Mon.Sep 23, 2024

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Biogen, UCB get the lupus data they’ve waited two decades for

Bio Pharma Dive

The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.

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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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After setback, Biohaven to seek approval of neurological disorder drug

Bio Pharma Dive

With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.

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Leading Artificial Intelligence (AI) Companies in Pharma

Pharmaceutical Technology

View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.

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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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Streamlining IND applications for cell and gene therapy innovations

Bio Pharma Dive

Regulatory and strategic challenges can delay the delivery of life-changing cell and gene therapies.

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Active Pharmaceutical Ingredients and Intermediates for the Pharmaceutical Industry

Pharmaceutical Technology

Download our free, extensive list of the leading Active Pharmaceutical Ingredients and Intermediates companies and suppliers today.

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More Trending

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The golden era of GLP-1 drugs: Where we are and what comes next

Bio Pharma Dive

GLP-1 drugs went from helping with blood sugar management to supporting weight loss. What’s next?

Drugs 162
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CDSCO revises guidance document for functions & responsibilities of zonal, sub-zonal & port offices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has revised the guidance document for functions and responsibilities of its zonal, sub-zonal and port offices after almost 13 years, updating the adding procedures including for Risk Based Inspection (RBI) of drug manufacturing sites.

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Startup Vicebio banks $100M in bid to make ‘cost-effective’ vaccines

Bio Pharma Dive

The company’s technology, which enables it to target viral proteins in their “prefusion” shape and skip a manufacturing step, could lead to vaccines that are more potent and easier to produce, said CEO Emmanuel Hanon.

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Telesis Bio gets grant for methods for synthesizing dna molecules with defined sequences

Pharmaceutical Technology

Discover Telesis Bio Inc.'s groundbreaking patent for synthesizing specific DNA sequences. Learn how their innovative method enhances genetic engineering and biotechnology.

DNA 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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AstraZeneca, Daiichi’s Enhertu successor faces more questions after latest stumble

Bio Pharma Dive

The partners said their antibody-drug conjugate datopotomab deruxtecan didn’t extend survival in a breast cancer study, fueling additional doubts about its approval prospects.

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Lyell Immunopharma gets grant for egfr-derived polypeptides for improved cell surface expression

Pharmaceutical Technology

Discover Lyell Immunopharma's groundbreaking patent for EGFR-derived polypeptides, enhancing cancer treatment through innovative nucleic acid technologies and engineered T cells.

Engineer 130
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Data advancements are finally unlocking drug safety during pregnancy

Bio Pharma Dive

Dr. Meg Richards from Panalgo discusses how real-world data is unlocking advancements in drug safety during pregnancy.

Drugs 130
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Sanofi gains exclusivity rights to Ventyx’s CNS-penetrant drug in $27m deal

Pharmaceutical Technology

Under the terms of the agreement, Sanofi will gain an exclusive right to first negotiation for the CNS-penetrant, VTX3232.

Drugs 130
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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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UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals

Fierce Pharma

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

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Vicebio secures $100m to advance RSV and hMPV vaccine combo to Phase I

Pharmaceutical Technology

The company has initiated a Phase I trial of its bivalent RSV and hMPV-targeting vaccine called VXB-241.

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J&J hopes 3rd time's the charm for Texas two-step strategy as it lifts talc settlement offer to $8B

Fierce Pharma

Despite being thrown off its rhythm twice already, Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the compan | Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the company’s talc products caused users to develop cancer.

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Teva touts safety profile of once monthly schizophrenia therapy

Pharmaceutical Technology

New safety data shows an absence of post-injection syndrome, a rare and serious side effect of long-acting olanzapine.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA clears first drug for Niemann-Pick disease

pharmaphorum

Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.

Drugs 115
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Ipsen’s Iqirvo wins European approval for primary biliary cholangitis

Pharmaceutical Technology

The approval sets up a showdown between Iqirvo and Intercept’s PBC treatment Ocaliva.

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Appeals Court resurrects PhRMA's lawsuit challenging pricing provisions in IRA

Fierce Pharma

For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet. | Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February, punting the complaint back to a lower Texas court.

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Pancreatic cancer: The clinical trial landscape and progress for 2024 

Pharmaceutical Technology

Pancreatic cancer is resistant to conventional therapies, but cutting-edge research may improve survival rates and patient quality of life.

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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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FDA clears RHYTHM AI's new algorithm for atrial fibrillation

pharmaphorum

RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation

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MHRA approves Takeda’s fruquintinib for metastatic colorectal cancer

Pharmaceutical Technology

Takeda UK has announced the UK's MHRA approval of fruquintinib for adults with metastatic colorectal cancer (CRC).

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Legend Biotech inks deal for 'priority access' to Multiply Labs' robotic cell therapy production tech

Fierce Pharma

After several years spent honing its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer. | After several years spent building partnerships to hone its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer: Legend Biotech.

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EMA CHMP recommends MSD’s KEYTRUDA for gynaecological cancers

Pharmaceutical Technology

The EMA CHMP has recommended approval of MSD’s KEYTRUDA for two gynaecological cancers: endometrial and cervical.

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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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How to Succeed in Generic Drug Market Entry

Drug Patent Watch

The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. However, the industry faces several challenges, including commoditization, regulatory hurdles, and intense competition.

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FDA approves Zevra Therapeutics’ Miplyffa for Niemann-Pick disease

Pharmaceutical Technology

Zevra Therapeutics has gained FDA approval for Miplyffa (arimoclomol) to treat Niemann-Pick disease type C (NPC).

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Warren, others urge government to allow generics to Novo's blockbuster GLP-1s ahead of CEO hearing

Fierce Pharma

Ahead of a Senate hearing centered on high prices for Novo Nordisk’s in-demand semaglutide medications, lawmakers are pressing the government to use its “march-in” rights and allow generic versions | In a letter to HHS secretary Xavier Becerra, several lawmakers urged the government to allow generic licenses for Novo's GLP-1 medicines Ozempic and Wegovy.

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Innovating pharma: How technology can ensure a steady medication supply

pharmaphorum

Innovative pharmaceutical technology can help ensure a consistent medication supply, reducing patient anxiety. Learn more about how advancements in the field are making a difference.

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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.