Thu.Feb 20, 2025

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AstraZeneca deepens China presence with FibroGen deal

Bio Pharma Dive

The $160 million acquisition of a FibroGen subsidiary expands AstraZeneca’s foothold in China while the company works through government investigations into its business practices there.

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Pharma and medtech industry reacts to FDA, CDC and NIH job cuts

Pharmaceutical Technology

The FDA, NIH and CDC has cut 5,200 probationary staff in a job cull across the HHS over the Valentine's Day weekend.

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In FDA job cuts, experts see threat of far-reaching impact

Bio Pharma Dive

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.

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FDA authorises ImmunityBio’s BCG alternative to treat bladder cancer

Pharmaceutical Technology

ImmunityBio has gained the FDA authorisation for an EAP to supply an alternative source of BCG for treating bladder cancer.

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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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CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed

Bio Pharma Dive

Originally scheduled for next week, the meeting of agency advisers will be delayed to give more time for public comment, according to an HHS spokesperson.

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Zealand Pharma steadfastly upholds amylin-based obesity drug strategy

Pharmaceutical Technology

Zealands CEO Adam Steensberg said that the company is exactly where it wants to be in terms of its partnering and development timeline.

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More Trending

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FibroGen sells China unit to AstraZeneca for $160m

Pharmaceutical Technology

AstraZeneca will gain full rights for roxadustat in China where it is approved to treat anaemia seen with chronic kidney disease.

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FDA approves Deciphera’s Romvimza for rare tumour type

Pharma Times

Tenosynovial giant cell tumours can cause pain, stiffness, swelling and movement limitations

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X4 and taiba to distribute WHIM syndrome therapy in Middle East

Pharmaceutical Technology

X4 has entered an exclusive agreement with taiba rare for distributing and commercialising Xolremdi in select Middle Eastern countries.

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Device industry scrambles amid concern FDA layoffs will cause delays

Bio Pharma Dive

Layoffs at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

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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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Key pharma launch trends in 2024

Pharmaceutical Technology

In this review, GlobalData considers the products both approved and priced in 2024 and the factors that influenced their launch strategy.

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FTC case against PBMs can move forward, judge rules

Bio Pharma Dive

A Missouri district court judge said stopping the FTC’s suit against Caremark, Express Scripts and Optum Rx would be “against the public’s interest.

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FDA grants priority review for Boehringer’s zongertinib NDA in NSCLC

Pharmaceutical Technology

FDA has granted priority review for Boehringer Ingelheims zongertinib NDA for treating unresectable or metastatic NSCLC.

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SMA treatment with Evrysdi 'could start prenatally'

pharmaphorum

SMA treatment with Evrysdi 'could start prenatally' Phil.

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

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Join This Study Today and Support Research on Aging and Vision Health!

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center Study Location Research Center: University of Maryland Baltimore Location: 419 W. Redwood St., Suite 470 Lead Researcher: Dr. Osamah Saeedi IRB: This study has been reviewed and approved by the University of Maryland IRB About the Study Vision changes can be a major concern, especially as we age, and researchers are studying how age-related cognitive changes may affect vision.

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Boehringer eyes third quarter FDA verdict for oral HER2 drug

pharmaphorum

Boehringer Ingelheim's oral HER2 inhibitor zongertinib has started an FDA review as a lung cancer treatment with a decision due in the third quarter.

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ImmunityBio to Supply Recombinant BCG to Alleviate Tice BCG Shortage

Pharmaceutical Commerce

FDA approves an expanded access program that would offer patients an alternative to Mercks bladder cancer medication.

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UCB's non-cannabis drug for severe epilepsy gets NHS okay

pharmaphorum

Around 1,400 patients with Lennox-Gastaut Syndrome will be eligible for NHS treatment with UCB's Fintepla after a NICE recommendation

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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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Pharma Pulse 2/20/25: Global Launch Strategies in the Current Political Climate, Pharmacists Help Navigate Vaccine Schedules & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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The "Wicked" prescription: Humanising healthcare marketing

pharmaphorum

Learn how incorporating storytelling techniques can humanise healthcare marketing and enhance patient engagement in "The 'Wicked' Prescription.

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Enhancing Pharma Supply Chain Transparency and Trust

Pharmaceutical Commerce

In the third part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, discusses why the demand for supply chain transparency is continuing to gain momentum, while also explaining the role that track-and-trace initiatives are playing in that effort.

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The rise and market race of anti-IL23p19 therapies in IBD: How ECCO 2025 readouts will shape the anti-interleukin landscape

pharmaphorum

The rise and market race of anti-IL23p19 therapies in IBD: How ECCO 2025 readouts will shape the anti-interleukin landscape Mike.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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WHO targets over half a million children in Gaza for polio vaccine drive

Pharmaceutical Technology

The World Health Organization (WHO) said it will conduct another mass vaccination round in the Gaza Strip to protect children against polio.

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Paediatric rare diseases: Children are not small adults

pharmaphorum

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Dr Helen Thackray, chief R&D officer at biotech company BioCryst, as well as an alumnus of the Childrens National Medical Center.

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How to Achieve High-Quality Standards in Generic Drugs

Drug Patent Watch

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses. I'm talking about the generic drug manufacturers who play a vital role in making life-saving treatments accessible to people worldwide.

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NICE changes its mind on BMS' lymphoma cell therapy

pharmaphorum

Around 600 people with various types of B-cell lymphoma will be eligible for treatment with BMS' CAR-T therapy Breyanzi under new NICE guidance.

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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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Sionna Therapeutics IPO Could Fuel Next-Gen Cystic Fibrosis Therapies

XTalks

On February 10, 2025, Sionna Therapeutics Inc. announced the successful closing of its upsized initial public offering (IPO). The Sionna Therapeutics IPO saw the company sell 12,176,467 shares of common stock at $18.00 per share including an additional 1,588,234 shares from the underwriters option. With gross proceeds of approximately $219.2 million (before deducting underwriting discounts, commissions and other expenses) Sionna has marked a major milestone in its growth journey.

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Building Trust With Education and Innovation: Rare Disease Marketing

Intouch Solutions

Rare and ultra-rare diseases face problems most brands do turned up to 11. Budgets? Smaller. Patient pool? Even smaller. Healthcare providers (HCPs) who understand the condition? Sometimes even smaller than that. Treatment options can be limited, access can be hard to find and diagnosis time can sometimes be measured in decades rather than months. Its a perfect storm.

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Pharma and Biotech M&As in 2025 Roundup

XTalks

The pharmaceutical and biotechnology industry has kicked off 2025 with some notable mergers and acquisitions (M&A), signaling a renewed focus on innovation, pipeline expansion and strategic growth. After a relatively subdued 2024, where companies favored smaller, strategic deals over large-scale acquisitions, major players are now aggressively pursuing deals to strengthen their positions in therapeutic areas such as oncology, neuroscience and cell therapy.

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Nano Insights: Unveiling the role of mRNA analytics in cGMP manufacturing with Lonza and beyond

Drug Discovery World podcast

In this sponsored DDW Sitting Down With podcast we speak to experts from Lonza and Oxford Nanopore about their collaboration to bring direct mRNA sequencing (including N1-Methyl-pseudouridine) to a regulated environment and establish the new gold standard in sequencing technology. We discuss how nanopore sequencing will be used to perform unbiased identity testing while enabling the simultaneous analyses of multiple critical quality attributes such as integrity (mRNA length and poly-A tail lengt

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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