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U.S. FDA Approves Pfizer’s Vaccine for Meningococcal Disease
The U.S. Food and Drug Administration (FDA) has approved Pfizer‘s (PFE.N) vaccine Penbraya, making it the first shot to protect against five groups of deadly bacteria that can cause meningitis and blood poisoning, the company said on Friday.
Meningococcal diseases are rare bacterial infections that commonly affect the brain, spinal cord and bloodstream, and can be deadly in a matter of hours. The pentavalent vaccine protects against five meningococcal bacteria groups — A, B, C, W and Y — which are known to commonly cause the disease.
Pfizer currently sells two vaccines to protect against the disease, with Trumenba targeting the B group and Nimenrix protecting against the other four bacteria groups.
Penbraya combines components from those two vaccines and is approved for use in individuals 10 through 25 years of age. It is administered as a two-dose series given six months apart. After the FDA approval, the Centers for Disease Control and Prevention’s advisers are scheduled to meet on Oct. 25 to discuss the use of the vaccine, the company said.
Moderna Shaves Off $7 Billion in Value After Pfizer Warning
The pandemic officially ended months ago, allowing a weary public to get back to normal living. That was great news for large swaths of the economy. But not all of it. Moderna Inc., which shot to fame when it became one the first companies to bring the world COVID-19 vaccines, has been searching for its next big thing ever since. Investors have bailed in droves as waning demand for shots and treatments for the virus drove an eight-day losing streak in the stock.
Moderna has erased $6.8 billion in market value this week after rival shotmaker Pfizer Inc. slashed its profit outlook late last Friday, sounding the alarm on dwindling demand for its COVID shots and pills. Moderna’s stock closed at the lowest since November 2020 — that’s when the company was still racing to get its COVID jab authorized for U.S. use.
As Moderna struggles to position itself beyond its blockbuster Spikevax vaccine, Wall Street has been divided on its fate with half of the 24 analysts tracked by Bloomberg rating it a buy. The other side, including Singh who rates the stock market performance, is less enthusiastic with 10 analysts saying to hold the stock and two recommending selling.
The vaccine maker is striving to prove its messenger-RNA technology will work against other diseases, including cancer. A flu and COVID combo shot as well as an RSV vaccine are also in the works.
The Opioid Crisis Has Gotten Much, Much Worse Despite Congress’ Efforts to Stop It
America’s drug overdose crisis is out of control. Washington, despite a bipartisan desire to combat it, is finding its addiction-fighting programs are failing.
In 2018, Republicans, Democrats and then-President Donald Trump united around legislation that threw $20 billion into treatment, prevention and recovery. But five years later, the SUPPORT Act has lapsed and the number of Americans dying from overdoses has grown more than 60%, driven by illicit fentanyl. The battle has turned into a slog.
Even though 105,000 Americans died last year, Congress is showing little urgency about reupping the law since it expired on Sept. 30. That’s not because of partisan division, but a realization that there are no quick fixes a new law could bring to bear.
Scientists Infect Volunteers With Zika in Hunt for Vaccines, Treatments
Researchers in the United States have shown for the first time they can safely and effectively infect human volunteers with Zika virus, a step towards learning more about the disease and developing vaccines and treatments.
The study — known as a “controlled human infection model” — has previously been controversial for Zika because of the risks to participants and lack of treatments. But U.S. regulators and the World Health Organization ruled the new model, developed by a team at the Johns Hopkins Bloomberg School of Public Health, was safe and scientifically important.
There are no vaccines or treatments, and the outbreak in the Americas ended before new ones could be fully tested. Infections have dwindled worldwide since, with about 40,000 reported last year from that region.
Anna Durbin, the Johns Hopkins professor who led the study, said several vaccine manufacturers have already asked to use the strains to test experimental products.
From COVID Meds to Abortion. Why Conservatives Are Fighting the FDA’s Power to Regulate Drugs
The world was more than a year into the coronavirus pandemic when the Food and Drug Administration became alarmed about reports of Americans treating COVID-19 with an anti-parasitic drug often used in horses and cows.
“You are not a horse. You are not a cow,” the FDA posted to social media in mid-2021 as COVID-19 vaccines were already widely available in the USA. “Seriously, y’all. Stop it.”
Those warnings are now the subject of a pending lawsuit by three doctors who claim the FDA overstepped its authority by weighing in with medical advice they say should be left to physicians. The ivermectin suit is one of several working through federal courts challenging the FDA’s power to make decisions or dispense information.
Though the FDA never approved ivermectin to treat COVID-19, it is approved in humans for infections caused by certain parasites. The doctors who sued last year argued that physicians, not the federal government, should make decisions about off-label drug use. They say their reputations were harmed by the FDA posts because they prescribed the human version of the drug to patients.
Using Opioid Settlement Cash for Police Gear Like Squad Cars and Scanners Sparks Debate
Policing expenses mount quickly: $25,000 for a law enforcement conference about fentanyl in Colorado; $18,000 for technology to unlock cellphones in Southington, Connecticut; $2,900 for surveillance cameras and to train officers and canines in New Lexington, Ohio. And in other communities around the country, hundreds of thousands for vehicles, body scanners, and other equipment.
In these cases and many others, state and local governments are turning to a new means to pay those bills: opioid settlement cash.
This money — totaling more than $50 billion across 18 years — comes from national settlements with more than a dozen companies that made, sold, or distributed opioid painkillers, including Johnson & Johnson, AmerisourceBergen, and Walmart, which were accused of fueling the epidemic that addicted and killed millions.
Directing the funds to police has triggered difficult questions about what the money was meant for and whether such spending truly helps save lives. Terms vary slightly across settlements, but, in most cases, state and local governments must spend at least 85% of the cash on “opioid remediation.”
Sanofi Seeing ‘Unprecedented’ Demand for RSV Therapy
French drugmaker Sanofi (SASY.PA) said on Friday it was seeing an “unprecedented level” of demand for an antibody therapy it co-developed to prevent respiratory syncytial virus (RSV), a leading cause of hospitalizations in infants.
The therapy, branded Beyfortus and jointly developed by Sanofi and AstraZeneca, was approved in July to prevent RSV in infants and toddlers.
Before the approval of Sanofi’s drug, Swedish Orphan Biovitrum’s (SOBIV.ST) treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants.
Sanofi said it is working with AstraZeneca (AZN.L) to identify further solutions to meet surging demand.
EU Authorities Fine Boehringer, Others for Operating Drug-Ingredient ‘Cartel’
Five pharmaceutical companies, including the global player Boehringer Ingelheim, have landed in hot water for running a “cartel” to dominate the market for a specific drug ingredient in Europe.
The European Commission (EC) is fining Alkaloids of Australia, Alkaloids Corporation, Boehringer, Linnea and Transo-Pharm a total of €13.4 million ($14.2 million) to settle claims that the companies agreed to fix prices and allocate business on the pharmaceutical component N-Butylbromide Scopolamine/ Hyoscine (SNBB), which is used to make the decades-old abdominal antispasmodic Buscopan and its generics.
Boehringer received the largest fine by far, settling with the EC for €10.4 million.
All six companies “admitted their involvement in the cartel and agreed to settle the case,” the European Commission said in a press release.
