Search Results for “Pfizer” – Page 26 – media

Bayer’s trial flop, courtroom setback could restrict CEO’s options amid strategic review

After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. Still, the German conglomerate is trying to keep its head up as it presses on with a strategic review under new CEO Bill Anderson. Bayer’s very bad week started with the failure of its potential blockbuster-in-waiting asundexian to top Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial. In light of the blood thinner’s inferior efficacy, Bayer elected to stop the study early while continuing to advance the asset in stroke. Bayer is counting on new drugs like asundexian to offset the upcoming loss of exclusivity on its Johnson & Johnson-partnered med Xarelto. Separately, a Missouri jury on Monday ordered Bayer to shell out $1.56 billion to four plaintiffs over claims the company’s Roundup weedkiller caused their cancer. Bayer ...
- Source: drugdu
- 96
- November 23, 2023
Outclassed by Eliquis, Bayer Halts Atrial Fibrillation Study of Factor XIa Inhibitor

By Tristan Manalac Pictured: Bayer’s office in New Jersey Bayer on Sunday announced it was stopping the Phase III OCEANIC-AF study ahead of schedule due to the disappointing performance of its investigational factor XIa inhibitor asundexian. The decision to end OCEANIC-AF early is in line with the recommendation of an Independent Data Monitoring Committee, which during the ongoing surveillance of the study found that asundexian had “inferior efficacy” versus Bristol Myers Squibb’s and Pfizer’s Eliquis (apixaban). Bayer will take “appropriate measures” to close the study and will work with investigators to determine the next steps for patients. Bayer did not provide specific data from OCEANIC-AF in its news release, but said it will continue to analyze its results and publish the findings. Asundexian is an investigational inhibitor of the blood protein factor XIa, which is a key player in the coagulation cascade. The drug candidate is designed to be orally ...
- Source: drugdu
- 127
- November 22, 2023
CDC rushes extra doses of Sanofi, AZ’s Beyfortus to ease supply shortfall

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation. More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement. Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added. The supply strain began last month despite Sanofi’s “aggressive” plan that was designed to “outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership. Sanofi previously noted ...
- Source: drugdu
- 139
- November 21, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
- 103
- November 20, 2023
Jazz Inks $770M Deal with GSK Spinout Autifony, Nabs Two Neuro Assets

By Tyler Patchen Pictured: A neurosurgeon analyzes an MRI/iStock, gorodenkoff GSK spinout Autifony Therapeutics has entered into an exclusive global licensing deal potentially worth $770.5 million with Jazz Pharmaceuticals for two different ion channel targets associated with neurological disorders. Under the deal announced on Tuesday, the U.K.-based biotech Autifony will receive an undisclosed upfront payment from Jazz and is eligible to receive development, regulatory and commercial milestone payments as well as royalties on any future net sales. Autifony, which is focused on developing treatments for central nervous system disorders and other brain diseases, will spearhead the drug discovery and the preclinical development of the two ion channel targets. Prior to the completion of preclinical development, Jazz will take over clinical development and assume responsibility for manufacturing, regulatory actions and commercialization. “Jazz has an exceptional track record of rapidly advancing neuroscience development programs and effectively commercializing novel therapies that offer improvements ...
- Source: drugdu
- 118
- November 16, 2023
Major trial finds apixaban reduces stroke risk in patients with device-detected atrial fibrillation

The widely available blood thinner apixaban substantially reduced stroke in at-risk patients with a type of atrial fibrillation only detectable by a pacemaker or other implanted cardiac electronic device, a global study has found. The oral anticoagulant medication, which helps to prevent dangerous blood clots by thinning the blood, reduced the risk of stroke and blood clotting by 37% and reduced fatal or disabling stroke by 49% in individuals with device-detected atrial fibrillation, also known as sub-clinical atrial fibrillation (SCAF). This condition is not easily detectable through standard tests like electrocardiograms, unlike clinical atrial fibrillation. The study was published on Nov. 12 in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association Scientific Sessions by lead researcher Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI), a joint research institute of McMaster University and Hamilton Health Sciences. Healey and a global ...
- Source: drugdu
- 109
- November 15, 2023
Combination Vaccines Are Coming for Respiratory Diseases

By Kate Goodwin Pictured: A researcher at work in a Novavax laboratory/Novavax, Patrick Siebert Combination vaccines are nothing new for the healthcare industry. Childhood vaccines, as well as a single shot for tetanus, diphtheria and pertussis for adults, have long been combined for ease of administration and increased compliance rates. Now, as vaccines for COVID-19 and, for older people, RSV and pneumococcal disease join the annual flu shot as routine care recommendations for adults, healthcare professionals are increasingly concerned over getting the word out, vaccine fatigue and logistical hurdles. Biopharma companies are betting there will be a market for vaccines that combine protection against two or more diseases in a single jab. Benefit to the Population “The data are pretty unequivocal that when there are combo vaccines available, people generally prefer [them],” said Andrea C. Love, an immunologist and microbiologist and founder of the Unbiased Science Podcast. Love pointed out ...
- Source: drugdu
- 111
- November 4, 2023
Moderna Posts Q3 Loss, Takes $1.3B in Write-Downs on COVID-19 Shots

By Tyler Patchen While Moderna’s total revenue for the third quarter beat Wall Street expectations, the vaccine maker on Thursday posted a loss as demand for its COVID-19 shots declined. Moderna announced that overall sales for the third quarter were $1.8 billion, down from $3.4 billion in the same period of 2022. Net product sales for Moderna were also down 44% from last year due to a “lower sales volume” but partially offset by a higher average selling price the company unveiled. In the third quarter, Moderna said it saw charges of $1.3 billion for “inventory writedowns,” which were related to “excess and obsolete COVID-19 products.” Investors were not pleased as Moderna’s stock price fell over 15% pre-market on Thursday. “Through this quarter, we demonstrated our ability to increase share in the U.S. market, and we now expect this year’s vaccination rate to be similar to last fall,” Moderna CEO ...
- Source: drugdu
- 162
- November 4, 2023
Alliance for mRNA Medicines launched to accelerate global innovation

A group of 31 biotechnology, biopharma and life sciences companies and educational institutions have launched the first global organisation dedicated to advancing mRNA medicines. The Alliance for mRNA Medicines (AMM), which issued its first announcement at the International mRNA Health Conference in Germany, is now the only scientific and policy organisation singularly focused on global mRNA innovation. It also serves as an advocate for policies before legislative and regulatory bodies in North America, Europe and Asia to support innovation, define regulatory standards and enhance patient access to mRNA medicines. The AMM states that its mission is to “propel the future of mRNA medicine, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA industry leaders, innovators, scientists and other key stakeholders”. Founding members of the organisation include BioNTech, CSL, CureVac, Ginkgo Bioworks, Ethris, Johns Hopkins University, Mayo Clinic, Replicate Bioscience and Verve Therapeutics. “This is a pivotal moment ...
- Source: drugdu
- 100
- November 4, 2023
Eli Lilly Strikes $250M Deal to Add Gene-Editing Medicines for Cardio Conditions

Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target. By FRANK VINLUAN Eli Lilly signaled its growing interest in genetic medicines for cardiovascular conditions when it partnered with Verve Therapeutics earlier this year, committing to share in development of a preclinical gene-editing therapy addressing a key heart target. The pharmaceutical giant is now adding more cardiovascular disease drug prospects, pledging $250 million to secure the right to opt into development and commercialization of three additional Verve gene-editing therapies for other key targets. This time, however, the cash isn’t going to Verve. Lilly is paying Beam Therapeutics, whose base-editing technology is used in Verve’s experimental genetic medicines. Their original alliance, started in 2019, gave Beam the option to share in the ...
- Source: drugdu
- 186
- November 2, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.