25 Sep 2020


  • Johnson & Johnson’s next-gen Darzalex sparks drug delivery royalties battle – FiercePharma  
  • Cancer blood-test data lift Exact Sciences by most in 6 months – Bloomberg  
  • Covid-19: The Lancet publishes promising data of Apeiron’s APN01 (rhsACE2) to treat Covid-19 in named patient use
  • Hansa Biopharma announces positive high-level data from investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease 
  • Covid-19: Novavax kicks off 10,000 patient Covid vaccine study in UK – Bloomberg 
  • Covid-19: Pfizer partner BioNTech sees no role for its vaccine in UK challenge trial – Reuters 
  • Covid-19: AstraZeneca gets partial immunity in low-cost EU vaccine deal – Reuters 
  • Covid-19: FDA greenlights its first coronavirus antibody blood test for the point of care – FierceBiotech 
  • Covid-19: Drugs bosses may be more open about vaccines after pause in AstraZeneca trial – The Times 
  • Bayer resolves more Roundup cases, judge keeps pause on litigation – Reuters 
  • US appeals court rejects novel opioid settlement framework – Reuters 
  • Trump says he will protect coverage for pre-existing health conditions – Financial Times 
Fraiser Kansteiner of FiercePharma reports Johnson & Johnson (J&J) scaled back its Darzalex royalty payments to Genmab in the second quarter, just as its new subcutaneous formulation was hitting the market. Genmab owed a portion of those royalties to drug delivery specialist Halozyme for its subQ technology, J&J argued. But Genmab didn’t agree, and now it’s taking the dispute into arbitration. Genmab will take J&J and its Janssen unit to arbitration to determine if the company must help cover Janssen’s royalty payments to Halozyme.  FiercePharma >>
Bailey Lipschultz of Bloomberg reports Exact Sciences surged the most since March after its chief executive unveiled data for its liquid biopsy that detected multiple cancers from a blood sample, a move that could further establish the diagnostics maker as a heavyweight in the industry. Shares jumped as much as 29% Thursday to a seven-week high after preliminary results were showcased at Cowen’s Liquid Biopsy Summit.   Bloomberg >>
Apeiron Biologics’ data with its clinical drug candidate APN01 to treat severe Covid-19 were published in the peer-reviewed journal The Lancet Respiratory Medicine. The data show the expected observations of an adaptive immune response, rapid loss of virus load, reduction in inflammatory mediators, and development of neutralising antibodies. Dr. Alexander Zoufaly, MD, Senior physician at the Department of Infectious Diseases/Clinic Favoriten and author of the publication said: “The encouraging results support the rationale to further explore APN01 as a Covid-19 therapy.”  Apeiron Biologics >>
Hansa Biopharma announced positive high-level data from an investigator-initiated phase 2 trial that evaluated safety, tolerability and efficacy of imlifidase in 15 patients with severe anti-GBM antibody disease. “The positive results from the phase 2 trial suggest the potential for treatment and thereby the opportunity to increase the chances of renal survival in difficult to treat patients with anti-GBM disease”, says Sponsor and Coordinating Principle Investigator, Mårten Segelmark, Professor of Nephrology at Lund University and Linköping University.  Hansa Biopharma >>
Cristin Flanagan of Bloomberg reports Novavax climbed as much as 6.7% in extended trading on plans to start enrolling participants for a late-stage study of its experimental shot for the novel coronavirus in 10,000 patients in the UK. The company joins the ranks of AstraZenecaPfizer with German partner BioNTech and Moderna as its vaccine enters the final stretch on the path toward regulatory approval. There are roughly 38 shots being tested in humans around the world and more than 140 others in earlier stages of study.  Bloomberg >>
Reuters reports Pfizer’s German development partner BioNTech joined other leading Covid-19 vaccine developers in ruling out participation in British plans to test experimental inoculations by deliberately infecting trial volunteers.  Britain is planning to host so-called “challenge trials”, and is working with partners on the potential for human challenge trials without commenting on a specific plan. AstraZeneca and Sanofi and Moderna, among the leading vaccine developers, have said their vaccine candidates were not involved in the programme.    Reuters >>
Francesco Guarascio of Reuters reports European governments will pay claims above an agreed limit against AstraZeneca over side-effects from its potential Covid-19 vaccine, under different terms to a deal struck with Sanofi. The deals reflect different strategies by two of the world’s top drugmakers for protecting themselves as a debate rages about liabilities for vaccines aimed at ending the pandemic.   Reuters >>
Conor Hale of FierceBiotech reports the FDA has authorised its first Covid-19 antibody test designed to be used on-site at the point of care, such as within doctors’ offices, urgent care centres and emergency rooms—as opposed to having samples shipped and tested within a central laboratory. The fingerstick blood test, which operates using only a lined strip similar to a pregnancy test, is designed to provide results for two types of coronavirus antibodies within 15 minutes. FierceBiotech >>
Alex Ralph of the Times reports pharmaceutical industry bosses are reviewing the level of transparency related to coronavirus trials amid concerns over the pausing of the Oxford University and AstraZeneca studies. Pascal Soriot, the chief executive of AstraZeneca, said that it was discussing with other companies “what kind of transparency we could offer without compromising patient privacy and the trial”. This follows calls from scientists for more clarity on why the late-stage trial of Oxford University’s Covid-19 vaccine is still on hold in the US.   The Times >>
Tom Hals of Reuters reports attorneys for Bayer and consumers suing the company over allegations its Roundup weedkiller caused cancer told a judge they are continuing to resolve thousands more cases, improving prospects for its $11bn deal to end the litigation. The parties have binding deals to resolve about 45,000 of the 125,000 filed and unfiled claims, according to attorneys involved. Settlements have been reached with each of the lawyers who took cases to trial.  Reuters >>
Nate Raymond of Reuters reports a federal appeals court overturned a judge’s approval of a novel plan by lawyers representing cities and counties suing drug companies over the US opioid crisis that would bring every community nationally into their settlement talks. The 6th US Circuit Court of Appeals by a 2-1 vote declined to approve an unprecedented “negotiation class” of 33,000 cities, towns and counties which could have a vote on whether to accept any settlements proposed with drug manufacturers and distributors.   Reuters >>
Kiran Stacey of the Financial Times reports Donald Trump announced his long-awaited alternative to Barack Obama’s signature healthcare law, claiming patients would continue to be covered for pre-existing conditions, but without saying how. The US president said during a speech that he would sign executive orders to tackle some of the thorniest issues in healthcare policy, including how to provide insurance coverage for previously-known conditions, and how to stop patients getting surprise bills for care outside the scope of their insurance.     Financial Times >>

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