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Moderna Combination COVID, Flu Vaccine Moves to Final Stage Trial After Positive Data
Moderna on Wednesday said its combination vaccine targeting COVID and the flu will move to a final stage trial in adults ages 50 and above this year after showing positive results in an early to mid-stage study.
The biotech company hopes its shot, mRNA-1083, can win approval from regulators in 2025. The mRNA-1083 shot generated an immune response similar to or greater than two currently available flu vaccines from GlaxoSmithKline in the early to mid-stage clinical trial.
Moderna’s combination shot also produced an immune response similar to its bivalent COVID vaccine, which targets the Omicron variants BA.4 and BA.5 and the original strain of the virus.
Moderna is also developing a combination shot targeting the flu and RSV, and another vaccine targeting all three respiratory viruses: COVID, flu and RSV.
Court Tosses $223.8 Million Verdict Against J&J in Talc Cancer Case
A New Jersey appeals court on Tuesday threw out a $223.8 million verdict against Johnson & Johnson (JNJ.N) that a jury had awarded to four plaintiffs who claimed they developed cancer from being exposed to asbestos in the company’s talc powder products.
The Superior Court of New Jersey, Appellate Division found that a lower court judge should not have allowed some of the scientific expert testimony the plaintiffs presented to jurors at trial.
In reversing the verdict and ordering a new trial, a three-judge panel of the appeals court found that the trial court failed to fulfill its “gatekeeping role” of assessing whether the plaintiffs’ experts based their testimony on sound science.
In their opinion, the judges found that three experts had not explained the facts or methods they used to support their opinions that the plaintiffs got cancer from being exposed to asbestos in talc products.
Novavax Updated COVID Vaccine Wins FDA, CDC Backing, Paving Way to Reach Americans Within Days
Novavax’s updated COVID vaccine won the backing of the Food and Drug Administration on Tuesday, putting the shot on track to roll out weeks after new jabs from Pfizer and Moderna reached Americans.
The FDA authorized Novavax’s single-strain vaccine, which targets Omicron subvariant XBB.1.5, for emergency use in people ages 12 and up.
The Centers for Disease Control and Prevention is including Novavax’s shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated COVID jab.
Novavax said in a statement that doses of the shot will likely be available within the next few days.
Public health officials see Novavax’s vaccine as a valuable alternative for people who don’t want to take messenger RNA shots from Pfizer and Moderna, which teach cells how to make proteins that trigger an immune response against COVID. Novavax’s shot fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.
With Novo Nordisk, Eli Lilly and AstraZeneca Leading the Way, Big Pharma’s Sales Will Grow 4% Annually Through 2030: Analysts
Despite patent expirations that will weigh heavy later in the decade, the pharma industry is on course for solid growth in both sales and earnings, according to analysts at TD Cowen.
Cumulatively, the analysts expect Big Pharma‘s sales to grow at 4% annually and earnings per share to grow at 7% annually. The projections cover more than a dozen leading drug companies and extend from 2023 to 2030.
Companies leading the charge in sales growth are of little surprise. Manufacturers of game-changing GLP-1 weight loss products Eli Lilly and Novo Nordisk will enjoy compounded annual revenue growth of 11% and 9%, respectively, according to the analysts.
Cowen points out that pharma companies have nearly 1,000 products in development, many of which will reach the market in this decade. Other companies that Cowen projects will deliver compounded annual sales increases at or above the industry standard are AstraZeneca (8%), Roche (5%), Sanofi (5%), Pfizer (4%) and GSK (4%).
1 in 20 Used Ivermectin, Hydroxychloroquine to Treat COVID: Research
A new nationwide survey found that about one out of 20 U.S. adults reported using ivermectin or hydroxychloroquine to treat COVID-19 despite the lack of evidence that these medicines do anything to fight the virus.
The study published in the peer-reviewed Journal of the American Medical Association (JAMA) included 13,438 people who said they had previously contracted COVID-19 infections. This group included adults from all 50 U.S. states.
Among study participants, 6 percent said they had used either ivermectin or hydroxychloroquine to treat their infections. Neither drug is approved for treating SARS-CoV-2 by the Food and Drug Administration (FDA).
U.S. Plans Shift of Merck COVID Treatment to Commercial Market
The U.S. government will stop distributing free doses of Merck & Co’s (MRK.N) COVID-19 antiviral treatment molnupiravir by the middle of next month and expects it to be sold on the commercial market instead.
The Administration for Strategic Preparedness and Response (ASPR), a division of the U.S. Department of Health and Human Services, said in a statement posted on its website late last week they anticipate transition of the drug, sold under the brand name Lagevrio, from government-managed to traditional commercial distribution in November.
Merck, which developed the drug with Ridgeback Biotherapeutics, said in an emailed statement on Wednesday that it needs an updated letter of authorization from the U.S. Food and Drug Administration to allow it to start selling the drug commercially.
Molnupiravir was initially hailed as a potential breakthrough when few treatment options were available but was soon eclipsed by Pfizer‘s (PFE.N) rival treatment Paxlovid, which had more impressive data.
U.S. Announces Sweeping Action Against Chinese Fentanyl Supply Chain Producers
The Biden administration took aim Tuesday at the fentanyl trafficking threat, announcing a series of indictments and sanctions against Chinese companies and executives blamed for importing the chemicals used to make the deadly drug.
Officials described the actions, which include charges against eight Chinese companies accused of advertising, manufacturing and distributing precursor chemicals for synthetic opioids like fentanyl, as the latest effort in their fight against the deadliest overdose crisis in U.S. history. The moves come one day before senior administration officials are set to visit Mexico, whose cartels are part of the global trafficking network, for meetings expected to involve discussion of the drug threat.
Eli Lilly Appoints New Obesity Unit Head Ahead of Key Mounjaro Decision
Eli Lilly and Co (LLY.N) on Wednesday appointed a new chief for its diabetes and obesity unit in a string of leadership changes ahead of a key regulatory decision on the use of its potential blockbuster drug Mounjaro as a weight-loss treatment.
Mounjaro, chemically known as tirzepatide, is already being prescribed by doctors off-label as an obesity treatment.
The diabetes drug, which clocked in sales of $979.7 million in the latest quarter, belongs to a class of drugs known as GLP-1s that stimulate insulin production.
GLP-1s have kick-started a market for obesity drugs that is estimated to reach $100 billion within a decade.
