Roche shares upbeat Phase 3 data for Hemlibra in hemophilia

Facing potential competition from Novo Nordisk’s (NYSE:NVO) investigational blood coagulation factor stimulants Mim8, Roche (SIX:RO, ROG; OTCQX:RHHBY) released positive new data from the Phase 3 HAVEN 6 study focused on the use of Hemlibra (emicizumab) in patients with mild or moderate hemophilia A.

Hemlibra won FDA approval in 2018 for hemophilia A without factor VIII inhibitors.

The drug raked in almost $2.8 billion in sales in 2021.

In the open-label, single-arm HAVEN 6 study, two-thirds of Hemlibra recipients with mild or moderate hemophilia A had no treated bleeds at 55.6 weeks median follow-up.

Basel, Switzerland–based Roche said the drug continued to have a favorable safety profile in patients without factor VIII inhibitors.

The company plans on presenting the data at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress on July 11, 2022 in London.

Roche intends to ask the European Medicines Agency to …

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Semaglutide supply shortfall fuels demand for alternatives

Novo Nordisk (NYSE:NVO) continues to face supply shortages for its Wegovy (semaglutide) pens, which are FDA approved for weight management. 

Against that backdrop, a growing number of companies have begun selling compounded versions of the drug. 

Drug compounding involves “combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” according to the FDA. The regulatory agency does not approve compounded drugs, nor does it validate their safety, effectiveness or quality.

Novo Nordisk notes on its website that it has “become aware of an increasing trend in compounding pharmacies purporting to have availability of Wegovy or semaglutide.” The company adds that it “does not sell Wegovy (or its active ingredient, semaglutide) for the purposes of compounding with other products.” Novo Nordisk is the only company with FDA approval related to Wegovy, which is offered as a pr…

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Novo Nordisk wins FDA approval for higher-dose Ozempic for adults with type 2 diabetes

FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes.

To win the new indication, the Bagsværd, Denmark–based company provided data showing the 2 mg dose led to an average 2.1% blood glucose reduction and weight loss in adults with type 2 diabetes.

In the SUSTAIN Phase 3 clinical trial, a 1 mg dose of Ozempic helped up to 73% of people with type 2 diabetes reach the American Diabetes Association target of <7%.

Ozempic image courtesy of Novo Nordisk

The 2 mg dose could help individuals who need additional glycemic control.

“With its proven safety and efficacy, Ozempic helps deliver on blood glucose control…

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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Novo Nordisk settles Danish securities lawsuit

Novo Nordisk (NYSE:NVO) has settled a securities lawsuit in Denmark filed in August 2019 in the district court of Glostrup. 

In 2019, Novo Nordisk vowed to fight the allegations contained in the lawsuit, which alleged that the company’s insulin-related profits fell at the same time prices and sales increased from February 2015 and February 2017. The dip in profits resulted from an uptick in rebates to pharmacy benefit managers.

Investors behind the suit claimed that Novo Nordisk had exaggerated its U.S. insulin revenue in this time period.

In the settlement, the Bagsværd, Denmark–based company did not admit any liability or wrongdoing.

The lawsuit was related to several shareholders alleging that Novo Nordisk did not appropriately disclose facts related to its U.S. sales of insulin products. The shareholders initially sought DKK 11,785,192,218 (approximately $1.8 billion) in damages.

NVO shares have fallen steadily in January 2022 in …

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Novo Nordisk faces Wegovy supply challenges in US

Novo Nordisk (NYSE:NVO) announced that one of its contract manufacturers filling syringes for its Wegovy (semaglutide) pens in the U.S. market has temporarily ceased manufacturing following Good Manufacturing Practices problems.

The company projects it will be unable to meet U.S. demand for the drug in the first half of 2022 and that use of the drug will likely be constrained to a limited number of patients.

NVO shares dipped 8.21% to $107.45 today.

Novo Nordisk anticipates a resolution of the supply shortage by the second half of 2022.

The obesity drug Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for patients with a body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater (overweight) with at least one weight-related comorbidity.

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Lilly cuts price of Lispro insulin by 40%

Starting January 1, 2021, Eli Lilly and Company (NYSE:LLY) will reduce the list price of Insulin Lispro Injection in the U.S. to match 2008 levels. The 40% price cut will also extend to the company’s non-branded insulins.

Still, the company acknowledged that people with fixed insurance co-pays or beneficiaries of Lilly’s affordability programs might not see direct savings for Insulin Lispro Injection.

In recent years, a number of politicians and physicians have complained about the high cost of insulin in the U.S.

For instance, Senator Chuck Grassley (R-Iowa) lamented earlier this year that insulin prices had “gone through the roof.” Several Democratic presidential candidates in 2020 also lambasted the high cost of insulin.

A 2020 article published in Mayo Clinic Proceedings reported that analog insulin costs 10 times more in the U.S. than in other developed nations.

Three companies, Lilly, Novo Nordisk and Sanofi-Aventis, control the bulk …

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Novo Nordisk settles U.S. securities class action suit

Novo Nordisk (NYSE:NVO) has agreed in principle to settle securities class action litigation in the Federal District Court of New Jersey. The Bagsværd, Denmark–based company would pay $100 million in the settlement.

That amount includes plaintiffs’ attorneys’ fees, expenses and settlement costs.

The lawsuit alleged that the company made misleading statements regarding the price of its insulin.

The agreement contains no admission of liability or wrongdoing. The company stressed in a statement that it believes the “plaintiffs’ claims are without any merit.”

“While we are confident in the facts and merits of our position, we believe that resolving this matter is the right business decision for Novo Nordisk and our shareholders,” said Tomas Haagen, general counsel at Novo Nordisk.

Purchasers of American Depository Receipts initially filed the lawsuit in 2017.

Novo Nordisk, along with Eli Lilly and Sanofi-Aventis, has faced litigation ove…

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Noninvasive liver exam plays role in fighting viral hepatitis and fatty liver disease

 The FibroScan device pictured here assesses liver stiffness using Echosens patented VCTE technology.

Millions of Americans who are living with hepatitis C virus (HCV) will develop a chronic infection that, if left untreated, can cause serious health problems, including liver disease, cirrhosis, liver failure and liver cancer. More than one-third of HCV-infected individuals progress to advanced fibrosis and cirrhosis, and among those with cirrhosis, about 3–5% per year develop decompensated cirrhosis or hepatocellular carcinoma (HCC).

Nearly one-third of Americans have asymptomatic liver disease, also known as fatty liver disease (FLD). Approximately 85 million Americans have nonalcoholic fatty liver disease (NAFLD). In addition, a total of 20% have its more severe form, nonalcoholic steatohepatitis (NASH).

Liver disease often leads to developing other issues, such as advanced fibrosis, increased risk…

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Lilly’s tirzepatide bests semaglutide in type 2 diabetes trial 

Eli Lilly (NYSE:LLY) has announced that its investigational drug tirzepatide led to more substantial blood glucose and body weight improvements in a Phase 3 trial than semaglutide, a diabetes drug from Novo Nordisk (NYSE:NVO) that recently scored FDA approval for weight loss in early June.

Lilly’s SURPASS-2 results published in The New England Journal of Medicine show tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes.

A JAMA opinion article recently posited that semaglutide could lead to a ‘new dawn’ for obesity treatment.

The Lilly trial randomly assigned patients to receive tirzepatide at doses of 5 mg, 10 mg, or 15 mg or a 1-mg dose of semaglutide.

Semaglutide is a glucagon-like peptide 1 receptor agonist. Conversely, tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

In the 40-week SURPASS-2 trial, i…

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FDA approves Novo Nordisk’s semaglutide for weight management

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B).

The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019.

Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use.

In clinical trials, Novo Nordisk people led to an average weight loss of 15% to 18% of body weight over 68 weeks in patients with obesity without diabetes.

In a clinical trial published in JAMA and The New England Journal of Medicine, semaglutide tripled weight loss for participants who received lifestyle management coaching.

Novo Nordisk continues to research new potential uses of the drug. It has launched clinical trials to test its use for conditions ranging from atherosclerosis to Alzheimer’s and Parkinson’s disease. A posthoc analysis involving three cardiovascular clinical trials found that participants recei…

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Why Lilly’s tirzepatide has blockbuster potential 

Tirzepatide from Eli Lilly (NYSE:LLY) continues to show promise for diabetes, outperforming popular diabetes drugs in head-to-head clinical trials, according to GlobalData. 

In the recent SURPASS-4 study, tirzepatide supported the reduction of hemoglobin A1C (HbA1c) in people with type 2 diabetes while also supporting weight loss. The study pitted tirzepatide against insulin glargine. 

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (RA). 

The experimental drug also bested the injectable anti-diabetes drug semaglutide in the SURPASS-2 trial. Semaglutide from Novo Nordisk (NYSE:NVO) is currently FDA indicated as a treatment for type 2 diabetes. Semaglutide also supported substantial weight loss in a recent clinical trial, potentially supporting its use as an obesity treatment. Semaglutide is also a GLP-1 receptor agonist.  

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