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What's the rationale behind COVID-19 vaccine and drug prices? You don’t have a need to know—or so say a couple of the leading contenders...Two major players in the pandemic fight, Pfizer and Johnson & Johnson, are urging the Securities and Exchange Commission to forestall shareholder resolutions that would require them to disclose how they set prices on their COVID-19 vaccines...Several not-for-profit groups are pushing the two companies—along with fellow pharmas Eli Lilly, Gilead, Merck & Co. and Regeneron—for information on their drug and vaccine pricing decisions, citing the federal money all have received, either for supplies, R&D or manufacturing scale-up. Or all three...READ MORE

With Novavax and Johnson & Johnson data now in hand, the world has efficacy numbers on at least five COVID-19 vaccine programs. That's plenty for analysts to parse—and they're busy doing not only that, but also sizing up the market as the field of top players grows...The upshot? Blockbuster sales to go around, but Pfizer and Moderna will continue to lead the pack, partly thanks to their ability to quickly deploy mRNA against new variants. And for Moderna, at least, that means almost $14 billion in projected sales just this year from one team of analysts...READ MORE

The data is continuing to come in on the various COVID-19 variants, and so far the news is pretty good. Pfizer and BioNTech announced that their COVID-19 vaccine appears effective against an engineered virus developed with three key mutations found in the South African variant. This was conducted in a laboratory test by Pfizer and the University of Texas Medical Branch...the data has not yet been peer-reviewed, it demonstrated a less than two-fold decrease in antibody titer levels. The bottom line is that the Pfizer-BioNTech vaccine is likely effective in neutralizing the E484K and N501Y mutations found in the South African variant...READ MORE

Merck announced that it is going to stop developing its two COVID-19 vaccine candidates, dubbed V590 and V591, after poor responses in Phase I trials. They are shifting their attention to advancing two therapeutic drugs for COVID-19, MK-4482 and MK-7110...“We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dean Y. Li, president, Merck Research Laboratories. “We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems and communities.”...READ MORE

A new Vizient report highlights trends in drug pricing for pharmaceutical products used across multiple health system settings...Drug price increases remain prevalent in the oncology and rheumatology therapeutic areas, while use of other high-cost drugs appears to have surged in light of the coronavirus disease 2019 (COVID-19) pandemic. However, the report also points to an overall trend toward moderation of price increases and the projected effects of biosimilar and generic competition in the marketplace...According to the report, Vizient projects a 2.67% increase in the price of pharmaceuticals purchased by health systems, academic medical centers, pediatric hospitals, and non-acute practices during this time frame...READ MORE

Scientists gave Russia’s Sputnik V vaccine the green light...saying it was almost 92% effective in fighting COVID-19 based on peer-reviewed late-stage trial results published in The Lancet international medical journal...The results, collated by the Gamaleya Institute in Moscow that developed and tested the vaccine, were in line with efficacy data reported at earlier stages of the trial, which has been running in Moscow since September...READ MORE

Within days of AstraZeneca's surprise cut to first-quarter COVID-19 vaccine deliveries to Europe, a fierce debate between the drugmaker and government officials is playing out behind the scenes—and in the press...CEO Pascal Soriot said the company has no legal obligation to deliver vaccines on a specific timeline. The EU maintains AZ’s new delivery schedule is “not acceptable.”...The sides were set to meet Wednesday, but an EU official told Politico the drugmaker had pulled out. AstraZeneca told Fierce Pharma via email it hadn't...READ MORE

New coronavirus variants have prompted COVID-19 vaccine makers to start developing updates to their existing offerings. To speed their journey to a pandemic-fatigued public, the FDA says it’s developing expedited review rules for the follow-up shots...The FDA’s working on guidance for the types of data needed to support changes to COVID-19 vaccines. The new rules would provide for “streamlined clinical programs” that can demonstrate an immune response to new variants and “can be executed quickly,” FDA’s acting commissioner, Janet Woodcock, said in a statement...READ MORE

McKinsey & Company, the consultant to blue-chip corporations and governments around the world, has agreed to pay nearly $600 million to settle investigations into its role in helping “turbocharge” opioid sales, a rare instance of it being held publicly accountable for its work with clients...The firm has reached a $573 million agreement with attorneys general in 47 states, the District of Columbia and five territories, according to a court filing in Massachusetts on Thursday. Separate deals were announced in Washington State, for $13 million, and in West Virginia, for $10 million...The settlements come after lawsuits unearthed a trove of documents showing how McKinsey worked to drive sales of Purdue Pharma’s OxyContin painkiller...READ MORE

Moderna announced it has started development on a booster to its COVID-19 vaccine, which the company hopes will work against the recently discovered (and more transmissible) SARS-CoV-2 variant from South Africa...Moderna’s COVID-19 vaccine mRNA-1273 appears to be effective for protecting against B.1.1.7 and B.1.351, two highly infectious strains first discovered in the U.K. and South Africa, respectively...The South African B.1.351 variant features ten mutations found in the spike protein of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Variants from both the U.K. and South Africa have spread quickly across the globe, with some data suggesting these variants are associated with increased transmission and greater post-infection viral burden...READ MORE