Rethinking Clinical Trials

JULY 23, 2024

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent and their implications for transparency managing and resp

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Trials Clinical Trials Clinical Trials Doctors 315

Bio Pharma Dive

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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Regulation Sales Marketing Drugs 169

Bio Pharma Dive

JULY 22, 2024

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

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Drugs Trials 293

Pharmaceutical Technology

JULY 22, 2024

As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.

Marketing 272

Marketing 272

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 25, 2024

Ahead of the upcoming Union Budget, prominent voices in the healthcare sector are urging the government to allocate substantial funds to support early diagnosis and intervention for children with autism and neurodevelopmental delays, alongside enhanced training for medical personnel on early disease detection.

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Clinical Trials Clinical Trials Clinical Research Trials 184

Worldwide Clinical Trials

JULY 26, 2024

At Worldwide Clinical Trials’ bioanalytical lab, we view challenges as opportunities to excel and set new standards. The path to drug approval is complex, with many variables and potential delays. That’s why our team is committed to continuous improvement through our initiative, WorldwideEdge, where we optimize everything from our processes to our teams’ performance for each drug development program.

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Clinical Trials Clinical Trials Trials Development 130

Bio Pharma Dive

JULY 22, 2024

Private biotech company acquisitions are on their fastest pace in years, a trend some in the industry say is driven by the abundance of mature, but not yet public, drug startups.

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Marketing Drugs 253

Pharmaceutical Technology

JULY 25, 2024

JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.

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Vaccination Vaccine 237

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 23, 2024

Ultra long, thick eyelashes might be in vogue but are they worth the expense – and the risk to health? Our natural eyelashes perform important functions. The eye is exposed to the elements so it’s a window for bacteria and viruses to enter the body – potentially causing death.

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Bacteria Clinical Trials Clinical Trials Trials 178

Fierce Pharma

JULY 25, 2024

Three months after bagging FDA approval, Pfizer’s hemophilia B gene therapy has been cleared to expand its reach across the pond. | The company's first gene therapy will debut in Europe as Durveqtix. In the U.S., the drug is approved under the brand name Beqvez.

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Gene Therapy Gene FDA Approval Branding 111

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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

Clinical Trials

BioSpace

JULY 23, 2024

AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.

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Bio Pharma Dive

JULY 22, 2024

Serum-based glycoproteins demonstrate success in predicting immune checkpoint inhibitor therapy outcomes.

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Pharmaceutical Technology

JULY 23, 2024

Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 25, 2024

The search for alcohol hangover cures is as old as alcohol itself. Many cures and remedies are sold, but scientific evidence for their effectiveness is lacking. Recently, the notion that taking a shot of olive oil before consuming alcohol can prevent hangovers has garnered attention.

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Clinical Trials Clinical Trials Clinical Research Trials 154

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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.

Clinical Trials

Fierce Pharma

JULY 22, 2024

As lawmakers and industry groups seek to get a handle on U.S. | As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat.

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Medicine Marketing Drugs 118

pharmaphorum

JULY 23, 2024

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.

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Manufacturing Medicine Production Development 111

Pharmaceutical Technology

JULY 24, 2024

BioNTech and Triastek have entered a research partnership focusing on the development of 3D-printed oral RNA therapeutics.

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RNA Development Research 182

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 24, 2024

We’ve known for over a century that mice and rats live longer when they are fed less, but a new study reveals the secret might be an imbalance between energy consumed and burned, rather than a lack of energy or protein.

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Protein Research Clinical Trials Clinical Trials 160

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Fierce Pharma

JULY 24, 2024

From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. | From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.

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Regulation 105

Pharma Times

JULY 24, 2024

The neurodegenerative disease is currently the most common cause of dementia

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Production Research 157

Bio Pharma Dive

JULY 25, 2024

CEO Thomas Schinecker claimed the company has “many opportunities” to stand out in the competitive field, and can get to market “much faster” than investors expect.

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Drugs Marketing 177

Pharmaceutical Technology

JULY 26, 2024

Mankind Pharma has announced a definitive agreement for the acquisition of Bharat Serums and Vaccines (BSV) for Rs136.3bn ($1.6bn).

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Vaccination Vaccine 147

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 24, 2024

India’s lower-income groups face significant financial challenges when it comes to cancer treatment. High medical costs, lack of insurance coverage, and limited access to quality healthcare services exacerbate the situation. Many families are seen to opt between basic necessities and treatment, leading to increased mortality rates and a higher burden of disease.

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Clinical Trials Clinical Trials Clinical Research Trials 166

Fierce Pharma

JULY 25, 2024

While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus (RSV) drug, the near-term expected approval of a pair of new filling lines is giving the | While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus drug, the near-term expected approval of a pair of new filling lines is giving the French pharma assurance that its AstraZeneca-partnered antibody Beyfortus can breach the billion-dollar thre

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Sales Drugs Manufacturing Antibody 108

pharmaphorum

JULY 25, 2024

Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for common brain cancer glioma from Day One Biopharmaceuticals.

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Licensing Licensing Drugs 105

Bio Pharma Dive

JULY 25, 2024

Some analysts described Sanofi’s pipeline of immune system therapies, which includes more than half a dozen drugs in mid- to late-stage testing, as “underappreciated” by investors, as sales of Dupixent rose over the last quarter.

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Sales Drugs 169

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Pharmaceutical Technology

JULY 25, 2024

The UK MHRA has authorised Pfizer-BioNTech’s adapted Comirnaty vaccine against the JN.1 Covid-19 subvariant for adults and children.

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Vaccination Vaccine 147

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 22, 2024

Scientists have figured out a non-invasive way to determine if a transplanted organ is failing to take in a patient – no matter if it’s a kidney, liver, lung, or heart.

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Scientist Clinical Trials Clinical Trials Clinical Research 142

Fierce Pharma

JULY 25, 2024

Among AstraZeneca’s growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. | Among AstraZeneca's growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. And stalling sales underscore the challenges facing the HER2 drug.

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Sales Drugs 106

pharmaphorum

JULY 24, 2024

The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over their business practices and accused them of monopolising the supply chain.

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Pharmacy Drugs 108

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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.

Clinical Trials