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.
Camargo
AUGUST 18, 2021
Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings. Their goal is to detect any effects of a drug within a complete reproductive cycle as relevant to humans: from initial conception to reproductive capacity in the next generation. They can be designed to measure the effects of a drug on male and female fertility, the full span of embryonic and fetal development (EFD), and pre- and post-natal development (PPND)
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World of DTC Marketing
JULY 28, 2021
SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content. HCPs increasingly turn to trusted colleagues on digital networks for reliable information. Source: Build Relationships and Personalize Your Interactions With HCPs (Wolters Kluwer).
Delveinsight
FEBRUARY 8, 2021
Cystic Fibrosis is a rare inherited disorder that causes loss of lung function and damages the digestive system. It has a higher prevalence in the Caucasian population. For years there was no treatment available targeting the underlying cause, however, this changed in 2012 with the launch of Vertex Pharma’s Kalydeco. Analysts at DelveInsight expect major changes in the Cystic Fibrosis market landscape in the foreseeable future.
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Pharmacy Checkers
JANUARY 7, 2021
This week the prices of over 500 drugs went up in America, according to drug price transparency non-profit organization 46Brooklyn. This happens every year, usually coinciding with shouts of anger and disgust with the pharmaceutical industry’s greed. The shouts are muted this year, probably because, like it or not, we’re counting on Big Pharma to manufacture enough Covid-19 vaccines to end the pandemic.
Pharma Mirror
OCTOBER 4, 2021
By Kambiz Shekdar, Ph.D. Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most. Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
OCTOBER 25, 2021
The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.
World of DTC Marketing
JULY 22, 2021
SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient. Don’t hire people who want big salaries; hire people who want to be part of an industry that helps patients.
Druggist
APRIL 1, 2021
Amlodipine is one of the most commonly prescribed drugs in the UK and the most prescribed high blood pressure ( BP ) medication. When patients are diagnosed with high blood pressure and a drug is recommended, amlodipine may be the first choice, but not always. Taking any drugs comes with a risk of side effects, with amlodipine associated with few common side effects.
Bio Pharma Dive
SEPTEMBER 1, 2021
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Bio Pharma Dive
AUGUST 26, 2021
Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week.
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.
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.
Bio Pharma Dive
SEPTEMBER 3, 2021
A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field.
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
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.
Bio Pharma Dive
JUNE 21, 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy.
Bio Pharma Dive
MAY 6, 2021
A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy.
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
MAY 24, 2021
The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).
Bio Pharma Dive
APRIL 19, 2021
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.
Bio Pharma Dive
MAY 19, 2021
A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.
Bio Pharma Dive
FEBRUARY 9, 2021
Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots?
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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.
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.
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
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.
Bio Pharma Dive
AUGUST 4, 2021
Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option.
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
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
MARCH 27, 2021
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.
Bio Pharma Dive
JANUARY 8, 2021
With additional financing, Celularity will have $372 million to back development of experimental off-the-shelf treatments for cancer and autoimmune diseases.
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.
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