Study Looks at GLP-1 Use in Pregnancy and Gestational Weight Gain

 GLP-1 receptor agonist use for weight loss early in pregnancy was associated with a lower likelihood that gestational weight gain would be below recommended levels, according to a retrospective cohort study.

For women taking GLP-1 drugs for weight management, there was a significant decrease in the odds of gestational weight gain below recommended Institute of Medicine (IOM) levels during early pregnancy (adjusted OR 0.29, 95% CI 0.12-0.70), reported Nishita Pondugula, MD, MS, a first-year resident at Duke University Medical Center in Durham, North Carolina, at the American College of Obstetricians and Gynecologists annual meeting.

Prepregnancy-only exposure did not have a significant effect on gestational weight gain, which Pondugula said may indicate "slowing of rebound weight gain after more time has passed since GLP-1 cessation." She also noted that there were no significant differences when looking at exceeding IOM recommendations. Weight re-gain is common after stopping GLP-1 agents.

In addition, exposure to GLP-1 drugs up to 1 year prior to pregnancy did not significantly affect the odds of developing hypertensive disorders of pregnancy for women taking the drugs for pregestational diabetes (aOR 0.72, 95% CI 0.42-1.25) or weight management (aOR 0.83, 95% CI 0.45-1.52).

Pondugula pointed to a signal for risk of fetal death after GLP-1 exposure in the weight-management cohort (2.9% vs 0.5%), though this did not reach statistical significance, and that signal was not present in the diabetes cohort. Some animal studies have raised concerns about fetal death and GLP-1 medications, though observational research in humans has not shown an increased risk.

There's extremely limited evidence on the effects of GLP-1 drugs in pre-pregnancy and early pregnancy, but an increasing number of patients are using the drugs for both diabetes and weight management.

A previous analysis of health records that primarily included women with obesity suggested that the recommended discontinuation of GLP-1 receptor agonists during pregnancy was associated with more gestational weight gain and higher risks of pregnancy complications. In a small retrospective study, using GLP-1 agents before pregnancy was linked to a lower risk of gestational diabetes, but not preeclampsia.

Nikki Zite, MD, MPH, an ob/gyn at the University of Tennessee Graduate School of Medicine in Knoxville, who was not involved with the research, said that with "the increase in use of these medications across the board, but especially in reproductive-age women, it is important that we continue to evaluate the potential risks and benefits to provide evidence-based guidance."

She told MedPage Today that she was not surprised that fewer patients gained below the recommended amount of weight, considering the weight gain seen when patients discontinue GLP-1 agents and typical weight gain seen during pregnancy.

While the researchers didn't find a significant association between the medications and hypertensive disorders of pregnancy, Zite said that "given the biologic plausibility and the non-significant risk reduction they noted, further investigation is warranted."

This study sought to evaluate the effects of exposure to GLP-1 receptor agonists up to 1 year prior to pregnancy on maternal gestational weight gain and development of hypertensive disorders of pregnancy for women taking the drugs for weight management or diabetes.

Pondugula and team queried electronic medical records for all deliveries within the Yale New Haven Health system between 2014 and 2024 with hand abstraction to confirm GLP-1 drug exposure and dates of use up until 1 year prior to pregnancy. In all, 243 people were exposed to GLP-1 medications.

The researchers included 103 patients who had used GLP-1 drugs for diabetes and 175 patients in a control group, and 140 patients who used the drugs for weight management and 200 patients in a control group.

Semaglutide (Ozempic, Wegovy) was the most commonly used GLP-1 medication (63%). The last use of a GLP-1 medication was a mean 14 days prior to pregnancy. For those who used the drugs in the prepregnancy period, discontinuation was a mean 142 days prior to pregnancy. For those who had exposure in early pregnancy, the last use was a mean 53 days into pregnancy.

The primary outcome was maternal gestational weight gain, transformed based on weekly IOM recommendations and accounting for gestational age at delivery. The co-primary outcome was diagnosis of a hypertensive disorder of pregnancy, including gestational hypertension, preeclampsia with or without severe features, superimposed preeclampsia, eclampsia, and HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome.

Among the cohort with pregestational diabetes, Black patients were significantly more likely to be exposed to GLP-1 medications, as were those with a prepregnancy body mass index (BMI) of ≥30, and the control group was significantly more likely to be using metformin. In the weight-management cohort, those with GLP-1 drug exposure were significantly more likely to have chronic hypertension or polycystic ovary syndrome and significantly less likely to have a prepregnancy BMI of ≥30.

Future research should clarify the optimal timing of peripregnancy GLP-1 receptor agonist cessation and the safety of continuation into pregnancy, especially for those taking the drugs for pregestational diabetes, Pondugula said.

Disclosures

Pondugula had no disclosures.

Zite had no conflicts of interest.

Primary Source

American College of Obstetricians and Gynecologists

Source Reference: Pondugula N, et al "Gestational weight gain and hypertensive disorders of pregnancy with prepregnancy and early pregnancy GLP-1 receptor agonist (GLP-1RA) exposure" ACOG 2026.

https://www.medpagetoday.com/meetingcoverage/acog/121128

RFK Jr. Launches Effort to Encourage Antidepressant Deprescribing

 Clinicians need to do more to help wean patients off of antidepressants, according to HHS Secretary Robert F. Kennedy Jr.

"The U.S. doesn't just face a mental health crisis; we face a dependency crisis driven by overmedication," Kennedy said Monday at a MAHA Institute conference. "One in six adults takes an antidepressant and one in 10 children are on a prescription for mental health ... Too many patients begin treatment without a clear understanding of the risks or how long they'll stay on these drugs or how they'll come off them."

Kennedy has long been opposed to antidepressant use and said on X last year that the CDC was going to "confront the long-taboo question of whether SSRIs [selective serotonin reuptake inhibitors] and other psychoactive drugs contribute to mass violence."

As part of the initiative announced Monday, the agency sent physicians a "Dear Colleague" letter that "encourages providers to prioritize informed consent and shared decision-making, and to regularly review the risks and benefits of psychiatric medications with patients," HHS said in a press release. "The letter highlights nonmedication approaches, such as family support, psychotherapy, nutrition, and physical activity when clinically appropriate."

The letter also lists billing codes that providers can use to get paid for tasks associated with deprescribing and the use of "evidence-based nonmedication treatments."

"Psychiatric medicines have a role in care, but we will no longer treat them as the default," Kennedy said at the event.

Also on Monday, the Centers for Medicare & Medicaid Services (CMS) released guidance for physicians and other practitioners "on the importance of deprescribing and related medical care," according to the HHS press release. This guidance explains more about how clinicians can be paid by Medicare for deprescribing, and also directs clinicians to resources such as professional society guidelines, peer-reviewed deprescribing protocols, and FDA instructions for taper schedules.

At the conference, Kennedy touted his own expertise on the deprescribing issue. "I made a statement early on in my administration that withdrawal from SSRIs can be more difficult than withdrawal from heroin," he said. "The New York Times said experts disagree ... We all know when they say, 'trust the experts,' they've got nothing. I happen to be an actual expert on this because I was addicted to heroin for 14 years."

He said that although heroin withdrawal involves 72 hours of misery, "I've watched people come off SSRIs and it's not even comparable" because the latter is so much worse. One family member "was suicidal literally every day ... I've heard that from hundreds of people and it's the same story again and again."

However, he added, physicians will often say that the withdrawal effects "are the original symptom reasserting itself; you need to get back on the SSRI," and it becomes a lifetime cycle.

The American Psychiatric Association (APA) reacted cautiously to the HHS announcement. "APA welcomes the attention placed squarely on the nation's mental health crisis and is committed to advancing solutions that improve access to high-quality evidence-based care," the association said in a statement. "We are supportive of the Administration's plans for further investment in research and clinician training on the issues of prescribing and deprescribing."

However, "while APA supports efforts to improve the quality, safety, and evidence base of mental health treatment, we strongly object to framing the nation's mental health crisis as primarily a problem of 'overmedicalization' or 'overprescribing.' That characterization oversimplifies a complex crisis and ignores the larger reality: too many patients cannot access timely, comprehensive care, while care remains unevenly distributed across our health system," the group added. "It also fails to account for persistent workforce shortages, limited psychiatric beds, inadequate visit time, barriers to psychotherapy and social supports, insufficient integration of psychiatric expertise in primary care through the Collaborative Care model, and the lack of a true continuum of care."

"Deprescribing alone is not a sufficient response to this crisis," the APA continued. "In psychiatry, as in all areas of medicine, prescribing and deprescribing occur every day as part of individualized, evidence-based treatment planning between physicians and patients. The solution is not to stigmatize psychiatric medication or impose broad assumptions on clinical care, but to ensure that patients have access to the full range of evidence-based treatments and that decisions are guided by the best available science and each patient's needs."

The APA, along with five other psychiatric and psychopharmacology groups, also spoke out a year ago regarding the safety of antidepressants and other psychiatric medications.

"The safety and efficacy of traditional antidepressants, antipsychotics, and mood stabilizers (such as lithium and some anticonvulsants) and stimulant medications have been established through decades of rigorous research, randomized clinical trials, peer-reviewed studies, meta-analyses, national registry studies of thousands of people, post-marketing pharmacovigilance monitoring, and FDA oversight," the groups said in a joint statement published online in the Journal of Clinical Psychiatry. "These drugs provide relief for many young people enabling them to participate fully in treatment, school, social activities, and family life -- all key aspects of healthy development. Efforts to discourage, stigmatize, or curtail the use of evidence-based treatments for mental illness will have serious deleterious consequences, particularly for individuals with serious mental illness, their loved ones, and the communities in which they live."

Protect Our Care, a nonprofit organization whose mission is to make "high-quality, affordable, and equitable healthcare a right, and not a privilege," panned the announcement from HHS.

"While RFK Jr.'s HHS makes no mention of how they intend to incentivize therapists to be in-network with private insurance and Medicare, major studies and surveys have shown that 82.7% of psychotherapists did not accept any public insurance like Medicare while more than one-third of practicing psychologists do not accept private insurance," the group said in a statement. "Meanwhile, the Trump administration's [fiscal year] 2027 budget plan seeks to gut over half a billion dollars from mental health programs while eliminating the Substance Abuse and Mental Health Services Administration."

https://www.medpagetoday.com/psychiatry/depression/121129

UK says cargo ship struck in Strait of Hormuz

 The United Kingdom Maritime Trade Operations (UKMTO) said in a notice on Tuesday that a cargo ship was hit by a projectile in the Strait of Hormuz.

"A verified source reported a cargo vessel has been struck by an unknown projectile. Environmental impact is unknown at [the] time of [the] report," the UKMTO noted. The organization once again urged ships transiting the Strait of Hormuz to report "any suspicious activity."

The news comes after the United States launched Project Freedom to guide ships going through this critical waterway. Iran, on the other hand, warned vessels to transit Hormuz only through routes previously authorized by Tehran.

https://breakingthenews.net/Article/UK-says-cargo-ship-struck-in-Strait-of-Hormuz/66223780

IQVIA beats, raise guidance, signs AI-supported deal with Pfizer across 23 European countries

 

IQVIA beats Q1 2026 estimates, raises FY26 EPS guidance to $12.65–$12.95, signs AI-supported commercial intelligence deal with Pfizer across 23 European countries

• Q1 2026 non-GAAP EPS was $2.90, up 7% YoY and beating estimates.
• Q1 2026 revenue was $4.2B, up 8% YoY, also beating estimates.
• Company reaffirmed full‑year 2026 revenue and EBITDA targets alongside the raised adjusted EPS guidance.

https://finviz.com/quote?t=IQV&p=d

'Seismic shift' as obesity overtakes cancer for R&D returns

 In 2022, obesity contributed just 1% of the projected value of pharma industry pipeline, as calculated by Deloitte. Now, its share has rocketed to 25%, grouped around just a few drugs with the potential to be mega-blockbusters.

In the latest edition of Deloitte's annual report looking at the return on pharma innovation, the accounting giant says that the late-stage obesity pipeline in 2025 pushed cancer – which is estimated to account for around 20% of value – into second-place for the first time in 16 years.

Overall, the average internal rate of return (IRR) has improved for the third consecutive year, reaching 7% from 5.9% in 2024, but the report notes this is largely driven by a few programmes – mostly GLP-1 and GIP candidates and combinations for obesity, diabetes, and related conditions like heart and liver disease – and underlying productivity is "strained".

The concentration in mega-blockbusters is at an all-time high, with just 54 blockbuster assets, or around 9% of the late-stage pipeline, projected to generate approximately 70% of total risk-adjusted peak sales.

As might be expected, those assets have driven the predicted average forecast peak sales per asset to $598 million last year, compared to $510 million in 2024.

Deloitte says this is creating "a precarious balance of high potential returns and the risk of significant value destruction from a single programme failure."

For the companies developing those mega-blockbuster assets, that also introduces the risk of future shocks from tightening of pricing or market access – which is already evident in recent developments involving GLP-1 and GIP drugs in the US market under the Trump administration's Most-Favoured Nation (MFN) pricing drive – or other factors like increased competition, unexpected safety signals, or manufacturing supply constraints.

GLP-1-based assets are now forecast to account for an estimated 38% of projected commercial inflows from the 2025 late-stage pipeline, says the report.

"Organisations who succeed at bringing obesity assets to market will need to be highly sophisticated in terms of patient segmentation and targeting across reimbursed and direct-to-consumer markets," according to the report.

Meanwhile, costs keep rising, with the average cost to develop a drug from discovery to launch increased to $2.67 billion in 2025 from $2.23 billion in 2024, which Deloitte notes raises the bar for commercial success.

There is also evidence that developers are widening the net to find new therapies, as assets with a 'novel' mechanism of action rose sharply to 53% of total programmes in 2025 from 35% in 2024. And the well-established trend toward developing large-molecule, rather than small-molecule, medicines continues to accelerate.

The authors of the report recommend that developers evolve how they allocate capital, choose where to compete, and operationalise AI to build a resilient innovation engine and sustain value beyond the current GLP-1 wave.

https://pharmaphorum.com/news/seismic-shift-obesity-overtakes-cancer-rd-returns

After rival fails, Cytokinetics could broaden Myqorzo label

 Cytokinetics' cardiac myosin inhibitor Myqorzo has succeeded where first-to-market Camzyos from Bristol Myers Squibb failed, hitting the mark in a phase 3 trial in non-obstructive hypertrophic cardiomyopathy (HCM).

Myqorzo (aficamten) was approved by the FDA for obstructive HCM last December, more than three years after Camzyos (mavacamten) reached the market for that form of the disease, which is characterised by thickening of cardiac muscle and stiffness in the left ventricle that interferes with the function of the heart.

BMS's efforts to expand the label of its drug into the non-obstructive setting – a milder form of the disease in which there is no obstruction in blood flow from the heart to the body – suffered a major setback a year ago, however, when the ODYSSEY-HCM trial failed to show a statistically significant benefit.

That led to some speculation that obstructive and non-obstructive HCM might actually be two distinct diseases, requiring different treatment strategies. Now, however, the results of the ACACIA-HCM study of Myqorzo could set those fears aside.

In a statement, Cytokinetics said the trial met both its primary endpoints – the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance based on the pVO2 biomarker – compared to placebo after 36 weeks.

In what appears to be a home run for Myqorzo, there were also statistically significant improvements compared to placebo in a range of secondary endpoints, including the proportion of participants with improvements in New York Heart Association (NYHA) Functional Class, the composite z-score of ventilatory efficiency and pVO2, and NT-proBNP, a biomarker for heart damage.

The readout puts Cytokinetics in pole position to bring the first treatment for non-obstructive HCM to market, which could double the number of patients eligible for its drug.

"We believe that the totality and consistency of evidence favouring aficamten across multiple patient-reported and physician-assessed endpoints of symptom improvement and physical function are clinically meaningful for patients with non-obstructive HCM," said the company's head of R&D, Fady Malik.

Myqorzo launched in the US in January and has also been approved in Europe and China, with a launch in Germany due in the next three months, so there will be great interest in the initial sales data for the drug when Cytokinetics reports its first-quarter results, due later today.

The potential market is witnessed by the stellar growth recorded by BMS for Camzyos, which broke the blockbuster barrier last year with a 77% rise in annual sales to reach almost $1.1 billion.

Analyst Srikripa Devarakonda of Truist said Myqorzo's approval for non-obstructive HCM could "solidify its ⁠status as the preferred HCM therapy over Camzyos," according to a Reuters report.

https://pharmaphorum.com/news/after-rival-fails-cytokinetics-could-broaden-myqorzo-label

Embecta 2026 guidance cut sharply on U.S. pen needle collapse

 

Embecta Q2 2026 EPS $0.27 (-61% YoY), revenue $221.8M (-14% YoY) miss as 2026 guidance cut sharply on U.S. pen needle collapse

• Q2 revenue fell 17% constant currency, with U.S. down nearly 30%, missing expectations.
• Full-year revenue, margin and EPS guidance cut sharply; free cash flow outlook nearly halved.
• U.S. pen needle share loss at major retailer and market softness drive ~70% downgrade.
• Management sees emerging structural headwinds from GLP-1 adoption and insurance changes, uncertainty remains high.
• Owen Mumford acquisition proceeds; adds auto-injector platform and diversifies beyond insulin devices.
• Acquisition and lower U.S. profitability raise tax rate to 28% and pressure EPS.
• Cost structure and footprint under review; company still targeting $150M 2026 debt repayment.
• Dividend slashed from $0.15 to $0.01 to fund $100M buyback, enhance flexibility.
• International performance largely on plan; China stabilizing after last year’s significant declines.
• GLP-1 B2B pipeline expanding, with early launches in India and retail packs globally.
• Main concern: Structural decline in insulin pen/needle demand and embecta’s ability to stabilize U.S. share.
• Weak quarter, driven by U.S. pen needle share loss and broad reductions to 2026 guidance.

https://finviz.com/quote?t=EMBC&p=d