Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. Now, as 2023 comes to a close, the group is taking pharma giants to task over their patenting strategies and potential human rights shortfalls. In proposals to AbbVie, Eli Lilly, Gilead, Johnson & Johnson, Merck and Pfizer, the group is pushing the companies to review how add-on patents for medicines can affect patient access. Additionally, Bristol Myers Squibb, Pfizer and Eli Lilly face calls to review and update their human rights policies. While ICCR has voiced pharma-related complaints plenty of times in the past, its proposals haven’t been met with much enthusiasm by the companies’ larger pools of shareholders. In 2019, for instance, investors at several large pharma companies rejected the group’s proposals to study the potential link between CEO pay and drug prices. In ...
BY SEAN WHOOLEY The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year. Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed ...
A BMJ investigation has shone a spotlight on the marketing of semaglutide in the U.K., raising questions about the effectiveness of regulatory oversight of materials on the weight loss and diabetes treatment. Novo Nordisk is the marketing authorization holder for semaglutide, the active ingredient in diabetes drug Ozempic and obesity therapy Wegovy, but the results of online searches for the molecule include pharmacy websites unrelated to the drugmaker. The BMJ looked into whether any of those pages break the rules on the advertising of prescription drugs and how authorities in the U.K. respond to allegations of illegal promotion. A complaint filed by academics in the U.K. and Sweden forms the centerpiece of the report. Writing to the U.K. drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the academics said they were “appalled” to find Pharmadoctor, a provider of clinical services to pharmacists, was marketing Wegovy “directly to the ...
After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
Vanda Pharmaceuticals has a new commercial asset under its belt after striking a deal to buy certain rights to Johnson & Johnson’s multiple sclerosis med Ponvory for $100 million. Vanda secured U.S. and Canadian rights to the daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator from J&J’s Actelion subsidiary. Ponvory was approved in 2021 to treat relapsing forms of multiple sclerosis and could be a potential treatment for a group of inflammatory and autoimmune disorders, including psoriasis and ulcerative colitis, Vanda said in its Thursday press release. The buy is a “significant milestone” for Vanda, CEO and chairman Mihael H. Polymeropoulos, M.D., said in a statement. The deal “expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders,” the chief added. J&J’s sale of certain Ponvory rights comes after Fierce Pharma in February ...
In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. Using Sarclisa on top of Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), significantly reduced the risk of disease progression or death versus VRd alone in patients with newly diagnosed multiple myeloma not eligible for transplant, Sanofi said Thursday. Sanofi’s phase 3 IMROZ readout comes as Sarclisa’s in-class rival, Johnson & Johnson’s Darzalex, is sharing a positive phase 3 for its VRd combo in transplant-eligible patients at the upcoming American Society of Hematology annual meeting. Still, the J&J data don’t prevent Sanofi from claiming the first phase 3 win for an anti-CD38 antibody with VRd in transplant-ineligible patients. Results from the IMROZ trial will be shared at a future medical meeting and will support a regulatory filing, Sanofi said. A ...
Dive Brief Intuitive Surgical’s venture capital arm has launched a second investment fund with $150 million in new capital. The Intuitive Ventures fund will support startups focused on improving healthcare access and coordination, developing precision diagnostics and interventions, and integrating digital technology, the firm said Monday. The new fund follows the launch of Intuitive’s first venture capital fund three years ago and brings the firm’s total assets under management to $250 million. Dive Insight The robotic surgery leader is among a number of large medtech companies to establish a venture capital operation dedicated to supporting a portfolio of early-stage companies. GE HealthCare, Johnson & Johnson and Boston Scientific have also launched venture funds. The venture has since invested in more than 10 startups, supported by Intuitive Surgical’s network and corporate oversight. Those companies include Capstan Medical, Endogenex, Flywheel, KelaHealth, MedCrypt, Neocis Optellum and Surge Therapeutics. “Fund II deepens Intuitive’s commitment ...
As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs. Together, those meds will help the company deliver pharmaceutical sales growth of 5% to 7% between 2025 and 2030, the company said Tuesday. That phalanx of novel products will be essential as J&J’s longstanding immunology star, Stelara, nears its tumble over the patent cliff. Last year, the drug generated $9.7 billion and was J&J’s top product by sales. During an enterprise business review Tuesday, J&J laid out its expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast 10 or more drugs with peak sales potential of at least $5 billion, including cancer launches Talvey and Tecvayli, plus another 15-plus products with sales potential of at least $1 billion. The latter group of therapeutics ...
Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
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