Patient dies in Pfizer study of Duchenne gene therapy
Bio Pharma Dive
MAY 7, 2024
Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.
Tue.May 07, 2024
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CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 7, 2024
The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.
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Prologue, Flagship’s newest startup, looks to mine viruses for new drugs
Bio Pharma Dive
MAY 7, 2024
The company is using what it claims is the largest database of viral protein structures to unearth medicines for a range of diseases, said CEO and Flagship origination partner Lovisa Afzelius.
AstraZeneca concludes equity investment in Cellectis
Pharmaceutical Technology
MAY 7, 2024
AstraZeneca has concluded an equity investment in clinical-stage biotechnology company Cellectis following a deal signed in November 2023.
Zenas, with new funding, aims dual-targeting antibody at lupus and MS
Bio Pharma Dive
MAY 7, 2024
The $200 million round is the latest evidence that surging interest in autoimmune disease cell therapies could expand to include developers of bispecific antibodies, too.
How sham patents are hurting the pharma industry
Pharmaceutical Technology
MAY 7, 2024
The FTC is cracking down on pharma companies filing sham patents in the Orange Book to delay generics competition.
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Gossamer Bio and Chiesi partner for pulmonary hypertension treatment
Pharmaceutical Technology
MAY 7, 2024
Gossamer Bio and Chiesi signed a partnership and licence agreement aimed at developing and marketing seralutinib for pulmonary hypertension.
FDA sets date for advisory meeting on Lilly’s closely watched Alzheimer’s drug
Bio Pharma Dive
MAY 7, 2024
After delaying an approval decision for Lilly’s donanemab, the agency now intends to hold an advisory committee meeting on June 10.
Psilocybin effective in treating depression
Pharmaceutical Technology
MAY 7, 2024
A new study has further supported psilocybin's potential to treat depression, which impacts around 300 million people globally.
Vertex Touts 13% Revenue Jump, Beats Profit Estimates on Strong Cystic Fibrosis Performance
BioSpace
MAY 7, 2024
With a total revenue of nearly $2.7 billion, Vertex exceeded analyst estimates in the first quarter, bolstered by strong uptake of its cystic fibrosis products.
The New Age of Decentralized Clinical Trials
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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
Vertex reports net profits of $2.69bn in Q1 2024
Pharmaceutical Technology
MAY 7, 2024
The increase in revenue was primarily driven by strong product sales of the cystic fibrosis drug Trikafta in ex-US markets.
Preliminary Findings Point to Low Risk of Secondary Cancers from CAR-T Therap.
BioSpace
MAY 7, 2024
In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.
China’s NMPA grants breakthrough therapy status for Innovent’s IBI343
Pharmaceutical Technology
MAY 7, 2024
The CDE of China's NMPA has granted breakthrough therapy designation (BTD) for Innovent Biologics’ IBI343 monotherapy.
Kenvue maps out hundreds of layoffs as service pact with J&J winds down
Fierce Pharma
MAY 7, 2024
Even after consumer outfit Kenvue split from Johnson & Johnson one year ago, the company has been performing certain services for the pharma and medtech giant as part of a transition process. | Kenvue’s board of directors on Monday approved a plan to cut 4% of the company’s global workforce. The J&J spinoff employed about 23,000 staffers at the end of last year, so the layoff initiative could affect some 920 workers.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
BioNTech reports net loss of €315.1m in Q1 2024
Pharmaceutical Technology
MAY 7, 2024
BioNTech experienced a significant shift in its financial standing, reporting a net loss of €315.1m ($339.3m) in Q1 2024.
‘Remarkable interest’: Madrigal touts early launch progress for first MASH drug Rezdiffra despite VA hurdle
Fierce Pharma
MAY 7, 2024
With $1.1 billion cash on | With $1.1 billion cash on Madrigal Pharmaceuticals’ balance sheet, CEO Bill Sibold believes the company can “fully resource” the launch of Rezdiffra, the first FDA-approved therapy for fatty liver disease.
Broken String Biosciences teams up with Francis Crick Institute for ALS research
Pharmaceutical Technology
MAY 7, 2024
The companies will utilise Broken String’s DNA break mapping platform Induce-seq for ALS research.
Sandoz delivers 6% sales growth with Humira biosimilar leading the charge
Fierce Pharma
MAY 7, 2024
In its opening months, after spinning off as a separate business from Novartis, Sandoz is riding the wave of a strong launch of its biosimilar version of AbbVie’s Humira (adalimumab). | After spinning off as a separate business from Novartis, Sandoz is riding the wave of a strong launch of its biosimilar version of AbbVie’s Humira (adalimumab). With Hyrimoz leading the way, sales of the company’s biosimilars reached $623 million in the first three months of this year.
The New Age of Decentralized Clinical Trials
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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.
NHS to roll out fibre optic laser therapy to prevent seizures in epileptic patients
Pharma Times
MAY 7, 2024
The chronic brain disease that causes seizures currently affects around 600,000 people living in the UK
Flagship-Backed Prologue Launches with $50M to DELVE into Viral Proteome
BioSpace
MAY 7, 2024
The newest company by the life sciences venture capital firm, Prologue Medicines will search through the vast viral proteome to identify proteins with therapeutic potential.
Francis Crick Institute and Broken String Biosciences partner for ALS research
Pharma Times
MAY 7, 2024
The rare and fatal progressive neurodegenerative disease is estimated to affect 5,000 people in the UK
Generative AI Finds Its Footing in Drug Development
BioSpace
MAY 7, 2024
Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Displaid's heart tech, liberation from the constraints of traditional monitoring?
Outsourcing Pharma
MAY 7, 2024
In an article published in Outsourcing Pharma last week, one of four pitches from Montrealâs non-profit organization, Centech.
Vertex's Casgevy launch progresses as CF business posts impressive growth
Fierce Pharma
MAY 7, 2024
While cystic fibrosis has long been Vertex Pharmaceuticals’ bread and butter, the company has been eager to diversify its revenue base in recent years. | As of mid-April, Vertex said it had collected 5 patients' cells for eventual treatment with sickle cell disease therapy Casgevy. That puts Vertex ahead of its gene therapy rival bluebird bio, which recently said it had collected just one patient's cells for its own SCD treatment Lyfgenia.
ADC Therapeutics Posts Early Phase II Lymphoma Data for Zynlonta as Revenue Drops 5.8%
BioSpace
MAY 7, 2024
ADC Therapeutics is positioning Zynlonta for a label expansion with new Phase II data showing that the treatment can elicit high rates of complete response in patients with relapsed or refractory marginal zone lymphoma.
GSK commits to further support of BioVersys’ TB drug
pharmaphorum
MAY 7, 2024
GSK commits to further support of BioVersys’ TB drug Phil.
How Machine Learning Drives Clinical Trial Efficiency
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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.
AAV Manufacturing Takes Center Stage at ASGCT24
BioSpace
MAY 7, 2024
Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production.
Sorcero genAI conjures plain language from scientific papers
pharmaphorum
MAY 7, 2024
Understanding complex scientific studies is often a challenge for patients as well as healthcare professionals, but one that may become easier thanks to artificial intelligence.
Antidote to be announced as Corporate Honoree at MSAA Improving Lives Benefit
Antidote
MAY 7, 2024
We are thrilled to be honored as the Multiple Sclerosis Association of America’s Corporate Honoree at their 10th annual Improving Lives Benefit on May 15! This inspiring event supports MSAA’s free programs and services and honors key players in the MS research space.
FDA, CTTI Convening Hybrid Public Workshop on Artificial Intelligence in Drug & Biological Product Development
CTTI (Clinical Trials Transformation Initiative)
MAY 7, 2024
The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a hybrid public workshop on the use of AI in drug and biological product development. Registration is now open for this free hybrid public workshop, which will be held both in person and virtually via Zoom. Please join us as we discuss guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs.
Accelerating Clinical Supply Through Integrated Drug Development
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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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