Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established.
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Sanofi concludes Blueprint Medicines acquisition
Sanofi has completed its acquisition of Blueprint Medicines, enhancing its portfolio with a commercialised therapy and the expertise of a company focused on systemic mastocytosis (SM) and other KIT-driven diseases. In June 2025, Sanofi agreed to acquire Blueprint for an equity value of $9.1bn. The acquisition of Blueprint provides Sanofi with a well-established foothold among dermatologists, allergists and immunologists, which strengthens Sanofi's efforts in advancing its expanding immunology pipeline. It also includes Ayvakit/Ayvakyt (avapritinib), a treatment for rare immunological diseases that has received approval in both the US and the European Union. The acquisition also covers elenestinib, a treatment for SM. It is currently being evaluated in the HARBOR study, a Phase II/III clinical trial. This ongoing, randomised, double-blind, placebo-controlled study aims to assess the efficacy and safety of elenestinib in combination with symptom-directed therapy for patients with indolent ISM and SM. Sanofi has acquired BLU-808, an investigational oral medication that serves as a highly potent and selective inhibitor of wild-type KIT. The tender offer for all outstanding Blueprint common stock shares expired on 17 July 2025. All conditions were met, and Sanofi accepted and will pay for all valid tendered shares. Sanofi completed its acquisition of Blueprint through a merger, with the latter becoming a wholly owned subsidiary. The transaction is financed with cash and commercial paper proceeds and will not significantly impact Sanofi's 2025 financial guidance. It is expected to enhance gross margin and contribute positively to operating income and earnings per share after 2026. In mid-July 2025, Thermo Fisher announced the acquisition of Sanofi's sterile manufacturing facility in the US. The transaction is expected to be finalised in the second quarter of 2025, pending the usual closing conditions. "Sanofi concludes Blueprint Medicines acquisition" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
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Man wearing heavy metallic necklace dies after being sucked into MRI machine
A 61-year-old man has died after he was sucked into a Magnetic Resonance Imaging (MRI) machine at a medical centre while he was wearing a heavy metal necklace. The man entered a room at Nassau Open MRI in Westbury, on New York's Long Island, without permission as the MRI machine was running, Nassau County Police Department said. His wife told local media she had called him into the MRI room after her scan and his chain necklace caused him to be hurled towards the machine when he walked in. Officials say the incident "resulted in a medical episode" and the man was later pronounced dead. MRI machines use a strong magnetic field to produce detailed images. Patients are typically asked to remove metal items and change out of their clothes before undergoing MRI scans or going near the machine. "The male victim was wearing a large metallic chain around his neck causing him to be drawn into the machine, which resulted in a medical episode," said Nassau County Police Department, which is investigating the incident. Though police have not named the victim, Adrienne Jones-McAllister told local television station News 12 Long Island that it was her husband, Keith, who died. "He waved goodbye to me and then his whole body went limp," she said. Ms Jones-McAllister said she was getting an MRI scan on her knee and asked her husband to come in to help her get up afterwards. She said he was wearing a 20lb (9kg) chain with a lock that he used for weight training. "At that instant, the machine switched him around, pulled him in, and he hit the MRI," she said. Ms Jones-McAllister said the visit on 16 July was not her and her husband's first time at the MRI facility. It was also not the first time that the employee had seen her husband's weight that he used for training, she said. She claimed an employee and her husband previously "had a conversation about it before: 'Oh that's a big chain'". Ms Jones-McAllister said the technician tried to pull her husband away from the machine. "I'm saying, 'Could you turn off the machine?" she said. "Call 911. Do something. Turn this damn thing off!'" The BBC has contacted Nassau Open MRI for comment. According to the US Food and Drug Administration, MRI machines have magnetic fields that will attract magnetic objects of all sizes - keys, mobile phones and even oxygen tanks - which "may cause damage to the scanner or injury to the patient or medical professionals if those objects become projectiles". In 2001, a six-year-old boy died of a fractured skull at a New York City medical centre while undergoing an MRI exam after its powerful magnetic force propelled an oxygen tank across the room. Solve the daily Crossword
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Medtronic's $106m heart valve patent infringement ruling overturned
The US Court of Appeals has overturned a $106.5m ruling wherein a California court jury found that Medtronic infringed on a heart valve replacement method developed by Colibri Heart Valve. Colibri sued Medtronic in 2020, alleging that the medtech giant's Evolut transcatheter aortic valve replacement (TAVR) systems for treating severe aortic stenosis infringed on its patented method for controlled release of replacement heart valves. The Colorado-based company's filing with a California court alleged that Medtronic's systems infringed on its patented method (No. 8,900,294) of partially deploying a replacement valve from the delivery apparatus and recapturing the valve within the delivery apparatus before full deployment if it looks like the positioning will be off. Colibri's lawsuit asserted that Medtronic learned about its patented methods in a 2014 conference call and during a presentation given by Colibri CEO Joseph Horn about its technology to Medtronic's marketing director and senior clinical programme manager. The patent claimed the 'do-over' method of partial deployment could involve pushing out the valve from an outer sheath of the delivery apparatus or retracting the outer sheath to expose the valve. The case went to trial in 2023, with Medtronic attesting that the accused's use of its product involved partial deployment by retracting, not pushing. During the trial, Colibri dropped its initial assertion of 'literal' infringement and relied solely on the doctrine of equivalents to establish patent infringement using the accused method. Medtronic sought judgment as a matter of law (JMOL) to get this change rejected, deeming the entire premise of the lawsuit invalid; however, the invalidity challenge was rejected. Medtronic was subsequently found to have 'induced infringement', with Colibri awarded $106.5m in damages. The overrule from the US Court of Appeals read: 'We now conclude that prosecution history estoppel, based on Colibri's cancelling of a claim to 'retraction' for partial deployment of the replacement valve and Colibri's own recognition of the close linkage of the subject matter of the cancelled and retained claims, bars application of the doctrine of equivalents. We therefore reverse the district court's denial of JMOL of noninfringement.' A Medtronic spokesperson told Reuters that the court outcome 'affirms our longstanding position that Colibri's patent infringement claims lacked merit". Medical Device Network has reached out to Colibri for comment. "Medtronic's $106m heart valve patent infringement ruling overturned" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
