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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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Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare

MedCity News

During a fireside chat at AHIP 2024, Mary Langowski, executive vice president and president of U.S. healthcare at Walgreens Boots Alliance, said she sees a bright future for retail in healthcare. The post Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare appeared first on MedCity News.

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

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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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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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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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AbbVie and FutureGen link on inflammatory bowel disease

Pharmaceutical Technology

AbbVie has made a licence agreement with FutureGen Biopharmaceutical for developing FG-M701 for inflammatory bowel disease (IBD).

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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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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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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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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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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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FDA approves AstraZeneca’s Farxiga for paediatric T2D patients

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.

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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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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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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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Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study

MedCity News

Palliative care provided by video was equivalent to in-person visits with a clinician, according to study results presented during the recent annual meeting of the American Society of Clinical Oncology. Investigators say these results indicate telehealth can make palliative care accessible to more cancer patients. The post Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study appeared first on MedCity News.

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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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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.

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J&J’s nipocalimab raises hope for Sjogren’s patients

pharmaphorum

J&J’s ‘Swiss army knife’ for autoimmune diseases, FcRn inhibitor nipocalimab, has shown efficacy in Sjogren’s disease

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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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Pre-diabetes rates increase amidst a renaissance for type 2 diabetes research

Pharmaceutical Technology

England’s NHS has reported an 18% increase in the number of people with non-diabetic hyperglycaemia, also known as pre-diabetes.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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New paediatric blood test to prevent sudden death from hereditary heart condition

PharmaTimes

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

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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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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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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

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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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A "Dashboard of Zero" for your Sales Pipeline

Clear Pivot

One of the best ways to find aging deals in your sales pipeline is to build a report that specifically highlights them. Here's how we do that in HubSpot.

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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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Pfizer expects 8 blockbuster cancer drugs to come from each of 4 focus areas: exec

Fierce Pharma

Pfizer's oncology division plans to have eight blockbusters by 2030, with contributions from each of its four focused therapeutic areas.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.