Pharmaceutical Technology
AUGUST 12, 2024
As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.
pharmaphorum
AUGUST 14, 2024
The rapid spread of a new variant of mpox – previously known as monkeypox – has prompted the Africa Centers for Disease Control and Prevention (Africa CDC) to declare a public health emergency.
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Fierce Pharma
AUGUST 14, 2024
Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.
Bio Pharma Dive
AUGUST 15, 2024
The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.
Rethinking Clinical Trials
AUGUST 14, 2024
In this Friday’s PCT Grand Rounds, Runar Solberg of the Norwegian Institute of Public Health will present “Methodological Insights and Lessons Learned From Conducting a Pragmatic Randomized Trial on Surgical Face Masks.” The Grand Rounds session will be held on Friday, August 16, 2024, at 1:00 pm eastern. Solberg is a research scientist in the Centre for Epidemic Interventions Research at the Norwegian Institute of Public Health.
pharmaphorum
AUGUST 15, 2024
FDA clears Incyte's potential blockbuster Niktimvo as a treatment for chronic GvHD, making it a companion to the company's Jakafi for the disorder.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Commerce
AUGUST 14, 2024
In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, describes the outcome of the joint public meeting held by the Partnership for DSCSA Governance and the FDA.
XTalks
AUGUST 12, 2024
Mendel AI and the University of Massachusetts Amherst (UMass Amherst) have published key data on addressing the critical issue of hallucinations in AI-generated medical summaries using a pioneering artificial intelligence (AI) framework called “Hypercube”. This collaboration is a step forward in ensuring the reliability and safety of AI applications in healthcare.
Bio Pharma Dive
AUGUST 16, 2024
The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.
Pharmaceutical Technology
AUGUST 16, 2024
The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.
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Fierce Pharma
AUGUST 14, 2024
With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.
pharmaphorum
AUGUST 16, 2024
AstraZeneca has claimed FDA approval for its immunotherapy Imfinzi before and after surgery for non-small cell lung cancer, setting up a contest with MSD's rival Keytruda.PD-L1 inhibitor Imfinzi (durvalumab) has been cleared for use in adult patients who need surgery for early-stage (IIA-IIIB) NSCLC and have no ALK or EGFR mutations that would make them suitable for targeted therapies.
Bio Pharma Dive
AUGUST 12, 2024
Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.
Pharmaceutical Technology
AUGUST 15, 2024
Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.
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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.
Fierce Pharma
AUGUST 13, 2024
When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.
pharmaphorum
AUGUST 14, 2024
Baxter International has agreed to sell its kidney treatment division to private equity firm Carlyle Group in a $3.8 billion cash deal, continuing its efforts to streamline its operations and reduce debt.
Bio Pharma Dive
AUGUST 15, 2024
The layoffs are part of a larger reorganization that will also see the departure of Lykos’ founder, the psychedelics advocate Rick Doblin.
Pharmaceutical Technology
AUGUST 16, 2024
While the vaccine demonstrated high responses for neutralizing influenza A titers, it failed to show sufficient efficacy against influenza B.
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.
Fierce Pharma
AUGUST 16, 2024
Even as supplies of Novo Nordisk’s immensely popular GLP-1 drugs Ozempic and Wegovy start to stabilize, the Danish drugmaker continues to announce manufacturing and capacity upgrades at a rapid cli | Novo Nordisk Pharmatech, a unit that specializes in producing drug ingredients, is spending 1.5 billion Danish kroner ($220 million) to build a plant in Køge, Denmark, that will make raw materials, the company said Friday.
pharmaphorum
AUGUST 13, 2024
Our longtime Finance Director Paul Bannister was a part of the fabric of pharmaphorum almost from the beginning and an integral part of keeping the publication running. And, most importantly, he was the soul of the place and a friend to all.
Bio Pharma Dive
AUGUST 12, 2024
The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.
Pharmaceutical Technology
AUGUST 16, 2024
Genomic medicines offer new techniques for treating conditions once thought to be intractable - a world of opportunity awaits.
Fierce Pharma
AUGUST 16, 2024
After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation. | After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation, thanks to a decision in Florida that put the kibosh on suspect expert testimony.
BioPharma Reporter
AUGUST 15, 2024
Katarina Wikstrom has worked for over 20 years in the field of translational molecular oncology and holds the position of VP global product development at Almac Diagnostic Services.
Bio Pharma Dive
AUGUST 12, 2024
Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.
Pharmaceutical Technology
AUGUST 14, 2024
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan), has received conditional approval in China for gastric cancer.
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Fierce Pharma
AUGUST 12, 2024
Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.
Pharmaceutical Commerce
AUGUST 16, 2024
In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.
Bio Pharma Dive
AUGUST 16, 2024
Some industry watchers described the level of price discounts announced by Medicare as a "relief," though they warned of bigger future implications for drug research.
Pharmaceutical Technology
AUGUST 13, 2024
Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.
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