Bluebird preps for first commercial use of sickle cell gene therapy
Bio Pharma Dive
MAY 6, 2024
A 12-year-old boy in the Washington, D.C., area is set become the first patient treated with Lyfgenia since its U.S. approval last December.
Sat.May 04, 2024 - Fri.May 10, 2024
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UK MHRA approves ViiV Healthcare’s cabotegravir formulations for HIV-1
Pharmaceutical Technology
MAY 6, 2024
The UK MHRA approved two formulations of ViiV Healthcare’s cabotegravir, offering a new prevention option for HIV-1 infection.
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Exercising in Midlife May ‘Reverse’ Years of Inactivity, Large Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 5, 2024
As the world’s aging population grows, and dementia, cardiovascular disease, and osteoporosis reach epidemic levels, people of all ages want to know how they can live healthier, not just longer, lives. For women in their 40s and 50s, it’s not too late to take action.
ASGCT 2024 Comes at Pivotal Time for Gene and Cell Therapy Sector
BioSpace
MAY 6, 2024
Jeffrey Chamberlain, president of the American Society of Gene & Cell Therapy, spoke with BioSpace about what we can expect to learn about in Baltimore this week.
As drug shortages reach record highs, regulators weigh next steps
Bio Pharma Dive
MAY 6, 2024
With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.
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.
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BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint
Fierce Pharma
MAY 6, 2024
As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.
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.
Lantern Pharma and Oregon partner to develop cancer treatment
Pharmaceutical Technology
MAY 6, 2024
Lantern Pharma has entered into a partnership with Oregon for optimising the development of XCE853, through an AI-driven approach.
A Healthy Lifestyle Could Offset Genetic Risk For Early Death by a Hopeful 62%
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 7, 2024
When research tells us that our grandparents’ diets can affect our health decades later, it can be hard to shake the feeling that genetics spells out the trajectory of our wellbeing. But how much of our health is actually determined by our genes, and what effect does our lifestyle have, for better or worse?
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
Amneal agrees to $272.5M settlement to resolve opioid lawsuits
Fierce Pharma
MAY 6, 2024
Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer fueled the opioid crisis by failing to act on suspicious opioid orders.
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.
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.
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.
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.
AAVs in Focus at ASGCT: Improved Precision, Targeting Common Diseases
BioSpace
MAY 6, 2024
Adeno-associated viruses have long been go-to vectors for gene therapies. How AAVs are improving will be among the cell and gene therapy topics to be covered in Baltimore this week.
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.
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.
Indian medical care providers explore HCX platforms to reduce administrative tasks in insurance claims
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 5, 2024
Indian medical care providers are exploring Health Exchange (HCX) platforms for reducing administrative tasks in insurance claims. It maximises cloud computing, allowing access in real-time, and secure information related to insurance claims. It enables seamless interoperability of health claim data between different systems, whilst safeguarding sensitive medical information at all costs.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices
FDA Law Blog
MAY 6, 2024
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).
AstraZeneca ups stake in Cellectis in latest cell therapy bet
Bio Pharma Dive
MAY 6, 2024
The British drugmaker, which has made genetic medicine a larger priority of late, added $140 million to a deal to develop up to 10 gene and cell therapies.
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.
Scientists Reveal Optimal Daily Ratio of Sitting, Standing, Sleeping And Movement
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 6, 2024
People have a pretty intuitive sense of what is healthy – standing is better than sitting, exercise is great for overall health and getting good sleep is imperative.
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
Eli Lilly Gears Up for Donanemab Adcomm as FDA Ponders Changes to Format
BioSpace
MAY 6, 2024
FDA Commissioner Robert Califf has said that advisory committee meetings should focus more on discussion and be “less about the outcome,” but other agency officials recently advocated for retaining the vote on whether to approve a product under review.
Verve moves forward with backup base editing therapy
Bio Pharma Dive
MAY 7, 2024
Weeks after a safety setback derailed its lead candidate, the company has treated the first participant in a trial of its heart disease treatment Verve-102.
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.
Pfizer hires Citi analyst Andrew Baum to manage portfolio strategy, business development
Fierce Pharma
MAY 6, 2024
“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.
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.
BioNTech Misses Q1 Earnings, Revenue on Lower COVID-19 Sales
BioSpace
MAY 6, 2024
Reeling from “endemic-level demand” for its COVID-19 vaccine, BioNTech on Monday reported a steep decline in revenues and a loss per share that fell short of analysts’ consensus estimates for the first quarter of 2024.
Gossamer sells rights to drug it hopes can rival a new Merck therapy
Bio Pharma Dive
MAY 6, 2024
One analyst thinks the collaboration “bodes well” for Gossamer, which has had trouble convincing investors its drug seralutinib can compete on the market.
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.
Activist investor urges changes to Novavax board
pharmaphorum
MAY 6, 2024
Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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