Sat.Jun 08, 2024 - Fri.Jun 14, 2024

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

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Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment

MedCity News

Physical and mental health are inextricably intertwined — senior-focused primary care can help bridge the treatment gap The post Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment appeared first on MedCity News.

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A Perfect Fit: June and Men's Health

ALULA

June is National Men's Health Month and a call to prioritize men's mental and physical well-being, the bedrock for success in all aspects of life. Leaders know that our health lays the foundation for our career achievements, team relationships, and overall resilience. However, one piece of men's health puzzle is often missing in our conversations.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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AbbVie to advance TL1A antibody for IBD

European Pharmaceutical Review

AbbVie and FutureGen Biopharmaceutical (Beijing) Co., Ltd. have made a license agreement, whereby AbbVie will develop, manufacture and commercialise a next generation TL1A antibody for inflammatory bowel disease (IBD). FG-M701 is a fully human monoclonal antibody targeting TL1A. This target plays a role in inflammatory autoimmune diseases. While AbbVie is set to advance the monoclonal antibody through development and beyond, the treatment is currently in preclinical development.

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BMS chief Boerner says company is still hungry for deals after spending more than $20B on M&A last year

Fierce Pharma

As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.

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Being an Ally Isn’t Just for Pride Month

ALULA

Every June, companies plaster rainbow flags across their logos in a show of LGBTQIA+ "allyship" for Pride Month. But true allyship isn't just a celebration - it's an ongoing commitment to supporting LGBTQIA+ individuals every day.

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Haemophilia drug could reduce treated bleeding episodes

European Pharmaceutical Review

A next-generation FVIIIa mimetic bispecific antibody has demonstrated statistically significant and superior reduction of treated bleeding episodes in haemophilia A, new headline data from a pivotal Phase IIIa trial show. Mim8 was evaluated in participants aged 12 years or older as both a once-weekly and once-monthly treatment versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment.

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Takeda circles leukemia rival to Novartis' Scemblix in up to $1.3B deal with Ascentage

Fierce Pharma

With a deal worth up to $1.3 billion, Takeda could get its hands on a “potentially best-in-class” third-generation BCR-ABL tyrosine kinase inhibitor (TKI) that could rival Novartis' Scemblix.< | In deal potentially worth up to $1.3 billion, Takeda has gained an option to license Ascentage's third-generation tyrosine kinase inhibitor, which could go up against Novartis' Scemblix in chronic myeloid leukemia.

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Healthcare’s Smokejumpers: Filling Critical Clinical Gaps with Independent Contractor Physicians

MedCity News

What if working with independent contractor physicians is the key to unlocking a more stable sustainable healthcare workforce? The post Healthcare’s Smokejumpers: Filling Critical Clinical Gaps with Independent Contractor Physicians appeared first on MedCity News.

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

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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

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ABPI embraces proposals for pharma’s growth ahead of UK elections

European Pharmaceutical Review

The Association of the British Pharmaceutical Industry (ABPI) has welcomed proposals from the Conservative and Unionist Party’s recently published Manifesto for the UK’s 2024 general election. We encourage other parties to come forward with equally specific proposals to boost the sector, so that the progress of recent years can be maintained” For example, this includes plans to accelerate NHS patient access to new medicines, which propose to “ remove bureaucratic obstacles to the use of

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Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Fierce Pharma

After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents. | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.

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Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial

MedCity News

An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses. The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial appeared first on MedCity News.

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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.

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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Innovative radioligand manufacturing facility inaugurated

European Pharmaceutical Review

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Orano Med (a subsidiary of the Orano Group)’s ATLab (Alpha Therapy Laboratory) facility in Brownsburg, near Indianapolis, Indiana, US, is set to help address the production and supply challenges of lead-212 radioligand therapies.

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After M&A stretch, Pfizer CEO says company needs 'breathing period' from large deals

Fierce Pharma

Amid a recent biopharma M&A resurgence, one major player plans to stay out of the waters after making multiple recent splashes. | Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking “breathing period,” CEO Albert Bourla told investors this week at Goldman Sachs’ 2024 annual Global Healthcare Conference in Miami.

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Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval

MedCity News

A Pfizer gene therapy for Duchenne muscular dystrophy failed its Phase 3 clinical trial. But analysts draw distinctions between that therapy and Sarepta Therapeutics’ Elevidys, which awaits an FDA decision that could grant it full regulatory approval. The post Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval appeared first on MedCity News.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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Five-year data from Genentech SMA study released

European Pharmaceutical Review

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). What did the FIREFISH extension study find? The study found that after five years without treatment, 91 percent of children were alive.

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GSK notches another Zantac win as plaintiff drops case in Illinois

Fierce Pharma

As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. | Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday.

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Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

MedCity News

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. The post Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease appeared first on MedCity News.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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Mahana’s DTx for IBS gets permanent reimbursement in Germany

pharmaphorum

Mahana Therapeutics has granted permanent reimbursement in Germany for its Cara Care digital therapeutic for irritable bowel syndrome

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Gilead forks over $40M to settle thousands of claims in web of litigation over alleged delay of safer HIV meds

Fierce Pharma

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement t | More than 2,000 plaintiffs accused the HIV drugmaker of purposely waiting to launch safer TAF-based meds in the early 2000s in order to maximize profits from its older TDF-based products.

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Why Is Moon Surgical’s New Commercial Robot System Important?

MedCity News

This month, Moon Surgical received FDA clearance for the commercial version of its Maestro surgical robot system. The system is designed to support surgeons and other operating room staff, specifically for the 18.8 million annual soft tissue surgical procedures not currently supported by available telerobotic systems. The post Why Is Moon Surgical’s New Commercial Robot System Important?

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Data sharing will be key in repairing the UK clinical ecosystem

Pharmaceutical Technology

Lord James O'Shaughnessy, the former health minister, outlines places where the UK is falling behind other countries with clinical research.

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Flagship, ProFound set off on obesity drug hunt for Pfizer

pharmaphorum

Pfizer has had some setbacks in its efforts to develop drugs for the lucrative obesity market, but could see its pipeline swell thanks to its $7 billion partnership with venture capital firm Flagship Pioneering. Flagship has just announced that it will work with biotech startup ProFound Therapeutics to find first-in-class protein therapeutics with potential in obesity, confirming this is the first programme in the alliance with Pfizer signed last July.

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Vertex presents longer-term data that shows durability and consistency of Casgevy

Fierce Pharma

Six months after Vertex earned a historic FDA approval for sickle cell d | Six months after Vertex earned a historic FDA approval for sickle cell disease (SCD) gene therapy Casgevy (exa-cel), long-term data is beginning to show the consistent efficacy and durability of the treatment, which is the first ever to be developed using CRISPR gene editing technology.

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Who Should Be Responsible for Rationing GLP-1s?

MedCity News

There is a shortage of GLP-1s in the U.S. But experts have differing opinions on whose responsibility it is to be rationing the drugs. The post Who Should Be Responsible for Rationing GLP-1s? appeared first on MedCity News.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.