The co-founders of a Chinese biotech have countersued their former employer Pfizer in a legal battle over alleged trade secret theft. Eli Lilly and Innovent Biologics have received bad news for their PD-1 inhibitor. Aurobindo is closing off operations at a New Jersey facility. And more.
After Pfizer accused two former employees of stealing trade secrets related its GLP-1 program for diabetes and obesity, the two ex-staffers, co-founders of Qilu Regor Therapeutics, have countersued the Big Pharma company. The Chinese startup said its own GLP-1 receptor agonists, which have attracted a partnership with Eli Lilly, are the result of R&D efforts unrelated to Pfizer’s work.
The FDA has officially rejected Eli Lilly and Innovent Biologics’ PD-1 inhibitor sintilimab—marketed as Tyvyt in China—in newly diagnosed nonsquamous non-small cell lung cancer. The agency asks that the partners run an additional global clinical trial. The thumbs-down serves as a warning for other companies looking to use clinical data generated solely or predominantly in China to seek U.S. approvals.
Aurobindo is shuttering its Aurolife Pharma site in New Jersey, putting 99 jobs on the chopping block. The Garden State facility has a history of running afoul of manufacturing standards. Most recently, in a warning letter issued in October 2020, the FDA cited a raft of issues at the plant including water leaks and impurity concerns tied to drug ingredients for a generic antipsychotic medicine.
AstraZeneca, the largest multinational pharma in China with $6 billion sales in the country in 2021, is projecting a mid-single-digit percentage decline for its business there in 2022, mainly thanks to pricing pressures. Despite the headwinds, analysts at Jefferies still projected that China’s branded drug market could grow to $85 billion in 2030 from $31 billion in 2021.
Takeda has received an FDA complete response letter for its proposed changes to get hypoparathyroidism drug Natpara relaunched in the U.S. Takeda stopped shipping commercial Natpara and issued a recall in 2019 on concerns that rubber from the injector cartridge could shed into the medicine after repeated use. Takeda said it’s evaluating the letter to decide next steps.
Sun Pharma is shelling out $485 million to settle a class-action antitrust lawsuit it inherited from the Ranbaxy Laboratories buyout eight years ago. Several buyers claimed Ranbaxy violated antitrust laws by submitting multiple applications for FDA approval that contained missing or fraudulent information to win 180-days exclusivity for several of its generic drugs under the FDA’s “first applicant” rule.
HDT Bio is waging a trade secret theft lawsuit against Emcure Pharmaceuticals, the parent of HDT’s COVID-19 vaccine manufacturing partner, Gennova Biopharmaceuticals. HDT is developing a self-amplifying RNA shot with funding from the National Institutes of Health. But instead of helping out, Emcure filed patent applications on the vaccine tech that HDT says was its own.
Fujifilm has acquired Pennsylvania-based Shenandoah Biotechnology for an undisclosed sum to increase its cell and gene therapy capabilities. The purchase follows a string of Fujifilm investments in the cell and gene therapy space, and it boosts the company’s ability to produce recombinant proteins, especially growth factors and cytokines.
Moderna last year suffered a reputation crisis in Japan after some COVID-19 vaccine vials were found to be contaminated with metallic particles. To win back Japanese customers amid a push for a fourth dose, the Massachusetts-based company is deploying ads that include sumo flags and imagery.