Tue.Oct 31, 2023

article thumbnail

Vertex, CRISPR therapy for sickle cell passes FDA panel test

Bio Pharma Dive

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

article thumbnail

ArriVent’s lung cancer therapy gains FDA breakthrough therapy status 

Pharmaceutical Technology

ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.

264
264
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

Bio Pharma Dive

Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.

article thumbnail

Do You Bruise Easily? It Could Be A Sign Of Something More Serious

AuroBlog - Aurous Healthcare Clinical Trials blog

After a bump, we can expect a bruise. But what if we find ourselves bruising without any noticeable cause? What might be behind it? Should we worry? Around 18 percent of adults report easy bruising. As hematologists (blood doctors), we are often asked for advice when people are worried they might bruise too easily.

Doctor 245
article thumbnail

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

article thumbnail

Lilly buys out Beam in heart drug alliance with Verve

Bio Pharma Dive

Already a partner to Verve, the pharma is paying $200 million upfront and investing another $50 million in Beam to acquire option rights to several gene editing programs.

article thumbnail

Adoption of laser vision correction procedures picks up in India at a frantic pace: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

Adoption of laser vision correction procedure is picking up in India at a frantic pace, according to ophthalmologists which they attribute to advancements in technology making these treatments minimally invasive, safe and effective with quick recovery and impeccable results.

More Trending

article thumbnail

Pfizer RSV vaccine gets off to fast start on market

Bio Pharma Dive

The pharma’s shot Abrysvo made over $300 million in sales during the first few months of its launch, and will be an important product to help offset declining COVID vaccine sales.

Vaccine 189
article thumbnail

October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New Demonstration Projects

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects, which will extend the program’s mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.

Trials 162
article thumbnail

Roivant’s $7B Roche deal was a ‘moment of opportunity,’ CEO says

Bio Pharma Dive

The acquisition of Telavant and its TL1A drug was born out of a J.P. Morgan conference meeting, Roivant chief executive Matt Gline said, and reflects the biotech’s flexible business strategy.

Drugs 162
article thumbnail

NHS patients to be offered the opportunity to travel for treatment

Pharma Times

Around 400,000 eligible patients are set to benefit from the travel offer - News - PharmaTimes

152
152
article thumbnail

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

article thumbnail

Roche seeks label expansion for Elevidys amid missing Phase III endpoint

Pharmaceutical Technology

Roche and Sarepta’s DMD drug failed to meet its primary endpoint in patients with patients with DMD aged 4-7 years.

Drugs 147
article thumbnail

As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty

Fierce Pharma

For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.

Sales 140
article thumbnail

Aragen invests $30m in new biologics manufacturing facility in India

Pharmaceutical Technology

The laboratory will be operational by Q3 2024, and the first manufacturing suite is expected to be operational in Q3 2025.

article thumbnail

High-performance computing could improve therapy for hard-to-treat cancer

Pharma Times

Researchers reduced 4D-MRI image reconstruction times to 60 seconds - News - PharmaTimes

Research 138
article thumbnail

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

article thumbnail

Half of top 20 biopharma company market cap impacted amid the IRA in Q3 2023

Pharmaceutical Technology

Leading biopharmas are reshaping their strategies after the announcement regarding the first drugs subject to Medicare price negotiations under the Inflation Reduction Act (IRA).

Marketing 130
article thumbnail

Battling new rivals and bracing for Jakafi's patent cliff, Incyte shores up growth plan

Fierce Pharma

As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff. | As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff.

124
124
article thumbnail

Sellas presses ahead with fast track designation for lymphoma

Pharmaceutical Technology

Sellas will be meeting with the FDA in Q4 2023 to discuss Breakthrough Therapy Designation for SLS009 as a treatment for r/r PTCL.

Drugs 130
article thumbnail

Galapagos plans to cut 100 jobs after striking deal to transfer Jyseleca, 400 staffers to Alfasigma

Fierce Pharma

For 170 million euros plus royalties, Galapagos has transferred Jyseleca and its operations to Alfasigma. The deal includes 400 employees who will transfer to Alfasigma.

124
124
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

M&A market performance suffered in Q3 2023

Pharmaceutical Technology

The third quarter of 2023 saw a slight fall in deal activity after the recovery in the global M&A market in the second quarter.

Marketing 130
article thumbnail

With Tepezza sales still stagnant, Amgen has a plan to boost the newly acquired TED drug

Fierce Pharma

As Amgen’s $27.8 billion buyout of Horizon Therapeutics became official earlier this month, one of the first orders of business for the California biotech giant was to get acquired blockbuster Tepe | As Amgen’s $27.8 billion buyout of Horizon Therapeutics became official earlier this month, one of the first orders of business for the California biotech giant was to get acquired blockbuster Tepezza back on track.

Sales 119
article thumbnail

Phase I/II trial begins for SpyGlass intraocular drug delivery implant

Pharmaceutical Technology

The platform consists of an intraocular lens with drug-eluting pads and is designed so that patients need not self-administer eye drops post-surgery.

article thumbnail

MHRA imposes restrictions on acne drug in children

pharmaphorum

MHRA imposes restrictions on acne drug in children Phil.

Drugs 111
article thumbnail

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.

article thumbnail

Shorla acquires methotrexate solution from Therakind in the US 

Pharmaceutical Technology

The acquisition of the oral methotrexate solution, marketed as Jylamvo, marks the second FDA-approved oncology product in Shorla’s portfolio.

article thumbnail

Lilly buys Beam’s option on Verve drug programmes

pharmaphorum

Lilly buys Beam’s option on Verve drug programmes Phil.

Drugs 110
article thumbnail

Vect-Horus and Novo Nordisk link for targeted therapeutics development

Pharmaceutical Technology

Biotechnology company Vect-Horus has signed a global licence agreement with Novo Nordisk for the development of targeted therapeutics.

article thumbnail

Combination Vaccines Are Coming for Respiratory Diseases

BioSpace

Pfizer, Moderna, Novavax and more are working to combine preventative shots for COVID-19, flu, RSV and other illnesses. Will convenience be enough to overcome vaccine fatigue?

Vaccine 108
article thumbnail

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

article thumbnail

AnHeart and Nippon Kayaku enter taletrectinib licence deal

Pharmaceutical Technology

AnHeart Therapeutics and Nippon Kayaku have signed an exclusive agreement for the former’s investigational therapy, taletrectinib.

130
130
article thumbnail

Despite trial miss, Sarepta plans new filing for DMD therapy

pharmaphorum

Despite trial miss, Sarepta plans new filing for DMD therapy Phil.

Trials 105
article thumbnail

FDA accepts Day One’s NDA for tovorafenib

Pharmaceutical Technology

The US FDA has accepted a Day One NDA and priority review for tovorafenib as a single agent in relapsed or progressive pLGG.

130
130
article thumbnail

After period of decline, dementia may be on the rise again

pharmaphorum

After period of decline, dementia may be on the rise again Phil.

105
105
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.