Monday, December 1, 2025
'WHO backs use of GLP-1 therapies for obesity, warns access will remain limited'
Fewer than one in 10 people who could benefit from obesity jabs like Wegovy are able to get them, warns the World Health Organization as it releases its first guidance on the drugs.
With more than one billion people worldwide now obese, it is calling for more widespread and fairer access to GLP-1 medication.
According to projections, more than two billion will be obese by 2030 unless action is taken.
High costs, limited production capacity, and supply-chain constraints are major barriers to universal access to the injections that can help people shift significant weight, says WHO.
It has already added them to its "essential" medicines list that countries are advised to provide.
WHO director-general Tedros Adhanom Ghebreyesus said: "Our new guidance recognises that obesity is a chronic disease that can be treated with comprehensive and lifelong care.
"While medication alone won't solve this global health crisis, GLP-1 therapies can help millions overcome obesity and reduce its associated harms."
WHO says these drugs, sometime called skinny jabs, represent a new chapter in the gradual conceptual shift in how society approaches obesity, from a "lifestyle condition" to a complex, preventable, and treatable chronic disease.
It says the drugs can be taken long-term - for six months or more - but must be prescribed along with advice on diet and exercise, so that people can keep the weight off.
Too few people around the world can access them, says WHO. "Our greatest concern is equitable access," said Tedros.
Even under the current best projected scenario, the production of GLP-1 therapies could only cover around 100 million people - less than 10% of those who need them, according to the WHO.
The guideline calls on countries and companies to expand access, through strategies such as voluntary licensing - where a pharmaceutical company grants permission for others to make affordable non-brand versions of its patented drug.
A patent on semaglutide - the core ingredient of Novo Nordisk's Wegovy - is due to expire in several countries in 2026, meaning other drug-makers will soon be free to produce and sell cheap versions in places like India, Canada, China, Brazil and Turkey.
WHO says countries must also create healthier environments to promote good health and prevent obesity.
GLP-1 drugs mimick a natural hormone to slow digestion, curb appetite and increase feelings of fullness so people eat less.
In the UK, the injections are prescription only medicines, which means they can only be prescribed by a healthcare professional for a person who clinically needs it.
Some are available on the NHS, but more are sold privately.
There is a black market and to be safe people should avoid buying from unregulated sellers such as beauty salons or via social media.
People typically start to lose weight within a few weeks of starting on the weekly injections.
Research suggests people may put most of the weight back on within a year of stopping the medication though, as their normal food cravings return.
Being overweight or obese increases your risk for developing health problems, such as diabetes, heart disease, stroke, and certain cancers.
Obesity affects people in every country and was associated with 3.7 million deaths worldwide in 2024, according to the WHO.
https://www.bbc.com/news/articles/cze8n0753zzo
Merck Drug Gets Fast-Track Designation from FDA for Alzheimer's Treatment
Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.
MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.
Merck also shared early clinical results for MK-1167, a separate Alzheimer’s drug candidate that modulates the alpha-7 nicotinic acetylcholine receptor. That drug is being studied in a phase 2 trial.
MK-2214 is being developed in collaboration with Teijin Pharma.
Is FDA about to restrict vaccination even further?
Reports have emerged that Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research (CBER), is planning to tighten up the regulations surrounding vaccines after concluding that COVID-19 shots resulted in the deaths of 10 children.
The source of the reports is an internal email to CBER staff in which Prasad said that, in a "profound revelation," the US medicines regulator will "for the first time […] acknowledge that COVID-19 vaccines have killed American children."
The memo – first revealed on X.com by a PBS journalist and subsequently obtained by various news agencies – also said: "Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death."
Prasad said in the email that the FDA is looking into a new approval process for vaccines that will require more evidence of their safety and efficacy before they can be cleared for marketing, particularly if they are to be used in pregnant women, which has raised fears of a slowdown in the development of new vaccines for the US market.
He also said there would be a re-examination of annual flu shot policies, calling it an "evidence-based catastrophe," and limits on the administration of combination vaccines, in a new signal of an increasingly vaccine-sceptic stance at the agency under Health and Human Services (HHS) Secretary, Robert F Kennedy Jr, a prominent figure in the anti-vaccine movement.
Prasad said that a review had revealed at least 10 children had died "after and because of" a COVID-19 vaccine, citing data reported to the Vaccine Adverse Event Reporting System (VAERS) on 96 deaths between 2021 and 2024, but did not provide any details about the cases or the circumstances behind their deaths.
In an autocratic move that is increasingly familiar among federal agencies under the Trump administration, Prasad also said that anyone who disagreed with the new regulatory direction should resign.
In the summer, the FDA imposed new restrictions on who can access COVID-19 vaccines, saying that new jabs would only be approved for those over 65 or those at high risk due to other conditions. Previously, they were available to everyone over six months of age under emergency authorisations.
A few weeks later, the CDC's Advisory Committee on Immunization Practices (ACIP) stopped short of requiring prescriptions for a COVID jab, but did indicate they should be used only after discussions between a patient and doctor.
The ACIP is scheduled to meet later this week and has vaccine risk monitoring and the childhood and adolescent immunisation schedule on its agenda, along with a full day on hepatitis B vaccines, having previously postponed a vote on banning the dose administered at birth.
Meanwhile, mRNA-based COVID vaccines had stronger warnings added to their labels earlier this year, and Kennedy cancelled $500 million of federal funding for mRNA vaccine projects, to the delight of vaccine sceptics.
Last month, to the consternation of medical and autism advocacy groups, the CDC also changed wording on its website to suggest vaccines may cause autism, despite decades of research refuting such a link.
https://pharmaphorum.com/news/fda-about-restrict-vaccination-even-further
Trump urges Israel to keep 'strong' dialogue with Syria
United States President Donald Trump urged Israel in a Truth Social post on Monday to "maintain a strong and true dialogue with Syria," noting that nothing should "interfere" with the Middle Eastern country's "evolution into a prosperous state."
The US president also remarked how Washington was "very satisfied" with the "results" displayed by Syria's new government. "One of the things that has helped them greatly was my termination of very strong and biting sanctions — I believe this was truly appreciated by Syria, its Leadership," he stated.
In addition, Trump hoped Israel and Syria would "have a long and prosperous relationship together." In November, he hosted Syria's interim President, Ahmed al-Sharaa, at the White House amid strengthening relations between the two nations.
https://breakingthenews.net/Article/Trump-urges-Israel-to-keep-'strong'-dialogue-with-Syria/65275378
Bitcoin drops over 4% to just above $86,000
Bitcoin slid more than 4%, dropping from the mid-$90,000 range to a session low of $86,172.
Last week, Bitcoin hit its lowest level since April, then recovered toward $90,000 after the Federal Reserve signaled support for another interest rate cut. That recovery proved short-lived as renewed selling now pushed the digital asset back toward $86,000.
At 10:56 pm ET, the world's most famous cryptocurrency was trading at $86,356.590, down 4.44%, while Ether was priced at $2,827.8169, reflecting a 5.49% drop.
https://breakingthenews.net/Article/Bitcoin-drops-over-4-to-just-above-dollar86000/65270008
Trump set to hold meeting on Venezuela today
United States President Donald Trump will hold a meeting on Venezuela, CNN reported on Monday. The meeting is set to take place at the Oval Office at 5 pm ET, and will allegedly include State Secretary Marco Rubio, Defense Secretary Pete Hegseth, Chairman of the Joint Chiefs of Staff Dan Caine, and White House Chief of Staff Susie Wiles and Deputy Chief of Staff Stephen Miller.
On Saturday, Trump said that the Venezuelan airspace should be considered "CLOSED IN ITS ENTIRETY," effectively warning aircraft to avoid it. On Sunday, he confirmed that he spoke with Venezuelan President Nicolas Maduro, but did not reveal any details. The US has been striking boats near the Venezuelan coast, claiming they are involved in drug trafficking. The Trump administration has also claimed that Maduro is the leader of the Cartel de los Soles, which it designated as a terrorist organization.
https://breakingthenews.net/Article/Trump-set-to-hold-meeting-on-Venezuela-today/65274296
FDA Action Alert: BMS, GSK, Amgen and More
The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.
December is shaping up to be a loaded month for the FDA, with more than 15 decisions lined up. Over the next two weeks, the regulator is scheduled to render some big verdicts, including ones for a previously rejected nasal spray tachycardia drug and two gonorrhea treatments.
Read below for more.
BMS Seeks Fifth Indication for CAR T Blockbuster Breyanzi
To kick off the year-end craze, the FDA will decide whether to authorize an expansion of Bristol Myers Squibb’s CAR T cell therapy Breyanzi into marginal zone lymphoma (MZL). The agency is set to release its verdict on Dec. 5.
First approved in 2021 for relapsed or refractory large B cell lymphoma, Breyanzi has become one of the industry’s biggest and fastest-growing CAR T brands. Last year, the product surged 105% to bring in $747 million worldwide, with sales bolstered by additional indications picked up over the years, including chronic lymphocytic leukemia and small lymphocytic leukemia in March, and relapsed or refractory follicular lymphoma in May.
To support its latest bid, BMS filed data from the MZL cohort of the Phase II TRANSCEND FL study, which found a 95.5% overall response rate after Breyanzi treatment, including a 62.1% complete response rate. Progression-free survival at 24 months was 85.7% while overall survival reached 90.4%.
If approved, Breyanzi would be the first CAR T option for MZL.
GSK Eyes Approval for Gonorrhea Antibiotic
A few days later, GSK is looking at a Dec. 11 decision date for its oral antibiotic Blujepa for the treatment of uncomplicated urogenital gonorrhea.
In particular, the pharma is targeting patients 12 years and up, in whom the drug elicited a 92.6% treatment success rate, according to an analysis of urogenital samples in the Phase III EAGLE-1 study. Comparators treated with intramuscular ceftriaxone plus oral azithromycin saw a success rate of 91.2%. Blujepa’s benefit, according to GSK, cleared the criteria for non-inferiority versus the current standard regimen for this disease.
Caused by the bacteria Neisseria gonorrhoeae, gonorrhea is a common sexually transmitted infection that the CDC has deemed an “urgent” threat to public health, particularly given the rising rates of antimicrobial resistance.
In March, the FDA approved Blujepa for uncomplicated urinary tract infections, marking the first new class of oral antibiotic for this disease in almost 30 years.
BioCryst’s Pediatric Push for Orladeyo Nears Verdict Following Delay
On or before Dec. 12, the FDA is expected to decide on BioCryst’s application to expand its hereditary angioedema (HAE) drug Orladeyo into a younger patient population.
This verdict will come after a three-month delay the FDA handed down in June, citing the need for more time to review BioCryst’s additional submissions, which the regulator classified as a major amendment to the data package.
Orladeyo, a plasma kallikrein blocker, is already approved for HAE, but is currently indicated only for adults and adolescents 12 years old and older. BioCryst is proposing to broaden the drug’s patient coverage to include children with HAE from 2 to 11 years of age. Interim data from the Phase III APeX-P study back this expansion bid, showing that the drug induced early and sustained improvements in monthly HAE attack rates, while also maintaining its safety profile in this younger age group.
Follow-on findings from APeX-P last month showed that 65.5% of patients were attack-free at one month after Orladeyo initiation, growing to 70.4% at 12 months.
FDA To Decide on Milestone’s Response to Cardamyst Rejection
In March, the FDA handed Milestone Pharmaceuticals a surprise rejection for its tachycardia nasal spray Cardamyst, citing chemistry, manufacturing and controls issues.
The company has since met with the regulator and filed its response to address the problems raised. The FDA is currently reviewing Milestone’s answers and is expected to release a decision on Dec. 13.
Cardamyst is a calcium channel blocker that achieves the efficacy of intravenous drugs despite being delivered via a nasal spray, CEO Joe Oliveto told BioSpace in an interview prior to the rejection. The company is proposing the drug for paroxysmal supraventricular tachycardia, a heart rhythm abnormality. Data from the pivotal Phase III RAPID study showed that 64% of patients treated with self-administered Cardamyst achieved normal heart rhythm within 30 minutes, as opposed to 31% of placebo controls.
Cardamyst has had a difficult regulatory road so far, being hit with a refusal to file letter in December 2023 after the FDA found Milestone’s data package for the drug insufficient for a full review. Milestone resubmitted in March 2024.
Amgen Aims for Uplizna Expansion Into Myasthenia Gravis
Amgen is gunning for another expansion for its anti-CD19 antibody Uplizna, this time targeting generalized myasthenia gravis (gMG). The FDA has a target action date of Dec. 14.
Supporting the gMG push are data from the Phase III MINT study, which in September 2024 showed significant improvements in activities of daily living at 26 weeks as compared with placebo. Uplizna treatment also significantly eased disease severity.
Follow-on data presented in March showed that Uplizna’s benefits on activities of daily living and disease activity are robust up to 1 year of follow-up, especially in patients positive for acetylcholine antibodies. William Blair analysts at the time said Uplizna had “strong efficacy with impressive durability” and noted that its dosing schedule—one injection every six months—could set it apart from other gMG therapies that have to be given weekly or monthly.
Outside of gMG, Uplizna in April won the FDA’s blessing for IgG4-related disease, marking the regulator’s first approval in this indication.
Innoviva Also Seeks Gonorrhea Greenlight With Oral Antibiotic
Rounding out the front half of December is Innoviva, which is proposing its oral drug zoliflodacin for the treatment of uncomplicated gonorrhea in patients 12 years and older. The FDA’s decision is expected on Dec. 15.
Zoliflodacin is a potentially first-in-class antibacterial agent that works by targeting and deactivating a bacterial enzyme called type II topoisomerase, which is crucial for their function and reproduction. According to Innoviva, in vitro studies have demonstrated zoliflodacin’s activity against N. gonorrhoeae, even when used on multidrug-resistant strains.
Pivotal Phase III data presented at the European Society of Clinical Microbiology and Infectious Disease Global meeting in April 2024 showed that zoliflodacin elicited a 90.9% microbiological cure rate in patients with uncomplicated gonorrhea, as opposed to 96.2% with the current standard regimen of intramuscular ceftriaxone plus oral azithromycin. While the treatment difference favored the control, the results nevertheless satisfied statistical non-inferiority, Innoviva said at the time.
Follow-up data presented in October additionally established zoliflodacin’s efficacy across key subgroups, including patients positive for infections at urogenital, rectal and pharyngeal sites. Cure rates for zoliflodacin likewise remained above 95% in patients with ciprofloxacin-resistant and -susceptible infections.
https://www.biospace.com/fda/fda-action-alert-bms-gsk-amgen-and-more
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