Bio Pharma Dive
MAY 15, 2024
The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.
Pharmaceutical Technology
MAY 16, 2024
The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.
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Bio Pharma Dive
MAY 13, 2024
Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.
Worldwide Clinical Trials
MAY 10, 2024
By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 12, 2024
Running 10 hours a week for more than 120 km (75 miles) is extreme exercise, to be sure. Yet far from pushing the body beyond its limits, a new study suggests some professional athletes are adding years to their lives with such brutal routines.
Rethinking Clinical Trials
MAY 16, 2024
According to a report from the NIH Pragmatic Trials Collaboratory Coordinating Center, journal editors and peer reviewers were familiar with pragmatic clinical trials and their designs and analytic approaches, but they often asked for more information about intervention implementation. The report was published this week in the Living Textbook of Pragmatic Clinical Trials.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 13, 2024
Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.
BioSpace
MAY 12, 2024
The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.
Bio Pharma Dive
MAY 16, 2024
Full study results disclosed ahead of a medical meeting showed elinzanetant consistently reduced the frequency and severity of hot flashes.
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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
Pharmaceutical Technology
MAY 15, 2024
Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.
pharmaphorum
MAY 15, 2024
GSK has become the first founding partner of the new Fleming Initiative, which aims to tackle the rising threat of antimicrobial resistance (AMR) and is also backed by the UK government.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 14, 2024
A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.
BioSpace
MAY 15, 2024
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
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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
MAY 16, 2024
The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.
Pharmaceutical Technology
MAY 13, 2024
As the debate over using tau levels to guide patient treatment persists, the landscape for Alzheimer’s diagnostics continues to move ahead.
Fierce Pharma
MAY 14, 2024
With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
Miniscule fragments of plastic pollution invade the human body every day without our knowing it, not just from eating and drinking but from simply breathing. By some estimates, the average person inhales a credit card’s worth of plastic every week with unknown health effects.
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.
BioSpace
MAY 14, 2024
Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.
Bio Pharma Dive
MAY 10, 2024
Interim data surpassed expectations, iTeos said. Elsewhere, Acelyrin revealed chief executive officer Shao-Lee Lin is departing and Bluebird bio gave a fuller account of its gene therapy launches.
Pharmaceutical Technology
MAY 15, 2024
Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.
pharmaphorum
MAY 14, 2024
The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).
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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.
Fierce Pharma
MAY 14, 2024
It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.
BioSpace
MAY 14, 2024
Armed with a $300 million commitment from Blackstone Life Sciences and a former Merck monoclonal antibody, Uniquity Bio is starting Phase II clinical trials in asthma and chronic obstructive pulmonary disease.
Bio Pharma Dive
MAY 10, 2024
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
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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
pharmaphorum
MAY 14, 2024
Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold
Fierce Pharma
MAY 14, 2024
When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.
BioSpace
MAY 13, 2024
Presented at this week’s European Congress on Obesity, the two studies also demonstrate that Novo Nordisk’s Wegovy (semaglutide) provides cardiovascular benefits irrespective of starting weight and the amount of weight lost.
Bio Pharma Dive
MAY 16, 2024
The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.
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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.
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