Cardiovascular

The FDA has approved a sweeping label update for Bristol Myers Squibb’s Camzyos (mavacamten), the first‑and‑only FDA‑approved cardiac myosin inhibitor for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Until Camzyos reached the market in 2022, physicians mainly relied on beta‑blockers, calcium‑channel blockers, disopyramide or invasive septal‑reduction surgery to relieve outflow obstruction. The latest update lets…

YTD 2024 FDA approvals: By the numbers 44 Novel Drug Approvals As of December 5, 2024, the FDA had approved a total of 44 novel drugs, spanning a diverse array of therapeutic areas and patient populations. These new treatments address both widespread public health concerns, such as cardiovascular disease and COPD, and more narrowly defined…

In 2025, genetic validation is poised to emerge as a high-stakes litmus test in cardiovascular R&D, investors will continue to get better at funneling cash into proven science, and patients will continue their evolution to become more-active partners shaping their healthcare. To hear more about each of these trends, we considered feedback from three industry…

Protein Data Bank Eli Lilly is suing three medical spas and online vendors for selling products purportedly containing tirzepatide—the active ingredient in its weight-loss drug Zepbound. Similarly, Novo Nordisk has pursued legal action against a string of organizations to protect its semaglutide-based drugs from unauthorized competition and potentially unsafe copycat products. The company has filed…

Heart disease remains the number one killer globally, but the megablockbuster tirzepatide is proving it can do more than just help people lose weight – it’s now showing promise in fighting heart failure, too. In topline results from the phase 3 SUMMIT study, Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide cut the risk of heart failure…

Generic giant Teva Pharmaceuticals will launch the first generic version of Victoza (liraglutide injection 1.8mg) in the U.S, making it the first generic GLP-1 drug to enter the U.S. market. The patent for Novo Nordisk–developed liraglutide is set to expire until November 18, 2024. Other popular GLP-1 drugs, such as semaglutide (marketed as Ozempic and…

Pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening blood vessel disorder, affects some 500 to 1,000 new patients each year in the U.S. FDA recently approved Opsynvi, a first-of-its-kind once-daily single-tablet combination therapy from Johnson & Johnson. “With this approval, our portfolio now includes treatments that address all three guideline-recommended pathways,” said a J&J…

The recent FDA approval of a cardiovascular risk reduction indication for Wegovy (semaglutide) could point toward a significant opportunity for pharma companies seeking to reshape payer perceptions and expand coverage for next-gen metabolic therapies. This regulatory shift, allowing Wegovy to be prescribed for reducing the risk of major adverse cardiovascular events such as heart attack…

Pulmonary arterial hypertension (PAH) is a relatively rare disorder, affecting roughly 15 to 50 people per million within the U.S. and Europe. Treating it with a single therapy can be challenging, and medication adherence often presents a common hurdle for the condition. Combination therapy has thus become a widely used option in the treatment of…

The entry of AI into healthcare is starkly different from the accepted adage of “move fast and break things” in consumerism. In episode 1 of AI Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks, and Brian Buntz, pharma and biotech editor, discuss the opportunities, limitations, and direct impact of Ai in healthcare fields including…

Prix Galien names 2023 winners in pharma and biotech In the world of medical innovation, few accolades carry as much weight as the Prix Galien Awards, which highlight the advances in biotech, pharmaceuticals, and other domains. The 2023 winners include Bristol Myers Squibb’s Camzyos (mavacamten) as the best biotechnology product and Lilly’s Mounjaro (tirzepatide) and…

The explosive sales growth of GLP-1 drugs has analysts projecting that the antiobesity drugs could be a $44 billion market by 2030. Some observers are more upbeat, projecting that the sector could be worth more than $100 billion in the coming years. Pfizer CEO Albert Bourla projects that the market will reach $90 billion by…

 Data sourced from Our World in Data Cardiovascular disease and cancer remain the leading causes of death in the world, based on an analysis of data sources ranging from World Health Organization and Our World in Data. While respiratory illnesses were the third most common cause of death in 2019, deaths in this category…

As obesity rates continue to soar across the globe, analysts anticipate that the market for anti-obesity drugs will skyrocket in the coming years. Goldman Sachs projects the market to be worth $44 billion by 2030. That’s an almost 16-fold expansion from its valuation of approximately $2.82 billion in 2022. Barclays is even more upbeat on…

For patients with an elevated stroke risk, switching anticoagulant medications could be a health gamble. Those who change from Eliquis (apixaban) to Xarelto (rivaroxaban) could face almost double the risk of stroke or severe bleeding. Conversely, sticking with Eliquis or transitioning from rivaroxaban to Eliquis appears to be a safer option. Those are key takeaways…

In 2020, researchers witnessed the emergence of post-acute sequelae of SARS-CoV-2 (PASC) — more commonly referred to as “long COVID.” Now, the notion of “long vax,” persistent and varying symptoms following COVID-19 vaccination, has come into focus, as Science has noted. This phenomenon, while not as widespread as long COVID, has concerned some in the…

Lilly has announced promising data from its NCT 04881760 phase 2 study of retatrutide, a potential obesity drug. The drug candidate, a single peptide with agonist activity at the glucose-dependent insulinotropic polypeptide (GIP), GLP-1 and glucagon receptors, was associated with significant weight loss, improved glycemic control and cardiovascular health. At 24 weeks, retatrutide (1 mg,…

AstraZeneca and the Bellvitge University Hospital plan to launch the first pilot program for the Cordio Medical HearO app. The HearO smartphone app provides widespread access to medical-grade technology for patients with congestive heart failure (CHF). It enables the patient to monitor symptoms, manage treatment and improve quality of life. Astrazeneca said the pilot program aims to…

FDA has approved an expanded indication for AstraZeneca’s Farxiga (dapagliflozin). This decision, marking a significant milestone in Farxiga’s development, opens up its use in patients with heart failure, regardless of their ejection fraction status. This brings the total number of Farxiga’s approved indications to five. Ejection fraction in heart failure Ejection fraction is a key measure…

Eli Lilly‘s (NYSE:LLY) tirzepatide achieved up to 15.7% weight loss in the SURMOUNT-2 study, sparking a potential tirzepatide versus semaglutide competition in the obesity and type 2 diabetes treatment markets. The phase 3 study enrolled 938 participants with diverse backgrounds. Tirzepatide promises to be a megablockbuster with a number of analysts pegging peak annual sales…

The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…

Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. This review highlights ten promising antihypertensive drug candidates with the potential to address pulmonary arterial hypertension (PAH), resistant hypertension and uncontrolled hypertension. Aprocitentan, developed by Janssen NYSE:JNJ) and Idorsia (SIX:IDIA), is an experimental oral drug designed to treat resistant hypertension. As a dual endothelin…

A recently published paper in Cardiovascular Research found that a gene frequently found in centenarians could safeguard heart functionality. In a rodent model, a team of researchers found that the bactericidal/permeability-increasing fold-containing family-B member-4 gene (BPIFB4) gene protected against deterioration of heart function in middle-aged mice (14 months old). The researchers, led by Professor Paolo Madeddu of the University…

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). Some 37 million people in the U.S. have CKD. Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim. The…

AstraZeneca (LON:AZN) announced it had reached an agreement to acquire CinCor Pharma (Nasdaq:CINC). After announcing the proposed deal, CinCor’s share price jumped 144% to $28.74. AstraZeneca has agreed to a tender offer to acquire outstanding shares of CinCor for $26 per share, or $1.3 billion. CinCor specializes in developing therapies for hypertension and chronic kidney…