Pharmaceutical Technology

FEBRUARY 7, 2023

One general trend throughout Europe is the use of cost-containment measures to control public spending. As most of the evidence presented during P&R negotiations is generated from the Phase III clinical trial, it becomes critical that payers’ inputs and perspectives have been included in the trial design.

Marketing 130

Marketing Drugs Medicine Clinical Trials 130

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. There are also several ECG patches currently in clinical trials that could soon enter the market. This device is designed such that the electronic components can be easily removed and reused.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Camargo

JUNE 4, 2021

The new product, Zynrelef, is the first modified-release formulation for pain that will be labeled as extended-release; in the three Phase 3 clinical trials, it demonstrated pain reduction through 72 hours. The term “drug” encompasses the whole drug product, including the active ingredient(s), formulation, packaging, and labeling.

Development 130

Development Production Drugs Marketing 130

Sciensano

MARCH 27, 2024

In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day. It is also being promoted as a low-cost medicine via social media, but there is no clinical evidence to confirm that ivermectin is an effective treatment of COVID -19.

Contamination 52

Contamination Bacteria Packaging Packaging 52

Pharmaceutical Technology

NOVEMBER 25, 2022

In one specific case, Cambrex developed a PDF containing two APIs in suspension in an 80/20 ratio. A dedicated team-based approach to project management from formulation and development through manufacturing, analytical, packaging, and regulatory review can also streamline PDF production. Faster to market.

Manufacturing 130

Manufacturing Production Pharma Companies Development 130

Pharma in Brief

MARCH 18, 2021

The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label. The draft guidance also does not address clinical trial use.

Drugs 40

Drugs Packaging Packaging Containment 40

The Pharma Data

DECEMBER 30, 2020

Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. Adding to the list of sketchy hand sanitizers and mouthwashes, a hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, CBS News reported Tuesday. Shane Erickson Inc.

Contamination 52

Contamination Vaccination Vaccine Pharmacy 52

Placebo Control

MAY 23, 2017

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Trials 40

Trials Clinical Trials Clinical Trials Research 40

Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. Traditional human ADME investigations, studies using IVMTs and microdoses, and integrated study designs are all areas in which we specialize.

Bioavailability 130

Bioavailability Manufacturing Drugs Production 130

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements. Could you please confirm?

Packaging 52

Packaging Packaging Drugs Containment 52

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 13, 2022. For more information, please visit www.PAXLOVID.com. . Disclosure Notice.

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

APRIL 26, 2023

We’ve pioneered solutions to distribution and storage requirements In the last few months alone, Pfizer has developed cutting-edge packaging and storage solutions to meet the needs of the varied locations that will be distributing the vaccine - whether they are in a major cites or rural towns. In the U.S.,

Vaccination 52

Vaccination Vaccine Manufacturing Containment 52

The Pharma Data

JANUARY 6, 2021

The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 5, 2020

About the Trial The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Trials 52

Trials Production Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 7, 2023

Rugo, MD, professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, US and principal investigator of the TROPiCS-02 study, in the press release. Trodelvy contains a monoclonal antibody linked to the anticancer cytotoxic drug SN-38.

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

DECEMBER 14, 2020

The filing of an IND will enable participation of US medical centers in future clinical studies of Rabeximod in Covid-19, rheumatoid arthritis and potential other indications. The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies.

Clinical Trials 40

Clinical Trials Clinical Trials Clinical Development Drugs 40

The Pharma Data

APRIL 27, 2021

For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The information contained in this release is as of April 19, 2021. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

Druggist

NOVEMBER 17, 2020

Note: Nexium Control, which is available over the counter contains 20mg of esomeprazole, which is equivalent to prescription-only esomeprazole 20mg. . One study looked at all clinical trials and aided to see if esomeprazole is better than omeprazole in gastroesophageal reflux disease and Helicobacter pylori infection.

Drugs 87

Drugs Production Branding Medicine 87

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 20, 2022. For more information, please visit www.PAXLOVID.com. Disclosure Notice.

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

NOVEMBER 30, 2020

I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice The information contained in this statement is as of January 27, 2023.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

OCTOBER 30, 2020

If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

NOVEMBER 20, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Data from these trials will be used to support a future BLA submission.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 Total global revenue from Cosentyx was $4.79 billion in 2022. and $16,382.51

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

SEPTEMBER 1, 2020

COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia.

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

Production 40

Production Development Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

JUNE 25, 2021

NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against the B.1.351 and Australia.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40

The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Based on this finding, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 17, 2020

Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Antibody 52

Antibody Medicine Production Trials 52

XTalks

FEBRUARY 8, 2024

for a 2-pen package (0.6 & 1.2 for a 3-pen package (1.8 In a clinical trial involving over 3,900 patients across 40 countries, liraglutide demonstrated improved glycemic control as monotherapy by reducing HbA1c values compared with placebo or active comparators. for a pack of three pens, each containing 1.5

Sales 52

Sales Insulin FDA Approval Drugs 52

Druggist

NOVEMBER 17, 2020

Note: Nexium Control, which is available over the counter contains 20mg of esomeprazole, which is equivalent to prescription-only esomeprazole 20mg. . One study looked at all clinical trials and aided to see if esomeprazole is better than omeprazole in gastroesophageal reflux disease and Helicobacter pylori infection.

Drugs 52

Drugs Production Branding Medicine 52

The Pharma Data

OCTOBER 14, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

FDA Approval 52

FDA Approval Antibody Production Trials 52

The Pharma Data

NOVEMBER 21, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Data from these trials will be used to support a future BLA submission.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 11, 2020

managing partner and director of clinical research, Sierra Eye Associates, clinical associate professor of ophthalmology, University of Nevada Presentation date and time: The pre-recorded presentation containing slides and audio will be available to AAO 2020 Virtual attendees starting on Wednesday, November 11.

Development 40

Development Antibody Production Engineer 40

Cloudbyz

AUGUST 19, 2024

Incident Response: Establishing a plan for responding to cybersecurity incidents, including detection, containment, eradication, and recovery. It is conducted through: Clinical Literature Review: Reviewing existing clinical literature and studies related to the device or similar devices to gather evidence of safety and effectiveness.

Compliance 52

Compliance Manufacturing Regulation Marketing 52