About pharma
FDA Outlines Its Conditions for Approving a Covid-19 Vaccine: “The Food and Drug Administration released guidance Tuesday outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the disease.
The FDA said that no vaccine would be approved unless a vaccine company had ‘clearly demonstrated’ proof of a vaccine’s safety and effectiveness through a clinical study, according to the guidance.
The FDA also said a vaccine wouldn’t be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.” The 50% seems low but is in line with acceptable effectiveness of flu vaccines.
Big Pharma Hikes Drug Prices in the Midst of COVID-19 Crisis: “ According to a new analysis by Patients For Affordable Drugs, drug companies raised the list prices of 245 drugs by an average of 23.8 percent since the first case of the novel coronavirus in the U.S. was reported in January. The research found that 75 percent of those price hikes were drugs directly linked to COVID-19 treatment or conditions that place people at higher risk of the virus.”
CVS Health reportedly launching a GPO called Zinc: “While very few details about the plan were revealed, Zinc is expected to be similar to Ascent Health Services, a Switzerland-based GPO that Express Scripts launched in 2019, according to the report.
Ascent helps conduct rebate negotiations for Express Scripts. Prime Therapeutics also has relied on Ascent for rebate negotiations, according to the report.”
Houston pharmacist dubbed 'Compound King' gets 10-year prison sentence in $21M fraud case: “According to court documents, Tompkins and his co-conspirators billed the Department of Labor for about $21.8 million in compounded gels and creams that were not medically necessary and were predicated on kickbacks. The scheme specifically targeted injured state and federal employees, according to the DOJ.” Again, note that it was governmental units that were defrauded not private entities.
Biopharma tackles COVID-19, HIV and other viruses with gene and cell therapies: Interesting summary of how these therapies are being developed to treat COVID-19.
Pharma giants to unveil major $1 billion venture to push novel antibiotics:”Amid escalating concerns over antibiotic resistance, several big drug makers are creating a new $1 billion for-profit venture to acquire or invest in small antibiotic companies and their nascent products, according to two people familiar with the plans.
The effort will be announced on July 9 by the chief executive officers at Pfizer, Merck, Eli Lilly, Novo Nordisk, Boehringer Ingelheim, Bayer Pharmaceuticals, and Merck KGaA, among others. Also on hand will be government officials from Germany, Sweden, the U.K., and France, as well as representatives from Wellcome Trust and Pew Charitable Trusts.”
About hospitals and health systems
IBM Watson Health Recognizes Top-Performing U.S. Hospitals and Health Systems: “IBM Watson Health® today announced its 2020 Fortune/IBM Watson Health 100 Top Hospitals list and 15 Top Health Systems award winners, naming the top-performing hospitals and health systems in the U.S. Extrapolating the results of this year's studies, if all Medicare hospitalized patients received the same level of care as those treated in the award-winning facilities, more than 100,000 additional lives and billions of dollars in inpatient costs could be saved. The lists of the top hospitals and health systems were published by Fortune.”
About health insurance
House fires back at Trump by passing ObamaCare expansion: “The legislation, which passed in a largely party-line vote of 234 to 179, would increase the 2010 health law’s subsidies that help people afford their premiums and add more federal funding for Medicaid expansion.
Democrats timed the vote to contrast with the Trump administration’s legal brief filed with the Supreme Court last week calling for the ACA to be struck down, a move Democrats said would be even more harmful during the coronavirus pandemic.” Obviously no chance for passage in the Republican-controlled Senate.
About the public’s health
Flu virus with 'pandemic potential' found in China: “The new flu strain that has been identified in China is similar to 2009 swine flu, but with some new changes…Current flu vaccines do not appear to protect against it, although they could be adapted to do so if needed.”
CDC says U.S. has ‘way too much virus’ to control pandemic as cases surge across country: “The coronavirus is spreading too rapidly and too broadly for the U.S. to bring it under control, Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention, said Monday.
The U.S. has set records for daily new infections in recent days as outbreaks surge mostly across the South and West. The recent spike in new cases has outpaced daily infections in April when the virus rocked Washington state and the northeast, and when public officials thought the outbreak was hitting its peak in the U.S.”
Fauci testifies new coronavirus cases could 'go up to 100,000 a day if this does not turn around’: “‘“We are now having 40-plus thousand new cases a day. I would not be surprised if we go up to 100,000 a day if this does not turn around. And so I am very concerned,’ Fauci said in response to questioning from Sen. Elizabeth Warren (D-Mass.) on what the overall U.S. death toll is likely to be.” The article also has a summary of updates on the pandemic, including the growing Republican acknowledgement of the need to wear masks.
HHS will renew public health emergency: “HHS spokesperson Michael Caputo on Monday tweeted that HHS intends to extend the COVID-19 public health emergency that is set to expire on July 25.
The extension would prolong the emergency designation by 90 days. Several payment policies and regulatory adjustments are attached to the public health emergency, so the extension is welcome news for healthcare providers.”