Pharmaceutical Technology

OCTOBER 6, 2022

The company will create a comprehensive manufacturing process for NGoXIM to generate batches of the vaccine that are Good Manufacturing Practices-compliant. Additionally, it will work on non-clinical toxicity (TOX) and Clinical Trial Material batch to conduct a Phase I clinical trial of the vaccine in healthy adult subjects.

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Pharmaceutical Technology

AUGUST 15, 2022

The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints.

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Vaccine Vaccination Immune Response Clinical Trials 214

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccine Vaccination Trials Protein 104

XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.

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Manufacturing Vaccine Vaccination Allergies 83

Pharmaceutical Technology

MARCH 31, 2023

Moreover, these events also have ramifications for planned clinical trials. The NHS will be using Covid-19 vaccines manufactured by Pfizer, Moderna and Sanofi. The Sanofi vaccine contains an adjuvant, like Bimervax, to help strengthen the immune response to the vaccine.

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Vaccine Vaccination Immune Response Antibody 277

Pharmaceutical Technology

JUNE 8, 2023

Arexvy contains a combination of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) and GSK’s AS01E adjuvant. Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.”

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Vaccine Vaccination Marketing Manufacturing 147

Pharmaceutical Technology

JUNE 5, 2023

The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities. ITM-11 is being studied in the Phase III COMPETE (NCT03049189) and COMPOSE (NCT04919226) trials, which investigate the drug’s use in patients with different grades of GEP-NETs.

Trials 147

Trials Containment Antibody Manufacturing 147

pharmaphorum

JUNE 14, 2022

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. Coherus’ treatment was rejected on grounds related to the manufacturing process for the drug.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Development 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

The document contains detailed information on the suppliers and their products, alongside contact details to aid your purchasing or hiring decisions. The post Leading API chemical companies in contract marketing appeared first on Pharmaceutical Technology.

Marketing 100

Marketing Manufacturing Generic Drugs Containment 100

Pharmaceutical Technology

OCTOBER 26, 2022

Collaboration and integrated manufacturing. Streamlined clinical trial design with integrated manufacturing can ensure that gene and cell therapies are developed much faster. As the market grows, biopharmaceutical companies will need to be mindful of the scalability of their gene therapy manufacturing processes.

Gene Therapy 130

Gene Therapy Gene Marketing Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

Marketing 100

Marketing Contract Manufacturing Sales Clinical Trials 100

XTalks

APRIL 24, 2023

Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

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.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics. What is driving the biologics API manufacturing services industry.

Gene 100

Gene Marketing Vaccine Vaccination 100

Creogenic Pharma

JULY 8, 2024

Pharma Contract Manufacturing: From the pharmaceutical sector there is a group of businesses that have tasked themselves to assist other businesses to provide better solutions to customers. The CMO supplies technical services assisting the consumer to prevent liability for the hidden costs that may include manufacturing.

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Contract Manufacturing Manufacturing Pharma Companies Containment 52

Delveinsight

JULY 27, 2021

Remarkable drop was observed in altered filamin A plasma levels after treatment with simufilam in Phase 2b trials. a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. P-tau 181 plasma levels were also reduced in a good amount. gingivalis.

Vaccine 96

Vaccine Vaccination Trials Manufacturing 96

Camargo

SEPTEMBER 14, 2021

An IND submission serves as a request to start clinical studies, containing a summary of information known about the drug, including nonclinical studies; chemistry, manufacturing and controls (CMC); and a proposed clinical plan. INDs must contain full study reports of nonclinical and clinical (if available) studies.

Clinical Trials 144

Clinical Trials Clinical Trials Medicine Production 144

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccine Vaccination 75

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We need to consider how to use diverse populations in gene therapy trials. Sites are struggling to activate — even now. .

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Gene Therapy Gene Clinical Trials Clinical Trials 130

XTalks

JANUARY 26, 2021

Resembling silica gel packets found in certain food and commercial products, SAVRPak’s frozen peel-and-stick patches can be placed inside most delivery containers — including clamshell containers, pizza boxes and paper bags — to remove moisture and reduce humidity.

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Containment Packaging Packaging Engineer 111

Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. Fusion proteins. Interferons. Monoclonal antibodies (mAbs).

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Pharmaceutical Technology

AUGUST 3, 2022

During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.

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Development Production Manufacturing Bioavailability 130

Camargo

OCTOBER 14, 2021

Continued development of the use of complex innovative trial designs. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Container-closure changes. Improved predictability in Human Factors and User-Related Risk reviews.

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Development Packaging Packaging Generic Drugs 189

Pharmaceutical Technology

MAY 24, 2023

Braeburn submitted data from a 24-week Phase III trial (NCT02651584) to support approval. The year 2023 has seen some landmark regulatory developments to contain the crisis. In 428 adults with moderate to severe OUD, Brixadi performed similarly to daily sublingual buprenorphine with naloxone, meeting its non-inferiority endpoint.

FDA Approval 147

FDA Approval Pharmacy Pharma Companies Containment 147

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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Vaccine Vaccination Protein Trials 98

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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Bioequivalency Production Contamination Branding 130

The Pharma Data

DECEMBER 4, 2021

company (NASDAQ: AMZN), announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinical trials. (AWS), an Amazon.com, Inc.

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Manufacturing Development Drugs Clinical Supply Chain 52

XTalks

NOVEMBER 23, 2020

Severe cases of the infection did not occur among trial participants, nor were any hospitalizations reported. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

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Vaccine Vaccination Clinical Trials Clinical Trials 97

The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

pharmaphorum

JANUARY 29, 2023

One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti. The post Trial sets up earlier use of J&J’s Carvykti in myeloma appeared first on.

Trials 64

Trials Sales Antibody Clinical Trials 64

XTalks

DECEMBER 8, 2021

While it embodies all the properties of table sugar, Cambya contains no added sucrose or artificial additives. Food and beverage manufacturers are actively seeking feasible means of reformulating their products with reduced levels of sugar due to new legislations and tax levies being placed on sugar. Sweet, in the same press release.

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Branding Manufacturing Marketing Production 121

pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

Gene Therapy 97

Gene Therapy Gene Manufacturing Clinical Trials 97

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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Production Manufacturing Marketing Regulation 115

Pfizer

AUGUST 3, 2022

Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. The information contained in this release is as of August 3, 2022. Disclosure Notice.

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Development Vaccine Vaccination Production 101

Pharmaceutical Technology

FEBRUARY 27, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Antares Pharma overview Antares Pharma is a specialty pharmaceutical company engaged in the development, manufacturing, and commercialization of pharmaceutical products and technologies.

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Drug Delivery Drug Delivery Systems Production Drugs 100