Bio Pharma Dive
JULY 31, 2023
According to the company, FDA officials have signaled openness to using a surrogate endpoint for assessing accelerated approval of a treatment for limb-girdle muscular dystrophy.
Pharmaceutical Technology
JULY 31, 2023
While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Rethinking Clinical Trials
JULY 31, 2023
The NIH this month published notice of a funding opportunity to support the next round of pragmatic clinical trials within the NIH-DoD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-004). The PMC was established in 2017 with an initial cohort of 11 pragmatic trials. The new funding opportunity leverages the experience, expertise, and leadership of the PMC Coordinating Center with a new round of pragmatic trials evaluating nonpharmacologic solutions
Pharmaceutical Technology
JULY 31, 2023
Alexion has signed a definitive agreement for acquiring and licencing Pfizer’s early-stage gene therapy portfolio for rare diseases.
Bio Pharma Dive
JULY 31, 2023
Perrigo received the first FDA approval for an over-the-counter birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.
Pharmaceutical Technology
JULY 31, 2023
Deploying robots in pharmaceutical manufacturing will remove snags in cell and gene therapies and enable breakthroughs
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 31, 2023
Pharma sales have undergone a seismic transformation after Covid-19, with the adoption of artificial intelligence tools.
Rethinking Clinical Trials
JULY 31, 2023
Pilot and Feasibility Testing: The LIRE Example Description NIH Collaboratory investigator Dr. Jerry Jarvik, principal investigator of the LIRE Demonstration Project, discusses pilot and feasibility testing in pragmatic clinical trials. Biography Jerry Jarvik, MD, MPH Radiologist, University of Washington Medical Center Professor of Radiology, Neuroradiology, Health Services and Neurological Surgery, University of Washington Adjunct Professor of Orthopedics & Sports Medicine and Pharmacy LIR
Pharmaceutical Technology
JULY 31, 2023
Precision and personalised medicine has a significant impact on how pharma companies and other stakeholders engage with patients, providing treatments that better fit specific patient populations, rather than generating inconsistent results in a broader patient population.
Rethinking Clinical Trials
JULY 31, 2023
Building a Study Team for a Pragmatic Clinical Trial Description NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinical trials. Biography Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair The post Building a Study Team for a Pragmatic Clinical Trial appeared first on Rethinking Clinical Trials.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JULY 31, 2023
In Germany pharmaceutical industry, there were 3 private equity deals announced in Q2 2023, worth a total value of $271.4m, according to GlobalData's Deals Database.
FDA Law Blog
JULY 31, 2023
By Larry K. Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72
Pharmaceutical Technology
JULY 31, 2023
In Germany pharmaceutical industry, there were 3 private equity deals announced in Q2 2023, worth a total value of $271.4m, according to GlobalData's Deals Database.
Outsourcing Pharma
JULY 31, 2023
The US Food and Drug Administration (FDA) has today (July 31) given clearance via its 510(k) process to one of the artificial intelligence solutions cleared for colonoscopy.
Advertisement
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
Pharmaceutical Technology
JULY 31, 2023
According to GlobalData, it is projected that the market for hepatitis B treatments will experience a sharp increase over the next six years.
XTalks
JULY 31, 2023
Fast-food giant McDonald’s is gearing up to pilot a fresh restaurant concept, called “CosMc’s,” whose name derives from a lesser-known McDonald’s character — a robotic alien. As CEO Chris Kempczinski said in a call with analysts discussing the firm’s Q2 financial results, “CosMc’s is a small format concept with all the DNA of McDonald’s but its own unique personality.
Pharmaceutical Technology
JULY 31, 2023
Harm Reduction Therapeutics won FDA approval for the second OTC naloxone nasal spray to treat known or suspected opioid overdose emergencies.
Fierce Pharma
JULY 31, 2023
GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. | GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation.
Advertisement
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.
Pharmaceutical Technology
JULY 31, 2023
Daewoong Pharmaceutical has submitted an NDA for its Fexuprazan to China’s CDE under the National Medical Products Administration (NMPA).
Fierce Pharma
JULY 31, 2023
Johnson & Johnson’s attempt to end its talc litigation with a sweeping $8.9 billion settlement didn’t pass muster at the bankruptcy court, which instead dismissed the company's latest bankruptc | U.S. Bankruptcy Judge Michael Kaplan ruled that J&J's LTL Management subsidiary didn't establish immediate financial distress when it applied for bankruptcy protections.
Pharmaceutical Technology
JULY 31, 2023
Research by the UK’s NHS found that only 41% of people trust AI to support healthcare professionals in decision-making and diagnoses.
Fierce Pharma
JULY 31, 2023
An accelerated approval for a potential growth driver for Takeda is in danger. | Takeda's targeted non-small cell lung med Exkivity has failed in a phase 3 trial in newly diagnosed patients, just days after Johnson & Johnson touted a win for its rival EGFR inhibitor.
Advertisement
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.
Pharmaceutical Technology
JULY 31, 2023
Each week, Pharmaceutical Technology’s journalists explore movements in job postings that shed light on hiring trends in our sector.
Outsourcing Pharma
JULY 31, 2023
Phastar, a biometrics contract research organization (CRO) can now officially call its business âa force for goodâ after it received B Corp certification.
Pharmaceutical Technology
JULY 31, 2023
US FDA and China’s NMPA have approved the Phase I trial of anti-GPRC5D/CD3 bispecific antibody (LBL-034) by Leads Biolabs.
Outsourcing Pharma
JULY 31, 2023
Vivoryon Therapeutics is a precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases.
Advertisement
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.
Pharmaceutical Technology
JULY 31, 2023
Santhera Pharmaceuticals announced the complete worldwide divestment of Raxone (idebenone) to Chiesi Farmaceutici.
Pharma Times
JULY 31, 2023
The phase 2 study involves company’s eftilagimod alpha therapy - News - PharmaTimes
Pharmaceutical Technology
JULY 31, 2023
Biogen has entered into a definitive agreement to acquire Reata Pharmaceuticals for an enterprise value of $7.3bn.
Fierce Pharma
JULY 31, 2023
Viatris has successfully held its ground in a pitched battle with the Internal Revenue Service over tens of millions of dollars. | Viatris has successfully held its ground in a pitched battle with the Internal Revenue Service over tens of millions of dollars. The case hinges on charges Viatris accrued in patent litigation tied to its generic drug approvals in the 2010s.
Advertisement
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Expert insights. Personalized for you.
246 
Let's personalize your content