Bio Pharma Dive
AUGUST 23, 2021
The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year.
Outsourcing Pharma
AUGUST 23, 2021
Thanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.
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Bio Pharma Dive
AUGUST 23, 2021
The long-awaited decision could strengthen the case for vaccine mandates as public health officials seek to boost rates of immunization amid a wave of COVID-19 cases.
BioSpace
AUGUST 23, 2021
With a handful of drugs for cystic fibrosis already approved, Vertex Pharmaceuticals has turned its attention to expanding its pipeline through collaborations and acquisitions the past few years.
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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
Bio Pharma Dive
AUGUST 23, 2021
The decision, which follows the recommendation of a data monitoring committee, is yet another setback in the search for more treatments for the neurological disease.
Drug Patent Watch
AUGUST 23, 2021
Annual Drug Patent Expirations for JARDIANCE Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from four suppliers. There are six patents…. The post New patent for Boehringer Ingelheim drug JARDIANCE appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
AUGUST 23, 2021
Pfizer will acquire Trillium Therapeutics Inc.; strengthening its work in oncology with the addition of next-generation, investigational immuno-therapeutics for hematological malignancies.
XTalks
AUGUST 23, 2021
Apeel Sciences, known for its food-safe powder coating which is used to reduce food waste, raised $250 million in a Series E round of funding led by Temasek. The company now has funding that exceeds $635 million and a valuation of over $2 billion. Some investors include Mirae Asset Global Investments, GIC, Viking Global Investors, sisters Anne Wojcicki of 23andMe and Susan Wojcicki of YouTube, and Katy Perry. “The pandemic has completely shaken up food retail: people are increasingly buyin
pharmaphorum
AUGUST 23, 2021
The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. This is the first DNA vaccine ever to receive regulatory authorisation anywhere in the world, the first COVID-19 jab approved in India to treat children aged 12 and above as well as adults, as well as the first coronavirus shot that can be administered using needle-free delivery.
BioSpace
AUGUST 23, 2021
?Izencitinib was generally well tolerated and its safety data were consistent with expectations, but it failed to achieve its primary endpoint of seeing a change in the total Mayo score at week eight.
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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
Pharma Times
AUGUST 23, 2021
Investment will be used to support the development of disease modifying drugs to treat Parkinson’s disease
BioSpace
AUGUST 23, 2021
Shares of Tonix Pharmaceuticals were up nearly 11% in premarket trading after the company announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for Long COVID Syndrome following a positive meeting with the U.S. FDA.
BioPharma Reporter
AUGUST 23, 2021
Valneva today commenced rolling submission for initial approval of its COVID-19 vaccine candidate, VLA2001, with the UK health regulator.
BioSpace
AUGUST 23, 2021
?The FDA has approved the use of the injectable drug KORSUVA in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney 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.
Outsourcing Pharma
AUGUST 23, 2021
The drug discovery company reportedly used AI-powered drug discovery to come up with a promising preclinical candidate for treatment of the kidney ailment.
BioSpace
AUGUST 23, 2021
In order to mimic (or exceed!) your office productivity, assuming that you were most productive at the office, time blocking should become your new habit.
Outsourcing Pharma
AUGUST 23, 2021
The two firms will work together on solutions to connect de-identified, first-party data to real-world data to help advance precision medicine development.
BioSpace
AUGUST 23, 2021
The new authorization is expected to be the final reassurance for many of those who had hesitated when the vaccine was approved under emergency use only.
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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.
Pharma Times
AUGUST 23, 2021
Talazoparib delayed disease progression in Phase II trial
BioSpace
AUGUST 23, 2021
Tyra Biosciences aspires to raise a $100 million IPO, according to its S-1 form filed with the U.S. Securities and Exchange commission late last week.
pharmaphorum
AUGUST 23, 2021
The NHS’ much-vaunted GP data-sharing initiative looks to be on a prolonged hiatus, with at least one report suggesting it has been hit by 1.2 million people choosing to opt out of the scheme in the space of two months. The General Practice Data for Planning and Research (GPDPR) is now on hold “with no new date for implementation,” according to The Observer newspaper.
BioSpace
AUGUST 23, 2021
The report also highlighted that an unvaccinated individual is five times more likely to get COVID-19 than someone who is fully vaccinated.
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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.
Pharma Times
AUGUST 23, 2021
VLA2001 is an inactivated, adjuvanted vaccine candidate
BioSpace
AUGUST 23, 2021
Roche will apply RNAfix and Shape’s AAVid technology platform to develop next-generation tissue-specific adeno-associated viruses for new gene therapies aimed at these indications.
Pharma Times
AUGUST 23, 2021
NICE decision also extends treatment to people aged up to 22 years old
NY Times
AUGUST 23, 2021
The move was expected to kick off a round of new vaccination mandates from hospitals, schools and private companies.
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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 23, 2021
Novartis reported that its Kymriah failed to hit its primary endpoint in the Phase III BELINDA trial in aggressive B-cell non-Hodgkin lymphoma after relapse or lack of response to first-line treatment.
JAMA Internal Medicine
AUGUST 23, 2021
The diabetes epidemic in the US continues unabated hand in hand with the concurrent epidemics of obesity and physical inactivity. At present, there are about 34 million US adults living with type 2 diabetes (10.2% of the US adult population). Another 88 million US adults have abnormal glucose levels that fall short of a diabetes diagnosis (an additional 34.5% of the adult US population).
BioSpace
AUGUST 23, 2021
Shoreline Biosciences was propelled into the proverbial catbird’s seat this summer with two mega-deals, and now plans to double its employee base from 50 to 100 in the coming months.
pharmaphorum
AUGUST 23, 2021
Pfizer is the latest big pharma company to take a position on drugs that target CD47 – a ‘don’t eat me’ signal that protects cancer cells from being attacked by the immune system. The drugmaker has agreed a $2.3 billion deal to buy Canadian biotech Trillium Therapeutics and its two lead candidates – TTI-622 and TTI-621 – which both act on signal-regulatory protein alpha (SIRP alpha)/CD47 pathway.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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