Login
Moderna Moves Three Vaccines Into Final Stage Trials as It Works to Rebound From COVID Slump
Moderna has more to offer beyond its COVID vaccine. The biotech company Wednesday announced positive clinical trial data on three experimental vaccines against other viruses. The company is moving those shots to final stage studies, it said.
The update brings Moderna a step closer to having multiple products on the market, which it badly needs amid plunging demand for COVID shots worldwide. The company’s COVID jab is its only commercially available product. Moderna’s stock has long been tied to that vaccine, with shares falling nearly 45% last year. But shares of the company rose more than 3% in premarket trading Wednesday after the announcements.
Moderna will chart its post-Covid future Wednesday during its fifth annual “Vaccines Day,” an investor event in Boston focused on the company’s vaccine portfolio. Those vaccines include a shot against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea; a vaccine against Epstein-Barr virus, a common herpes virus that can cause contagious infections and is associated with some cancers; and a shot designed to target a virus that causes shingles and chickenpox.
Moderna will also discuss other updates across its vaccine business. The company has five other shots in late-stage clinical trials and said it expects to release data on two of those jabs this year. That includes its combination vaccine against COVID and the flu and a shot against another common herpes virus called cytomegalovirus, or CMV.
It also includes a new and improved version of Moderna’s COVID shot. The company on Tuesday said its “next-generation” COVID shot triggered a stronger immune response against the virus than its current vaccine on the market in a late-stage clinical trial.
Drug Overdoses Have Reached Record High, per Latest CDC Report: ‘Grim Statistics’
Drug overdoses reached a new high last year in the U.S., according to a new report from the Centers for Disease Control and Prevention (CDC).
Nearly 108,000 people died from drug overdoses in 2022, the agency said. This was a marginal increase from 2021, when 106,669 people died of drug overdoses. Overdoses are still the leading cause of death for adults in the country, largely driven by fentanyl, a synthetic opioid drug.
“When it comes to the intractable problem of substance abuse, one thing is evidently clear: America has an appetite for drugs, and not enough is being done about it,” Dr. David Campbell, clinical and program director of Recover Together in Bend, Oregon, who was not involved in the CDC report, told Fox News Digital.
“It should come as no surprise, then, that overdoses have emerged as one of the top 10 causes of non-genetic deaths and a leading contributor to the first drop in life expectancy in the United States in over two decades.”
Pharmacies Take Appeal of $650 Million Opioid Award to Ohio Top Court
Pharmacy operators CVS (CVS.N), Walmart (WMT.N) and Walgreens (WBA.O) on Tuesday urged Ohio’s highest court to conclude they cannot be held liable for fueling an opioid epidemic in two of the state’s counties that won a $650.9 million judgment against them.
A federal jury in Cleveland in 2021 concluded an oversupply of addictive pain pills and the diversion of those opioids to the black market created a public nuisance in the counties and that the companies helped cause it. The counties had alleged the companies did so by disregarding “red flags” and failing to ensure the prescriptions pharmacies were filling were valid. The companies denied wrongdoing.
U.S. District Judge Dan Polster, who is overseeing the federal multidistrict litigation over the opioid epidemic, afterward ordered CVS, Walmart and Walgreens to pay a combined $650.9 million to help the two counties address, or abate, the harms caused by the epidemic.
CVS, Walmart and Walgreens subsequently agreed to a collective $13.8 billion to settle the nationwide lawsuits against them by states and local governments. But the two Ohio counties did not settle and defended their verdict on appeal. The 6th U.S. Circuit Court of Appeals in September asked the Ohio Supreme Court to review the matter, saying it raised “novel and unresolved questions” of state law.
DNA Test Says It Can Predict Opioid Addiction Risk. Skeptics Aren’t so Sure.
Using a swab inside the cheek and a sophisticated computer algorithm, a DNA test recently approved by federal regulators promises to assess the genetic risk of opioid addiction. The test’s maker says results give doctors and patients a crucial tool when considering the use of the very pain pills that ignited the nation’s opioid crisis.
But as the company, SOLVD Health, prepares to roll out AvertD in the coming months, skeptics remain unconvinced. They worry that patients shown to have a low risk of addiction may feel emboldened to pop pain pills — then get hooked. Or that doctors will deny painkillers to patients errantly deemed at elevated risk.
Above all, some geneticists and public health experts say AvertD relies on unsound science. The Food and Drug Administration approved the AvertD cheek-swab test in December, despite an agency committee of experts voting overwhelmingly, 11-2, against recommending approval.
Andrew Kolodny, an opioid researcher at Brandeis University, blasted the test as a “sham.”
“You’ve got an alignment: profiteering by industry and federal agencies that feel they’re under the gun to do something about the problem, even if that something is counterproductive,” said Kolodny, president of Physicians for Responsible Opioid Prescribing, which aims to educate prescribers and patients.
Pharmaceutical Company Amgen Sues Colorado Over Price-Setting Prescription Drug Board
Amgen, the multinational pharmaceutical company that makes the blockbuster arthritis drug Enbrel, has sued Colorado over a state board’s efforts to possibly cap the price of the drug.
In a lawsuit filed Friday in U.S. District Court in Denver, Amgen argues that the actions of Colorado’s Prescription Drug Affordability Board are unconstitutional because they conflict with federal laws and because they violate rights to due process. The company is seeking not just to overturn the board’s recent decisions about Enbrel but also to strike down major parts of the law creating the board.
Colorado lawmakers, backed by Gov. Jared Polis, created the Prescription Drug Affordability Board, or PDAB, in 2021 with the goal of lowering prescription costs. The board has the ability after extensive review to set so-called upper payment limits — basically, price caps — on drugs it deems unaffordable.
Its first reviews of prescription drugs brought outcries from patient groups worried that price caps would cause their needed drugs to be pulled from the market in Colorado. But, last month, the board voted unanimously to declare Enbrel unaffordable, setting in motion a roughly six-month process to weigh whether to become the first state to place a price cap on prescription medication.
Amgen reported making about $3.7 billion from Enbrel sales worldwide in the 2023 fiscal year, down 10% from the year before.
2 New Lyme Disease Vaccines Could Mean End of Debilitating Illness
A vaccine for Lyme disease is not currently available, but two scientific initiatives to fight the condition are showing promising results, with one soon to be rolled out. Memphis-based U.S. Biologic aims to solve the epidemic by going straight to the source and vaccinating mice via food pellets, and studies have shown the method holds promise.
Meanwhile, Pfizer and French biotech company Valneva have developed a vaccine candidate — VLA15 — that’s already in Phase 3 human trials, the CDC said.
Researchers at the Massachusetts Institute of Technology and the University of Helsinki also recently determined that human sweat contains a protein that inhibits the growth of a bacterium that causes the disease.
“This protein may provide some protection from Lyme disease, and we think there are real implications here for a preventative and possibly a therapeutic based on this protein,” Michal Caspi Tal, a principal research scientist in MIT’s Department of Biological Engineering and one of the senior study authors, said in a statement.
Novo Nordisk Boosts Cardiovascular Pipeline With $1.1 Billion Purchase of Cardior Pharmaceuticals
The Wall Street Journal reported:
Novo Nordisk is buying Cardior Pharmaceuticals for up to 1.03 billion euros ($1.11 billion) as the Wegovy maker moves to strengthen its pipeline of drugs to treat cardiovascular disease and expand into areas outside of its core diabetes and weight-loss market.
The Danish pharmaceutical giant is enjoying blockbuster success for its Wegovy and Ozempic obesity and diabetes treatments, which aren’t only proving highly effective at regulating blood sugar and helping patients lose weight but are also yielding extra health benefits such as cutting the risk of stroke and heart attacks and slowing the progression of kidney disease.
Viking Therapeutics’ Weight-Loss Tablet Shows Promise in Small Study
Viking Therapeutics’ (VKTX.O) experimental tablet reduced weight by as much as 3.3% when tested in volunteers enrolled in a small early-stage trial, meeting Wall Street expectations and sending the company’s shares up 15% in premarket trading on Tuesday.
Popular market leaders from Eli Lilly (LLY.N) and Novo Nordisk (NOVOb.CO) are administered under the skin, with companies also testing oral versions that they hope will offer patients a more convenient option.
FDA Approves Merck’s Drug for Rare, Deadly Lung Condition
The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease.
The agency greenlighted the therapy, which will be marketed as Winrevair, for adults with pulmonary arterial hypertension. The decision is a big step for the roughly 40,000 people in the U.S. living with that disease because Winrevair is the first drug to target the root cause of the condition. Other available medicines only help manage symptoms.
It will priced at $14,000 per vial before insurance, a Merck spokesperson said in a statement. But the company has a program that offers eligible patients help with out-of-pocket costs and copays.
The approval is critical for Merck, which is working to diversify its revenue stream as its top-selling cancer immunotherapy Keytruda approaches a loss of market exclusivity in 2028.
AbbVie to Bolster Immunity Illness Drug Pipeline With Landos Deal
AbbVie (ABBV.N) will buy drug developer Landos Biopharma (LABP.O) for up to $212 million as the Humira-maker aims to expand its pipeline of medicines to treat immune system-related illnesses, the companies said on Monday.
Landos is currently conducting a mid-stage study of its lead experimental drug NX-13 in a type of an inflammatory bowel disease called ulcerative colitis.
AbbVie’s blockbuster drug Rinvoq is approved to treat the disease while the company has also sought the U.S. Food and Drug Administration’s approval for its other key drug Skyrizi.
