Bio Pharma Dive
DECEMBER 8, 2023
In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.
Pharmaceutical Technology
DECEMBER 8, 2023
Pfizer has added the EU to its growing number of markets for its targeted immunotherapy intended for relapsed/refractory multiple myeloma.
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Bio Pharma Dive
DECEMBER 8, 2023
Casgevy, the first CRISPR therapy approved by the FDA, will cost $2.2 million, while a competing genetic medicine also cleared Friday is priced at $3.1 million.
Pharmaceutical Technology
DECEMBER 8, 2023
The newly announced plans would allow third parties to manufacture such drugs if manufacturers make them unaffordable.
Bio Pharma Dive
DECEMBER 8, 2023
The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.
Pharmaceutical Technology
DECEMBER 8, 2023
The combination therapy of Keytruda and Lenvima failed to meet the dual primary endpoints in a Phase III advanced endometrial cancer trial.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
DECEMBER 8, 2023
The US FDA has accepted Alpha Cognition’s new drug application (NDA) for ALPHA-1062 to treat mild-to-moderate Alzheimer’s disease.
Fierce Pharma
DECEMBER 8, 2023
Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).
Pharmaceutical Technology
DECEMBER 8, 2023
NextPoint plans to kickstart the first-in-human Phase I clinical trial in early 2024, investigating NPX887 in patients with HHLA2-positive tumours.
Fierce Pharma
DECEMBER 8, 2023
Groundbreaking? Game-changing? Transformational? Historic? | Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.
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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
DECEMBER 8, 2023
Following the dosing of the first patient in Phase II atopic dermatitis trial, Kymera received a $15m milestone payment from Sanofi.
Fierce Pharma
DECEMBER 8, 2023
Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. | Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. Elizabeth Mily, who replaced BMS’ former M&A czar Paul Biondi back in 2020, is headed for the exit, the company confirmed Friday.
Pharmaceutical Technology
DECEMBER 8, 2023
AbelZeta Pharma and AstraZeneca have signed an agreement to jointly develop a CAR-T therapy, C-CAR031, for hepatocellular carcinoma.
Pharma Times
DECEMBER 8, 2023
One-third of patients who received Pfizer’s COVID-19 vaccine had unintended immune responses - 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
DECEMBER 8, 2023
VIPER-101 has received FDA clearance to begin clinical studies in the midst of a broader investigation on CAR-T cell therapies.
Fierce Pharma
DECEMBER 8, 2023
Merck and Eisai’s combo of Keytruda and Lenvima has missed the mark yet again, rounding out a year of multiple trial flops for the pairing. | The combo missed both endpoints in a phase 3 study in certain patients with advanced or recurrent endometrial carcinoma, adding yet another entry to a long list of recent trial failures.
Pharmaceutical Technology
DECEMBER 8, 2023
Vanda Pharmaceuticals has acquired rights to Actelion Pharmaceuticals’ Ponvory for relapsing forms of multiple sclerosis (RMS).
XTalks
DECEMBER 8, 2023
In 2023, a significant trend has reshaped the landscape of the fast food industry: the rise of the pizza vending machine. This innovative concept isn’t just a novelty; it’s a strategic business move that’s changing how companies approach quick-service dining. Let’s look at some of the players in this burgeoning field, including PizzaForno, as well as some of the challenges and environmental considerations of operating a pizza vending machine.
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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
DECEMBER 8, 2023
ARTBIO has secured $90m in a Series A funding round to advance its pipeline of targeted alpha radioligand therapies (ARTs).
My Local Study
DECEMBER 8, 2023
Clinical trials are the backbone of medical research, paving the way for groundbreaking discoveries and advancements in healthcare. One crucial element of these trials is the use of placebos, inert substances with no therapeutic effect. While the idea of administering something that lacks active ingredients may seem counterintuitive, the use of placebos plays a vital.
Antidote
DECEMBER 8, 2023
At Antidote, matching individuals to clinical trials is our driving force — and one of the key ways we do this is by prioritizing our connection to patients. Understanding the real-world impact of our work allows us to continually improve our processes and approach clinical trial recruiting from a patient-centric perspective.
Pharma Times
DECEMBER 8, 2023
The project will explore the biology of human autoreactive plasma cells - News - PharmaTimes
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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.
Drug Channels
DECEMBER 8, 2023
Today’s guest post comes from Kelly Martin, Vice President of Product Management at CoverMyMeds. Kelly discusses the obstacles that patients face when attempting to access, afford, and adhere to specialty therapies. She describes how CoverMyMeds improves the patient experience by blending technology with human expertise and connection. Click here to learn about CoverMyMed’s next-generation patient support services.
Pharmaceutical Commerce
DECEMBER 8, 2023
Study analyzes and predicts how conditions in research and development can be predicted via computer simulation.
Outsourcing Pharma
DECEMBER 8, 2023
Pharma and plant-based ingredient giant, Roquette, has confirmed its acquisition of Qualicaps from the Mitsubishu Chemical Group.
pharmaphorum
DECEMBER 8, 2023
The US FDA has cleared two novel gene therapies for sickle cell disease: Vertex Pharmaceuticals' Casgevy and bluebird bio's Lyfgenia.
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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.
Drug Discovery World
DECEMBER 8, 2023
Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The once-fictional artificial intelligence (AI) depicted in literature and movies has transitioned into a tangible and easily accessible tool in our modern world. General AI tools such as ChatGPT have acted as a catalyst, igniting a wave of AI innovation akin to the early days of the internet era.
pharmaphorum
DECEMBER 8, 2023
Why pharma needs to leave digital transformation behind and embrace digital business Mike.
Drug Patent Watch
DECEMBER 8, 2023
Annual Drug Patent Expirations for AUVI-Q Auvi-q is a drug marketed by Kaleo Inc and is included in one NDA. It is available from three suppliers. There are thirty-one patents… The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
DECEMBER 8, 2023
Pfizer’s initiative to return clinical trial data to patients 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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