With several COVID-19 vaccines already in phase 3 trials and investigators aiming to enroll tens of thousands of participants, Johnson & Johnson is prepping the largest study yet.
The drugmaker is planning to enroll a whopping 60,000 participants in a phase 3 trial set to begin next month, according to the government’s clinical trial database.
That’s twice the enrollment rival vaccine makers Moderna and Pfizer are planning for their own phase 3 tests. Pfizer has already enrolled more than 11,000 people, according to a Thursday update. And Moderna signed up 8,374 participants in the first three weeks of its own trial, CNN reported earlier this week. But officials were concerned about a dearth of minorities enrolled in the Moderna trial, CNN reports.
Aside from those companies, AstraZeneca’s vaccine is also in phase 3 testing in the U.K., Brazil and South Africa. The company has enrolled about 8,000 participants in the U.K. out of an expected 10,000, a spokesman told Politico on August 13. Investigators have vaccinated about 3,000 people in Brazil and 900 people in South Africa.
As for J&J, investigators plan to test the company’s vaccine, Ad26.COV2.S, against placebo to see whether the candidate can reduce moderate to severe COVID-19. J&J expects the study to start around September 5.
These companies represent the COVID-19 frontrunners, but many other players are involved in the hunt for a COVID-19 vaccine, including Novavax and a partnership between Sanofi and GlaxoSmithKline. Novavax is prepping a 30,000-person phase 3 trial for this fall.
As the vaccines move forward, governments around the world have been negotiating supply deals to be ready if the candidates succeed. The U.S. has inked agreements for 800 million doses, and Europe is in advanced discussions with several companies after signing a pact for 400 million doses with AstraZeneca.
By: Eric Sagonowsky
Source: Fierce Pharma
Novo Holdings has concluded the acquisition of all outstanding shares of commercial-stage biopharmaceutical company Paratek Pharmaceuticals for nearly $462m (€433.67m) to bolster its antimicrobial resistance (AMR) expertise. Paratek develops and commercialises new treatments for life-threatening ailments. Its speciality pharmaceutical platform aids in developing new therapeutics.
Glenmark Pharmaceuticals has signed a definitive agreement for the divestiture of a 75% stake in its division, Glenmark Life Sciences (GLS), to Indian company Nirma in a deal valued at Rs56.51bn ($679.85m). Glenmark Life Sciences focuses on producing active pharmaceutical ingredients (API).
Pierre-Alain Ruffieux, CEO of Lonza, will leave the Basel-based company at the end of September. According to the Swiss Contract Development and Manufacturing Organization (CDMO), the separation is by mutual agreement.
