Cardiovascular

Amgen (Nasdaq:AMGN) announced that it would purchase the San Carlos, California–based ChemoCentryx (Nasdaq:CCXI) for $52 per share in cash, which equates to a total of approximately $3.7 billion. The centerpiece of the proposed acquisition is Tavneos (avacopan), which scored FDA approval last year for the adjunctive treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The disease…

Astellas Pharma (TSE:4503) has revealed that the FDA has slapped a clinical hold on its Phase 1/2 FORTIS Pompe disease study after observing a serious adverse event (SAE) — peripheral sensory neuropathy — in a trial participant. Peripheral sensory neuropathy results from damage to nerves outside of the central nervous system. The condition can lead…

The clinical-stage pharma company Acer Therapeutics Inc. (Nasdaq:ACER) has begun screening patients for its Phase 3 DiSCOVER (Decentralized Study of Celiprolol on vEDS-related Event Reduction) clinical study of EDSIVO (celiprolol) to treat COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS). There are presently no FDA-approved drugs available for vEDS, which is associated with a risk of internal bleeding,…

AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study.  First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney…

Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto. The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).…

Eli Lilly and Company (NYSE:LLY) has announced that the FDA has approved Jardiance (empagliflozin) 10 mg to lower the risk of cardiovascular death and hospitalization in adults with heart failure. Lilly developed the drug, an SGLT2 inhibitor, in collaboration with Boehringer Ingelheim. Jardiance is contraindicated in adults with type 1 diabetes, given its potential to…

Pfizer (NYSE:PFE) is suing Regor Therapeutics, a China-headquartered company that announced a $1.5 billion diabetes alliance with Eli Lilly (NYSE:LLY) in late 2021. Filed in the U.S. District Court for the District of Delaware, Pfizer’s lawsuit also accuses former employees Xiayang Qiu, Min Zhong and 10 unnamed individuals of using its trade secrets as the…

Pfizer Inc. (NYSE:PFE) is abandoning plans to develop an investigational antisense therapy known as vupanorsen for potential use for cardiovascular indications and severe hypertriglyceridemia (SHTG). The company had projected that vupanorsen could generate up to $3 billion in peak sales. Pfizer is returning development rights of the drug to Ionis Pharmaceuticals (NSDQ:IONS), from whom it…

Last December,’s (NYSE:JNJ) blockbuster blood thinner Xarelto (rivaroxaban) won FDA approval for two new indications for pediatric indications. The drug now has 11 indications in the U.S., more than any other direct oral anticoagulant (DOAC). In 2020, the drug generated nearly $6.5 billion in revenue globally. To learn more about the new indications, we spoke…

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

FDA has informed Bristol Myers Squibb (NSDQ:GILD) that it has extended its review of mavacamten, an allosteric modulator of cardiac myosin. Bristol Myers Squibb aims to win an FDA nod for the drug as a treatment for obstructive symptomatic hypertrophic cardiomyopathy (oHCM), a disease associated with heart muscle thickening. Mavacamten addresses the molecular defect involved…

The gene therapy company Voyager Therapeutics, Inc. (NSDQ: VYGR) has reached an agreement with Pfizer (NYSE:PFE) to license novel capsids from its RNA-driven TRACER screening technology. A capsid refers to the protein shell of a virus protecting its genome. “We believe that our TRACER platform has the ability to produce not only enhanced blood-brain-barrier penetrant…

Drugs that work well in adults don’t always translate well for treating pediatric patients. The problem has inspired clinicians such as the pediatric cardiologist Dr. Brian McCrindle at the Hospital for Sick Children in Toronto to work with the pharma industry on trials focused on pediatric patient populations and introduce newer agents to clinical practice.…

Merck (NYSE:MRK) has agreed to acquire the biopharma Acceleron Pharma (NSDQ:XLRN) for $180 per share in cash, bringing the purchase price to roughly $11.5 billion. The companies expect the deal to close in the fourth quarter of 2021. Cambridge, Massachusetts–based Acceleron specializes in developing drugs that aim to balance transforming growth factor (TGF)-beta, which plays…

Janssen (NYSE:JNJ) has announced that its blockbuster blood thinner Xarelto (rivaroxaban) had a similar safety profile to aspirin in pediatric patients a Phase 3 study. The trial focused on pediatric patients who underwent the Fontan procedure, a type of open-heart surgery intended to correct single ventricle anomalies in the heart. Physicians have traditionally relied on aspirin…

In recent years, regulators including FDA have increased their focus on the potential of drugs to cause blood pressure increases. To that end, the agency asked Urovant (Irvine, California) to study the impact of the beta-3 adrenergic receptor agonist vibegron on blood pressure. The study, recently published in the Journal of Urology, found no significant change…

Theravance Biopharma (NSDQ:TBPH) has announced today that it is laying off 75%, or roughly 270, of its employees. The South San Francisco, California–based company employed 359 people in 2020, according to its most recent annual report. The company plans on making the bulk of the cuts in November, with more to follow in early 2022.…

Despite the rare risk of myocarditis in children, the benefits of the Pfizer-BioNTech BNT162b2 vaccine likely outweigh the risks, according to a recent JAMA Cardiology report. A separate pre-print study found that adolescents’ risk of contracting myocarditis is substantially higher after contracting COVID-19 than from receiving mRNA vaccines targeting the novel coronavirus. An earlier JAMA…

Entresto (sacubitril-valsartan) from Novartis is FDA indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure. Entresto remains the only FDA-approved option for patients with a variety of heart failure symptoms. A recent pilot study shows that the drug may also benefit patients with heart failure…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Nexletol is similar to Nexlizet in its FDA indication as an adjunct to diet and statin therapy to treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who need additional help lowering of LDL cholesterol. In September, Nexletol began a direct-to-consumer campaign advertising the potential of the drug to support LDL cholesterol-lowering as an adjunct…

Nexlizet from Esperion is FDA-indicated for heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. The indication is intended as an adjunct to diet and statin therapy for patients who need additional help reducing LDL cholesterol levels. The drug, which combines two cholesterol-reducing medicines (bempedoic acid and ezetimibe), won FDA approval early last year.  

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.  The conditions appear to be more common in males.  The FDA warning…

The FDA has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets for children with venous thromboembolism between 3 months and under 12 years old. The indication stipulates that children receiving Pradaxa have received prior treatment with an injectable blood thinner given by injection for at least five days. FDA has also approved Pradaxa in capsule…

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). More than five million people in the country have received the vaccine. The agency, however, has not yet established a causal relationship between the events and the vaccine. Pfizer has…