Johnson & Johnson (J&J) will spin off its consumer health division as a stand-alone public company, leaving J&J to focus on its pharmaceutical and medical device businesses.
Shares of Alkermes plc slipped 15% Nov. 9 on news that longtime partner Janssen Pharmaceutica NV plans to partially terminate two license agreements related to know-how royalties on U.S. sales of paliperidone products using Alkermes’ nanoparticulate technology. While the move is expected to result in only a modest near-term impact on the Dublin-based firm’s bottom line, it took both company management and investors by surprise.
Lawfully selling prescription opioid drugs is not a public nuisance, the Oklahoma Supreme Court said in overturning a $465 million judgment against Johnson & Johnson (J&J).
Trendlines Group Ltd. reported the acquisition of its portfolio company Orthospin Ltd. by Synthes GmbH, a division of Depuy Synthes, the orthopedics company of Johnson & Johnson (J&J), for $79.5 million in cash. Johnson & Johnson’s involvement in the company goes back to July 2018, when J&J Innovation (JJDC) led the company’s series A round.
Pfizer Inc. said that, in children aged 5 through 11, the COVID-19 vaccine it co-developed with Biontech SE showed 90.7% efficacy against all variants of concern following two doses. The data were included in briefing documents filed ahead of a full discussion at the FDA’s Vaccines and Related Biological Products advisory committee meeting set for Oct. 26.
Despite some concerns from a few members, the Advisory Committee on Immunization Practices unanimously approved recommendations to the CDC that boosters be made available to those wanting them. The advisory committee recommended that a single COVID-19 vaccine booster dose be given six months or more after completing an mRNA primary series in the same risk group for whom the CDC recommended a booster dose of Pfizer Inc-Biontech SA’s vaccine. The CDC presented data to the committee that the single mRNA COVID-19 vaccine dose be given to those age 65 and older, for those at least 18 years old and reside in long-term-care settings, and also for those ages 50 to 60 with certain underlying medical conditions.
As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally.
With only three bispecific antibodies on the market, potential for the technology remains largely untapped. Johnson & Johnson’s Janssen Biotech Inc. is trying to change that. In a new deal with U.K.-based F-star Therapeutics Inc., it’s seeking develop a new generation of bispecifics for undisclosed targets.
LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.
