Astrazeneca plc’s recently acquired Alexion Pharmaceuticals Inc. has signed a deal worth up to $760 million with Neurimmune AG, the Swiss biotech that discovered Alzheimer’s drug Aduhelm (aducanumab), buying rights to amyloidosis drug NI-006. While Biogen Inc.’s Aduhelm targets amyloid plaques thought to cause Alzheimer’s in the brain, the phase Ib drug in Alexion’s deal is intended to tackle the build-up of the rogue protein that causes heart disease caused by transthyretin amyloid cardiomyopathy (ATTR-CM).
Be careful who you’re doing business with. That’s the warning the U.S. Court of Appeals for the District of Columbia Circuit sent this week to multinational drug and device companies doing business in terrorist hot spots around the world. Reversing a lower court, the D.C. Circuit cleared the way Jan. 4 for 21 drug and device companies to potentially be held accountable for doing business with Jaysh al-Mahdi terrorists, operating through the Iraqi Ministry of Health, who injured or killed hundreds of U.S. troops and civilians in Iraq.
PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone.
Astrazeneca plc has confirmed it is working with Oxford University to produce a vaccine against the Omicron variant of the SARS-CoV-2 virus. The Cambridge, U.K.-based pharma was one of the first to get a COVID-19 vaccine okayed by regulators, after acquiring rights to the shot from Vaccitech plc, a spin-out from Oxford University’s Jenner Institute specialist vaccine unit.
The FDA has approved Astrazeneca plc and Amgen Inc.’s first-in-class biologic, tezepelumab, for the add-on maintenance treatment of adults and children ages 12 and older with severe asthma, adding further competition to a hotly contested market. An injection marketed under the brand name Tezspire, tezepelumab inhibits the action of thymic stromal lymphopoietin (anti-TLSP). This is a signaling molecule at the top of several cascades influencing allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
LONDON – There was a substantial fall in neutralization titers against the Omicron variant of SARS-CoV-2 in the stored sera of people who had received two doses of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s COVID-19 vaccines, with some samples failing to neutralize the virus at all, according to the latest data from the U.K. Com-Cov study.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
After struggling in the past year, Ionis Pharmaceuticals Inc. will collaborate with Astrazeneca plc to develop eplontersen for treating transthyretin amyloidosis, which is systemic, progressive and fatal. At stake for Ionis is $2.9 billion in potential sales-related milestone payments.
LONDON – Each of six different COVID-19 vaccines given as booster doses were safe and increased immunity when administered after two doses of either Pfizer Inc.’s or Astrazeneca plc’s vaccine, according to the latest data from the U.K. Cov-Boost trial.
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.
