Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
Sanofi and Regeneron have shared positive results from a late-stage trial of Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD). The phase 3 NOTUS trial has been evaluating the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation. The trial met its primary endpoint, with Dupixent shown to reduce moderate or severe acute COPD exacerbations by 34% compared to placebo. Results from the interim analysis also demonstrated that Dupixent improved lung function from baseline by 139ml at 12 weeks compared to 57ml for placebo, with this benefit sustained at week 52. COPD is a chronic respiratory disease that causes lung function to progressively decline. Approximately 300,000 people in the US live with uncontrolled cases of the condition and evidence of type 2 inflammation. The positive readout from NOTUS builds on the previous results from the ...
By Kate Goodwin Pictured: Closed sign/iStock, StockSeller_ukr After a couple of disappointing years, a microbiome biotech founded by Flagship Pioneering is calling it quits. In an SEC filing Monday, Evelo Biosciences reported that dissolution is “in the best interest” of the company as well as its creditors and stockholders. The company was launched in 2015 by Flagship to develop inflammation-resolving microbe medicines to act on cells in the small intestine with systemic therapeutic effects for inflammatory diseases. However, the past two years have been tough for Cambridge, Mass.-based Evelo as one by one each of its assets disappointed. After a Phase II failure in April 2022, its second atopic dermatitis candidate in Phase II testing did not meet the trial’s primary endpoint in February 2023. The company pointed to an unusually high placebo response rate. The results sent Evelo’s stock tumbling 50% at the time and the company cut around ...
The US Food and Drug Administration has approved Krystal Biotech’s Investigational New Drug (IND) for a Phase I clinical trial of the investigational alpha-1 antitrypsin deficiency (AATD) treatment KB408. Earlier this month, the FDA granted orphan-drug status for KB408 in AATD. The first patient in the planned Phase I trial is expected to receive treatment in Q1 2024. The Phase I trial, involving adult patients with AATD and the PI*ZZ genotype, will assess the safety, tolerability, and efficacy at three planned dose levels. AATD is a rare genetic disorder that occurs when there is insufficient production or impaired functionality of the alpha-1 antitrypsin (AAT) protein. Low AAT levels result in damage to lung tissue, leading to chronic obstructive pulmonary disorder (COPD). KB408 is a gene therapy consisting of a modified herpes simplex virus 1 (HSV-1) derived vector, which delivers two full-length copies of the SERPINA1 gene to enable AAT expression. ...
People living with lung conditions, such as asthma and chronic obstructive pulmonary disease (COPD), face even greater risks from climate change, according to an expert report published today (Monday) in the European Respiratory Journal. The report brings together evidence on how the effects of climate change, such as heatwaves, wildfires and flooding, will exacerbate breathing difficulties for millions of people around the world, particularly babies, young children and the elderly. On behalf of the European Respiratory Society, which represents more than 30,000 lung specialists from 160 countries, the authors are calling on the European Parliament and governments around the world to urgently reduce emissions of greenhouse gasses and mitigate effects of climate change. Professor Zorana Jovanovic Andersen, Chair of the European Respiratory Society’s Environment and Health Committee and based at the University of Copenhagen, was an author of the report, ‘Climate change and respiratory health: a European Respiratory Society position ...
A pair of internationally renowned stem cell cloning experts at the University of Houston is reporting their findings of variant cells in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF) which likely represent key targets in any future therapy for the condition. IPF is a progressive, irreversible and fatal lung disease in which the lungs become scarred and breathing becomes difficult. The rapid development and fatal progression of the disease occur by uncertain mechanisms, but the most pervasive school of thought is that IPF arises from recurrent, subclinical lung injury that imparts changes to epithelial and stromal cells, which, in turn, compromise lung repair and favor fibrosis. To dig deeper into the cause of IPF, Frank McKeon, professor of biology and biochemistry and director of the Stem Cell Center, and Wa Xian, research associate professor at the center, used single cell cloning technologies to generate libraries of basal stem ...
Systems will support millions of patients with chronic respiratory conditions throughout Europe Kry – a company focused on digital healthcare – is launching a number of digital care pathways to transform treatment approaches for chronic respiratory diseases (CRDs) such as asthma, lung cancer and chronic obstructive pulmonary disease (COPD). The new pathways will help early diagnosis, prevention and wider management of the conditions. It is also hoped that integrated digital healthcare can complement and enhance primary care access. An estimated 235 million people suffering from asthma, while more than 200 million people are living with COPD across the world. Currently, in Sweden, improving access to national screening programs for lung cancer is vital, especially when encouraging better prevention through early detection and establishing treatments. With this considered, Kry is developing a testing and diagnostic solution which uses track and trace in order to assist patients. This enables them be assessed ...
The percentage of adults who smoked cigarettes in the United States fell to a historic low last year, the US Centers for Disease Control and Prevention found. However, e-cigarettes are becoming even more popular. About 11% of adults told the CDC last year that they were current cigarette smokers, according to the latest preliminary data from the National Health Interview Survey, a biannual survey that provides general information about health-related topics. The survey includes responses from 27,000 people age 18 and older. In 2020 and 2021, about 12.5% of adults said they smoked cigarettes. This is a significant drop from when surveys like these started. Surveys of Americans in the 1940s found that about half of all adults said they smoked cigarettes. Rates began to decline in the 1960s, and more recently, in 2016, 15.5% of adults said they smoked cigarettes. Recent studies have shown some groups ...
March 23 (Reuters) – Sanofi’s (SASY.PA) asthma drug Dupixent met all targets in a trial to treat “smoker’s lung”, potentially adding billions to the French drugmaker’s growth prospects, but also underscoring a heavy reliance on its bestseller. In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline. Shares in Sanofi and Regeneron surged after they said in a joint statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and respiratory symptoms. The French group’s stock was up 5.2% at 1205 GMT, reaching a seven-month high and far outperforming the STOXX Europe 600 Health Care index (.SXDP), which was little changed. Regeneron jumped 8.6% in U.S. ...
Journal reference: Tsampasian, V., et al. (2023) Risk Factors Associated With Post−COVID-19 Condition. JAMA Internal Medicine. doi.org/10.1001/jamainternmed.2023.0750. Being vaccinated against Covid halves people’s risk of developing long Covid, according to new research from the University of East Anglia. Long Covid still affects some two million people in the UK, and new research published today reveals the risk factors associated with developing the condition. Overweight people, women, smokers and those over the age of 40 are also more likely to suffer from long Covid according to the study – which includes more than 860,000 patients and is thought to be the largest of its kind. The study also finds that co-morbidities such as asthma, COPD, Type 2 Diabetes, coronary heart disease, immunosuppression, anxiety and depression are also associated with increased risk of long Covid. And patients who are hospitalized during their acute Covid infection are also ...
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