The US Department of Health and Human Services (HHS), as part of the Centers for Medicare and Medicaid Services (CMS), has announced that all ten pharmaceutical manufacturers taking part in the Medicare drug price negotiations have submitted counteroffers. The announcement comes after the HHS sent initial offers on 1 February in an ongoing effort to lower drug prices in the US as part of the Inflation Reduction Act (IRA) and negotiations will continue over the next several months. First selected last August, the ten medicines subject to the first round of Medicare pricing negotiations included therapies for diabetes, heart failure, immunological disorders and cancer, as well as anticoagulants. The medicines selected included Bristol Myers Squibb/Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), AstraZeneca’s Farxiga (dapagliflozin), AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban). According to the HHS, collectively, the drugs were ...
Australia-based global biopharmaceutical company Telix Pharmaceuticals has agreed to acquire US-based QSAM Biosciences for $123.1m.The deal comes after the companies signed a conditional non-binding term sheet for the prospective acquisition.Telix will also acquire QSAM’s lead investigational drug, Samarium-153-DOTMP (153Sm-DOTMP), a new kit-based bone-seeking targeted radiopharmaceutical candidate. The acquisition terms include an upfront payment of $33.1m (A$50.8m), payable as 4,369,914 ordinary shares of Telix.The deal also comprises contingent value rights that could see additional payments of $90m on meeting clinical and commercial milestones. These payments may be made in cash and/or shares.QSAM focuses on the development of therapeutic radiopharmaceuticals for primary and metastatic bone cancer. Its 153Sm-DOTMP for bone cancer has applications in pain management and therapy for bone metastases and osteosarcoma, including for paediatric patients.It complements Telix’s focus on oncology therapies and has shown promising safety, efficacy and commercial potential in early trials. The drug also has an improved safety ...
Barrett’s esophagus is a condition often resulting from reflux, characterized by stomach acid damaging the esophagus lining and causing cell changes. While these cells aren’t initially cancerous, there’s a risk they might transform into esophageal cancer, a type where cells in the esophagus proliferate uncontrollably, potentially spreading to other body parts. Esophageal cancer is among the deadliest cancers in adults, and early detection significantly improves survival rates compared to a diagnosis at an advanced stage. Since the symptoms of esophageal cancer can mimic heartburn and reflux, conducting early tests for cancer detection is crucial. Now, a non-endoscopic capsule sponge device has been designed to collect pan-esophageal samples which are then sent for laboratory testing to detect esophageal pre-cancer and other conditions. Cyted’s (Cambridge, UK) EndoSign cell collection device is designed to detect and monitor conditions such as chronic reflux and Barrett’s esophagus, ultimately aiming to prevent esophageal adenocarcinoma. The EndoSign ...
AnaMar has received orphan drug designations for its systemic sclerosis candidate AM1476 from the FDA and the EMA. The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition. AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated with fibrosis in a 5 February press release. Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring ...
When the Biden administration welcomed the passing of the Inflation Reduction Act (IRA) in August 2022, it marked a rare defeat for the pharmaceutical industry in Washington, D.C. Naturally, drugmakers didn’t lie down without a fight on the controversial topic of Medicare price negotiations. Now, new developments show that the Biden administration is willing to go to the mat in defense of the IRA negotiations. Wednesday, lawyers for AstraZeneca are set to engage in oral arguments against the U.S. Department of Justice in a federal court, according to a September court order and a new report from Bloomberg Law. The British drugmaker aims to challenge the legality of the drug pricing provisions put in place under the IRA, which will allow Medicare to haggle over the prices of some of the costliest drugs it covers starting in 2026. AstraZeneca’s diabetes blockbuster Farxiga ranks among the 10 drugs that were selected ...
AbbVie took the top two TV drug ad spending spots with its immunology duo Rinvoq and Skyrizi, respectively, in December as it looks to cement its place as the pharma with the deepest direct-to-consumer pockets. AbbVie spent nearly identical amounts on all DTCs for each drug: $39.8 million for Rinvoq across its five spots and $39.7 million for Skyrizi across seven spots. In November, the positions of the two drugs were swapped, with Skyrizi taking the top spot and Rinvoq coming in second. Coming in third place was rival Dupixent, marketed by Sanofi and Regeneron, with a much smaller $27.6 million spent across its ads for the blockbuster med. And Pfizer has suddenly started to spend big on its new RSV vaccine Abrysvo, coming in fourth place with a strong spend of $18 million last month, more than five times the $4 million it spent in November. In fifth place ...
This year, CVS Health plans to employ the classic “out with the old, in with the new” mantra when it comes to AbbVie’s Humira. Come April 1, the branded drug will be replaced by cheaper biosimilars across the company’s major commercial formularies nationwide. The move is part of CVS Caremark’s efforts to expand the adoption of biosimilars. As it stands, the U.S. biosimilar market is expected to grow from less than $10 billion in 2022 to more than $100 billion by 2029, CVS Caremark cited in a recent press release. The company is “committed” to ramping up adoption of the cheaper biologic drugs and enabling customer choice, CVS Health’s executive vice president and president of CVS Caremark David Joyner noted in a statement. “By preferring biosimilars that have a significantly lower list price than their reference product, CVS Caremark is putting our customers in the driver’s seat to best meet ...
After a pair of high-profile approvals for sickle cell disease gene therapies in the U.S. last month, Pfizer is ushering in the New Year with a regulatory endorsement for its hemophilia B gene therapy north of the border. Health Canada has approved Pfizer’s adeno-associated viral (AAV) vector-based gene therapy, Beqvez, for the treatment of certain adults with hemophilia B, the company said Wednesday. Specifically, the agency endorsed the drug to treat patients with moderate to severe disease who are negative for neutralizing antibodies to variant AAV serotype Rh74. The approval is based on an open-label, single-arm study called BENEGENE-2, which enrolled 45 patients and met its primary goal. In the study, Pfizer’s drug demonstrated noninferiority and superiority to the standard of care, a recurrent Factor IX regimen, on the measure of annualized bleeding rates. Traditionally, patients with hemophilia B have needed to receive routine infusions of Factor IX treatment to ...
Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry. By KATIE ADAMS This roundup will be published monthly. It is meant to highlight some of healthcare’s recent hiring news and is not intended to be comprehensive. If you have news about an executive appointment, resignation or layoff that you would like to share for this roundup or the MedCity Moves podcast, please reach out to moves@medcitynews.com. Here is a selection of recent executive hires, promotions, departures and layoffs occurring across the healthcare industry. Hires Aledade, an independent primary care network focused on value-based care, brought Rosemary Weldon onto its team as its new chief product officer. She spent the last decade at CVS Health, where she most recently served as vice president of digital health product management. Amgen welcomed James Bradner to its C-suite, where he now serves as chief scientific officer and ...
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