Pfizer wins cancer drug patent case against AstraZeneca
Pharmaceutical Technology
MAY 20, 2024
The US District Court of Delaware has ordered AstraZeneca to pay $107.5m to Pfizer in damages for infringing patents related to Tagrisso.
Mon.May 20, 2024
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Therapies designed to dismantle cancer’s escape mechanisms show promise for patients
Bio Pharma Dive
MAY 20, 2024
Hear from IO Biotech CEO Dr. Mai-Britt Zocca about the potential of therapeutic vaccines to strip the defenses used by cancer cells to keep the immune system at bay.
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Final report says UK infected blood scandal “should have been avoided”
Pharmaceutical Technology
MAY 20, 2024
Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.
BIO to restructure, lay off staff in shakeup of lobbying group
Bio Pharma Dive
MAY 20, 2024
Thirty employees will leave as part of the reorganization, which the group said is meant to bring "stronger focus and greater impact" to its work.
Cervical cancer elimination in the UK is within sight with HPV vaccine
Pharmaceutical Technology
MAY 20, 2024
A recent study in England has shown that the HPV vaccine in teenagers reduced the rate of cervical cancer by up to 85%.
Forbion-backed biotech Progentos debuts with $65M for MS drug
Bio Pharma Dive
MAY 20, 2024
Progentos says the money will go toward expanding its pipeline and pushing an experimental treatment for multiple sclerosis through "proof of concept” testing.
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European Commission, in ‘unprecedented’ move, declines to revoke approval of PTC Duchenne drug
Bio Pharma Dive
MAY 20, 2024
Rather than endorse the recommendation of the EMA, the commission called for a new review for Translarna that considers “the totality of the evidence” compiled to date.
Understanding of effects of microplastics on human health urgently needed: Expert
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 20, 2024
Understanding of the effects of microplastics on human health is urgently needed, according to Dr. LeepikaParulekar, consultant, general medicine, Holy Family Hospital, Mumbai. Dr. Parulekar further explained that the health risks of exposure to micro plastics are just beginning to be understood.
Dyne shares jump on trial data for muscle disease drugs
Bio Pharma Dive
MAY 20, 2024
Updated study results for the biotech’s medicines for myotonic dystrophy Type 1 and Duchenne muscular dystrophy appeared to impress analysts and investors on Wall Street.
How to identify and remove CNS assessment errors to avoid jeopardising a trial
Pharmaceutical Technology
MAY 20, 2024
Integrating speech analysis for automated quality assurance provides can help identify CNS assessments at risk of quality inconsistencies.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
The ABCs of SDOH: Meaningful strategies to improve patient outcomes
Bio Pharma Dive
MAY 20, 2024
As biopharmaceutical and medical device companies increasingly recognize the impact of SDOH, a question emerges: how can these sponsors effectively integrate SDOH data into clinical trial recruitment and real-world evidence strategies?
Cold chain storage and distribution for the pharmaceutical industry
Pharmaceutical Technology
MAY 20, 2024
Download our comprehensive list of leading cold chain storage and distribution solution providers to make an informed purchasing decision.
May 20, 2024: BeatPain Utah and AIM-Back Trials Offer Insights Into Telehealth Delivery of Physical Therapy
Rethinking Clinical Trials
MAY 20, 2024
Dr. Julie Fritz, principal investigator for BeatPain Utah In a new article, investigators from 2 pragmatic clinical trials of telehealth-delivered physical therapy share insights into the challenges they faced in implementing the study interventions, especially in historically underserved communities. The article was published last month in Frontiers in Pain Research.
EMA recommends suspension of 17-OHPC medicines in EU
Pharmaceutical Technology
MAY 20, 2024
The EMA's PRAC has advised suspension of marketing authorisations for therapeutics containing 17-OHPC in the European Union (EU).
As Stelara nears patent cliff, J&J fortifies Tremfya for upcoming ulcerative colitis showdown
Fierce Pharma
MAY 20, 2024
The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space. | The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space.
Pharmaceutical Lyophilization Manufacturers, Companies and Solutions
Pharmaceutical Technology
MAY 20, 2024
Discover what to look for in pharmaceutical lyophilization manufacturers and stay ahead with the latest in freeze-drying technology.
Pfizer unit wins $107.5M verdict in cancer-drug patent case against AstraZeneca
Fierce Pharma
MAY 20, 2024
A Delaware federal jury has ordered AstraZeneca to fork over $107.5 million to Pfizer for infringing two of the latter company's patents with its marketing of blockbuster oncology med Tagrisso. | Pfizer's Wyeth subsidiary and licensee Puma Biotechnology sued AstraZeneca in 2021 for alleged patent infringement related to AZ's marketing of cancer blockbuster Tagrisso.
Amgen and AstraZeneca ponder label expansion for Tezspire in COPD
Pharmaceutical Technology
MAY 20, 2024
The companies plan to start Phase III trials for Tezspire in COPD despite missing the primary endpoint in the Phase IIb study.
The New Age of Decentralized Clinical Trials
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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.
AstraZeneca Sets $80B Revenue Target, Goal of 20 New Drugs by 2030
BioSpace
MAY 20, 2024
AstraZeneca on Tuesday laid out an ambitious plan to boost growth in its existing oncology, biopharma and rare disease portfolios, as well as launch 20 new medicines before the end of the decade.
UK clinical trials industry tackles recent changes in the sector
Pharmaceutical Technology
MAY 20, 2024
The Annual Outsourcing in Clinical Trials conference will gather pharma experts to discuss the UK clinical trial landscape.
GSK’s Long-Acting Asthma Drug Hits Primary Endpoint in Phase III Trials
BioSpace
MAY 20, 2024
Participants experienced fewer asthma attacks when receiving the antibody every six months, GSK said Tuesday, positioning the company to file for approval of the potential blockbuster.
China’s NMPA approves Zai Lab’s XACDURO NDA for pneumonia
Pharmaceutical Technology
MAY 20, 2024
Zai Lab and Innoviva have announced China’s NMPA approval for the former’s NDA submitted for XACDURO to treat HABP/VABP.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
FDA Greenlights Two Interchangeable Biosimilars to Regeneron’s Eylea
BioSpace
MAY 20, 2024
The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
Serum Institute of India to acquire stake in IntegriMedical
Pharmaceutical Technology
MAY 20, 2024
The Serum Institute of India (SII) has announced plans to invest in IntegriMedical, acquiring a stake of 20%.
Sanofi, Regeneron Post Strong Phase III COPD Data for Dupixent as FDA Decision Looms
BioSpace
MAY 20, 2024
Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.
Unlocking biotech insights: Top 10 podcasts you need to listen to
pharmaphorum
MAY 20, 2024
Unlocking biotech insights: discover the latest advancements in biotech with our top picks for podcasts. Stay informed and up-to-date with industry trends and news by listening to some of the best biotech podcasts featuring expert analysis, discussions of ethical issues, and interviews with industry leaders.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Lilly Inks Potential $1.1B Radiopharma Deal with Aktis Oncology
BioSpace
MAY 20, 2024
Eli Lilly is paying $60 million upfront to Aktis Oncology to discover and develop novel tumor-targeting radiopharmaceuticals, as radiopharma dealmaking continues to heat up in 2024.
Lab at center of Zantac saga claims GSK hid drug’s risks for decades
Fierce Pharma
MAY 20, 2024
Even as GSK defends itself against thousands of personal injury lawsuits relating to its sale of heartburn pill Zantac, a whistleblower lawsuit from the laboratory that first raised alarm bell | A newly unsealed complaint from the laboratory that first revealed Zantac's links to a carcinogenic impurity lays out a web of allegations about GSK's efforts to bring the drug to market in the 1980s and its attempts to hide the risks since then.
BIO Axes 30 Staff in Realignment as Congress Advances BIOSECURE Act
BioSpace
MAY 20, 2024
Following its recent about-face on the BIOSECURE Act, designed to combat China’s influence in the biopharma industry, lobbying group Biotechnology Innovation Organization in a realignment is laying off 30 employees.
Sanofi and Regeneron update trial data, strengthening case for Dupixent in COPD
Fierce Pharma
MAY 20, 2024
At the American Thoracic Society international conference in San Diego, one of the major themes is the advance of new therapies for chronic obstructive pulmonary disease (COPD). | At the American Thoracic Society international conference, one of the major themes is the advance of new therapies for COPD. On Monday, Sanofi and Regeneron had their answer to Amgen and AstraZeneca's presentation from the day before.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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