Think a friend or colleague should be getting this newsletter? Share this link with them to sign up. The Food and Drug Administration appears poised to approve Pfizer's RSV vaccine to protect infants as soon as August, in what would be a historic milestone for public health. The FDA's advisors endorsed Pfizer's vaccine Thursday, though they also raised safety concerns that the shot could be associated with a higher rate of preterm births. Though RSV is not dangerous to most people, the virus is a major cause of illness, hospitalization and death among infants. There currently is no approved RSV vaccine to protect newborns. The abortion pill mifepristone faced another day in court this week. Three federal appeals judges were deeply skeptical of the FDA's arguments in defense of mifepristone. The appeals court seems poised to rule against the abortion pill, which would set the stage for a Supreme Court battle over mifepristone. And President Joe Biden this week selected cancer surgeon Dr. Monica Bertagnolli to lead the National Institutes of Health. The NIH, which invests billions of dollars in medical research, has been without a Senate-appointed leader since Dr. Francis Collins stepped down in 2021.
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An independent panel of advisors to the FDA on Thursday recommended full approval of Pfizer's vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot.
A slightly higher number of preterm deliveries occurred among mothers who took the RSV shot compared to those who received a placebo.
Both Pfizer and the FDA said the difference does not appear to be statistically significant. But some advisors said those early births raise questions about the safety profile of the vaccine.
The FDA is slated to make a final decision on the shot in August, right before RSV season in the fall. |
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A panel of judges on Wednesday hammered the Food and Drug Administration and a pharmaceutical company during arguments over the abortion pill mifepristone.
The judges questioned whether allowing women to receive mifepristone by mail without having to see a doctor would result in more patients seeking emergency care. And Judge James Ho pushed back on the FDA and Danco's characterization of the case as unprecedented. "I don't understand this theme — the FDA can do no wrong. That is basically the narrative you all are putting forth — nobody should ever question the FDA," Ho said. |
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Dr. Monica Bertagnolli is currently the director of the National Cancer Institute and is the first woman to lead the organization. Bertagnolli previously was a professor of cancer surgery at Harvard Medical School and a surgeon at Brigham and Women's Hospital in Boston. Biden said as head of the National Cancer Institute, Bertagnolli has helped advance the White House's cancer moonshot initiative, which aims to slash the death from the disease 50% over the next 25 years. |
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The FTC on Tuesday sued to block Amgen's $27.8 billion acquisition of Horizon Therapeutics, arguing the proposed deal would stifle drug competition in the pharmaceutical industry.
The agency claimed the merger would allow California-based Amgen to "entrench the monopoly positions" of two of Horizon's fast-growing medications.
Both Amgen and Horizon said they are committed to closing the acquisition later this year. |
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Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drug maker Seagen, according to a new filing with the Securities and Exchange Commission.
Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024. The debt offering is expected to close Friday and is the largest since 2018.
Pfizer's move comes as companies rush to tap the U.S. bond market ahead of a potential spike in borrowing costs sparked by the debt ceiling standoff. | |
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Patients are now enrolling in an early stage clinical trial to test a universal flu vaccine based on messenger RNA technology, the National Institutes of Health announced Monday. Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year. |
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| The Centers for Disease Control and Prevention on Thursday urged gay men and other individuals at high risk from mpox to get fully vaccinated to prevent a summer resurgence of the virus. The CDC's call for those at risk to get up to date on their vaccines comes after a cluster of at least 21 mpox cases was reported in the Chicago area this month. Many of the people who caught mpox in the Chicago cluster were partially or fully vaccinated against the virus, raising questions about whether immunity from the shots might wane over time. |
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