Dive Brief Bausch + Lomb is seeking to raise almost $2 billion to fund the planned acquisition of Xiidra eye drops from Novartis. The eye health company struck a deal in June to buy the dry eye disease treatment Xiidra and other assets for $1.75 billion upfront, and followed up by agreeing to pay Johnson & Johnson $107 million for a line of eye and contact lens drops. It has the cash to fund the J&J deal but needs to arrange financing to close the larger acquisition of the Novartis assets. Fitch Ratings, in a note to investors, said the Xiidra deal will boost Bausch + Lomb’s ophthalmic pharmaceutical market presence while the company’s R&D efforts help drive revenue growth and support margins longer term. Dive Insight Bausch + Lomb, which split from parent company Bausch Health last year, has identified two ways to strengthen its balance sheet ahead of ...
The UK National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s tirzepatide (Mounjaro) for the treatment of adult patients with inadequately controlled type 2 diabetes. According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise. Clinical trials show that tirzepatide usage resulted in a substantial decline in both blood sugar levels and body weight, in comparison with insulin therapy, semaglutide or a placebo. Data also showed that tirzepatide aided between 81% and 97% of individuals in attaining improved glucose control, and 54% to 88% also showed a 5% or greater reduction in body weight. These figures were substantially higher than the comparators. The independent NICE committee provided a positive recommendation for tirzepatide after conducting additional assessments and modelling on clinical and cost-efficiency data provided by Lilly. NICE noted that 180,000 individuals with poorly managed type 2 diabetes will ...
By Mariko Oi The maker of weight-loss drug, Wegovy, has become Europe’s most valuable firm dethroning the French luxury conglomerate LVMH. Shares rose after the Danish pharmaceutical giant, Novo Nordisk, launched the popular drug in the UK. At the close of trading on Monday, the firm had a stock market valuation of $428bn (£339bn). The drug is now available in the UK public healthcare system and also on the private market. Wegovy is an obesity treatment that is taken once a week which tricks people into thinking that they are already full, so they end up eating less and losing weight. Famous personalities such as Elon Musk are among the reported users of the drug, which has captivated Hollywood and the public more widely since it was approved by regulators in the US in 2021. Wegovy and Ozempic – a diabetes treatment with similar effects – have been described as ...
When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. In the second quarter, sales of Kerendia reached 67 million euros ($73 million). For Bayer to achieve its ambitious peak sales target of 3 billion euros ($3.3 billion), it will have to expand the label of the nonsteroidal mineralocorticoid receptor antagonist (MRA). To get there, Bayer is making a big play in heart failure. Thursday, the company said it’s planning three new phase 3 trials in the indication, in addition to one that’s already underway. The new studies will evaluate Bayer’s medicine in roughly 9,000 new heart failure patients with reduced, mildly reduced and preserved ejection fraction. The REDEFINE-HF trial will investigate finerenone as a monotherapy in approximately 5,200 patients with an ejection fraction of greater than 40%. The FINALITY-HF trial will ...
Dive Brief Hamilton Medical’s recall of ventilators for a software problem was designated Class I by the U.S. Food and Drug Administration, the agency wrote in a Monday notice. Hamilton contacted customers in June after learning that its C1, C2, C3 and T1 ventilators switch to “ambient state” if used in neonates for more than 91 days without a restart. In ambient state, the device sounds an alarm and no active ventilation is provided to patients. In light of the fault, which has caused 80 complaints but no injuries or deaths, Hamilton is asking users of its ventilators to regularly restart their devices. Dive Insight Hamilton sells mechanical ventilators for use in adults, children and infants. The problem that caused the Class I recall happens when the devices “are used for long-term ventilation in neonatal group.” If the ventilation time exceeds 91 days, the devices enter ambient state, causing them ...
A man-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. Results of the study appear online Aug. 30 in the journal Science Translational Medicine. Imran J. Anwar, (M.D., lead author, surgical research fellow in Duke’s Department of Surgery) said, “Current medications to prevent organ rejection are good overall, but they have a lot of side effects. These therapies suppress the immune system, putting patients at risk of infections and organ damage, and many cause non-immune complications such as diabetes and high blood pressure. The push over the last 30 to 40 years has been to develop new, less toxic drugs. We are hopeful this antibody moves us closer to that goal.” Anwar and colleagues, including co-senior author Allan Kirk, M.D., Ph.D., chair ...
By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
A new study has revealed that a new dementia risk score ‘calculator’ can strongly predict the chances of people developing dementia within the next 14 years. Based on 11 mostly modifiable risk factors in people in the middle stages of life and onwards, the UK Biobank Dementia Risk Score (UKBDRS) outperformed three additional widely used risk sources, according to the results from the study published in the British Medical Journal. Around 50 million people are thought to be living with dementia worldwide, with numbers expected to triple by 2050. Targeting key risk factors could potentially avert around 40% of dementia cases, and various risk scores have been devised to predict a person’s chances of developing the disease while preventive measures are still possible. However, these scores have been shown to be unreliable across different age groups and geographies, and some are reliant on expensive and invasive tests. After analysing two ...
The U.S. has much higher list prices for several weight loss drugs when compared to other peer countries, a new KFF report found. KFF’s analysis compares list prices from website searches for a month’s supply of Ozempic, Rybelsus, Wegovy and Mounjaro, which are all approved for diabetes or weight loss in the U.S. In some countries, these drugs are not available. Ozempic, which is approved for diabetes in the U.S., costs $936 for a month’s supply in the U.S., versus $169 in Japan, $147 in Canada and $144 in Switzerland. Rybelsus, also approved in the U.S. for diabetes, costs $936 for a month’s supply in the U.S., while it costs $203 in the Netherlands, $158 in Canada and $147 in Switzerland. Wegovy has been approved for weight loss and costs $1,349 for a month’s supply in the U.S., versus $328 in Germany and $296 in the Netherlands. Mounjaro, approved for ...
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