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Headaches are a common symptom of a stressful lifestyle, your body not feeling well and other issues. While headaches can be dealt with easily, migraines are not so easy to handle. Migraines are a type of headache that feels like severe throbbing and pulsing sensation, almost like you are hearing your own heartbeat in your brain, usually on one side of the brain. Many people believe that migraines are not that big of a deal because you just have to deal with the pain, but that is not all migraine is, some people find it very difficult to do their daily tasks as they experience dizzying spells, nausea and extreme sensitivity to light and sound! These attacks can last hours and make it difficult for people to go about their daily lives as well. While there are medications available for migraine patients, these medications need time to take effect, so you may be in a lot of pain, but there are not many quick reliefs you can have in place other than learning the symptoms of a migraine attack and taking medication before it happens. But a new approval by the FDA may change this!
The U.S. Food and Drug Administration (FDA) has approved Symbravo, a new medicine to treat acute migraine attacks in adults. This means adults can now use Symbravo to get relief from their migraine symptoms. The FDA's decision was based on the results of three big studies, called Phase 3 trials. These trials involved over 21,000 migraine attacks, so the FDA has a lot of information about how well Symbravo works and how safe it is. The FDA only approves medicines that have been shown to be both safe and effective through a thorough testing process.
"Migraine attacks can happen suddenly and really mess up people's lives. It's estimated that over 39 million people in the U.S. alone get migraines," said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics told US News. This shows how common migraines are and how important it is to have good treatments. "Symbravo gives patients and doctors a new option that can quickly stop a migraine attack, keep it away, and let people get back to their normal activities, all with just one dose." Having a medicine that can give fast and long-lasting relief from migraine pain is a big deal for millions of people. This new treatment is a real step forward in how we treat migraines.
The trials took place in 3 steps, the Momentum trial study focused on people whose migraines had moderate to severe pain. The results showed that a lot more people taking Symbravo felt pain-free two hours after taking the medicine compared to those who took a placebo which is a dummy pill. Even better, many people felt relief for up to 24 and even 48 hours after just one dose. This long-lasting relief is really important for people with migraines because it means they can get back to their normal lives without worrying about the pain coming back. The study also looked at how many people were free from their worst symptom, like sensitivity to light or sound, or nausea. Symbravo worked better than the placebo in this area too.
While the intercept trial looked at people who took Symbravo when their migraine pain was still mild. Even when the pain was just starting, Symbravo was effective. The results were similar to the MOMENTUM trial, with many people getting pain relief and relief from their worst symptoms. Treating migraines early is often better because it can stop the pain from getting really bad.
And lastly the Movement trial which was to see how safe the medication is when people take it regularly. This study followed 706 people who had at least two migraines a month. The most common side effects people experienced were sleepiness and dizziness. While these side effects are important to know about, the study showed that Symbravo is generally safe for people to use on a regular basis.
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Meghalaya health officials have asked locals to avoid crowded places after two Agniveer trainees have died of suspected meningococcal bacterial infection at a training centre in Shillong in February.
While the first trainee died at the Military Hospital in the Assam Regimental Centre (ARC), the other died on February 23. The remaining 28 trainees have been placed in quarantine.
Joram Beda, Health and Family Welfare Commissioner-Secretary, said the East Khasi Hills District Surveillance Unit has initiated an active epidemiological investigation, including contact tracing, isolation of close contacts, and fumigation, which has been carried out in and around the affected military facility.
“Case investigation, contact tracing, laboratory review, and surveillance strengthening measures are currently underway,” the official advisory read.
The Health and Family Welfare Department also said the State Surveillance Unit has been activated and a detailed epidemiological investigation is currently underway. Authorities further added that surveillance has been strengthened not just within the Army training establishment but also in surrounding areas as a precaution.
The state government has asked people to avoid crowded areas, wear masks in crowded places, practise good respiratory hygiene and wash their hands regularly with soap and sanitiser.
It also asked residents to report to the nearest medical facility in cases of sudden high fever, headache, vomiting, rapidly spreading purpuric (purple-coloured spots or patches) rashes, pale limbs at a later stage, and circulatory collapse, shock, and multi-organ failure.
Meningococcal bacteria are transmitted through respiratory droplets, by coughing, sneezing, kissing, or sharing food and drinks. The greatest risk occurs between people with extended, close contact, such as family members and sexual partners. Prolonged riding in enclosed vehicles, such as buses, planes, with the infected person, also greatly increases risk.
CDC states that infants below one year, adolescents 16–23 years old, immunocompromised patients, and residents of communal environments are at greatest risk.
The infection at first presents a nonspecific viral illness, but can worsen suddenly. Adults must be aware of the following signs:
In the most severe cases, sepsis, exhaustion, coldness of extremities, and coma may ensue, all necessitating immediate medical intervention. Shockingly, worsening can happen within 12 hours of the onset of symptoms.
The gold-standard diagnosis for invasive meningococcal disease involves a combination of blood cultures and cerebrospinal fluid (CSF) analysis obtained through lumbar puncture.
However, in cases where increased intracranial pressure is suspected, performing a lumbar puncture may need to be delayed to avoid complications. Additionally, polymerase chain reaction (PCR) testing plays a crucial role in rapidly identifying the infection, particularly when prior antibiotic treatment may interfere with traditional culture results.
IMD survivors develop severe complications: hearing loss, neurological injury, kidney failure, or limb amputation by necrosis. Unfortunately, natural infection does not offer absolute lifelong immunity; recurrence, although infrequent, can occur, warranting immune deficiency assessments.
Vaccination is the best protection. Vaccines protect against several serogroups (A, B, C, W, Y, X) and are universally advised, particularly among adolescents, travelers, and those at risk.
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Wegovy maker Novo Nordisk has ended its legal dispute with the Hims & Hers Health platform, according to a media report.
The two companies are likely to partner and sell the blockbuster obesity drug Wegovy together on the Hims & Hers Health platform, Bloomberg News reported.
Market analysts have expressed surprise on the move, as both Novo and Hims have been previously engaged in legal battle over Wegovy.
“There is no other way to describe the Hims news as both a surprise and an unabashed positive for Hims' stock,” Leerink Partners analyst Michael Cherny was quoted as saying in a note to clients.
A Novo spokesperson said in an emailed statement that the company is "always in conversation with companies that can help improve patient access to FDA-approved medicines".
In February, Novo sued Hims for launching a similar version of its new Wegovy weight-loss pill for $49.
The Danish drugmaker accused Hims of patent infringement on Semaglutide -- the active ingredient behind its best-selling medications Ozempic and Wegovy.
Semaglutide is popularly known for weight loss , but is also effective for diabetes and is used primarily for that.
The US Food and Drug Administration (FDA) had also threatened action against Hims.
Last year, Novo had to end a short-lived agreement to sell Wegovy over Him's marketing tactics and continued sales of copycat versions of Wegovy.
Recently, the FDA has signaled plans to crack down on the proliferation of copycat, or compounded, weight-loss drugs.
Currently, Wegovy injections and pills cost $1,349.02 a month, whereas Ozempic and Rybelus cost $1,027.51, Novo told PEOPLE.
Individuals with commercial insurance pay $25 a month, whereas those using cash pay between $149 to $499. Patients on Medicare will pay $274 per month.
Late in February, Novo Nordisk announced it would slash the price for all doses:
"There are more than 100 million people living with obesity and over 35 million with type 2 diabetes and, and for some, list price has been a real barrier to access and affordability," Jamey Millar, Executive Vice President, US Operations of Novo Nordisk Inc., was quoted as saying to PEOPLE.
Meanwhile, amid the patent expiration of semaglutide, several pharma companies in India are planning big launches of Wegovy's generic versions.
Several leading drugmakers have already secured regulatory approval or recommendations to produce and market generic versions of the weight loss drugs in the country.
Hyderabad-based Dr. Reddy's already applied for a trademark with the brand name Obeda and a logo.
Other companies like Sun Pharma, Zydus Lifesciences, and Nacto Pharma are also entering the rat race of launching multiple generic versions to make the treatment more affordable for patients with obesity and weight-related health risks.
Sun Pharma also announced the plans for "day-one" launches of generic prefilled pens.
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The US Food and Drug Administration (FDA)’s Vinay Prasad has once again — for the second time in less than a year — stepped down from his post as director of the agency’s Center for Biologics Evaluation and Research, amid controversies over the review of vaccines and specialty drugs for rare diseases.
Announcing the news to FDA staff in an email late Friday, FDA Commissioner Marty Makary said Prasad would depart at the end of April. Makary added that Prasad would return to his academic position at the University of California, San Francisco (UCSF).
Taking to social media platform X, Makary said that under Prasad’s leadership, his center recorded a record number of approvals in December.
“A year ago, Dr. Prasad came to the FDA to implement four major long-lasting reforms: a 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified COVID vaccine framework, and the new plausible mechanism framework for ultra-rare diseases, which we launched last week,” Makary said.
The FDA commissioner noted that Prasad “got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning to his academic home later next month,” and thanked him “for his service and personal sacrifice in taking time away from his family.”
The FDA is expected to announce Prasad’s successor before his departure.
Vinay Prasad is an Indian-origin American hematologist-oncologist and author. He was first appointed as the FDA’s vaccines chief in May 2025.
Prasad, known as a longtime critic of the FDA’s standards for drug reviews, drew controversy for raising the bar for new drug approvals. The move did not sit well with pharmaceutical companies and reportedly dashed the hopes of some patients with rare diseases.
In July, he was removed from his position following disputes with biotechnology executives, patient organisations, and conservative allies of US President Donald Trump. He was later reinstated after Makary and US Health Secretary Robert F. Kennedy Jr. pushed for reconsideration.
While Prasad, along with Makary, announced several measures to make FDA drug reviews faster and easier for companies, he also imposed new warnings and study requirements for some biotech drugs and vaccines.
This was particularly evident in the case of COVID-19 vaccines, which have been a target of criticism from Kennedy, who was a longtime anti-vaccine activist before joining the Trump administration.
The latest controversy involves the FDA’s interactions with Dutch biopharma company uniQure, which developed an experimental gene therapy for Huntington’s disease that is injected directly into the brain during a surgical procedure.
Huntington’s is a deadly neurological condition affecting about 40,000 Americans, and currently has no cure.
UniQure faced a setback after Prasad’s centre said its earlier studies were insufficient to support a biologics licence application.
During an earnings call earlier this week, the company said the FDA was demanding a new trial involving sham surgery for some patients.
Executives said the request for a sham-controlled trial contradicted earlier FDA guidance. They also questioned whether such an approach would be ethical for patients with Huntington’s disease, which is progressive and ultimately fatal, typically in middle age.
Earlier, Prasad also refused to allow the FDA to review a highly anticipated flu vaccine from Moderna made using mRNA technology.
The rejection of the application -- highly unusual for the FDA -- prompted Moderna to go public with Prasad’s decision and vow to formally challenge it.
A week after the rejection became public, the FDA reversed course and said it would accept the vaccine for review, pending an additional study from the company.
Prasad’s handling of rare-disease therapy applications also drew criticism after the FDA asked Sarepta Therapeutics, a drugmaker developing treatments for Duchenne muscular dystrophy, to pause shipments following reports of patient deaths.
The company initially resisted, wanting to continue distributing treatments for patients who could still walk, but later agreed. The agency, however, reversed the pause just days later.
Duchenne muscular dystrophy affects a small number of boys and young men who typically lose their ability to walk before puberty and often die by around age 30.
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