Thu.Aug 22, 2024

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Secondary packaging for sterile injectables: Overcoming today’s design challenges

Pharmaceutical Technology

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

Packaging 246
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Updated COVID shots from Pfizer, Moderna cleared by FDA

Bio Pharma Dive

The approval of both reformulated messenger RNA vaccines, which are designed to target the KP.2 virus strain, comes just ahead of the fall and winter seasons.

RNA 288
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Surprise Alzheimer’s Finding: Brain’s Support Cells May Be Fueling Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

Neurons aren’t the only brain cells producing the proteins associated with Alzheimer’s disease, a new study of mouse models reveals. It turns out that cells supporting neurons contribute to this process too. Amyloid beta proteins occur naturally in our brains, but have long, and now controversially, been associated with Alzheimer’s disease.

Protein 238
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FDA defends med device chief’s tenure after report raises ethics concerns

Bio Pharma Dive

The FDA backed Jeff Shuren, the agency’s former CDRH leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.

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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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ICMR invites researchers to develop evidence-based guidelines for empirical use of antibiotics

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.

Research 233
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Versant reimagines its Chinook success with newest startup launch

Bio Pharma Dive

Borealis Biosciences launches with money from Novartis, which last year bought the biotech’s predecessor for a pair of drugs that treat a rare kidney disorder.

Drugs 173

More Trending

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UK approves Leqembi, but reimbursement may not follow

Bio Pharma Dive

Leqembi’s benefits are “too small to justify the significant cost to the NHS,” said the head of a UK agency in charge of determining medicine reimbursement.

Medicine 162
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Antisense Therapeutics gets grant for method for treating muscular dystrophy using oligonucleotides

Pharmaceutical Technology

Discover Antisense Therapeutics' groundbreaking patent for treating muscular dystrophy, enhancing muscle function with a unique oligonucleotide method.

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New drug trial to investigate treatment for patients with bronchiectasis

Pharma Times

200,000 people in the UK have what is considered a ‘hidden’ lung condition

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Heidelberg Pharma gets grant for methods for enhancing car immune cell acceptance using anti-cd5 adcs

Pharmaceutical Technology

Discover Heidelberg Pharma AG's innovative patent enhancing CAR T-cell therapy for cancer and autoimmune diseases using anti-CD5 antibody drug conjugates for better outcomes.

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

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FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

Fierce Pharma

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.

Drugs 126
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Zydus Lifesciences gets grant for liquid oral formulation of sildenafil for medical treatment

Pharmaceutical Technology

Discover Zydus Lifesciences' patented liquid sildenafil citrate formulation for treating pulmonary hypertension and erectile dysfunction, ensuring stability and effectiveness.

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The fall and rise of digital therapeutics

pharmaphorum

Discover how digital therapeutics (DTx) have evolved in the wake of COVID-19, and how they are changing the landscape of healthcare. Explore the fall and rise of DTx and their potential impact on patient care.

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Eisai’s Leqembi deemed too costly for NHS

Pharmaceutical Technology

Despite its marketing approval, Leqembi’s cost effectiveness falls short of NICE’s standards to justify wide range use in the UK.

Marketing 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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SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Pharma Times

The grant will support clinical trials of rare disease therapy for leukodystrophy

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Lexicon to face FDA AdComm for Zynquista approval in diabetes and CKD

Pharmaceutical Technology

A US FDA advisory committee (AdComm) is set to evaluate Zynquista as an adjunct therapy for type 1 diabetes and chronic kidney disease (CKD).

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Gilead’s Livdelzi (Seladelpar) for Primary Biliary Cholangitis Promises Pruritus Reduction

XTalks

The US Food and Drug Administration (FDA) has given the nod to Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC), a rare autoimmune disease that primarily affects women. PBC gradually destroys the bile ducts in the liver, leading to inflammation, scarring and, if untreated, potentially liver failure. For the 130,000 Americans living with this condition, many find existing treatments either ineffective or hard to tolerate.

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Leo Pharma’s Timber bet falls flat following Phase III failure

Pharmaceutical Technology

Leo Pharma spent $36m to acquire Timber Pharmaceuticals last year, along with its lead dermatology asset TMB-001.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With 36% increase, Eli Lilly leads industrywide sales boom in Q2

Fierce Pharma

Once again, fueled by booming sales of their GLP-1 products, Eli Lilly and Novo Nordisk were the top performers in the biopharma industry in the second quarter. | The momentum the biopharma industry showed in the first quarter of 2024 continued into the second quarter as 21 of the industry's top 25 companies achieved year-over-year revenue increases.

Sales 111
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Touchlight to supply GMP dbDNA for UK Zika vaccine study

Pharmaceutical Technology

Touchlight collaborated with the University of Nottingham to supply GMP-grade dbDNA tech to develop next-gen vaccine for the Zika virus.

Vaccine 130
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BioMarin revamps leadership with ex-Roche, Amgen execs

pharmaphorum

BioMarin names Amgen's Greg Friberg to lead its R&D and former Roche exec James Sabry as its chief dealmaker amid a strategy change

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CTI announces partnership for oncology drug development

Pharmaceutical Technology

CTI Clinical Trial & Consulting Services and Crown Bioscience have announced a strategic partnership to boost oncology drug development.

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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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GLP-1 Drugs Mounjaro, Zepbound, Wegovy Back in Stock After Extended Shortages

XTalks

After a nearly two-year-long shortage, the US Food and Drug Administration (FDA) announced earlier this month that Eli Lilly’s GLP-1 diabetes drug Mounjaro (tirzepatide) is back on shelves along with weight loss version Zepbound. A few days later, GLP-1 drug rival Novo Nordisk announced that four out of five dose strengths of its GLP-1 obesity drug Wegovy (0.5 mg, 1 mg, 1.7 mg and 2.4 mg) are now available in the US.

Drugs 111
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FDA accepts BMS’ sBLA for Opdivo-Yervoy combo for HCC

Pharmaceutical Technology

The FDA) has accepted the sBLA filed by BMS for Opdivo (nivolumab) and Yervoy (ipilimumab) to treat unresectable hepatocellular carcinoma.

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First bispecific CAR-T therapy for MS receives green light from FDA to start phase 1

BioPharma Reporter

ImmPACT Bio has received FDA clearance to start clinical trials for its CD19/CD20 bispecific CAR-T cell therapy in multiple sclerosis (MS) patients.

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Innovent’s Dupert approved in China to treat lung cancer

Pharmaceutical Technology

China's National Medical Products Administration (NMPA) has granted approval for Innovent Biologics’ Kristen rat sarcoma (KRAS) G12C inhibitor, Dupert (fulzerasib), to treat advanced non-small cell lung cancer (NSCLC) in adults.

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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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H1 Connect links doctors to global humanitarian missions

Outsourcing Pharma

H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.

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Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects

Fierce Pharma

Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts. | Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts, the company said.

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An Extra Layer of Transparency and Accountability

Pharmaceutical Commerce

In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.

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BMS eyes April FDA verdict on Opdivo/Yervoy in liver cancer

pharmaphorum

BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.

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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.