Bio Pharma Dive
SEPTEMBER 12, 2023
Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.
Pharmaceutical Technology
SEPTEMBER 12, 2023
The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.
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Bio Pharma Dive
SEPTEMBER 12, 2023
Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back some of its research spending.
Pharmaceutical Technology
SEPTEMBER 12, 2023
BioLineRx has received the US Food and Drug Administration approval for Aphexda plus filgrastim to mobilise haematopoietic stem cells.
Bio Pharma Dive
SEPTEMBER 12, 2023
The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.
Pharmaceutical Technology
SEPTEMBER 12, 2023
CancerVAX plans to adapt its universal cancer vaccine platform to develop a universal CAR-T cell platform.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 12, 2023
The biotech received $72m in a Series B extension round from Big Pharma to invest in autoimmune disease research.
Bio Pharma Dive
SEPTEMBER 12, 2023
Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.
Pharmaceutical Technology
SEPTEMBER 12, 2023
Novartis has announced a voluntary recall of one lot of Sandimmune Oral Solution in the US due to crystal formation observed in some bottles.
Bio Pharma Dive
SEPTEMBER 12, 2023
Fitch Ratings called the deal to buy the Xiidra treatment “strategically sound” even as the company’s plan for funding the deal would increase its leverage.
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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
SEPTEMBER 12, 2023
The company expects the 2023 sales of its CAR-T cell therapy to be upto $570m less than projected and plans to offset this by downsizing.
Fierce Pharma
SEPTEMBER 12, 2023
The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.
Pharmaceutical Technology
SEPTEMBER 12, 2023
The GARDP and Orchid Pharma have entered a sublicense agreement for the production of cefiderocol for Gram-negative infections.
Drug Patent Watch
SEPTEMBER 12, 2023
In the world of patents, the right to exclude others from using or selling an invention is granted only during the patent’s validity. Once a patent expires, this exclusivity vanishes.… The post Understanding Patent Term Extensions: An Overview appeared first on DrugPatentWatch - Make Better Decisions.
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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
Pharmaceutical Technology
SEPTEMBER 12, 2023
Regeneron is developing an antibody for Covid-19 prevention with the help of US government funding.
Drug Patent Watch
SEPTEMBER 12, 2023
In a recent STAT article Sanofi CEO Paul Hudson discusses the potential of artificial intelligence (AI) in the pharmaceutical industry. While some in the industry have been hesitant to embrace… The post From Expert AI to Snackable AI: A New Era in Pharma, as Seen by Sanofi’s CEO appeared first on DrugPatentWatch - Make Better Decisions.
Outsourcing Pharma
SEPTEMBER 12, 2023
The increasing prevalence of chronic diseases could see the market for active pharmaceutical ingredients (APIs) growing by 7.5% per year, says a report by Prophecy Market Insights.
Fierce Pharma
SEPTEMBER 12, 2023
Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. | Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or potentially earlier under certain circumstances.
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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
SEPTEMBER 12, 2023
Following a $540 million IPO in May, Acelyrin’s lead candidate izokibep failed to meet the primary endpoint in a Phase IIb/III study of patients with the chronic inflammatory skin condition.
Pharma Times
SEPTEMBER 12, 2023
The research will aim to reveal the mechanism of action of a drug target candidate - News - PharmaTimes
BioSpace
SEPTEMBER 12, 2023
The company plans to launch up to 15 new products and bring up to 50 new candidates to the clinic over the next five years as part of its growth plan, while scaling down COVID-19 manufacturing.
Outsourcing Pharma
SEPTEMBER 12, 2023
An oral treatment, developed by the U.S. company Crinetics Pharmaceuticals, Inc., has shown promise as an alternative to injected therapies for tackling the rare disease acromegaly in a phase 3 trial.
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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.
BioSpace
SEPTEMBER 12, 2023
Biopharma companies buying stock in one another did not used to be an unusual practice, but experts told BioSpace this is becoming less common due to greater market volatility.
Fierce Pharma
SEPTEMBER 12, 2023
Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. | The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.
BioSpace
SEPTEMBER 12, 2023
Topline data for the company’s CRF1 antagonist crinecerfont showed a significant drop in daily glucocorticoid dose, while maintaining androgen control in adult patients with the genetic disorder.
Drug Discovery World
SEPTEMBER 12, 2023
Twist Bioscience and Ono Pharmaceutical will combine their efforts to discover and develop novel antibodies for the treatment of autoimmune diseases. Under the terms of the agreement, Twist will use its ‘Library of Libraries’ to conduct research activities to discover novel antibodies against targets identified by Ono. Twist also recently entered a research collaboration with Cancer Research Horizons.
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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 12, 2023
The agency's briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.
BioPharma Reporter
SEPTEMBER 12, 2023
Kuano, a drug discovery company combining quantum mechanics with AI, has announced the close of its Â1.8 million seed funding round, led by Mercia Ventures, and including ACF Investors, Ascension Ventures, o2h Ventures, Meltwind Advisory LLP, and other Angel investors.
BioSpace
SEPTEMBER 12, 2023
Following cases of hepatobiliary toxicity leading to liver decompensation, Eiger has decided to drop its Phase III LIMT-2 trial of peginterferon lambda in chronic hepatitis delta.
pharmaphorum
SEPTEMBER 12, 2023
AI is enabling the rise of sophisticated digital therapeutics Mike.
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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.
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