Fri.Jan 19, 2024

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Novartis details first-line data for radiopharma drug Lutathera

Bio Pharma Dive

Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.

Drugs 308
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BridgeBio secures $1.25bn for genetic therapy development

Pharmaceutical Technology

BridgeBio Pharma has secured strategic financing of $1.25bn from Blue Owl Capital and CPP Investments for genetic therapies.

Genetics 246
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Ikena Oncology to lay off 35% of staff

Bio Pharma Dive

The cancer drugmaker is one of about a dozen biotechs that have announced workforce reductions so far in 2024.

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Biotech layoffs strike hard with PMV Pharma, Ikena, and Bayer sacking staff

Pharmaceutical Technology

The layoffs will free cash resources that will extend financial runways and focus pipeline developmental efforts.

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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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Sanders threatens to subpoena J&J, Merck CEOs over drug prices

Bio Pharma Dive

The Senate HELP committee, which is seeking testimony from J&J's Joaquin Duato and Merck's Robert Davis, hasn't issued a subpoena since 1981.

Drugs 173
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argenx’s VYVDURA gains approval in Japan for gMG treatment

Pharmaceutical Technology

Japan has approved argenx’s VYVDURA injection for subcutaneous administration to treat generalised myasthenia gravis (gMG) in adults.

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More Trending

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Former Pfizer statistician found guilty of insider trading on Paxlovid trial results

Fierce Pharma

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

Trials 144
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Navigating the 2024 Life Science Industry Trends Landscape

Pharma Mirror

As we step into 2024, the global life science industry finds itself at a crossroads, facing plenty of challenges alongside an abundance of exciting opportunities. The pharmaceutical and contract outsourcing space has shifted, with new trends emerging that will shape the future of this rapidly changing industry. The global stage has witnessed significant upheavals throughout 2023, with wars impacting everything from oil prices to work locations.

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NSCF embarks on fifth flight to investigate neurodegenerative disorders in space

Pharmaceutical Technology

Information gathered from the study will guide an upcoming two-week mission scheduled for launch in March.

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After row with Hungary and Poland, Pfizer sues Romania over missed COVID vaccine payments

Fierce Pharma

Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. | Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. The lawsuit marks the latest move in Pfizer’s campaign to press countries to honor COVID-19 vaccine contracts inked by the European Commission in May 2021.

Vaccine 128
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Call for earlier diagnosis to improve Gaucher disease outcomes

Pharmaceutical Technology

Delayed diagnoses in many Gaucher disease patients contribute to slower-than-optimal initiation of treatment and delayed medical care.

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Bristol Myers shows power of Opdivo-Yervoy combo in first-line colorectal cancer subset

Fierce Pharma

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnose | More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients.

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Ikena fires 35% of staff to funnel funds into clinical oncology programmes

Pharmaceutical Technology

Ikena has also paused exploratory research and discovery in addition to workforce reduction, which will occur over Q1 this year.

Research 130
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Stroke experts to test emerging nerve stimulation treatment

Pharma Times

New stroke therapy delivers electrical pulses to the brain

Research 125
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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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FDA grants fast track designation for Verastem’s NSCLC therapy

Pharmaceutical Technology

The US FDA has granted fast track designation for Verastem’s avutometinib for treating non-small cell lung cancer (NSCLC).

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Serac to present data from DETECT study

Pharma Times

Company will present vital findings at SRI annual meeting

Research 123
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FDA declines to approve Satsuma’s migraine treatment STS101

Pharmaceutical Technology

The US FDA has declined to grant approval for Satsuma Pharmaceuticals’ STS101 for acute migraine treatment in adults.

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AstraZeneca adds to rare blood disease portfolio with world-first Voydeya approval in Japan

Fierce Pharma

A month after Novartis made its entry into the paroxysmal nocturnal haemoglobinuria (PNH) field, AstraZeneca’s newest contender Voydeya bolsters the company’s presence in the disease area with a wo | The drug bolsters the company's portfolio in paroxysmal nocturnal haemoglobinuria (PNH) just as the market heats up thanks to new competitors from Novartis and Apellis.

Marketing 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AZ bags first approval for PNH therapy danicopan, in Japan

pharmaphorum

AstraZeneca gets its first approval for oral Factor D inhibitor danicopan, in Japan, for treatment of paroxysmal nocturnal haemoglobinuria

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We All Have Data. Now What?: Finding Your Edge in the Algorithmic Age

Intouch Solutions

Now, more than ever, inspiration is at a premium. Artificial Intelligence (AI) applications have high storage capacity demands that can easily start in the terabyte (a unit of information equal to one million million) range and scale into hundreds of petabytes (1024 terabytes). Where, once, we were limited by our data, in an age of AI, where we have more data than we know what to do with, we are only limited by our imaginations.

Engineer 105
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JP Morgan 2024 – Graham Heap

pharmaphorum

Learn more about Graham Heap, Takeda VP and the lead of TAK-279, in this exclusive live interview at JP Morgan in 2024. Gain insights into Heap's role, achievements, and the future of TAK-279.

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How Financialization Has Impacted the US Healthcare System

Pharmaceutical Commerce

Experts explore ways in which the financial sector refined the healthcare landscape, including its evolutions throughout the years.

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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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CG Oncology lines up $180m IPO and a $1bn valuation

pharmaphorum

CG Oncology joins the queue of US biotech companies hoping to complete an IPO, aiming to raise $181m for its late-stage bladder cancer therapy.

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Tiger mosquito detections double in Belgium

Sciensano

The tiger mosquito, an invasive species with the potential to transmit viruses, is making significant strides in Belgium. In 2023 the Institute of Tropical Medicine ( ITM ) in Antwerp and Sciensano found the species in twice as many location compared to 2022. This is a concerning rise. The citizen science platform MuggenSurveillance.be plays an important role in this, and recorded positive reports for the first time in Brussels and Wallonia.

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Redefining chronic disease management with novel digital solutions

pharmaphorum

Basel, Switzerland, is becoming an innovative biotech hub at the forefront of the digital revolution, proving fertile ground for a variety of start-ups in the healthcare space.

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FDA slaps boxed warning on Amgen's osteoporosis drug Prolia

Fierce Pharma

Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. | Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a boxed warning for the blockbuster treatment, which has been on the market for 14 years and loses patent protection next year.

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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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FDA turns down Satsuma’s nasal migraine treatment

pharmaphorum

Manufacturing problems have scuppered Satsuma Pharmaceuticals’ chances of a timely FDA approval for its intranasal migraine therapy STS101. The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without aura, in adult patients.

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In the Shadows of the Drug Affordability Debate, Patients Pay the Ultimate Price

Pharmaceutical Commerce

All healthcare stakeholders must participate to dismantle barriers and ensure access to medicines that save lives.

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Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

XTalks

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. Therapeutic radiopharmaceuticals are particularly used in the treatment of cancer.

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Pharmaceutical companies with the most orphan drugs

Drug Patent Watch

Orphan drug exclusivity is granted to drugs addressing rare ‘orphan diseases’ — those affecting fewer than 200,000 Americans. The protection granted to orphan drugs is quite strong. The FDA is… The post Pharmaceutical companies with the most orphan drugs appeared first on DrugPatentWatch - Make Better Decisions.

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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.