Johnson & Johnson and Legend Biotech have increased their investment in a New Jersey cell therapy facility to $500 million. Takeda has decided to drop global Natpara production permanently after years of trying to fix a manufacturing problem that triggered a recall in 2019. Merck is following through with its promise to invest up to $500 million in Singapore over five years.
1. J&J, Legend double CAR-T manufacturing investment to $500M as Carvykti eyes wider myeloma use
Johnson & Johnson and Legend Biotech have decided to double their investment in a cell therapy manufacturing site in New Jersey, bringing the total to $500 million, Legend CEO Ying Huang, Ph.D., said at an investor event. The move comes as the companies await a readout for Carvykti in earlier multiple myeloma following positive results from Bristol Myers Squibb’s rival Abecma.
2. After years of manufacturing woes, Takeda is calling it quits on Natpara
Takeda has decided to stop making hypoparathyroidism drug Natpara globally by then end of 2024 in the wake of a manufacturing problem that has put commercial supply on halt for years. The company has been offering the drug through a special use program to U.S. patients as it works to resolve the problem, which involves rubber particulate shedding into the vial.
3. In $500M expansion, Merck opens one Singapore facility and breaks ground on another
As part of a commitment to invest up to $500 million in Singapore, Merck has opened a new secondary packaging and sterile filling facility in the country. The company also broke ground on a new inhaler production facility in Singapore.
Samsung Biologics is “continuing to expand in all dimensions,” CEO John Rim said in a recent interview with Fierce Pharma. The CDMO giant is waiting for the right time to grow outside South Korea, even though most of its business already resides in Europe and the U.S. The company has looked at different locations in the U.S. and might also make an acquisition, the CEO said.
5. In Daiichi case, court upholds jury's $177.8M infringement ruling against Novartis
A California court has upheld a patent infringement verdict against Novartis, ordering the Swiss pharma to pay Daiichi Sankyo $177.8 million plus a 9% royalty on Novartis’ cancer drug Tafinlar until certain Daiichi patents expire later this decade. But the court reversed the jury’s original finding of willful infringement, which would have pushed the payments up even more.
6. FDA hits Lupin with another warning notice for troubled API plant
Following a Form 483 in April, Lupin has received an FDA warning letter for its active pharmaceutical ingredient plant in Tarapur, India. Lupin unveiled the problem in a stock filing but didn’t specify the exact issues cited by the FDA. The company doesn't believe the warning letter will disrupt supplies or existing revenues from the facility.
7. Myovant says no to Sumitomo's takeover bid but is open to negotiating a better deal
Japan’s Sumitomo has offered to buy the rest of Myovant Sciences for $22.75 per share in cash. Myovant’s board rejected the proposal, saying the price, which represented a 27% markup on the company’s share price as of last Friday, “significantly undervalues” the company. Sumitovant, a wholly owned subsidiary of Sumitomo Dainippon Pharma currently owns 52% of Myovant.
Otsuka’s Taiho Oncology has won FDA accelerated approval for Lytgobi, or futibatinib, for previously treated bile duct cancer, also known as cholangiocarcinoma, that bears FGFR2 genetic abnormalities. The new FGFR inhibitor is going up against Incyte’s Pemazyre and BridgeBio and QED Therapeutics’ Truseltiq.
9. Moderna rejects China’s request for mRNA technology transfer in failed COVID vaccine talks (Financial Times)
Moderna’s negotiation with the Chinese government to bring its COVID vaccine to China has collapsed, the Financial Times reports. The Massachusetts-based biotech rejected Beijing’s request to transfer mRNA technology out of commercial and safety concerns, FT reports, citing two people involved in negotiations that happened between 2020 and 2021.