Tue.May 07, 2024

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Patient dies in Pfizer study of Duchenne gene therapy

Bio Pharma Dive

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.

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Psilocybin effective in treating depression

Pharmaceutical Technology

A new study has further supported psilocybin's potential to treat depression, which impacts around 300 million people globally.

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A Healthy Lifestyle Could Offset Genetic Risk For Early Death by a Hopeful 62%

AuroBlog - Aurous Healthcare Clinical Trials blog

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?

Genetics 245
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AstraZeneca concludes equity investment in Cellectis

Pharmaceutical Technology

AstraZeneca has concluded an equity investment in clinical-stage biotechnology company Cellectis following a deal signed in November 2023.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

AuroBlog - Aurous Healthcare Clinical Trials blog

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved,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.

Drugs 241
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How sham patents are hurting the pharma industry

Pharmaceutical Technology

The FTC is cracking down on pharma companies filing sham patents in the Orange Book to delay generics competition.

More Trending

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NHS to roll out fibre optic laser therapy to prevent seizures in epileptic patients

Pharma Times

The chronic brain disease that causes seizures currently affects around 600,000 people living in the UK

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Zenas, with new funding, aims dual-targeting antibody at lupus and MS

Bio Pharma Dive

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.

Antibody 184
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Francis Crick Institute and Broken String Biosciences partner for ALS research

Pharma Times

The rare and fatal progressive neurodegenerative disease is estimated to affect 5,000 people in the UK

Research 145
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Verve moves forward with backup base editing therapy

Bio Pharma Dive

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.

Trials 176
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Vertex reports net profits of $2.69bn in Q1 2024

Pharmaceutical Technology

The increase in revenue was primarily driven by strong product sales of the cystic fibrosis drug Trikafta in ex-US markets.

Sales 130
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Prologue, Flagship’s newest startup, looks to mine viruses for new drugs

Bio Pharma Dive

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.

Protein 167
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Broken String Biosciences teams up with Francis Crick Institute for ALS research

Pharmaceutical Technology

The companies will utilise Broken String’s DNA break mapping platform Induce-seq for ALS research.

DNA 130
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Life sciences in Ireland: Nurturing talent, innovating excellence

pharmaphorum

The life sciences sector in Ireland is booming thanks to nurturing talent and fostering innovation. Companies like Eli Lilly and Regeneron have major operations driving excellence.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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China’s NMPA grants breakthrough therapy status for Innovent’s IBI343

Pharmaceutical Technology

The CDE of China's NMPA has granted breakthrough therapy designation (BTD) for Innovent Biologics’ IBI343 monotherapy.

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Sorcero genAI conjures plain language from scientific papers

pharmaphorum

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.

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BioNTech reports net loss of €315.1m in Q1 2024

Pharmaceutical Technology

BioNTech experienced a significant shift in its financial standing, reporting a net loss of €315.1m ($339.3m) in Q1 2024.

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Pfizer pauses DMD gene therapy trial after boy’s death

pharmaphorum

Pfizer has paused dosing in a study of its Duchenne muscular dystrophy gene therapy after a sudden patient death in another trial

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Gossamer Bio and Chiesi partner for pulmonary hypertension treatment

Pharmaceutical Technology

Gossamer Bio and Chiesi signed a partnership and licence agreement aimed at developing and marketing seralutinib for pulmonary hypertension.

Marketing 130
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Kenvue maps out hundreds of layoffs as service pact with J&J winds down

Fierce Pharma

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.

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GSK commits to further support of BioVersys’ TB drug

pharmaphorum

GSK commits to further support of BioVersys’ TB drug Phil.

Drugs 111
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Antidote to be announced as Corporate Honoree at MSAA Improving Lives Benefit

Antidote

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.

Research 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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eyeDNA plans pivotal trial of retinitis pigmentosa therapy

pharmaphorum

Two-year data from a phase 1/2 trial of eyeDNA Therapeutics' gene therapy for retinitis pigmentosa sets up pivotal trials, says the new biotech.

Trials 105
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Pharma Pulse 5/7/24: Biosimilars May Save Money — But What About Out-of-Pockets? How Diverse Skills Can Drive Success in Biotech & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Generative AI Finds Its Footing in Drug Development

BioSpace

Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.

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Myonex Finalizes Creapharm Deal

Pharmaceutical Commerce

The acquisition, the parties say, will benefit pharma and biotech in the clinical and commercial stages.

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The New Age of Decentralized Clinical Trials

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.

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Vertex Touts 13% Revenue Jump, Beats Profit Estimates on Strong Cystic Fibrosis Performance

BioSpace

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.

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Sandoz delivers 6% sales growth with Humira biosimilar leading the charge

Fierce Pharma

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.

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Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A May 2024 Update

Drug Channels

It's time for Drug Channels ’ annual update of vertical integration among insurers, PBMs, specialty pharmacies, and providers within U.S. drug channels. Below you’ll find our latest illustration of the major vertical business relationships among the largest companies along with some of the notable activity since our previous update. These organizations continue to exert greater control over patient access, sites of care/dispensing, and pricing, although some have started to unwind their vert

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Samsung Biologics poised for growth pending BIOSECURE bill approval in US

BioPharma Reporter

The US governmentâs unveiling of the BIOSECURE bill has created a great deal of discussion and debate in the pharma industry.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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