Bio Pharma Dive
AUGUST 24, 2023
Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.
Pharmaceutical Technology
AUGUST 24, 2023
The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.
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Bio Pharma Dive
AUGUST 24, 2023
The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.
Pharmaceutical Technology
AUGUST 24, 2023
Dizal has received approval from China’s NMPA for sunvozertinib to treat adult patients with locally advanced or metastatic NSCLC
Bio Pharma Dive
AUGUST 24, 2023
The deal, worth up to $500 million, is a bet by the drug rights dealmaker on the uncertain commercial prospects of Ferring's gene therapy Adstiladrin.
Pharmaceutical Technology
AUGUST 24, 2023
Japan has granted a new drug substance patent for BioArctic’s monoclonal antibody (mAb), BAN0805, to treat Parkinson’s disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 24, 2023
Gilead has recently announced early partnerships with biotechs centered on researching protein chemistry and therapeutics for different conditions.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 24, 2023
The Union Cabinet, chaired by the Prime Minister Narendra Modi, approved Memorandums of Understanding (MoUs) signed on June 4, 2023 between Indian drug standard and control organisations and the Ministry of Health, Government of the Republic of Suriname for cooperation in the field of medic product regulation and recognition of Indian Pharmacopoeia (IP).
Pharmaceutical Technology
AUGUST 24, 2023
The companies received a $3.67m grant to develop a low-cost, temperature-stable vaccine to improve market access in developing countries.
Pharma Times
AUGUST 24, 2023
The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes
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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
AUGUST 24, 2023
FORE Biotherapeutics has raised $75m in its Series D investment round led by SR One to expedite the clinical development of plixorafenib.
FDA Law Blog
AUGUST 24, 2023
Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.
Pharmaceutical Technology
AUGUST 24, 2023
XNK Therapeutics adds another research partner to evaluate XNK’s natural killer cell therapy candidate in acute myeloid leukaemia.
BioPharma Reporter
AUGUST 24, 2023
Cell and Gene Therapy Catapult, Rentschler Biopharma, and Refeyn have announced a new partnership to develop and apply âinnovativeâ process analytical technologies (PAT) to improve the process and efficiency of AAV manufacture.
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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
AUGUST 24, 2023
IDMO Cellares has raised $255m in a Series C financing round for a cell therapy development facility at Bridgewater in New Jersey.
XTalks
AUGUST 24, 2023
ModifyHealth , a leader in the burgeoning food as medicine industry, recently released four new meal plan offerings catering to a variety of dietary needs in the US. These new plans were thoughtfully introduced in response to the increasing demand from consumers managing specific medical conditions including celiac disease, type 2 diabetes, high blood pressure, polycystic ovarian syndrome (PCOS) and beyond.
Pharmaceutical Technology
AUGUST 24, 2023
As the UK economy slowly recovers, the life sciences sector is seeking candidates with data skills amid slow workforce growth.
Outsourcing Pharma
AUGUST 24, 2023
FORE Biotherapeutics yesterday (August 23) announced the closing of its $75 million (Â59 million) series D financing, led by the SR One and co-led by Medicxi and joined by existing investors.
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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
AUGUST 24, 2023
The diabetic macular oedema (DMO) market is expected to grow at a 6.0% CAGR over the course of the forecast period.
Fierce Pharma
AUGUST 24, 2023
It's not always a good thing when a drug developer stops a cancer trial. But in a recent case for Exelixis, a Cabometyx trial ended early because of an undeniable efficacy showing. | Exelixis' drug proved its worth in treating advanced pancreatic and extra-pancreatic neuroendocrine tumors, so much so that an independent board unanimously recommended an early stop.
Pharmaceutical Technology
AUGUST 24, 2023
The EMA accepted Novaliq’s marketing authorisation application for cyclosporine eye drops, following FDA approval.
Fierce Pharma
AUGUST 24, 2023
Just a few short weeks after Wegovy posted a major cardio outcomes win, Novo Nordisk has chalked up another heart-related victory for its semaglutide star. | In a phase 3 study, semaglutide at the 2.4 mg dose bested placebo at reducing symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction. The drug also led to greater improvements in exercise function and more weight loss versus a dummy drug, according to study results published in The New
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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.
Outsourcing Pharma
AUGUST 24, 2023
Cloud services and life sciences company, Oracle, has been recognized as a founding member of The White House's public-private partnership CancerX.
BioPharma Reporter
AUGUST 24, 2023
Kadans Science Partner is set to welcome AviadoBio to its recently completed wet lab innovation and workspace centre at 20 Water Street in Canary Wharf.
BioSpace
AUGUST 24, 2023
Wegovy’s highest dose significantly improved physical function and quality of life in obese patients with heart failure, according to results published Friday in The New England Journal of Medicine.
Fierce Pharma
AUGUST 24, 2023
Royalty Pharma has built a niche by finding innovative products pre- and post-approval from companies that need an infusion of cash in exchange for future royalties. | Royalty Pharma has signed a deal with Ferring Pharmaceuticals to collect royalties on bladder cancer drug Adstiladrin. Royalty will pay $300 million up front and $200 million in a potential milestone tied to Ferring meeting certain manufacturing goals.
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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
AUGUST 24, 2023
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.
Fierce Pharma
AUGUST 24, 2023
Moderna is considering pairing one of its mRNA cancer vaccine candidates with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a postmarketing trial in China. | Moderna is considering pairing an mRNA cancer vaccine candidate with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a Chinese post-marketing trial.
BioSpace
AUGUST 24, 2023
Following a late-stage victory on Monday, Exelixis on Thursday reported another Phase III win for its tyrosine kinase inhibitor Cabometyx—this time in advanced neuroendocrine tumors.
Fierce Pharma
AUGUST 24, 2023
After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for | After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a second bid at approval.
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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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