The EU cleared Johnson & Johnson’s Covid-19 vaccine for conditional marketing in all 27member states on Mar. 11 as expected. The single-dose adenovirus shot made by subsidiary Janssen Biotech, under a rolling review since December 2020, is the fourth to be approved by the European Medicines Agency (EMA).
Another “Big Pharma” company with a stalled candidate of its own is stepping in to help boost national or regional Covid-19 vaccine supply. US president Joe Biden was due to announce on Mar. 2 that Merck & Co will help make the Johnson & Johnson single-shot vaccine that received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on Feb. 27.
On the same day that Sanofi and GSK announced the start of a new Phase 2 study of their delayed adjuvanted recombinant protein-based Covid-19 vaccine candidate, Sanofi disclosed it had signed an agreement to manufacture 12 million doses of Johnson & Johnson’s single-dose adenovirus-based Covid vaccine.
As had been awaited, US healthcare giant Johnson & Johnson has applied to the European Medicines Authority (EMA) for conditional marketing authorization of its Covid-19 coronavirus vaccine throughout the EU.
Johnson & Johnson's Covid-19 vaccine just emerging from Phase 3 clinical trials showed 66% efficacy in moderate to severe disease, and as much as to 85% in severe disease, the US healthcare group said in its first report on trial results.
A New York state Supreme Court hearing Johnson & Johnson’s appeal of a 2019 baby powder judgment has agreed to reduce a $325 million jury award by two-thirds to $120 million. It declined to throw out the entire claim case, however, saying there was evidence to suggest the company’s talc-based powder caused the plaintiff’s mesothelioma as charged.
Johnson & Johnson is mulling whether to appeal a major financial setback in its ongoing talc baby powder litigation to the US Supreme Court.
Johnson & Johnson has temporarily paused all clinical trials of its adenovirus-based vaccine candidates, including the recently begun US Phase 3 trial, due to safety concerns after a study participant suffered an unexplained illness. A two-dose regimen was being tested separately.
Through its subsidiary Janssen Pharmaceutical Companies, US healthcare giant Johnson & Johnson has agreed to provide 200 million doses of its Covid-19 vaccine to the European Union, should the candidate win approval from the US Food and Drug Administration (FDA).
Johnson & Johnson (J&J) has agreed to pay in excess of $100 million to resolve more than 1,000 class action lawsuits claiming its talc-based baby powder caused their cancer, the Bloomberg news agency has reported.
With some potential Covid-19 vaccine makers suggesting they could have a candidate ready for approval and maybe even deployment this autumn, concerns are arising that a doubting public could shun inoculation.
After months of uncertainty and anxious glances across the water as potential Covid-19 vaccine manufacturers made deal after deal with other political blocs, the EU over the past four weeks has made rapid strides toward securing supplies for its 27 member states.
Johnson & Johnson has agreed to acquire autoimmune disease specialist Momenta Pharmaceuticals in an all-cash transaction of about $6.5 billion. Both companies’ boards of directors have unanimously approved the transaction set to close in the second half of 2020, subject to antitrust approvals and customary conditions.
Johnson & Johnson (J&J) has struck a deal with the US government worth just over $1 billion to supply 100 million doses of subsidiary Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S. The terms apply solely to manufacturing of the vaccine in the US but the company suggests it could be distributed worldwide.
European officials recently began talking to companies developing Covid-19 vaccines about supplying the EU’s 27 member states, in hope that none would fall behind bigger markets such as the US, which began making exclusive deals early on. Now Reuters suggests the talks may have hit a snag.
Through an acquisition dating back 14 years, BASF is embroiled in the same type of litigation trap as compatriot Bayer currently faces. The Ludwigshafen group’s US catalyst subsidiary formerly known as Engelhard, in conjunction with the New Jersey company’s former law firm, has just reached an out-of-court settlement of lawsuits alleging its talc was contaminated with asbestos.
The UK will not participate in a plan to distribute a potential coronavirus vaccine to Europe’s most vulnerable citizens first. Tim Barrow, the UK’s ambassador to the EU, said in a letter to the European Commission the British government would not join the effort because as a non- EU member it would have no decision-making power in negotiations about purchases.
