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Moderna cries foul as FDA blocks filing of mRNA flu shot

The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.

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Man yawning, covering his mouth with his hand

FDA kicks off review of Takeda's narcolepsy hopeful

The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year.

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Curran Simpson, Regenxbio's president and CEO

Dismay as FDA blocks Regenxbio's Hunter syndrome therapy

The FDA said it needs more information before it can approve Regenxbio's gene therapy for Hunter syndrome, in a devastating decision for patients.

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Black and white image of a white flag of surrender

Novo Nordisk rises as Hims & Hers backs down on oral GLP-1

Novo Nordisk's battered stock enjoyed a reprieve after Hims & Hers abandoned plans to launch a compounded version of the new Wegovy pill.

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Hims & Hers copies Novo Nordisk's new Wegovy pill

Competition has already arrived for Novo Nordisk's Wegovy pill, as telehealth company Hims & Hers launches a compounded version.

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Sanofi starts shipping RSV drug early as rival nears market

As an FDA decision nears from a rival MSD drug, Sanofi is speeding up the rollout of RSV antibody Beyfortus to get ahead of this year's season.

News

AZ claims EU approval for new Calquence regimens in CLL

AstraZeneca has secured a key approval for its BTK inhibitor Calquence in Europe, currently facing a strong challenge from BeOne's rival Brukinsa.

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Wockhardt has high hopes for novel antibiotic Zaynich

Wockhardt has completed a pre-filing meeting with the FDA and is preparing to submit its novel antibiotic Zaynich in the US and Europe.

News

Moderna cries foul as FDA blocks filing of mRNA flu shot

The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.

News

FDA kicks off review of Takeda's narcolepsy hopeful

The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year.

Press Releases

Market Access

VuuAI and Amiculum partner to transform content engagement i...

Amiculum, a global health communications agency, has entered into an exciting strategic collaboration with VuuAI, a GenAI-driven content production automation plat

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Immunocore's rare eye cancer drug backed by NICE

Patients in England with a rare form of eye cancer will be able to access Kimmtrak, a TCR therapy from Immunocore, after NICE changes its position.

Views & Analysis

Market Access

Biotech leaders: ‘They're shoving this industry into the arm...

At the Biotech Showcase during JPM Week, biotech leaders expressed frustration at the US's lack of concern about Chinese biotech progress.

Market Access

European biopharma at a crossroads

If Europe can bridge its operational gaps while leveraging its scientific base, it can carve out a distinctive and sustainable leadership position.

Deep Dive

Market Access

Will MFN drug pricing help patients – or hurt access?

Market Access

Inside Merck’s push to future-proof health systems

Market Access

EVERSANA leaders on digital-first models, affordability, and...

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IQVIA Webinar on Innovative Medicines Fund

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Innovative Medicines Fund and the opportunity for ICSs to mo...

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Medical Informatics and Rare Disease: a bridge between two w...

With more than 6,000 different diseases comprising the rare disease (RD) landscape, connecting patients and practitioners with the expertise needed to achieve th

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ICSs - an opportunity to improve Patient & Market Access at ...

With the new Health and Care Bill edging ever closer to receiving Royal Assent, life sciences companies in the UK are preparing to navigate the most significant piece of NHS legislation in

Podcasts

Market Access

Policy in Focus: Trump’s MFN deals, FDA vouchers, and the go...

Policy experts Alice Valder Curran and Elizabeth Jungman of Hogan Lovells weigh in on Trump's MFN deals, FDA vouchers, and the government shutdown.

Market Access

pharmaphorum podcast Episode 210 - Neal Masia

Smoothing a contract pathway through uncertainty: In convers...

Today's podcast with Entity Risk's Neal Masia includes insights on the 340B Program, PBMs, and risk-based contracts.

Market Access

Frontiers Health limited podcast series, Pilar Fernández Hermida

FH25: Commercialising Health Tech and Deeptech, with Pilar F...

In a new episode of our limited Frontiers Health series of the pharmaphorum podcast, we speak with commercial strategy expert Pilar Fernández Hermida.

Video

Market Access

Consolidating data strategy for global success: Insights fro...

At Frontiers Health 2025, Drew McCormick, Head of Data and Analytics at EVERSANA, emphasised a critical truth: data strategy is launch strategy.

Market Access

Interview at BIO 2025 with Paul Romness and Farah Ahmad

Global unity in the face of uncertainty, with Paul Romness a...

Market Access

Interview at BIO 2025 with Kyle Touchstone and Laura Rowley

Biotech opportunities in North Carolina, with Kyle Touchston...

From BIO 2025: Kyle Touchstone, director of Economic Development Raleigh and Laura Rowley, director of life sciences development for NCBiotech.

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Life Sciences Industry Report Part 1 Download

Life Sciences Industry Report 2025

In pharmaphorum’s inaugural Life Sciences Industry Report 2025, delve into the trends that propelled the pharmaceutical industry along in 2024.

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Navigating Routes to Commercial Excellence in Cell and Gene ...

'Navigating Routes to Commercial Success in Cell and Gene Therapy', authored by Franjo Hanzl, VP, Business Development, Commercial at EVERSANA, Dr.

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Pricing & Market Access Outlook 2015/2016 Edition

Pricing and market access (P&MA) are key issues for the pharma industry as healthcare budgets continue to tighten and the value of innovative drugs, particularly in areas of high unmet need

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Targeted Therapies Partnering & Licensing Summit Asia

Accelerate Licensing & Co-Development in Asia: Providing Pharma De-Risked Assets to Fuel Pipelines Faster, & Biotech Access to International Partnersh

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Measuring Patient Engagement Summit Europe

The World’s Only Patient Engagement Measurement Summit is coming to Europe!

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The Inaugural Market Access for CNS Therapeutics Summit Has ...

The only dedicated forum focused on tackling the unique commercial and reimbursement challenges facing treatments for neurodegeneration...

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Innovative contracting in Europe – a Trojan horse?

Overview

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Launch excellence in a disrupted world – challenges & opport...

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Orphan medicines launch excellence: sustaining launch succes...

Overview Launching orphan medicines excellently will become even more important over the next five years as more patients with rare diseases have pharmacotherapies available.

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Market Access

VuuAI and Amiculum partner to transform content engagement i...

Amiculum, a global health communications agency, has entered into an exciting strategic collaboration with VuuAI, a GenAI-driven content production automation plat

Market Access

Partner Content

Targeted Therapies Partnering & Licensing Summit Asia

Accelerate Licensing & Co-Development in Asia: Providing Pharma De-Risked Assets to Fuel Pipelines Faster, & Biotech Access to International Partnersh

Market Access

Partner Content

The 2nd Cell & Gene Therapy Regulatory Affairs Summit Return...

Navigate FDA changes & global alignment at the only CGT regulatory strategy summit.

Moderna cries foul as FDA blocks filing of mRNA flu shot

FDA kicks off review of Takeda's narcolepsy hopeful

Dismay as FDA blocks Regenxbio's Hunter syndrome therapy

Novo Nordisk rises as Hims & Hers backs down on oral GLP-1

Hims & Hers copies Novo Nordisk's new Wegovy pill

Sanofi starts shipping RSV drug early as rival nears market

AZ claims EU approval for new Calquence regimens in CLL

Wockhardt has high hopes for novel antibiotic Zaynich

Moderna cries foul as FDA blocks filing of mRNA flu shot

FDA kicks off review of Takeda's narcolepsy hopeful

VuuAI and Amiculum partner to transform content engagement i...

Immunocore's rare eye cancer drug backed by NICE

Biotech leaders: ‘They're shoving this industry into the arm...

European biopharma at a crossroads

Will MFN drug pricing help patients – or hurt access?

Inside Merck’s push to future-proof health systems

EVERSANA leaders on digital-first models, affordability, and...

Innovative Medicines Fund and the opportunity for ICSs to mo...

Medical Informatics and Rare Disease: a bridge between two w...

ICSs - an opportunity to improve Patient & Market Access at ...

Policy in Focus: Trump’s MFN deals, FDA vouchers, and the go...

Smoothing a contract pathway through uncertainty: In convers...

FH25: Commercialising Health Tech and Deeptech, with Pilar F...

Consolidating data strategy for global success: Insights fro...

Global unity in the face of uncertainty, with Paul Romness a...

Biotech opportunities in North Carolina, with Kyle Touchston...

Life Sciences Industry Report 2025

Navigating Routes to Commercial Excellence in Cell and Gene ...

Pricing & Market Access Outlook 2015/2016 Edition

Targeted Therapies Partnering & Licensing Summit Asia

Measuring Patient Engagement Summit Europe

The Inaugural Market Access for CNS Therapeutics Summit Has ...

Innovative contracting in Europe – a Trojan horse?

Launch excellence in a disrupted world – challenges & opport...

Orphan medicines launch excellence: sustaining launch succes...

VuuAI and Amiculum partner to transform content engagement i...

Targeted Therapies Partnering & Licensing Summit Asia

The 2nd Cell & Gene Therapy Regulatory Affairs Summit Return...

Precision medicine in action, with Cary Claiborne

How to meet your physicians where they are online

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