Bio Pharma Dive
JULY 21, 2023
The offering is a financial lifeline for Turnstone and the fourth for the sector this month, the first time that’s happened in nearly a year and a half, according to BioPharma Dive data.
Pharmaceutical Technology
JULY 21, 2023
Hutchmed has secured breakthrough therapy designation from China’s NMPA for fruquintinib and sintilimab combination to treat EMC.
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Bio Pharma Dive
JULY 21, 2023
The Swiss drugmaker now joins a lengthy list of biotechs that, amid a drawn-out market downturn, have turned to job cuts and research re-evaluations to save money.
Pharmaceutical Technology
JULY 21, 2023
While artificial intelligence (AI) in medical devices has regulatory boundaries, its use in a medicine’s life cycle is less clear.
Bio Pharma Dive
JULY 21, 2023
The regulator’s recommendation for approval of Pfizer’s shot as a maternal immunization comes ahead of the FDA, which is currently reviewing that indication.
Pharmaceutical Technology
JULY 21, 2023
In the global pharmaceutical industry, there were 7 private equity deals announced in Q2 2023, worth a total value of $535.3m, according to GlobalData's Deals Database.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 21, 2023
Other forms of immunotherapy have progressed rapidly in recent years, but oncolytic viruses remain restricted to the early stages of development.
Drug Discovery World
JULY 21, 2023
Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. Under the terms of the agreement, Cancer Research Horizons will license Twist’s ‘Library of Libraries’, an collection of synthesised antibody libraries designed based on naturally occurring sequences that harness innovative structural and developability features to cover a wide range of antibody drug targets, for a period of five years.
Pharmaceutical Technology
JULY 21, 2023
Johnson & Johnson (J&J) has reported sales of $25.53bn in Q2 of 2023, indicating an increase of 6.3% as against $24.02bn in Q2 2022.
XTalks
JULY 21, 2023
OncoHealth, an Atlanta-based digital health firm, is on a mission to address the multifaceted challenges of cancer care that include physical, mental and financial factors. The company recently announced the expansion of its Iris platform, extending its comprehensive digital cancer care services to 240,000 fully insured commercial members of HealthPartners.
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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
JULY 21, 2023
Janssen has plans to discontinue the CD388 influenza programme as part of pipeline prioritisation, but Cidara plans to continue development.
Drug Patent Watch
JULY 21, 2023
Annual Drug Patent Expirations for MOZOBIL Mozobil is a drug marketed by Genzyme and is included in one NDA. It is available from two suppliers. There are two patents protecting… The post New patent expiration for Genzyme drug MOZOBIL appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JULY 21, 2023
The Phase II trial for Zynlonta and Rituxan in DLBCL patients was discontinued after US FDA placed a partial clinical hold on the trial.
Pharma Times
JULY 21, 2023
The inhaler supports appropriate individuals presenting with asthma and chronic obstructive pulmonary disease - News - PharmaTimes
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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
JULY 21, 2023
The US FDA has granted approval for Daiichi Sankyo’s Vanflyta to treat adults with FLT3-ITD positive acute myeloid leukaemia (AML).
Pharmaceutical Commerce
JULY 21, 2023
The importance of industry, as it moves forward, in focusing on patient-centered care and prioritizing patient needs across the supply chain.
Pharmaceutical Technology
JULY 21, 2023
To reduce cash burn, the company has sold off its Asia Pacific operations, except in China, and looks to reduce R&D costs.
Fierce Pharma
JULY 21, 2023
If at first you don’t succeed, try, try again. That’s the lesson Daiichi Sankyo likely took home Friday after scoring a long-awaited U.S. | Some four years after Daiichi Sankyo's quizartinib scored its initial green light in Japan—and suffered a slap-down from drug regulators stateside—the acute myeloid leukemia medicine has won the FDA’s blessing.
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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
JULY 21, 2023
Biotechnology firm EpiBiologics has appointed Dr Ann Lee-Karlon as CEO, president and board member of the company.
Pharma Times
JULY 21, 2023
Data underlines the significance of the company’s anti-GDF-15 antibody candidate, visugromab - News - PharmaTimes
Pharmaceutical Technology
JULY 21, 2023
The FDA grants SN Bioscience’s nano-therapy SNB-101 an orphan drug designation for small cell lung cancer.
Drug Channels
JULY 21, 2023
Today’s guest post comes from Brent Clifton, Vice President of Product Management at CoverMyMeds. Brent discusses the challenges that patients, caregivers, and providers face when seeking access to medications requiring prior authorization. He explains how an electronic prior authorization solution can reduce delays and help patients start their therapies sooner—especially when patients and brands can play an active role in the process.
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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.
Fierce Pharma
JULY 21, 2023
A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether fol | After severe respiratory events and seven deaths held up ADC's Zynlonta study in unfit or frail patients with previously untreated diffuse large B-cell lymphoma, the company has scrapped the trial altogether.
pharmaphorum
JULY 21, 2023
Digital transformation in pharma: The importance of digitalisation Mike.
Fierce Pharma
JULY 21, 2023
Catalent’s onerous year just got even more complicated. | Proxy battler and shareholder dissident Elliott Management has acquired a stake in Catalent in a bid to shuffle the drugmaker’s board, The Wall Street Journal reported Thursday. Elliott has been in talks with potential director candidates in an effort to build a Rolodex of nominees for a potential proxy contest, according to the news outlet.
Drug Patent Watch
JULY 21, 2023
Annual Drug Patent Expirations for TRIJARDY+XR Trijardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fifteen… The post New patent for Boehringer Ingelheim drug TRIJARDY XR appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Fierce Pharma
JULY 21, 2023
In this episode of "The Top Line," we talk with Vimala Raghavendran, the vice president of informatics and product development at U.S.
Drug Patent Watch
JULY 21, 2023
Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are seventeen patents… The post New patent for Abbvie Inc drug RINVOQ appeared first on DrugPatentWatch - Make Better Decisions.
Fierce Pharma
JULY 21, 2023
In this episode of 'The Top Line' we replay an important show from April 28, 2023 regarding Narcan. | This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription.
Drug Patent Watch
JULY 21, 2023
Annual Drug Patent Expirations for TYMLOS Tymlos is a drug marketed by Radius Health Inc and is included in one NDA. It is available from one supplier. There are five… The post New patent for Radius Health drug TYMLOS appeared first on DrugPatentWatch - Make Better Decisions.
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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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