Dengue vaccine tetravalent(Takeda)

The World Health Organization prequalified Takeda’s new dengue vaccine on Wednesday, a year after the company withdrew its FDA application for the candidate — though the company now says it will soon “re-engage” with the FDA. The WHO wrote in a statement that the vaccine, known as TAK-003 or Qdenga, is recommended for children 6 to 16 years old in areas with a burden and transmission of dengue, adding that the vaccine should be administered in a two-dose schedule with a three-month interval between doses. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

BeiGene's business expansion, Bristol Myers' new India facility, and changes in AstraZeneca and FibroGen's Evrenzo pact made our news this week. BeiGene expanded its global workforce by 1,400 over the past 12 months amid fast revenue growth. Bristol Myers Squibb has launched a new innovation hub in India, which the company expects to be its largest site outside the U.S. by 2025. AstraZeneca has decided to hold onto Evrenzo in China and Korea while returning its rights to FibroGen in the U.S. and other territories. And more.  1. BeiGene grows global workforce by 1,000-plus as Brukinsa surges, Tevimbra launches outside China BeiGene has grown its head count by 1,400 between early 2023 and mid-February 2024. The global expansion came as BeiGene’s product sales climbed 75% year over year to reach $2.2 billion in 2023. The growth was led by BTK inhibitor Brukinsa, which crossed the blockbuster threshold, generating $1.3 billion in sales. The company is still waiting for the FDA’s decision on its PD-1 inhibitor Tevimbra. 2. BMS inaugurates India innovation hub to be its largest site outside US by 2025 (Reuters) Bristol Myers Squibb has opened a new innovation hub in Hyderabad, India. The facility, built with a $100 million investment, is expected to house more than 1,500 employees. It will enhance BMS’ drug development through the use of digital technologies and artificial intelligence, CEO Chris Boerner said. The New Jersey pharma expects the facility to become its largest site outside the U.S. by 2025, Reuters reported. 3. AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure AstraZeneca has parted ways with FibroGen on the ill-fated oral anemia drug roxadustat in the U.S. and certain other countries. The company kept its collaboration rights in China and South Korea, where the drug is approved as Evrenzo. Last year, Evrenzo’s sales in China rose 36% to $284 million, and FibroGen expects the figure to increase to around $300 million to $340 million this year. 4. FDA to ramp up inspections of manufacturing facilities in India (Reuters) The FDA conducted more than 200 inspections in India in 2023, and the agency is still looking to increase that number by adding more staffers to be stationed there, the FDA’s country director in India, Sarah McMullen, said, according to Reuters. The FDA official said Indian drugmakers need to invest more in automation to ensure better compliance. 5. Takeda taps Biological E to ⁠ramp up Qdenga manufacturing capacity on quest to make 100M doses a year Takeda has tapped India’s Biological E. to help manufacture the dengue fever vaccine Qdenga. The new partner will produce multidose vials for endemic countries by 2030 at the latest. The Indian firm will produce up to 50 million doses of Qdenga per year as part of Takeda’s overall goal to make 100 million doses per year within the decade. 6. With J&J settlement, Biocon Biologics gets a license to challenge Stelara in the US Biocon Biologics has joined the group of biosimilar makers that have signed settlements with Johnson & Johnson around the blockbuster inflammatory disease drug Stelara. Biocon’s deal allows its biosimilar to enter the U.S. market in February 2025, pending an FDA approval. 7. Teva partners up for Austedo marketing in China (Release) Teva has partnered with Jiangsu Nhwa Pharmaceutical to market and distribute the Israeli pharma company’s Austedo in China. In a press release, Teva’s general manager of greater China, Theodor Wee, praised Nhwa’s “deep neuro-psychiatry expertise and capabilities.” The deal follows a trend in which foreign pharmas are increasingly relying on local companies to handle commercialization in China.