Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. By Frank Vinluan Sleep apnea could be the next new indication for an Eli Lilly drug that’s already a blockbuster seller in metabolic indications. The pharmaceutical giant has preliminary Phase 3 data showing that treatment with the drug reduced the breathing interruptions characteristic of the common sleep disorder. With the positive data in hand, Lilly said it is now planning for regulatory submissions seeking to expand the label of tirzepatide, which is marketed as Mounjaro for type 2 diabetes and as Zepbound for weight management. Those submissions are expected in the middle of this year. Obstructive sleep apnea (OSA) is the collapse or partial collapse of the upper ...
Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
Liver cirrhosis, caused by long-term liver damage, is estimated to affect around 100 million people worldwide Researchers from University College London (UCL) have invented and tested innovative carbon beads that could help restore a healthy gut microbiome as well as reduce the progression of liver disease. The study, published in Gut and funded via the EU’s Horizon 2020 research and innovation programme, demonstrated that the CARBALIVE beads had a positive impact on gut health, liver, kidney and brain function in animal models. Estimated to affect around 100 million people worldwide, liver cirrhosis is caused by long-term liver damage, including alcohol, liver infections such as hepatitis B or C and obesity. In collaboration with Yaqrit, a UCL spinout, UCL researchers developed small oral carbon beads with a microscopic physical structure to absorb both large and small molecules in the gut. The “carbon beads… are swallowed and passed through the body unaltered” ...
Boehringer Ingelheim reported robust sales in 2023, with a 10.3% increase in human pharma sales that was strongly driven by Jardiance (empagliflozin) and Ofev (nintedanib). The German company announced that it had reached €20.8bn ($22.1bn) in human pharma sales in 2023, also achieving a 14.2% boost in research and development (R&D) investments that reached €5.8bn. Boehringer’s R&D investments accounted for 22.5% of net sales, as per a 16 April press release. In the press release, Michael Schmelmer, a member of Boehringer’s board of managing directors with responsibility for finance and group functions, said, “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives.” Last year, Jardiance propelled the company’s growth with a 31% sales jump, ...
HANGZHOU, China, April 17, 2024 /PRNewswire/ — Today, Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC (“Kind Pharmaceuticals”), together with its Chief Executive Officer Dr. Dong Liu and Chief Scientific Officer Dr. Shaojiang Deng, announced a resolution of their recent dispute with FibroGen, Inc. regarding Kind Pharmaceuticals’ hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF- PHI) technology. The parties have agreed to withdraw all pending legal proceedings between them regarding this HIF-PHI technology, without payment by either party. HIF-PHIs are a class of compounds that can be used to treat anemia. Kind Pharmaceuticals’ HIF-PHI drug candidate, AND017, is currently being studied in a clinical trial for the treatment of anemia in chronic kidney disease (CKD) patients. As a result of the settlement, Kind Pharmaceuticals remains free to develop AND017 and other HIF-PHIs in its pipeline. Dr. Liu, Chief Executive Officer of Kind, commented: “Kind is pleased that these disputes have been fully ...
Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR Researchers from the Universities of Bristol, Bath, King’s College London and the University Medical Center Utrecht have called for a reduction in the use of repeat antibiotic prescriptions in primary care for the same respiratory tract infection (RTI) episode, based on findings from a study. Published in the Journal of Infection, the study found high rates of repeat within-episode prescriptions for RTI in primary care in England, despite evidence of little benefit. Accounting for around 60% of antibiotic prescribing in primary care globally, RTIs are caused by viruses and are one of the key drivers of antimicrobial resistance. The study analysed over 900,000 RTI episodes from clinical records across 530 English general practices. Researchers found that nearly 30% of adults and 10% of children had received a second course of antibiotics within the same ...
Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant.Novartis, whose presence in prostate cancer is mainly through the radiopharmaceutical Pluvicto, is expanding its prospects in the disease, striking a deal that brings a Phase 3-ready small molecule in the emerging therapeutic modality called targeted protein degradation. The drug, ARV-766, was developed by New Haven, Connecticut-based Arvinas. The deal announced Thursday calls for Novartis to pay $150 million up front. The Swiss pharmaceutical giant could shell out up to $1 billion more if the molecule achieves development, regulatory, and commercial milestones. Targeted protein degradation involves using a small molecule to target a disease-causing protein, marking it for disposal by the cell’s built-in system for eliminating old or damaged proteins. Arvinas specializes in protein degrader drugs, and the company’s pipeline ...
Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels for hypothyroidism patients. However, the high cost of mass spectrometers, often reaching several hundred thousand dollars, restricts them to labs that require the transportation of blood samples for analysis, thereby complicating chronic disease management. Now, researchers have taken a big step towards building inexpensive hardware that could make mass spectrometry local. The team has used 3D printing to create a low-cost ionizer, a vital component of the mass spectrometer, that can deliver twice as good a performance as its high-end counterparts. The device developed at MIT (Cambridge, MA, USA) spans just a few centimeters and is designed for mass production, enabling its integration into mass spectrometers through robotic assembly method. This also makes it more economical than traditional ionizers which often ...
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