Samsung is plotting a $205 investment across its businesses including for its biosimilars and CDMO units. Moderna is probing contaminations in its COVID-19 vaccines in Japan as about 1.63 million doses are put on hold. Brii Biosciences reported positive phase 3 data from its antibody cocktail in nonhospitalized COVID-19 patients. And more.
1. Samsung plots $205B investment, massive hiring spree to ramp up CDMO, biosimilars and more
The Samsung Group is investing 240 trillion won ($205 billion) through 2023 across its many businesses including its biosimilars unit Samsung Bioepis and its contract manufacturing operation Samsung Biologics. The South Korean conglomerate will channel 180 trillion won ($154 billion) to upgrade its domestic facilities. Among them, Samsung Biologics will build two new plants, dubbed Plant 5 and Plant 6, at its existing hub in Incheon.
2. Moderna probes reports of COVID-19 vaccine contamination in Japan
Japan has suspended the use of about 1.63 million doses of Moderna’s COVID-19 vaccine after distributor Takeda received reports of impurities in some vials. Moderna said it hasn’t identified any safety concerns but has put the lot at question and two additional lots on hold. The company said it suspects the problem at a contract manufacturing facility in Spain might be the cause.
Brii Biosciences has reported positive data for its COVID-19 antibody cocktail. The two-drug combo, BRII-196/BRII-198, slashed the risk of hospitalization and death by 78% against placebo in high-risk, nonhospitalized COVID patients in the NIH-sponsored ACTIV-2 study. Brii’s figures compare favorably to phase 3 data from Regeneron’s antibody cocktail, REGEN-COV.
In an updated analysis of cost-effectiveness of hereditary angioedema therapies, the Institute for Clinical and Economic Review suggests Takeda’s Takhzyro should cost 53% less than its current U.S. list price and its predecessor, Cinryze, 75% less. The new calculation came after the drug cost watchdog found patients suffered fewer baseline hereditary angioedema attacks in the real world than in recorded in clinical trials, suggesting the drugs’ benefits are smaller.
FibroGen partner Astellas has won an EU nod for Evrenzo, better known as roxadustat, in anemia associated with chronic kidney disease. Astellas is also responsible for markets in Japan, Russia, the Middle East and South Africa. While the drug was recently rejected by the U.S. FDA, Mizuho analysts believe it can still collect $690 million sales from Europe and Japan at its peak.
6. Genevant pens $303M biobucks pact with Takeda aimed at rare liver diseases using gene therapy
Takeda already has a $600 million deal with Genevant to use the latter’s lipid nanoparticle tech to work on nucleic acid therapeutics that target liver fibrosis. Now, the Japanese pharma is back with another $303 million upfront-plus-biobucks pact to target two undisclosed rare liver diseases.
Lonza is adding a new fill-finish line at its biologics plant in Guangzhou, China, which just opened in the second quarter of this year. The addition is expected to be complete next year and will create over 150 jobs. The expansion follows a 20 million Swiss franc investment at the Swiss CDMO’s API plant in Nansha, China, which was unveiled in June.
8. FDA puts Jubilant Generics plant through the wringer for cleanliness, quality flubs
In its first publicly posted Form 483 in months, the FDA blasted Jubilant Generics for a slate of problems at the company’s facility in Haridwar, India. During an inspection in March, FDA inspectors found an array of problems including that the factory didn’t clean and maintain its equipment often enough and didn’t conduct a proper investigation after a recall.
9. After vandalism during unrest in South Africa, India-based Cipla reopens Durban manufacturing site
Cipla has reopened a manufacturing site in Durban, South Africa, more than a month after it was vandalized and looted July 13 during civil unrest triggered by the jailing of former President Jacob Zuma. To mitigate the supply disruptions, Cipla said it leveraged other manufacturing sources in the country.
10. Coffee talk: Sun brings Ilumya patient stories to light with informal diner meetups
For Sun Pharma’s latest ad campaign, four psoriasis patients on its IL-23 inhibitor meet for the first time at a Savannah, Georgia, diner to share their stories living with the disease and finding treatments. The idea for the “Patient Stories” campaign was inspired by findings from a national survey that patients are interested in talking to other patients.