Bio Pharma Dive
NOVEMBER 26, 2021
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
Bio Pharma Dive
OCTOBER 25, 2021
The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.
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pharmaphorum
DECEMBER 2, 2021
Personalised and tailored healthcare that utilises patient’s data is rapidly becoming a reality. Ben Hargreaves looks at the concrete steps already being taken by companies in the area. Amongst the many ways in which the pandemic has changed the way in which we live, one of the most common experiences for most people was to revise what it means to have a face-to-face meeting.
JAMA Internal Medicine
NOVEMBER 7, 2021
This cross-sectional study of individuals from the French CONSTANCES cohort assesses whether the belief in having been infected with SARS-CoV-2, having serological test–confirmed COVID-19 infection, or both are associated with persistent physical symptoms often attributed to long COVID in the general adult population.
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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.
BioSpace
JULY 19, 2021
Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.
BioPharma Reporter
FEBRUARY 22, 2021
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
OCTOBER 4, 2021
This is my talk from the 14th Annual Portfolio Planning and Partnership for Generic Conference. I discuss: Identifying generic entry opportunities at the earliest stages Discovering opportunities that avoid litigation…. The post Generic Portfolio Management, Partnering with Brands, and Staying Competitive appeared first on DrugPatentWatch - Make Better Decisions.
XTalks
JANUARY 8, 2021
The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. In the statement , the FDA said that it wants to “remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”.
Scienmag
MAY 28, 2021
Features of large systems yielded from tiny simulations with super-resolution techniques Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have enhanced “super-resolution” machine learning techniques to study phase transitions. They identified key features of how large arrays of interacting “particles” behave at different temperatures by simulating tiny arrays before using a […].
Pharma Times
JULY 13, 2021
Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms
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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
Outsourcing Pharma
DECEMBER 13, 2021
The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.
Bio Pharma Dive
AUGUST 31, 2021
Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.
pharmaphorum
DECEMBER 15, 2021
Words matter. In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. But the difference between them is not like the choice between “agreeing” and “aligning” or “getting together later” and “taking this offline.” Going from the vital activity of patient engagement to the more encompassing state of patient centricity requires big steps in the evolution of new-drug discovery, development, and delivery.
JAMA Internal Medicine
OCTOBER 31, 2021
This cohort study compares the sex- and age-adjusted incidence of cerebral venous sinus thrombosis before the COVID-19 pandemic with that during the first 92 days after Ad26.COV2.S vaccination.
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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.
BioSpace
SEPTEMBER 15, 2021
?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
BioPharma Reporter
JUNE 28, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a âstrong body of evidenceâ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a âtransformational milestoneâ.
NY Times
JULY 14, 2021
The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.
Bio Pharma Dive
AUGUST 10, 2021
Deals were few and far between last quarter. But the recent history of biopharma M&A suggests they'll return. Keep track of them as as they happen with BioPharma Dive's new database.
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.
Bio Pharma Dive
JUNE 26, 2021
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
Bio Pharma Dive
NOVEMBER 9, 2021
Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules.
Bio Pharma Dive
JULY 9, 2021
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
Bio Pharma Dive
AUGUST 23, 2021
The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Bio Pharma Dive
FEBRUARY 5, 2021
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.
Bio Pharma Dive
MAY 28, 2021
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.
Bio Pharma Dive
JUNE 15, 2021
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
Bio Pharma Dive
SEPTEMBER 7, 2021
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Bio Pharma Dive
MARCH 29, 2021
A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.
Bio Pharma Dive
OCTOBER 31, 2021
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
Bio Pharma Dive
AUGUST 18, 2021
The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan.
Bio Pharma Dive
SEPTEMBER 15, 2021
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.
Advertiser: Aggregage
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