Bio Pharma Dive
MAY 14, 2024
The biotechs aim to marry FogPharma’s polypeptide science with Artbio’s lead-based radiopharmaceutical technology in one of the industry’s hottest fields.
Worldwide Clinical Trials
MAY 14, 2024
By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.
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Pharmaceutical Technology
MAY 14, 2024
The two companies will develop neuroplastogens for psychiatric disorders as psychedelic market activity ramps up.
Bio Pharma Dive
MAY 14, 2024
The reduction of 1,500 roles in the first quarter is part of CEO Bill Anderson’s plan to shrink Bayer’s bureaucracy and “radically realign” its culture.
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.
Bio Pharma Dive
MAY 14, 2024
The firm, one of the sector’s more active crossover investors, closed the fund during a surge in the financings that bridge biotechs to the public markets.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 14, 2024
Walden reported positive topline data from a Phase I clinical trial of its lead candidate WAL0921, a humanised mAb to treat kidney disease.
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.
Pharmaceutical Technology
MAY 14, 2024
Dandelion Health’s database can be used as a tool for sponsors to decide which indications to next investigate GLP1-RAs in.
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.
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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 14, 2024
The UK Government is set to revise legislation, allowing professionals to supply naloxone, an opioid overdose antidote, without prescription.
Fierce Pharma
MAY 14, 2024
A tough biotech funding environment and a downturn in COVID-related contracts has weighed heavily on CDMOs of all stripes in recent years. | With a new CEO waiting in the wings, Swiss manufacturing juggernaut Lonza is attempting to reassure the market that a CDMO industry stabilization is playing out.
Pharmaceutical Technology
MAY 14, 2024
Cytokinetics plans to file for approval in both the US and Europe for its hypertrophic cardiomyopathy therapy by the end of the year.
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.
Pharmaceutical Technology
MAY 14, 2024
Sanofi has announced a significant investment exceeding €1bn ($1.07bn) to expand biomanufacturing capacities at its sites in France.
BioPharma Reporter
MAY 14, 2024
Anti-obesity jabs could reduce the risk of heart attacks, strokes or heart failure in obese people irrespective of the amount of weight they lose while using the medication, according to a new study.
Pharmaceutical Technology
MAY 14, 2024
Pint Pharma has announced that COFEPRIS in Mexico has approved ORLADEYO (berotralstat) for the prophylaxis of hereditary angioedema.
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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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
MAY 14, 2024
Bayer announced a fall in Q1 sales and predicted future challenges in the Xarelto market in its Q1 update.
Outsourcing Pharma
MAY 14, 2024
The Global Heart Hub, an international alliance of heart patient organizations based in Ireland, has unveiled the first findings from their patient-led Insights from Patients living with Elevated Cholesterol (IPEC) data generation program.
Pharmaceutical Technology
MAY 14, 2024
The UK NHS has introduced Pfizer's tafamidis for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a rare heart condition.
BioSpace
MAY 14, 2024
Applications of the technology range from data collection to drug design to raising the alarm on product safety, but its adoption is also creating some anxiety.
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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
Fierce Pharma
MAY 14, 2024
After suffering a setback with U.S. regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. | Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency.
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
Drug Channels
MAY 14, 2024
Contrary to what you may have heard, the Inflation Reduction Act’s (IRA) inflation rebates for Medicare Part B drugs do not always save money for seniors. As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing , not declining. In many cases, the coinsurance rate declines only briefly before rebounding back to the standard 20% rate.
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.
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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.
Pharma Times
MAY 14, 2024
Heart failure is a cardiovascular disease that affects more than 64 million people worldwide
BioSpace
MAY 14, 2024
After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.
Outsourcing Pharma
MAY 14, 2024
Today (May 14) Everest Medicines, a biopharmaceutical company focused on progressive medicines and vaccines, announced the successful launch of small molecule Nefecon, a delayed-release capsule, in China, with the first prescription issued.
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.
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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.
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