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Moderna reported...that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of mRNA-1273...CHMP’s decision to commence the rolling review of data on mRNA-1273 has been based on the preliminary results from non-clinical and early clinical studies, which have suggested the vaccine has an efficacy of 94.5%. The rolling review will be performed by the committee until there is sufficient data to support a formal marketing authorization application...READ MORE

U.S. regulators...allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and delivers results in 30 minutes...The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19 beyond health care facilities and testing sites. However, the test will require a prescription, likely limiting its initial use...The FDA granted emergency authorization to the single-use test kit from Lucira Health, a California manufacturer...The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative...READ MORE

...FDA issued an emergency use authorization to Eli Lilly for the investigational monoclonal antibody therapy bamlanivimab to treat mild to moderate COVID-19 in adult and pediatric patients...Bamlanivimab is authorized for patients ages 12 years and older who test positive for SARS-CoV-2 virus, weigh at least 40 kg, and are at high risk for progressing to severe COVID-19 and/or hospitalization. It is also authorized for adults ages 65 years or older or those who have certain chronic medical conditions...READ MORE

While true innovation is still a rare currency in China, all but one of these 10 companies have attracted Big Pharma companies buying into their R&D...China has witnessed a biotech boom over the past decade. Many biotech entrepreneurs felt a calling to reshape the drug industry in a country that has long relied on generics with dubious quality, where demand is growing for more innovative drugs to improve treatment outcomes that can match China’s climbing economy...These so-called “sea turtles,” armed with top-notch training from foreign institutions and experience at large multinational biopharma companies, set up their own shops in the hope of creating the next blockbuster drugs out of China...READ MORE

BeiGene
Chi-Med
CStone Pharmaceuticals
Harbour BioMed
Hua Medicine
I-Mab Biopharma
Innovent Biologics
Junshi Biosciences
Legend Biotech
Zai Lab

...Pfizer and its German partner BioNTech said they plan to apply Friday to the Food and Drug Administration for an emergency use authorization for their Covid-19 vaccine, a watershed moment in the effort to curb the global pandemic...It is unclear how long the FDA will take to review the application, though the agency is expected to move swiftly. Agency officials have pledged to seek advice from an expert panel of outside experts, the Vaccines and Related Biological Products Advisory Committee...before ruling on the application. VRBPAC members have been asked to hold three days in December as potential meeting dates...READ MORE

The online colossus opened an online pharmacy Tuesday that allows customers to order medication or prescription refills, and have them delivered to their front door in a couple of days...The potential impact of Amazon’s arrival in the pharmaceutical space rippled through that sector immediately. Before the opening bell, shares of CVS Health Corp. fell almost 9%. Walgreens and Rite Aid both tumbled more than 10%...Amazon will begin offering commonly prescribed medications Tuesday in the U.S., including creams, pills, as well as medications that need to stay refrigerated, like insulin. Shoppers have to set up a profile on Amazon’s website and have their doctors send prescriptions there. The company said it won’t ship medications that can be abused, including many opioids...READ MORE

On Monday before the stock market opened, Pfizer announced that its COVID-19 mRNA vaccine had proven 90% effective so far in its ongoing late-stage trial, lifting the company’s shares nearly 8% through the course of the day...The same day, in a stock sale Pfizer says was planned months ago, CEO Albert Bourla offloaded 132,508 shares—more than 60% of his total holdings—for $5.6 million...Insider trading? Nope. Extraordinarily lucky? To be sure. And no doubt the size and timing of this sale, coupled with Bourla's confidence over the last few months leading to Monday's data announcement, are enough to rile up critics of executive pay packages in Big Pharma...READ MORE

A draft NHS England report on overprescribing leaked to HSJ [paywall], proposes that the law should require wider access to healthcare data, in a bid to improve patient safety...The review carried out for health secretary, Matt Hancock, highlights the issue of poor interoperability between NHS computer systems, which means clinicians cannot see or understand what medications patients are taking or when a medication should be reviewed...According to report author, chief pharmaceutical officer Keith Ridge, prescribers should be identified in the electronic health record so they can be contacted by other clinicians. He adds that a free-text box should be created in EHRs so clinicians can explain why a certain medication has been prescribed...READ MORE

More good news emerged from the COVID-19 vaccine front, with Moderna Inc. reporting that its candidate, mRNA-1273, has met the statistical criteria pre-specified in the study protocol for efficacy in an interim analysis, with efficacy of 94.5%. The product is an mRNA vaccine encoding for a prefusion stabilized form of the Spike protein...Moderna plans to submit for an emergency use authorization from the FDA in the weeks ahead, and expects the application will be based on the final analysis of 151 cases with a median follow-up of more than two months. The study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority...READ MORE

FDA investigators cited Tennessee compounder Surgery Pharmacy Services for a host of cleanliness issues at its Chattanooga plant, including workers' failure to change gloves after removing trash bins and to sanitize supplies carried between clean rooms...Inspectors further knocked Surgery for using a laminate work surface in one of its clean rooms that was "worn, stained, and chipped," as well as using a nonsterile disinfectant to clean one of the rooms...READ MORE