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U.S. FDA Approves Pfizer’s Next-Generation Pneumococcal Vaccine
The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc’s (PFE.N) next-generation vaccine to prevent pneumococcal disease in children aged six weeks to 17 years, the company said late on Thursday.
The vaccine, Prevnar 20, offers more protection against the disease versus the company’s widely-used Prevnar 13 vaccine, by targeting seven more serotypes of the streptococcus pneumoniae bacteria that cause those infections.
Prevnar 20 has also been approved to prevent a type of ear infection known as otitis media in infants six weeks through five years of age, the company said.
Obesity Drug Industry Could Be Worth $200 Billion Within the Decade, Says Barclays, as Market Valuations Grow
The burgeoning weight-loss drug industry, which is whetting investors’ appetites with its pledge to combat global obesity rates, could be worth as much as $200 billion within the next decade, according to Barclays Bank.
Dubbing obesity “the story of this decade,” Barclays’ head of European pharmaceuticals equity research said that, based on investor feedback, the bank’s previous valuation estimate may have been overly conservative.
According to the World Health Organization, global obesity rates have almost tripled over the past decade. It is currently estimated that 1 billion people are clinically obese, of whom around 650 million are adults, 340 million are adolescents and 39 million are children.
Pharmaceutical makers Novo Nordisk and Eli Lily are among those grabbing attention for tackling waistlines with their weight-loss drugs including Wegovy, Ozempic and Mounjaro.
Quitting Lilly’s Obesity Drug Tirzepatide May Be Difficult for Many Patients, Exec Says
On a day when Eli Lilly revealed stellar trial results for its obesity hopeful tirzepatide and spent more than half of its quarterly earnings presentation discussing the drug’s prospects, there was a disquieting side note.
Using tirzepatide might be a lifetime decision.
“Unfortunately, tirzepatide is probably like every other drug we have which requires you to take it to continue to get the benefits,” Dan Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, said during a conference call.
“My expectation is that many patients may try coming off the drug completely to see what happens,” Skovronsky said. “Maybe some will be successful maintaining their weight, but many of them will probably experience some regression of their weight back toward baseline and this could prompt them to come back on the drug.”
J&J to Retain All Talc-Related Liabilities From Litigation in U.S., Canada
Johnson & Johnson (JNJ.N) said on Thursday it has agreed to retain all talc-related liabilities arising from litigation in the United States and Canada and will “indemnify” newly formed consumer health unit Kenvue for all costs.
The statement comes after the Financial Times reported earlier in the day that Kenvue had been named in claims that its talcum powder can cause cancer.
Kenvue had been named in at least seven talc lawsuits filed since the start of April, according to the newspaper, which cited regulatory filings and people familiar with the matter.
Earlier this month, J&J agreed to pay $8.9 billion to settle tens of thousands of lawsuits alleging that talc in its iconic Baby Powder and other products caused cancer, dwarfing the company’s original offer of $2 billion.
MDL Judge Finds Tylenol Autism, ADHD Lawsuits Against J&J Are Not Preempted
The U.S. District Judge presiding over all federal Tylenol autism and ADHD lawsuits has determined that the failure to warn claims being pursued by families nationwide are not preempted by federal regulations, rejecting a request by Johnson & Johnson to have the litigation dismissed early in the proceedings.
Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the belief among consumers and the medical community that it poses little risk to developing children. However, a series of studies have been published in recent years, which indicate that in-utero exposure may increase the risk that a child is later diagnosed with autism or ADHD.
More than 100 families of children with ADHD or autism from Tylenol are now pursuing lawsuits against Johnson & Johnson, as well as major retailers who sold generic versions of the pain medication, including Walmart, CVS, Walgreens, Costco and others. However, it is widely expected that tens of thousands of claims will be brought in the coming months and years.
Each of the complaints raises similar allegations, indicating that information has been available to the manufacturers for decades about the link between autism and Tylenol, as well as attention deficit hyperactivity disorder (ADHD) and other developmental problems. However, rather than warning about the acetaminophen risks, the drug has been actively promoted as safe for use by pregnant women.
Moderna, the COVID Vaccine Maker, Wants to Expand in Marlborough. How It Could Happen
MetroWest Daily News reported:
Moderna, the Cambridge-based biomedical company that burst onto the scene in 2020 when it developed one of the most prominent COVID-19 vaccines, is eyeing Marlborough for its next major expansion.
The city is currently in negotiations with Moderna over a potential new manufacturing facility to be built at 149 Hayes Memorial Drive. In a letter to Mayor Arthur Vigeant, Moderna Senior Vice President of Manufacturing Scott Nickerson wrote that the company anticipates investing as much as $450 million in a new facility in Marlborough to help handle the company’s anticipated growth.
Nickerson added that the Moderna facility would operate 24/7, including around-the-clock manufacturing.
Why Antibiotics Fail — And How We Can Do Better
We are running out of new antibiotics that can be used to treat ever-increasing resistance in bacterial infections. By using a different culture medium to test antibiotics, a researcher at UCSB has shown that some common antibiotics may be useful against a wider range of bacterial infections than previously recognized.
However, there are several reasons that antibiotics don’t work as predicted, sometimes working when they “shouldn’t” or, more often, failing in people. Sometimes the wrong dose is prescribed, or they are given too infrequently. But sometimes lab testing suggests that a bacteria is susceptible to (sensitive to killing by) an antibiotic, and it is not.
Michael Mahan, Ph.D., professor of Molecular, Cellular, and Developmental Biology at UCSB, and colleagues have recently found a way to more accurately predict antibiotic effectiveness by using a different culture medium, Dulbecco’s modified Eagle medium (DMEM).
