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Greece has suggested EU member states jointly buy patent rights for vaccines against COVID-19 and rapid tests under development to help ensure that if they are effective they are quickly distributed to those in need across the bloc...Greek Prime Minister Kyriakos Mitsotakis said finding a solution for a rapid distribution of vaccines, when they are available, is difficult but also urgent...At least 20 vaccines against COVID-19 are under development, many of which are subsidised by individual governments or charities...“Ideally, once their efficacy has been proven, such vaccines should be distributed as quickly and fairly as possible, and at a reasonable cost,”...Purchasing such patent rights would give global pharmaceutical companies incentives for further research and development and ensure that European taxpayers’ money was “spent sensibly...READ MORE

The Food and Drug Administration on Friday announced a national study led by the Mayo Clinic that will help hospitals offer an experimental plasma therapy for COVID-19 patients, and track how they fare...The therapeutic agents—convalescent plasma and hyperimmune globulin—are both derived from the blood of people who have recovered from the disease...What the history books call “convalescent serum” was most famously used during the 1918 flu pandemic, and also against measles, bacterial pneumonia and numerous other infections before modern medicine came along...Some hospitals are already administering convalescent plasma to critical COVID-19 patients, a so-called “compassionate use” that in this case is allowed by what the FDA calls an emergency Investigational New Drug authorization...READ MORE

U.S. health regulators are telling drugmakers to immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought...The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. The drugs are widely used to treat stomach acid and ulcers...Dozens of recalls have been linked to the same probable carcinogen since last year. The FDA is still investigating the issue and has sanctioned at least one manufacturing plant in India that makes ingredients used in the medications...READ MORE

Associations representing generic drug makers, health insurers, pharmacy benefit managers and pharmacies have sent a letter to top administration and congressional leaders laying out how some policies and proposals to fight COVID-19 are making the situation worse...In an unusual display of coordinated frankness for the industry, a coalition representing generic drug makers, insurers, pharmacies and benefit managers told Vice President Mike Pence and congressional leaders that some policies in place or under consideration to fight COVID-19 are making it difficult and more expensive for patients to get some drugs...Signers of the letter are the Academy of Managed Care Pharmacy, America’s Health Insurance Plans, the Association for Accessible Medicines, the Blue Cross Blue Shield Association, the National Association of Chain Drug Stores, the National Association of Specialty Pharmacy, the Pharmaceutical Care Management Association and Pharmaceutical Research and Manufacturers of America...READ MORE

Britain said...it was launching the biggest clinical trial of possible treatments for coronavirus in the world but a leading health official cautioned that the results were likely a few months away...Almost 1,000 patients from 132 hospitals had been recruited in 15 days and thousands more were expected to join in the coming weeks...The trial is testing medicines more commonly used to treat malaria and HIV, and is designed so that when further medicines are identified, they can be added to the study within days...England’s Deputy Chief Medical Officer Jonathan Van-Tam said the next round of clinical trials should include new medicines, including those that might be in development for other diseases and might “have a role to play”...READ MORE

Pharmaceutical companies Novartis and Rising Pharmaceuticals are taking action to support the latest clinical trials exploring hydroxychloroquine as a treatment for the coronavirus disease 2019...Novartis announced March 30 that it is donating 20,000 doses of hydroxychloroquine to the University of Washington for a COVID-19 PEP clinical trial, which is expected to provide approximately 2000 patients with a 14 post-exposure regimen...Earlier in March, Novartis committed to donating up to 130 million doses, or 200mg tablets, of generic hydroxychloroquine to support COVID-19 research...Rising Pharmaceuticals has announced a collaborative agreement with the Division of Infectious Disease and International Medicine at the University of Minnesota, Department of Infectious Disease on a clinical trial investigating hydroxychloroquine as a preventive treatment for COVID-19...READ MORE

The U.S. Food and Drug Administration said malaria drugs hydroxychloroquine and chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic...The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency's website that lists drug shortages on Tuesday...Studies are underway in a number of countries to see whether hydroxychloroquine and the related malaria drug chloroquine may be effective in controlling the spread of coronavirus, which has led to a surge in demand for the treatments...READ MORE

...days after the FDA gave them (chloroquine and hydroxychloroquine) an emergency approval to treat COVID-19...European regulators are limiting their COVID-19 use to clinical trials only...The decision comes as limited data—some of it questionable—rolls in about the drugs and their potential as COVID-19 therapies. A French study that's made headlines continues to draw fire, but brand-new data from China add to the positive case...In guidance...the European Medicines Agency restricted general use of the drugs—already approved to treat malaria and autoimmune diseases—to patients taking them for approved indications. COVID-19 patients can receive the drugs as part of clinical trials or through national emergency use programs...READ MORE

Bristol Myers Squibb and Gilead Sciences have been locked in a CAR-T patent fight, with BMS scoring a lucrative victory following a trial late last year. Now, Gilead has failed to persuade a judge to overturn the $752 million verdict—and the company could face bigger damages down the line... Judge James Otero rejected numerous arguments from Gilead’s Kite Pharma unit that patents held by BMS’ Juno Therapeutics are invalid, plus that procedural flaws in the legal process warrant a new trial...READ MORE

Pharma’s pursuit of innovative oncology drugs has hit a fever pitch like the industry has never felt. On the heels of a treatment revolution that has fundamentally changed how we understand, fight and, in some cases, can cure cancer, pharma is mobilizing at a dazzling speed to develop the next holy grail in oncology...The current generation of cancer treatments is also still stymied by a number of challenges including manufacturing issues, limited therapeutic benefits for many patients and sky-high prices that have drawn public ire...All told, oncology has become a segment of the industry that is both bursting at the seams and begging for further innovations. Recognizing the potential to help both patients and business, pharma has become obsessed with oncology...READ MORE