PharmaFocus Today – Page 288 – media

Novo Nordisk, Eli Lilly face injury lawsuit from user of popular GLP-1 medicines

As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
- Source: drugdu
- 115
- August 7, 2023
GSK files lawsuit against Pfizer over RSV vaccine patent infringement

GSK has sued Pfizer in a US court, alleging infringement of the patents it holds on vaccines for respiratory syncytial virus (RSV). The lawsuit claims that Pfizer’s Abrysvo infringes on four of GSK’s patents that cover its rival vaccine, Arexvy. In May, Arexvy became the first RSV vaccine to be approved anywhere in the world after it received approval from the US Food and Drug Administration (FDA). The US approval of Pfizer’s vaccine followed shortly afterwards. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. Both companies’ vaccines aim to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older and are expected to be available in the US before the next RSV season. A GSK spokesperson said that “intellectual property protections ...
- Source: drugdu
- 114
- August 7, 2023
NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy

The National Institute for Health and Care Excellence (NICE) has issued a draft Appraisal Consultation Document that does not recommend CSL Behring’s Hemgenix (etranacogene dezaparvovec) gene therapy for haemophilia B. The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of factor IX inhibitors. In its guidance, NICE’s evaluation committee said that while there is clear evidence that the therapy reduces the number of bleeding episodes haemophilia B patients have each year, there is not enough evidence on how well it works in the long term, meaning cost-effectiveness estimates are “uncertain”. It also cited problems with the indirect comparison between the gene therapy and factor IX replacement therapies. Haemophilia B is a genetic bleeding disorder resulting from missing or insufficient levels of blood clotting factor IX, a protein needed to produce blood clots to stop bleeding. Patients ...
- Source: drugdu
- 106
- August 7, 2023
With Takeda and Hutchmed hot on the trail, Taiho wins FDA nod for stronger Lonsurf regimen in colorectal cancer

Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen. Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo. The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux. In that phase 3 trial, patients who received the combo lived a median 10.8 months, while ...
- Source: drugdu
- 131
- August 4, 2023
Augmedics picks up Surgalign’s digital health assets for $900K

Dive Brief Augmedics, a developer of surgical navigation technologies, will acquire the digital health assets of Surgalign Holdings for $900,000 in cash and assume unspecified liabilities after making a successful bid in a bankruptcy court auction. Surgalign, which is selling its assets under court supervision after filing for Chapter 11 bankruptcy protection, said in a statement on Friday that Xtant Medical Holdings also was selected in a bidding process to acquire its hardware and biologics assets for a cash purchase price of $5 million, along with the assumption of certain liabilities. Augmedics, in a separate statement, said the purchase of Surgalign’s digital health assets and intellectual property will strengthen its augmented reality and AI portfolio. Dive Insight Deerfield, Illinois-based Surgalign filed for bankruptcy in June, a year after the Securities and Exchange Commission charged the company with accounting fraud. The SEC accused Surgalign, formerly RTI Surgical Holdings, of shipping future ...
- Source: drugdu
- 113
- August 4, 2023
Liquid biopsy may be used to identify gene mutations in pediatric arteriovenous malformations

A study presented today at the Society of NeuroInterventional Surgery’s (SNIS) 20th Annual Meeting indicated that it may be possible to use a less invasive technique to identify the gene mutations responsible for some arteriovenous malformations (AVMs) in pediatric patients. AVMs, including vein of Galen malformations, which are usually diagnosed soon after birth, are tangled blood vessels that disrupt blood flow and oxygen circulation, and are most often found in the brain and spinal cord. These vessels can rupture and cause brain hemorrhage, stroke, and brain damage for children and adults. Many complex AVMs in children are caused by a few specific gene mutations, but it’s difficult to find out which mutation is responsible (and, therefore, which treatment to use) without taking a surgical biopsy of the AVM. A surgical biopsy comes with a risk of brain bleeding. As a result, researchers in Australia opted to try using “liquid biopsy”-;taking ...
- Source: drugdu
- 234
- August 4, 2023
Scleroderma Research Foundation launches clinical trial platform to advance treatments

The Scleroderma Research Foundation (SRF) has announced the launch of a new clinical trial platform aimed at advancing treatments for the rare autoimmune disease of the skin and organs. Using a model created over a decade ago to accelerate oncology drug development but not previously used for autoimmune disorders, the CONQUEST platform is designed to identify agents that are ready to progress from phase 2b to phase 3 clinical trials. The initiative, conceived and led by the SRF, will initially focus on interstitial lung disease secondary to scleroderma but will be expanded in the future to address other manifestations of the disease. The first iteration, which is expected to begin in the fourth quarter of this year, will include approximately 400 patients and will test two drugs, including one from Sanofi. The trial will measure forced vital capacity, the total volume of air that can be exhaled during a maximal ...
- Source: drugdu
- 112
- August 4, 2023
Amygdala scores $2m NIAAA grant to develop alcohol use disorder therapy

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) in the US has awarded a $2m grant to Amygdala Neurosciences to support investigational new drug (IND) application and early development of the aldehyde dehydrogenase (ALDH2) inhibitor for the treatment of alcohol use disorder. According to the 2021 survey by the NIAAA, 29.5 million people aged 12 years and older have experienced alcohol use disorder. Current treatments include behavioural therapy, medication, support groups, and counselling. ANS-858 is an investigational selective and reversible ALDH2 inhibitor, which has been reported to reduce craving and drug-seeking behaviour in preclinical studies. Amygdala CEO Brent Blackburn said in the press release: “This award will enable the development of ANS-858 through pre-clinical evaluation required of an investigational new drug (IND) application to the FDA.” There are multiple drugs currently in development for treating alcohol use disorder. These mainly investigate the use of psychedelic compounds, including Beckly Psytech’s ...
- Source: drugdu
- 100
- August 4, 2023
CS Pharmaceuticals snaps up AxeroVision to shore up ophthalmology portfolio

CS Pharmaceuticals (CSP) has acquired AxeroVision for an undisclosed fee, in a move that will involve a dry eye disease (DED) candidate being transferred over to the UK-based ocular therapeutics company. CSP, which is headquartered in London but develops and commercialises treatments for eye diseases in China, will continue developing AXR-270, a selective glucocorticoid receptor agonist. The drug has been in a phase of developmental dormancy. In August 2021, AxeroVision released positive Phase II results for the candidate in 129 patients with DED with meibomian gland dysfunction (MGD). In a statement announcing the 2021 results, AxeroVision – which spun out from GSK in 2016 – said it was planning to enrol around 800 patients in a Phase III trial comparing the eye cream with a vehicle, and a new drug application/marketed authorisation application filing expected in 2024. However, the company did not issue any further updates on the drug since ...
- Source: drugdu
- 167
- August 4, 2023
Terumo receives FDA clearance for automated whole blood processing system

Dive Brief Terumo Blood and Cell Technologies received clearance from the Food and Drug Administration for what it claims is the first whole blood automation device available in the U.S. The Reveos Automated Whole Blood System processes blood into platelets and other components in a single centrifugation cycle, eliminating some manual steps to separate platelets from the rest of the blood. The device can help blood centers make the process of collecting platelets from blood donations more efficient, increasing availability for people who need them for treatment, Chetan Makam, general manager of Terumo’s global blood solutions business, said in an interview. Dive Insight Platelets are used to treat trauma patients, for procedures like heart surgeries, and for patients who are undergoing chemotherapy. Demand for platelets continues to increase, Makam said. Currently, the majority of platelets available for transfusion in the U.S. come from a process called apheresis, where a donor’s ...
- Source: drugdu
- 116
- August 3, 2023

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