XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The Phase III MycarinG study was instrumental in securing this approval.

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pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies.

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Druggist

OCTOBER 21, 2020

I will review the best toenail fungus treatment options available over the counter in the UK. The advantage of the treatment is shorter treatment period as compared to topical products, lasting between 6 weeks and 3 months for fingernails, and 3–6 months for toenails (NICE, 2018). Visible results from two weeks on.

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XTalks

DECEMBER 13, 2023

The company’s sustained investment in R&D has led to a rapid expansion of its pipeline in 2023, with notable milestones such as four infectious disease vaccines in Phase III trials, including the recently submitted respiratory syncytial virus (RSV) vaccine for regulatory approval.

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XTalks

JANUARY 4, 2024

Beqvez is also being reviewed by the US Food and Drug Administration (FDA) with a decision anticipated by mid-2024. There is a significant focus on developing gene therapies as longer-term solutions for the disease. Treatment involves replacing the missing FIX clotting protein, traditionally through regular infusions. Priced at $3.5

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Gene Therapy Gene Gene Editing Sales 111

The Pharma Data

MARCH 18, 2021

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study.

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The Pharma Data

JULY 28, 2021

The positive opinion is based on data from the Phase 3 COMET study, which found that avalglucosidase alfa showed clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease.

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Medicine Clinical Development Vaccination Vaccine 52

Delveinsight

AUGUST 24, 2021

Alexion launched the CHAMPION ALS study – a Phase 3, randomized, placebo-controlled, double-blind clinical trial of C5 inhibitor Ultomoris (Ravulizumab) across a range of 382 ALS participants. The study was held in around 90 sites in Europe, Asia, and North America.

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The Pharma Data

JUNE 18, 2021

The EC approval is based on data from the Phase 3 TERIKIDS study. 3 , 4 Compared with adult-onset MS, pediatric patients often present with higher relapse rates and a greater lesion burden. 3 The symptoms of MS can impact all aspects of a young person’s life from physical health to social development and self-esteem.

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The Pharma Data

SEPTEMBER 6, 2021

First data to be presented from the phase II coopERA Breast Cancer study evaluating neoadjuvant giredestrant treatment for oestrogen receptor (ER)-positive, HER2-negative breast cancer. Breast Cancer Highlights. Lung Cancer Highlights. Innovation in Personalised Healthcare.

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Delveinsight

AUGUST 17, 2021

The efficacy and safety results were produced from a broad research study, multicenter, open-label, randomized phase 3 trial data from the Keynote-581 trial of the first-line therapy indicated to the patients that resulted in an extension of their survival. Acting FDA Commissioner Janet Woodcock, M.D.

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The Pharma Data

JULY 25, 2021

Allergan, an AbbVie company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. Waring IV, M.D.,

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Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. while the IND is in review? A: Yes, the EUA is just temporary. A: No, this is not allowed.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” said Levi Garraway, M.D.,

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The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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Camargo

JUNE 4, 2021

Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. The product was approved for use in adults, and the Pediatric Research Equity Act (PREA)-required pediatric studies were deferred.

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Clinical Trial Podcast

FEBRUARY 23, 2021

General Contractor” for the study. In some companies, Clinical Project Managers (CPM) may be referred to as Clinical Trial Managers (CTM) or Study Managers. A great PM will recognize the downstream effects of study startup delays. Not only that but the PM will also adjust the study budget. Want to refer to this later?

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WCG Clinical

MAY 24, 2023

Improving site feasibility is a complex challenge that demands a comprehensive solution. A Broken Status Quo Sponsors are stuck: The cycle times associated with study startup, including site identification and activation, have changed little over the past 20 years. The study team is identified. Sites are frustrated.

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Clinical Trial Podcast

JULY 18, 2020

Sites are responsible for site-specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. CEC is generally composed of 3 or more physicians.

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Eye on FDA

DECEMBER 10, 2020

Usually prior to an FDA Advisory Committee meeting where a product is being considered for approval, the posting of the FDA Reviewer comments is greatly anticipated for what it will say about the potential shortcomings of the investigative compound under consideration. Experience has taught us well that should not be the case.

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Vaccination Vaccine Development Trials 97

Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. NEW YORK and MAINZ, GERMANY, November 3, 2022 — Pfizer Inc.

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The Pharma Data

MARCH 22, 2021

The 2,400 mg and 1,200 mg doses tested in the phase III study had similar efficacy across all endpoints. Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab. Key results from phase III REGN-COV 2067 trial in non-hospitalised patients 1-3.

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The Pharma Data

APRIL 17, 2021

TECFIDERA was approved under the National Medical Products Administration priority review process evaluating therapies with urgent clinical needs. We thank the NMPA for undertaking priority review to approve TECFIDERA. Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy.

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The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . Data from the Phase 2 portion of BRAVE-AA1, an ongoing Phase 2/3 study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared.

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Dermatology Development Medicine Clinical Trials 52

The Pharma Data

MARCH 13, 2021

The submission of the New Drug Application in Japan is primarily based on results of the global Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE), in addition to interim results of a Phase 3 study evaluating the efficacy and safety of lanadelumab in Japanese subjects.

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The Pharma Data

MARCH 3, 2021

(Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. George Scangos, Ph.D., About the Vir and GSK Collaboration.

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Trials Antibody Vaccination Vaccine 52

XTalks

MAY 13, 2022

In a webinar presented by Curia (formerly AMRI), experts from the company discussed primary packaging solutions for pharmaceuticals and medical devices, including the different types of tests required by regulatory agencies to ensure that a product’s container closure system is adequate. Stability Studies. Packaging Testing.

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Packaging Packaging Containment Production 98

Drug Discovery World

OCTOBER 20, 2022

According to the Japan External Trade Organization (JETRO), Japan’s upper hand on ageing populations, advanced technologies and solutions means they are continuously developing in the fields of medical devices, regenerative medicine, pharmaceuticals, and preventive medicine. Start-up ecosystem . Academia and research .

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Development Drugs Life Science Marketing 52

WCG Clinical

JUNE 12, 2023

Over the last decade, Phase III trials saw a 70% increase in procedures and a 300% increase in data collection points. Yet, only 8% of protocols utilize a PAB, according to Tufts Center for the Study of Drug Development. Clear communication before, during and after the study can bolster enrollment and retention.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Drug Discovery World

MARCH 29, 2023

An example of the current disparity, drawn from data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), can be seen in Romania, Poland or Bulgaria, where a recently approved medicine will take more than 800 days on average before it becomes publicly available compared with Germany, where that figure is 133 days 3.

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The Pharma Data

MAY 4, 2021

360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. . For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization , Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers ( English ; Spanish ).

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pharmaphorum

DECEMBER 6, 2022

Recognising an opportunity to develop better tools for clinical trial leaders to share and stream data, YonaLink’s co-founders built a software solution that addresses the interoperability gap in clinical trial operations. As an average Phase 3 trial amasses over 3.6 It makes everything more efficient and more accurate.”.

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The Pharma Data

JUNE 18, 2021

The four- year results of the CLL14 study show that 74 percent of patients treated with fixed-duration venetoclax-obinutuzumab remain without PFS event, more than three years after treatment cessation,” said Othman Al-Sawaf, M.D., Efficacy was based on PFS as assessed by an independent review committee. NORTH CHICAGO, Ill.

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The Pharma Data

DECEMBER 11, 2020

The FDA based its decision on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published this week in The New England Journal of Medicine. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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XTalks

AUGUST 4, 2022

The webinar concluded with Dr. Sara Sampaio, MD, CCRP, Manager, Patient Recruitment, Medpace, describing the solutions to promote diversity, equity and inclusion in clinical trials. For example, 25 percent of the US Black population is Generation Z and population diversity by age can vary ( Figure 3 ). Diversity differences by age. “If

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The Pharma Data

APRIL 30, 2021

The applications are supported by two Phase 3 studies in which Skyrizi demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo. Results from the Phase 3 maintenance study and regulatory submissions are expected in 2H 2021.

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The Pharma Data

DECEMBER 14, 2020

Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204, or email: prospectus-eq_fi@jpmchase.com ; Goldman Sachs & Co. Umbralisib is currently under review by the U.S. Attention: Capital Markets, 499 Park Ave.,

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