BioSpace
JUNE 12, 2024
Building on last year’s potential $7 billion partnership with Flagship Pioneering, Pfizer and Flagship-founded ProFound Therapeutics will work on discovering new obesity candidates.
Bio Pharma Dive
JUNE 11, 2024
The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.
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Pharmaceutical Technology
JUNE 11, 2024
AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.
Fierce Pharma
JUNE 11, 2024
Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Rethinking Clinical Trials
JUNE 13, 2024
Dr. Diana Burgess Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems Research Cyberseminars series. The Learning to Apply Mindfulness to Pain (LAMP) trial is a multisite pragmatic clinical trial that compared 2 approaches for delivering mindfulness-based interventions via telehealth for veterans with chronic pain.
Bio Pharma Dive
JUNE 12, 2024
Study results indicated Avidity’s medicine muted target genes. Elsewhere, Syntis revealed obesity drug plans and Nodthera chalked up more positive data for its NLRP3 inhibitor.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
JUNE 12, 2024
As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.
Rethinking Clinical Trials
JUNE 12, 2024
Dr. Stefan James and Dr. Jonas Oldgren In this Friday’s PCT Grand Rounds, Stefan James and Jonas Oldgren of Uppsala University will present “DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed for Regulatory Evaluation.” The Grand Rounds session will be held on Friday, June 14, 2024, at 1:00 pm eastern. DAPA-MI (Dapagliflozin in Patients With MI) was a registry-based, placebo-controlled trial of dapagliflozin in patients hospitalized for myocardial infarction a
Bio Pharma Dive
JUNE 12, 2024
The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.
Pharmaceutical Technology
JUNE 10, 2024
Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.
Fierce Pharma
JUNE 12, 2024
After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents. | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.
Rethinking Clinical Trials
JUNE 11, 2024
Dr. Andrea Cook and Dr. Lynn DeBar, principal investigators of BackInAction Many older adults who participate in acupuncture research may have prior experience with acupuncture, according to an analysis of data from the BackInAction trial. The finding has implications for the design and conduct of future pragmatic clinical trials involving acupuncture.
Bio Pharma Dive
JUNE 10, 2024
Of the changes sparked by value-based care, perhaps the most valuable for the biopharmaceutical industry to embrace is the use of health economics and outcomes research (HEOR) to better understand a product’s value.
Pharmaceutical Technology
JUNE 13, 2024
The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.
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Fierce Pharma
JUNE 14, 2024
With a deal worth up to $1.3 billion, Takeda could get its hands on a “potentially best-in-class” third-generation BCR-ABL tyrosine kinase inhibitor (TKI) that could rival Novartis' Scemblix.< | In deal potentially worth up to $1.3 billion, Takeda has gained an option to license Ascentage's third-generation tyrosine kinase inhibitor, which could go up against Novartis' Scemblix in chronic myeloid leukemia.
Antidote
JUNE 10, 2024
Also known as endometrial carcinoma or uterine cancer, endometrial cancer occurs when the cells that line the uterus begin growing uncontrollably. Though the mortality rates are relatively low due to the high rate of early detection, it is a cancer that impacts nearly 70,000 people every year.
Bio Pharma Dive
JUNE 12, 2024
Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.
Pharmaceutical Technology
JUNE 14, 2024
If exercised, the option would allow Takeda to license the TKI olverembatinib outside China, Hong Kong, Macau, Taiwan and Russia.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
pharmaphorum
JUNE 13, 2024
Explore the key moments of truth in launch excellence for MSLs and commercial teams in this informative white paper. Gain valuable insights and strategies for successful launches.
Fierce Pharma
JUNE 11, 2024
Amid a recent biopharma M&A resurgence, one major player plans to stay out of the waters after making multiple recent splashes. | Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking “breathing period,” CEO Albert Bourla told investors this week at Goldman Sachs’ 2024 annual Global Healthcare Conference in Miami.
Bio Pharma Dive
JUNE 13, 2024
The failure of another trial adds to uncertainty around the benefits of the gene-based treatments, though industry analysts still expect Sarepta’s Elevidys’ to be unaffected.
Pharmaceutical Technology
JUNE 14, 2024
AbbVie has made a licence agreement with FutureGen Biopharmaceutical for developing FG-M701 for inflammatory bowel disease (IBD).
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
pharmaphorum
JUNE 11, 2024
Get the latest updates on clinical trials from 3rd to 7th June involving companies like uniQure, Takeda, Otsuka, CatalYm, Agios, and Transgene. Stay informed on the latest developments in the field.
FDA Law Blog
JUNE 13, 2024
By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.
Bio Pharma Dive
JUNE 10, 2024
Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.
Pharmaceutical Technology
JUNE 14, 2024
England’s NHS has reported an 18% increase in the number of people with non-diabetic hyperglycaemia, also known as pre-diabetes.
pharmaphorum
JUNE 10, 2024
Discover how pharmaceutical companies can leverage digital technologies to accelerate innovation and disrupt the industry. Learn about regulatory considerations and engagement with healthcare professionals (HCPs) for successful digital transformation.
Fierce Pharma
JUNE 10, 2024
As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. | Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday.
Bio Pharma Dive
JUNE 11, 2024
Newer components and drug combinations could expand use of the targeted cancer medicines, according to company executives.
Pharmaceutical Technology
JUNE 13, 2024
Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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