of mental health providers. The electronic version of the mental disorder drug Abilify is designed to help patients take their medications as directed.
9. SpringWorks names a CEO, inks a combo therapy deal with BeiGene
Launched a year ago with $103 million and a handful of Pfizer drugs, SpringWorks Therapeutics has now named its first CEO in Saqib Islam. It also inked a deal that combines its MEK inhibitor PD-0325901 with BeiGene’s RAF dimer inhibitor lifirafenib in patients with advanced solid tumors.
10. Italian CDMO buys India API plant that supplies Novartis
Italian CDMO Olon is buying an API plant in Mahad, India, which supplies ingredients to Novartis’ Sandoz. The company said the deal allows it to add new CDMO projects and “to develop new generic products for the Indian market.”
11. Suono Bio gets Fujifilm investment for its second-generation drug delivery tech, names new CEO
Japan’s Fujifilm is investing in Suono Bio’s second-generation drug delivery technology that uses speedy, formulation-independent application of therapeutics that include biologics and gene therapies.