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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Trials Drugs Clinical Trials Clinical Trials 136

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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Containment Drugs Clinical Trials Clinical Trials 181

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

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

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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Drugs Licensing Licensing Pharma Companies 143

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

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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FDA Approval Sales Drugs Clinical Trials 98

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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Drugs FDA Approval Trials Containment 115

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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Vaccination Vaccine Pharma Companies Trials 208

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

Pharmaceutical Technology

FEBRUARY 7, 2023

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. One general trend throughout Europe is the use of cost-containment measures to control public spending.

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Marketing Drugs Medicine Clinical Trials 130

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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Vaccination Vaccine FDA Approval Trials 147

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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Trials Containment Antibody Manufacturing 147

Camargo

SEPTEMBER 14, 2021

The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics. The primary goal of the initial submission is to demonstrate the product’s safety for clinical trial participants and to justify the proposed starting dose in humans.

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Clinical Trials Clinical Trials Medicine Production 144

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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Trials Clinical Trials Clinical Trials Development 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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Gene Therapy Gene Gene Expression Regulation 208

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

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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Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. This was a primary endpoint of the trial.

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FDA Approval Clinical Trials Clinical Trials Containment 130

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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Clinical Trials Clinical Trials Compliance Trials 94

Pharmaceutical Technology

APRIL 4, 2023

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). The trial was jointly conducted by Seagen and Astellas.

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Antibody Containment Clinical Development Trials 130

XTalks

JUNE 16, 2023

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US. The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

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Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

Camargo

OCTOBER 14, 2021

Continued development of the use of complex innovative trial designs. The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. Appellate Court Ruling Impacts Orphan Drug Exclusivity. Continue development of the use of Real-World Evidence.

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Development Packaging Packaging Generic Drugs 189

Delveinsight

JULY 27, 2021

Various Active Pharmaceuticals & Biotechnological Companies including Cassava Sciences, INmune Bio, Cognito Therapeutics, Cortexyme among others presented their new and upcoming drugs, therapies, shared their research studies and clinical data. P-tau 181 plasma levels were also reduced in a good amount. INmune Bio Inc. , gingivalis.

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Vaccination Vaccine Trials Manufacturing 96

Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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Packaging Packaging Marketing Clinical Trials 100

pharmaphorum

APRIL 27, 2021

The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq (atezolizumab) – across six types of cancer.

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Drugs Trials FDA Approval Marketing 90

FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Clinical Trials Trials Regulation 105

XTalks

JANUARY 31, 2022

COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. The third group will contain unimmunized individuals who will get three doses of the omicron shot. Moderna will be evaluating its omicron targeting booster through extension of an earlier study.

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Vaccination Vaccine Trials Antibody 98

Pharmaceutical Technology

JUNE 8, 2023

Last month, Arexvy received approval from the US Food and Drug Administration (FDA ) for the same indication. Arexvy contains a combination of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) and GSK’s AS01E adjuvant. Arexvy demonstrated a statistically significant and clinically meaningful 82.6%

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Vaccination Vaccine Marketing Manufacturing 147