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Exclusive: Drugmakers to Raise Prices on at Least 350 Drugs in U.S. in January

Reuters reported:

Drugmakers including Pfizer Inc. (PFE.N), GlaxoSmithKline PLC (GSK.L), Bristol Myers Squibb (BMY.N), AstraZeneca PLC (AZN.L) and Sanofi SA (SASY.PA) plan to raise prices in the United States on more than 350 unique drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.

The increases are expected to come as the pharmaceutical industry prepares for the Biden Administration’s Inflation Reduction Act (IRA), which allows the government’s Medicare health program to negotiate prices directly for some drugs starting in 2026. The industry is also contending with inflation and supply chain constraints that have led to higher manufacturing costs.

To date, Pfizer announced the most increases, with prices rising on 89 unique drug brands and an additional increase on 10 drug brands at its Hospira arm. That was followed by GSK, with planned increases so far on 26 unique drugs, including nearly a 7% increase on its popular shingles vaccine Shingrix.

49% of Americans Say It’s ‘Likely’ COVID Vaccines Caused ‘Significant Number’ of Mysterious Deaths

The Epoch Times reported:

A new poll shows that nearly half of Americans believe that the COVID-19 vaccines probably caused a “significant number of unexplained deaths,” while over a quarter said they personally know someone whose death may have been caused by vaccination side effects.

While previous polling showed that a majority of Americans think that COVID-19 vaccines are effective, they also have concerns about the side effects of the jab.

The latest Rasmussen Reports survey, released on Jan. 2 and based on a representative sample of 1,000 American adults, sought to gauge public opinion on the perceived safety of COVID-19 vaccines.

A large majority (71%) said they themselves have been vaccinated against COVID-19, with 38% of those believing that the vaccine side effects are at least somewhat likely responsible for unexplained deaths.

Omicron Offshoot XBB.1.5 Could Drive New COVID Surge in U.S.

CNN Health reported:

For weeks, scientists have been watching a slew of Omicron descendants duke it out for dominance of COVID-19 transmission in the United States, with the BQs — BQ.1 and BQ.1.1 — seeming to edge out all the others to claim a slight lead.

The result has been a gradual rise in cases and hospitalizations that never seemed to reach the peaks of this summer’s BA.5 wave and was certainly nothing like the tsunami of illness caused by the original Omicron strain a year ago.

But on Friday, the U.S. Centers for Disease Control and Prevention’s COVID-19 variant dashboard revealed a new dark horse that could soon sweep the field: XBB.1.5.

The CDC estimates that XBB.1.5 has more than doubled its share of the COVID-19 pie each week for the last four, rising from about 4% to 41% of new infections over the month of December. In the Northeast, the CDC estimates, XBB.1.5 is causing 75% of new cases.

Once-Favored COVID Drugs Ineffective on Omicron May Be Putting Millions at Risk

Politico reported:

The lack of specialized COVID-19 treatments for people with weak immune systems has left millions of Americans with limited options if they get sick as the pandemic heads into an uncertain winter.

Once heralded as game-changers for COVID patients considered at risk for getting seriously ill — one was used to treat then-President Donald Trump in 2020 — monoclonal antibodies are now largely ineffective against current COVID variants. Easier-to-administer antiviral drugs, such as Paxlovid, have largely taken their place but aren’t safe for all immune-compromised people because they interact with many other drugs.

But the federal government funding that drove drug development in the early days of the pandemic has dried up, and lawmakers have rebuffed the Biden administration’s pleas for more. Without that, there’s little incentive for drugmakers to work on new antibody treatments that could be more effective.

Monoclonal antibodies — which have been made by companies like Regeneron, Eli Lilly and Vir — are lab-created molecules designed to block a virus’ entry into human cells. But they must bind to the virus’ spike protein to neutralize it, and the coronavirus’ many mutations since its 2019 emergence have gradually rendered the available products ineffective.

Exclusive: U.S. Considers Airline Wastewater Testing as COVID Surges in China

Reuters reported:

As COVID-19 infections surge in China, the U.S. Centers for Disease Control and Prevention is considering sampling wastewater taken from international aircraft to track any emerging new variants, the agency told Reuters.

Such a policy would offer a better solution to tracking the virus and slowing its entry into the United States than new travel restrictions announced this week by the U.S. and other countries, which require mandatory negative COVID tests for travelers from China, three infectious disease experts told Reuters.

China Media Plays Down COVID Severity as WHO Seeks Detail on Variants

Reuters reported:

State media in China played down the severity of a surge of COVID-19 infections ahead of a briefing on Tuesday by its scientists to the World Health Organization, which was hoping for a “detailed discussion” on the evolution of the virus. China’s abrupt U-turn on COVID controls on Dec. 7, as well as the accuracy of its case and mortality data, have come under increasing scrutiny at home and abroad.

The WHO has urged Chinese health officials to regularly share specific and real-time information on the outbreak. The global body has invited Chinese scientists to present detailed data on viral sequencing at a technical advisory group meeting on Tuesday. It has also asked China to share data on hospitalizations, deaths and vaccinations.

On Tuesday, the People’s Daily, the Communist Party’s official newspaper, cited Chinese experts as saying the illness caused by the virus was relatively mild for most people. “Severe and critical illnesses account for 3% to 4% of infected patients currently admitted to designated hospitals in Beijing,” Tong Zhaohui, vice president of the Beijing Chaoyang Hospital, told the newspaper.

COVID Vaccines and Fever: Scientists Have Discovered a New Potential Link

SciTechDaily reported:

There has been some concern about the side effects of mRNA COVID-19 vaccines, such as fever and fatigue, which are generally considered normal and transient. However, the relationship between these adverse reactions and antibody production after receiving the vaccine has not been thoroughly studied.

A team of researchers from Okayama University recently conducted a study to examine this link. They recruited 49 university staff and students who had not previously had COVID-19 and found that there is a relationship between the incidence of fever and antibody counts, particularly after the third dose of the vaccine. Their findings were published in the Journal of Epidemiology.

All subjects were surveyed for adverse reactions a week after they received the third mRNA-1273 vaccine dose. Simultaneously, antibody levels of all subjects were measured just before receiving the vaccine, 3 days after, ~1 week after and finally 1 month after the dose. Using statistical modeling, correlations between the incidence of fever and antibody levels at various time points were stipulated. To account for factors contributing to the onset of fever post-vaccination, the team also looked at sex, age differences, a history of allergy and the use of antipyretics (fever-reducing drugs) amongst the participants.

This is the first study to highlight associations between the induction of fever and antibody levels at various time points after the third dose of the mRNA-1273 vaccine. “Antibody titers after mRNA-1273 vaccination may be faster in the group with post-vaccination fever, but the difference may not be significant 1-month post-vaccination,” concludes the team. The researchers also suggest that while these contradictory observations may not have significant clinical relevance, a study with a larger sample size might provide better insights.

Cancer Vaccine Hunt Makes Progress, Finally

Bloomberg reported:

The long-awaited cancer vaccine revolution is getting a little closer to reality. New data from Moderna Inc. and Merck & Co. suggest that after decades of failures, researchers are finally figuring out the right way to design a vaccine that can teach immune cells how to recognize and combat tumors.

Earlier this month, the companies said that when used in concert with Merck’s cancer immunotherapy Keytruda, Moderna’s mRNA cancer vaccine reduced the risk of certain skin cancers from returning or patient deaths by 44% compared with Keytruda alone.

That number justly generated a lot of excitement. It’s the first time an mRNA-based cancer vaccine has proven itself in a randomized study, and with an unambiguously positive outcome. If that result holds up in larger trials, it would be a huge advance both for the mRNA technology behind COVID vaccines and for the field of cancer vaccines in general.

But there are a lot of steps between achieving early, positive data for a subset of melanoma patients and developing a widely accessible, cost-effective treatment. Among the more daunting challenges: The vaccine needs to be tailored to the genetic makeup of an individual patient’s tumors.

Probe: Alzheimer’s Drug Approval ‘Rife With Irregularities’

Associated Press reported:

The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit as congressional investigators called the process “rife with irregularities.”

The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee — Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug.

The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Last Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer’s approvals aren’t met with “the same doubts about the integrity of FDA’s review.”