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 ...
The excitement for artificial intelligence (AI) use cases in healthcare—especially those involving generative AI and ChatGPT—is palpable, with experts predicting generative AI could help unlock $1 trillion in healthcare savings. However the AI solution that holds the strongest potential to strengthen care outcomes and health equity isn’t the one healthcare leaders think of first. Instead, right-now value could come from extractive AI. It’s a tool that gives organizations the power to put even handwritten text sent via images or PDF by digital fax into a structured data play. It’s also a practical solution for advancing data interoperability without a heavy technology lift to include healthcare’s “digital have-nots,” like post-acute care facilities and health clinics. A powerful lever for improving health equity A healthcare organization’s ability to support total care, especially for our nation’s most vulnerable patient populations, depends on access to data that enables a 360-degree view of the patient’s ...
Groundbreaking? Game-changing? Transformational? Historic? None of the buzzwords sound adequate to describe Friday’s FDA approval of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exa-cel) to treat sickle cell disease (SCD). The therapy is a long-awaited potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black. It’s also the first medicine using the revolutionary CRISPR gene-editing system, which earned its inventors a Nobel Prize in 2020 and holds tantalizing potential to cure diseases for which there is no treatment. Friday, in surprising timing, the FDA approved a second gene therapy for SCD, bluebird bio’s Lyfgenia (lovo-cel), which was due for a decision Dec. 20. Both approvals are for people 12 and older. The FDA has signed off on roughly two dozen cell or gene therapies, beginning with Novartis’ Kymriah in 2017, but none have the potential impact of Casgevy and Lyfgenia. ...
Eli Lilly has entered into a licence and collaboration agreement with PRISM BioLab aimed at discovering oral inhibitors of a protein-protein interaction (PPI) target, with the deal worth over $660m. The partnership centres around PRISM’s proprietary PepMetics technology, which the Japanese biotech says has the potential to “expand the field of drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules and by generating oral small molecule alternatives for injectable biologics”. Despite PPI dysfunction being implicated in a broad range of diseases, including cancer, fibrosis and autoimmune disorders, only a small proportion of PPIs are targeted by approved drugs. Lilly, which will select the first PPI target, has the option to add another two to the collaboration and will be responsible for the clinical development and commercialisation of any resulting products. In exchange, PRISM will receive undisclosed upfront payments from Lilly and will be eligible to ...
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