Biology Digest

  Eli Lilly said its two-drug COVID-19 antibody cocktail could prevent hospitalization or death among high-risk patients. The Indianapolis pharma in-licensed a neuroinflammatory pain candidate from Asahi Kasei Pharma for $20 million upfront. Takeda's new tyrosine kinase inhibitor mobocertinib reported positive phase 1/2 results in non-small cell lung cancer with the rare EGFR exon 20 insertions. And more. 1.  Lilly antibody combo slashed COVID-19 deaths, hospitalizations in high-risk patients Eli Lilly said its COVID-19 antibody cocktail of bamlanivimab and etesevimab cut the risk of hospitalization or death among high-risk patients by 70% in a phase 3 study. Lilly got bamlanivimab from AbCellera and etesevimab from China’s Junshi Biosciences. However, to rain on Lilly’s parade, a Columbia University team  found  the combo couldn’t neutralize the highly transmissible B.1.351 variant of the coronavirus in the lab. 2.  Lilly lands clinical-phase pai...

  Bristol Myers Squibb just broke into previously untreated non-small cell lung cancer less than a year ago with an FDA go-ahead in PD-L1-positive patients for the dual checkpoint inhibitor regimen of Opdivo and Yervoy. But rival Merck & Co. is already casting doubt on its place in the lucrative market. Adding Yervoy to Merck’s Keytruda  didn’t extend the lives  of first-line NSCLC patients whose tumors express biomarker PD-L1 at a tumor proportion score of at least 50%; instead, it increased the incidence of serious side effects, according to data unveiled at the World Conference on Lung Cancer. Specifically, patients on the Keytruda-Yervoy combo in the phase 3 Keynote-598 study lived a median 21.4 months, compared with 21.9 months for the solo Keytruda group. The combo receivers also lived a median 8.2 months without their disease worsening, shorter than the 8.4 months for those in the Keytruda monotherapy arm. “The monotherapy arm performed as expected,” Roy B...

  The PCSK9 cholesterol drug class was previously the target in an acrimonious squabble between drugmakers and the Institute for Clinical and Economic Review. Now, the U.S. drug cost watchdog has come up with its assessment for a new member of the family. Novartis’ inclisiran should cost between $3,600 and $6,000 a year to be cost-effective, ICER said in a recent report ( PDF ). That range falls in line with the current list prices of two existing PCSK9 therapies—around $5,400 to $5,850 for Amgen’s Repatha and Regeneron’s Praluent. Inclisiran’s different from the other two antibody drugs in that it uses a small-interfering RNA to target PCSK9. ICER’s price shouldn’t disturb Novartis much—unlike the harsh exchange of words the cost watchdog prompted from Amgen and Regeneron. The two antibody drugs first came to market in 2015 bearing annual costs of more than $14,000. At the time, ICER figured the drugs should cost much less—over 80% less. The companies initially...

Last year at the World Conference on Lung Cancer, Bristol Myers Squibb made waves in mesothelioma with data showing its Opdivo-Yervoy duo could slash the risk of death in previously untreated patients. This year, it grabbed the spotlight with another survival win in the tough-to-treat disease. Saturday, solo Opdivo became the first med to show in a randomized phase 3 trial that it could extend the lives of previously treated mesothelioma patients, cutting their risk of death by 28% against placebo. Those taking Opdivo lived for a median 9.2 months, versus 6.6 months for those in the placebo arm. Opdivo also staved off disease worsening, slashing the risk of progression or death by 39%. At the one-year mark, 14.5% of Opdivo patients hadn’t seen their cancer worsen, and only 4.9% of placebo patients could say the same. The results follow on the heels of Opdivo’s performance in first-line mesothelioma from the last WCLC meeting in August. In tandem with Yervoy, BMS’ checkpoint star pa...

Only a day after Novartis said it was looking at offering its manufacturing network to the global COVID-19 fight, the company is joining forces with Pfizer and BioNTech to help produce mRNA vaccines. It's the latest example of an unlikely Big Pharma partnership spurred by the urgent need to defeat the pandemic. Novartis  inked  an initial agreement with BioNTech to allow the mRNA biotech use of Novartis' facility in Stein, Switzerland. The production will start in the second quarter, and the partners expect dose deliveries to begin in the third quarter. The Pfizer/BioNTech shot is one of only a few that have been approved in countries around the world, and in the early stages of the rollout, demand has greatly outstripped supply. Pfizer and BioNTech have been working to scale up their manufacturing network to deliver 2 billion doses this year, but the effort led to a temporary supply disruption in Europe earlier this month. Under the Novartis pact, the Swiss drugmaker wil...

  Eli Lilly's COVID-19 antibody stole the show during the fourth quarter, and the company says there's more to come as the U.S. government just placed another big order—and Lilly itself projects blockbuster coronavirus revenues in 2021. Lilly's first COVID-19 antibody, bamlanivimab,  generated  $871 million in fourth-quarter revenues, driving the drugmaker to a 22% revenue increase for the period. Excluding the COVID-19 antibody, Lilly’s revenues grew 7%. The company isn't alone in seeing a big sales bump from pandemic drugs, vaccines and diagnostics. Last year, Gilead's antiviral remdesivir provided a sizable revenue contribution in the third quarter. Meanwhile, vaccine rollouts are underway that analysts project will deliver billions of dollars—or potentially tens of billions—in sales for leading players in the coming years. Moderna's CEO has  said  his company could leap into the ranks of the world's largest vaccine players by sales this year. ...

  (Reuters) - Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus. In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread. A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses. Those trials, however, were conducted mainly in the United States and before new variants emerged. The top U.S. infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging....

  The family of an Orange County man who died days after receiving a second dose of a COVID-19 vaccine say they remain firm believers in vaccination and are still hoping for better answers about his cause of death. Tim Zook, a 60-year-old X-ray technologist at South Coast Global Medical Center in Santa Ana, got his second dose of the Pfizer vaccine on Jan. 5. A few hours later he had trouble breathing and an upset stomach. He was hospitalized and  died four days later. His cause of death remains under investigation. The Orange County coroner's office says if it determines his death was related to the vaccine, it will notify the OC Health Care Agency. Zook's family said he had high blood pressure and was slightly overweight, but he was a proponent of the vaccine. Tim's widow Rochelle Zook says she is not ready at this point to attribute her husband's death to the vaccine. "We don't know," Rochelle Zook said. "I am not putting any blame on Pfizer or any...

  OKLAHOMA CITY (AP) — The Oklahoma attorney general’s office is attempting to return $2 million worth of a malaria drug once touted by former President Donald Trump as an effective treatment for COVID-19, a spokesman said Wednesday. Alex Gerszewski, a spokesman for Attorney General Mike Hunter, said Hunter is attempting to negotiate a return of the 1.2 million hydroxychloroquine pills Oklahoma acquired in April from a California-based supplier, FFF Enterprises. He said the office was acting on a request from the Oklahoma State Department of Health, which authorized the purchase. A spokeswoman for FFF Enterprises didn’t immediately return a message Wednesday seeking comment. The attempt by Oklahoma to return the hydroxychloroquine was  first reported  by the online news publication The Frontier. Republican Gov. Kevin Stitt defended the purchase last year, saying the drug was showing some promise as a treatment in early March and he didn’t want to miss an opportunity to ac...

  Reuters) - Severe COVID-19 infections are beginning to abate in many parts of the United States even as the death toll mounts, signaling an end to the pandemic’s post-holiday surge and prompting some states to ease public health restrictions. A slow but steady reduction in the number of Americans entering hospitals with the disease has paralleled a choppy rollout of vaccines that also are expected to reduce spread of the coronavirus that causes it. “We’re starting to see the light at the end of the horizon,” New Jersey Governor Phil Murphy told CNN on Wednesday. “I think this is now going in the right direction. It’s slow, admittedly.” About 4,300 Americans died of COVID-19 infections on Tuesday, the third highest daily toll since the first U.S. case was identified almost exactly a year ago on Jan. 20, 2020. The United States, one of the countries hardest hit by the pandemic, reported a total of 25.31 million cases and 425,120 deaths by day’s end on Tuesday. Concerns remain that ...

  WUHAN, China (AP) — A relative of a coronavirus victim in China is demanding to meet a visiting World Health Organization expert team, saying it should speak with affected families who allege they are being muffled by the Chinese government. China approved the visit by researchers under the auspices of the U.N. agency only after months of negotiations. It has not indicated whether they will be allowed to gather evidence or talk to families, saying only that the team can exchange views with Chinese scientists. “I hope the WHO experts don’t become a tool to spread lies,” said Zhang Hai, whose father died of COVID-19 on Feb. 1, 2020, after traveling to the Chinese city of Wuhan and getting infected. “We’ve been searching for the truth relentlessly. This was a criminal act, and I don’t want the WHO to be coming to China to cover up these crimes.” China’s Foreign Ministry did not immediately respond to a request for comment. The WHO team, which arrived in Wuhan on Jan. 14 to investiga...