Bio Pharma Dive
JUNE 12, 2023
Decentralized clinical trials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
Pharmaceutical Technology
JUNE 12, 2023
Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure. The company is a specialised pharmaceutical wholesaler and holds a licence, issued by the country’s ministry of health, to import non-registered pharmaceutical products, orphan drugs and other life-saving medicines.
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Bio Pharma Dive
JUNE 12, 2023
DeSouza is departing unrepentant about his decision to close the Grail deal, telling colleagues his belief in the merger “remains unshakeable.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 12, 2023
Switching to a diet full of fresh veggies and low in processed foods could do wonders for your brain’s biological age, new research shows.
Bio Pharma Dive
JUNE 12, 2023
The Swiss pharma is betting that two experimental drugs the biotech has developed for IgA nephropathy will succeed in late-stage testing, one of which will deliver results later this year.
Pharmaceutical Technology
JUNE 12, 2023
Clinical-stage biotechnology firm Eccogene has raised $25.23m (CNY180m) in a Series B financing round to support the development of its clinical-stage metabolic pipeline. Co-led by Zhangjiang Healthcare Venture Capital and New Alliance Capital, the financing round has seen participation from existing investors Qingsong Capital, Delos Capital and Oriza Seed Capital.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 12, 2023
Novartis will buy US-based clinical-stage biopharmaceutical company Chinook Therapeutics in a $3.5bn deal. Chinook common stockholders will receive $3.2bn and $0.3bn in cash through contingent value rights upon achieving certain regulatory milestones. The deal is a merger of a newly formed subsidiary of the company with Chinook, which has two late-stage medicines currently under development to treat IgA nephropathy (IgAN), a rare, progressive chronic kidney disease.
Bio Pharma Dive
JUNE 12, 2023
CVS Health was one of the first retailers to launch a clinical trials business. But a number of other competitors followed, arguing they could provide easier access and more diverse studies.
Pharmaceutical Technology
JUNE 12, 2023
The global pharmaceutical industry experienced a 120% rise in company filings mentions of internet of things in Q1 2023 compared with the previous quarter, with the highest share accounted for by Moderna, according to GlobalData’s analysis of over 61 pharmaceutical company filings. The growing application of Internet of Things will prove to have a transformative impact across the Healthcare sector.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 12, 2023
The Multidisciplinary Committee (MDC) of Experts has recommended the prices of various fixed dose combinations (FDCs) containing dapagliflozin, sitagliptin, vildagliptin, pioglitazone, among others in tune with the recent amendments made by the Department of Pharmaceuticals (DoP) in the Drugs (Prices Control) Order (DPCO), 2013 related to fixing prices of drugs with off patented molecules.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JUNE 12, 2023
The global pharmaceutical industry experienced a 149% rise in company filings mentions of cloud in Q1 2023 compared with the previous quarter, with the highest share accounted for by Pfizer with 14% year-on-year decrease, according to GlobalData’s analysis of over 140 pharmaceutical company filings. GlobalData’s Cloud Computing in Healthcare – Thematic Intelligence report offers a detailed understanding of how Cloud impacts the value chain in the Pharmaceutical sector.
Bio Pharma Dive
JUNE 12, 2023
Beacon Therapeutics will be led by former executives of other ocular gene therapy developers, including Nightstar, Gyroscope and AGTC.
Pharmaceutical Technology
JUNE 12, 2023
A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. All six members of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted in support of the Phase III Clarity AD (NCT03887455) data being adequate to verify the clinical benefit of Leqembi as an Alzheimer’s disease treatment, based
Bio Pharma Dive
JUNE 12, 2023
The CEO’s resignation signals a change of direction, as anti-trust regulators order Illumina to divest the liquid biopsy unit.
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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
Pharmaceutical Technology
JUNE 12, 2023
Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. The over-the-counter (OTC) marketing authorisation for the gel as a de novo medical device means the FDA has followed suit after the treatment received CE marking in Europe and UKCA marking in the UK in 2021 and 2022, respectively.
Fierce Pharma
JUNE 12, 2023
Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.
Pharmaceutical Technology
JUNE 12, 2023
Astellas Pharma has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab as a treatment option for advanced gastric and gastroesophageal cancer. Zolbetuximab is an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody that is a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma patients whose tumours are CLDN18.2-positive.
BioSpace
JUNE 12, 2023
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
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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.
Pharmaceutical Technology
JUNE 12, 2023
Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. The collaboration will combine the multi-modular Treg cell engineering and manufacturing expertise of Quell and AstraZeneca’s developmental, commercial and therapeutic capabilities.
Fierce Pharma
JUNE 12, 2023
Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.
Pharmaceutical Technology
JUNE 12, 2023
The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL. The injection is indicated for the sedation of initially intubated and mechanically ventilated patients receiving treatment in an intensive care setting. It is given by continuous infusion not exceeding 24 hours’ duration.
Pharma Times
JUNE 12, 2023
The treatment candidate, known as MDI-26478, is a positive allosteric modulator of the AMPA receptor - News - PharmaTimes
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Fierce Pharma
JUNE 12, 2023
Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement. | Following a deal with Amgen, J&J has granted Alvotech and Teva a license to launch their Stelara biosimilar no later than Feb. 21, 2025.
Velocity Clinical Research
JUNE 12, 2023
In this ongoing series, Velocity puts the spotlight on innovative Principal Investigators (PIs) whose work is changing the medical landscape at the intersection of research and patient care. Velocity Team Contributes to Potential Breakthrough Sleep Apnea Treatment Enjoying a good night’s sleep is vitally important both mentally and physically. Unfortunately, for many it’s a struggle to achieve each evening.
Antidote
JUNE 12, 2023
High blood pressure, also known as hypertension, is one of the most common conditions impacting U.S. adults. Often called the “silent killer” because it often presents no symptoms, hypertension is responsible for a vast majority of premature deaths around the world.
Intouch Solutions
JUNE 12, 2023
The MM+M Agency 100 is the annual definitive guide to the world of medical marketing agencies, and it’s an honor to be included each year. Once again, EVERSANA INTOUCH topped the charts at No. 5 (rankings are based on 2022 revenue). Check out our agency profile featuring comments from an interview with Faruk Capan, CEO of EVERSANA INTOUCH and Chief Innovation Officer of EVERSANA, Angela Tenuta, President, Full-Service Agencies, and Boris Kushkuley, President, Commercial and Consulting Services.
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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.
BioPharma Reporter
JUNE 12, 2023
Syncona has launched Beacon Therapeutics, a new ophthalmic gene therapy company with a purpose to restore and improve the vision of patients with retinal diseases, with Â96 million Series A financing.
XTalks
JUNE 12, 2023
Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA). This is BMS’ third commercial CAR T manufacturing facility in the US.
BioPharma Reporter
JUNE 12, 2023
Samsung Biologics has entered into a strategic partnership for the long-term commercial manufacturing of Pfizerâs multi-product biosimilars portfolio.
BioSpace
JUNE 12, 2023
More than 3,000 state and local governments will receive nearly $19 billion in payments from drugmakers and pharmacy chains in the most recent round of opioid settlements.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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