Fri.May 17, 2024

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Direct to consumer channels change patient-healthcare system relationship

Pharmaceutical Technology

With patients taking control over health, experts discuss how different players in the healthcare system are responding to the shifting relationship.

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FDA approves Amgen drug for tough-to-treat form of lung cancer

Bio Pharma Dive

Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.

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Sanders issues warning to Novo Nordisk amid GLP-1 drug price investigation

Pharmaceutical Technology

The US Senator took another swipe at the US prices of Novo Nordisk’s blockbuster GLP-1 receptor agonist drugs Ozempic and Wegovy.

Drugs 290
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Erasca restructures; Novartis moves to complete MorphoSys deal

Bio Pharma Dive

The cancer biotech is laying off one-fifth of its staff and scrapping three drugs. Elsewhere, Novartis secured sufficient support for its $3B buyout and Bristol Myers won a new CAR-T approval.

Drugs 173
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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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Liverpool and McMaster University announce £300,000 institutional strategic research partnership

Pharma Times

Areas include health research across life stages, from paediatrics to health ageing and resilience

Research 141
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J&J expands dermatology portfolio with $850m Proteologix acquisition

Pharmaceutical Technology

J&J has gained access to several bispecific antibody programmes, including the Phase I-ready asset PX128 for atopic dermatitis and asthma.

More Trending

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Erasca trims workforce and pipeline to focus on KRAS and molecular glues

Pharmaceutical Technology

Erasca has made operational cuts while licensing a molecular glue therapy and a KRAS inhibitor for $22.5m upfront.

Licensing 130
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Amgen's 'watershed' lung cancer drug nabs FDA nod in deadly, tough-to-treat form of the disease

Fierce Pharma

Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).

Trials 126
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Galapagos enters deal to boost decentralised CAR-T therapy production

Pharmaceutical Technology

Galapagos has signed a partnership with Blood Centers of America to expedite decentralised production of CAR-T cell therapies across the US.

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With EU agency's ruling, Moderna tallies a win in vaccine patent war against Pfizer and BioNTech

Fierce Pharma

After Moderna last year suffered a loss in its heated patent fight against Pfizer and BioNTech, the mRNA drugmaker can now celebrate a win. | The win comes after a prior decision from the European Patent Office that invalidated Moderna's other asserted patent.

Vaccine 122
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Moxifloxacin by Laboratorios Sophia for Bacterial Conjunctivitis: Likelihood of Approval

Pharmaceutical Technology

Moxifloxacin is under clinical development by Laboratorios Sophia and currently in Phase I for Bacterial Conjunctivitis.

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After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Fierce Pharma

Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.

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CinDome Pharma secures $40m to advance gastroparesis treatment

Pharmaceutical Technology

CinDome Pharma has secured $40m in a Series B financing extension round to develop deudomperidone for chronic gastroparesis.

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Overcoming challenges with maternal vaccine trials

pharmaphorum

Navigating maternal vaccine trials: addressing safety, efficacy, and preterm birth risks. Insights on vaccines for pregnant women and maternal health.

Vaccine 115
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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 breakthrough therapy status for Nuvalent’s NVL-655

Pharmaceutical Technology

The US FDA has granted breakthrough therapy designation (BTD) for Nuvalent’s NVL-655 for the treatment of non-small cell lung cancer.

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A greener catalysis: Talking sustainable, scalable chemistry with KCL

pharmaphorum

Explore sustainable catalysis and its potential to transform chemical reactions in drug discovery. Learn how green chemistry plays a pivotal role in shaping the future of catalysis.

Drugs 115
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Endeavor BioMedicines' ENV-101 improves lung function and reverses fibrosis in IPF patients

BioPharma Reporter

Endeavor BioMedicines, a clinical-stage biotech company, has announced promising phase 2a trial results for its lead investigational candidate, ENV-101.

Trials 105
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Lung disease imaging AI from Brainomix gets FDA nod

pharmaphorum

Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pharma Pulse 5/17/24: Apple Watch's Afib App certified by FDA, Learning Telehealth Platforms Benefits Pharmacy Students & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

Pharmacy 104
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Amgen adds BiTE to its cancer range as FDA clears Imdelltra

pharmaphorum

Amgen gets FDA approval for Imdelltra as a treatment for small cell lung cancer, becoming the first DLL3-targeted drug and the company's second BiTE therapy.

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How the New EU AI Act Will Impact Clinical Trials in the Life Sciences?

Cloudbyz

The European Parliament recently passed the EU’s new AI Act , which is now awaiting final approval. This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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Obesity drugs could bankrupt US healthcare, says Sanders

pharmaphorum

Bernie Sanders says high prices being charged for new obesity therapies like Novo Nordisk’s Wegovy could end up bankrupting US healthcare systems

Drugs 105
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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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PF-08046040 by Pfizer for Myelodysplastic Syndrome: Likelihood of Approval

Pharmaceutical Technology

PF-08046040 is under clinical development by Pfizer and currently in Phase I for Myelodysplastic Syndrome.

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J&J reels in bispecific specialist Proteologix in $850m deal

pharmaphorum

Johnson & Johnson has agreed a $850m deal to acquire Proteologix that will give it a pair of early-stage bispecific antibodies for atopic dermatitis and asthma.

Antibody 104
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Gene Therapy for Parkinson’s Disease by Innervate Therapeutics for Parkinson’s Disease: Likelihood of Approval

Pharmaceutical Technology

Gene Therapy for Parkinson’s Disease is under clinical development by Innervate Therapeutics and currently in Phase II for Parkinson's Disease.

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Fierce Pharma Asia—Eisai eyes Leqembi surge; Takeda nabs Alzheimer's drug option; BIOSECURE Act advances

Fierce Pharma

Following a reportedly bullish assessment from Medicare, Eisai has projected a significant sales increase for Leqembi. | Eisai has projected a significant sales increase for Leqembi. Takeda put down $100 million upfront for an option to license an anti-amyloid vaccine from AC Immune. The House oversight committee has voted overwhelmingly to advance a tweaked version of the BIOSECURE Act.

Sales 98
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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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MAI-001 by Nanjing Minova Pharmaceutical Technology for Depression: Likelihood of Approval

Pharmaceutical Technology

MAI-001 is under clinical development by Nanjing Minova Pharmaceutical Technology and currently in Phase I for Depression.

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Buyer’s Checklist for Selecting the Right eTMF Vendor

Cloudbyz

When choosing an Electronic Trial Master File (eTMF) system for your clinical trials, it’s crucial to ensure the system not only meets your organizational needs but also complies with regulatory requirements and enhances operational efficiency. Here is a detailed buyer’s checklist for your reference: File Management Capabilities Drag and Drop Uploads: Check if the system supports drag-and-drop functionality during file uploads to simplify the process Document Favorites and Navigation: The system

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IL13R alpha 2 CAR-T by TCR Cure Biopharma Technology for Glioma: Likelihood of Approval

Pharmaceutical Technology

IL13R alpha 2 CAR-T is under clinical development by TCR Cure Biopharma Technology and currently in Phase I for Glioma.

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AI-powered WhatsApp messaging cleared for NHS pilot

pharmaphorum

An artificial intelligence-driven WhatsApp messaging platform for scheduling cervical cancer screening appointments is being piloted in London to see if it can improve take-up rates. The pilot of the Asa AI assistant – cleared by the NHS North Central London Integrated Care Board (ICB) – will take place at the Islington GP Federation in London.

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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.