AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy. On July 13, 2023, the U.S.

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Pharmaceutical Technology

AUGUST 5, 2022

No progress in drug discovery. “We On the other hand, I think the progress in drug discovery is nil,” comments Requena on the prion disease landscape. According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials.

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pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. Jazz acquired rights to Sativex when it completed its $7.2 billion takeover of Sativex’ developer GW Pharma earlier this year.

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World of DTC Marketing

DECEMBER 13, 2021

Monthly drugs costs may reach $100,000, causing many Americans to struggle with the physical and emotional effects of high out-of-pocket medical costs. Some cancer patients may face out-of-pocket costs of nearly $12,000 a year for one drug. Anderson Cancer Center, argues the prices of these new cancer drugs are “absolutely immoral.”.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 20, 2024

The drug control department in Tamil Nadu will soon introduce an action plan to contain antimicrobial resistance (AMR), and a stakeholders meeting is likely to be held very soon, It is learnt from reliable source that in the state action plan, the drug control department will have a significant role in implementing the programmes.

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy. to treat the signs and symptoms of dry eye disease.

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FDA Approval Bioavailability Containment Drugs 246

Pharma Mirror

FEBRUARY 18, 2022

By Christopher Weikart, Chief Scientist, SiO2 Materials Science Even though drugs are meant to save lives, the primary packaging used for delivering drug therapies and vaccines may actually be putting us in danger. The pharmaceutical industry works hard to create cutting-edge drugs to save lives and keep people healthy.

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Packaging Packaging Drugs Clinical Trials 130

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

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XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).

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Research Dermatology Clinical Trials Clinical Trials 105

Worldwide Clinical Trials

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

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Clinical Trials Clinical Trials Trials Development 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 29, 2023

The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).

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Containment Drugs Research Clinical Trials 180

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 is advancing novel nasal spray-based hydrogels with two innovative platforms: Capture and Contain (C&C) and Trap and Target (T&T). Polyrizon Ltd., million in gross proceeds.

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pharmaphorum

JUNE 14, 2022

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Similar signs of growth can be seen in the amount of drugs, biologics and medical devices the country exports to the US.

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Clinical Trials Clinical Trials Trials Development 98

pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. The limits of animal models in drug discovery are well known. Organ-on-a-chip.

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Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples.

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Clinical Trials Clinical Trials Trials Development 130

Worldwide Clinical Trials

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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Clinical Trials Clinical Trials Pharmacy Trials 200

XTalks

MAY 4, 2023

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease.

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STAT News

DECEMBER 12, 2022

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on. Tasigna made sales of $1.56

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STAT News

JULY 18, 2022

Two members of an expert panel that recommended the Food and Drug Administration approve a fish-oil-based heart drug, Vascepa, said recently released data would have led them to reconsider their votes. Continue to STAT+ to read the full story…

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Drugs Clinical Trials Clinical Trials Containment 98

Advarra

DECEMBER 17, 2024

For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

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Clinical Research Research Trials Clinical Trials 98

World of DTC Marketing

NOVEMBER 27, 2020

Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases , which contained the highly promising news that both vaccines were 90 percent effective or more and have not presented any serious safety concerns. The results of trials were announced in press releases rather than peer-reviewed papers.

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pharmaphorum

AUGUST 6, 2021

Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these important trials. .

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Clinical Trials Clinical Trials Trials Clinical Research 105

Worldwide Clinical Trials

SEPTEMBER 29, 2022

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. Preclinical assays designed to assess drug toxicity and safety must detect total drug. anti-human IgG).

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Reagent Clinical Trials Clinical Trials Antibody 130

pharmaphorum

NOVEMBER 16, 2022

With cases of drug-resistant tuberculosis on the rise again around the world, GSK has sparked hopes of a new treatment option after reporting phase 2a data with a novel antitubercular drug for the disease. The post As resistant tuberculosis rises, GSK says trial backs novel antibiotic appeared first on.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.

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Vaccine Vaccination FDA Approval Trials 147

STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. Food and Drug Administration and the U.S. As for us, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is a Mardi Gras blend. And how is your morning going? To help you along, here are some tidbits.

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Crucial Data Soutions

DECEMBER 15, 2020

A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The sponsor has chosen to take a hybrid approach to their study to decrease risk and increase patient safety, adhering to the FDA’s guidance on conducting clinical trials during the pandemic. It’s winter 2020 and COVID-19 is in full swing.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Pharmaceutical Technology

JUNE 5, 2023

Led by the investment company Temasek, the round will also be used to improve the company’s commercial readiness as its lead radiopharmaceutical candidate ITM-11 is being studied in Phase III trials in gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Other investors included BlackRock, the Qatar Investment Authority, and Nextech.

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XTalks

NOVEMBER 29, 2022

Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.

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XTalks

MAY 24, 2022

There has been a lengthy search to find an HIV cure and there have been a few promising trials, including the stem cell transplantation reported at the 2022 Conference on Retroviruses and Opportunistic Infections (CROI-2022). During the early stage, the drug binds itself between two adjacent capsid monomers and stabilizes the capsid shell.

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Drugs Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities.

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pharmaphorum

OCTOBER 31, 2021

Pilocarpine is already used to reduce pressure inside the eye in ophthalmic diseases like glaucoma, so ophthalmologists are already familiar with the drug, and that could assist take-up of Vuity. The drug is in two phase 3 trials – NEAR-1 and NEAR-2 – that got underway a year ago. Brimochol is in phase 2 testing.

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Drugs FDA Approval Trials Development 105

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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Protein Vaccine Vaccination Trials 97

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Development Bioequivalency Generic Drugs Production 242

Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.

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