- Suspicious timing of Pfizer vaccine announcement (americanthinker.com)
On November 9, Pfizer announced that its COVID-19 vaccine candidate demonstrated efficacy of over 90% based on the mix of 94 cases between the placebo and vaccine groups in its Phase 3 clinical trial...Some of us had wondered about the timing of the announcement, given that the results far exceeded the primary efficacy endpoint of only 50% (with appropriate statistical confidence intervals) set by the FDA for a successful vaccine, and Dr. Fauci's concurrence that 50% would be acceptable...READ MORE
- Hey, pharma: When it comes to influencers, forget lifestyle gurus and stick to patient advocates, study says (fiercepharma.com)
When it comes to influencers in pharma marketing, companies should skip trendy avocado toast and aerial yoga guru types and rely on lesser-known patient advocates—at least, according to data gathered by WeGo Health...Its recent network survey found that only 14% percent of the WeGo users surveyed mostly or completely trust lifestyle influencers, while 51% completely or mostly trust patient influencers. When it comes to branded pharma products, the survey was even more positive for patient influencers: 85% said they would be very or somewhat receptive to an ad from a patient influencer promoting a drug-related to the patient’s condition...READ MORE
- Pfizer, BioNTech to submit formal application to FDA to authorize Covid-19 vaccine (statnews.com)
...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
- 10 biotechs to know in China (fiercepharma.com)
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
- Track-and-trace requirements go into effect on Friday (pharmacist.com)
Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013, also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode...“The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one,”...READ MORE
- Trump to unveil international pricing index, rebate crackdown rules: reports (fiercepharma.com)Trump Announces New Drug Pricing Model Is Set for January 2021 (drugtopics.com)
Several years after saying the pharmaceutical industry was “getting away with murder,” President Donald Trump appears poised to unveil new drug pricing rules that could shake up U.S. pricing dynamics in a big way. But it remains to be seen exactly how the implementation will play out...Trump plans to unveil two major measures—an international pricing index and a rule to crack down on drug rebates...The international pricing index—also called the “most-favored-nations" clause—would tie U.S. prices in Medicare to lower prices abroad. The pharmaceutical industry has intensely resisted the proposal. Eli Lilly CEO David Ricks, for one, characterized it as “horrible” policy, and Pfizer CEO Albert Bourla, Ph.D., said the president’s summer executive orders on drug pricing were “an enormous distraction” amid the COVID-19 fight and threatened American jobs...READ MORE
- Lucky Pfizer CEO Bourla cashes out $5.6M worth of stock—perfectly legally—as COVID vaccine data lifts market (fiercepharma.com)
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
- Regeneron, following in Lilly’s footsteps, wins FDA emergency nod for COVID-19 antibody cocktail (fiercepharma.com)
Regeneron’s COVID-19 antibody cocktail, one of the drugs President Donald Trump was given after he was infected with the SARS-CoV-02 virus, has been cleared for emergency use by the FDA. And, despite looming rollout of vaccines, one analyst still sees the therapy as a steady $1 billion-plus business...The emergency use authorization for REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, marks the second for an antibody therapy. The first one went to Eli Lilly’s bamlanivimab, which was given an EUA a few days ago...READ MORE
- EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate (biopharminternational.com)
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
- FDA knocks Tennessee compounder for raft of cleanliness issues (fiercepharma.com)
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