Olympian Clinical Research

JUNE 27, 2023

Typically, it’s wise to avoid: Dairy products and their alternatives (cow’s milk, cheese, butter) Gluten-containing grains (wheat, barley, rye) High-sugar foods and refined carbohydrates (sugary treats, sodas, processed snacks) Processed and packaged foods with additives, preservatives, and artificial ingredients.

Clinical Research 52

Clinical Research Packaging Packaging Doctors 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 Packaging 40

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The post How the IND 30-day Hold Impacts Clinical Trial Activities appeared first on Advarra. “Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. 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

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The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a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 The draft guidance also does not address clinical trial use.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

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. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

Packaging 52

Packaging Packaging Drugs Containment 52

XTalks

DECEMBER 8, 2021

While it embodies all the properties of table sugar, Cambya contains no added sucrose or artificial additives. For the time being, Cambya will be produced in Europe and will run on plug-and-play business models, helping food and beverage brands reformulate their consumer packaged goods (CPG) products. Sweet, in the same press release.

Branding 121

Branding Manufacturing Marketing Packaging 121

The Pharma Data

JANUARY 13, 2021

Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

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

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

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

Vaccination 52

Vaccination Vaccine Protein Genetics 52

Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

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

The Pharma Data

DECEMBER 14, 2020

The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinical development to the United States.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Development Drugs 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. In addition to the University of Oxford-led trials, the Company is conducting a large trial in the US as part of a global programme.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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

The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

Production 52

Production Antibody Manufacturing 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

XTalks

NOVEMBER 16, 2021

Kroger, America’s largest grocery chain, announced last month it would be expanding an online trial with Loop , a circular economy platform focused on reusable packaging for branded products. Now, the trial has resumed in 25 Fred Meyer store locations in Portland, Oregon. Zero-Waste Grocery Stores.

Packaging 98

Packaging Packaging Branding Production 98

The Pharma Data

MAY 14, 2021

And after many trials, I’ve perfected a simple, yet powerful formula, consisting of amazing vitamins and plants – such as Vitamins C and E, Magnesium, Zinc, Chromium, Bitter Mellor, Licorice, Cinnamon, Yarrow, Juniper and many others! CLICK NOW TO SECURE YOUR PACKAGE WHILE SUPPLIES LAST! for as long as supplies last.

Production 52

Production Packaging Packaging Insulin 52

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.

Containment 111

Containment Packaging Packaging Engineer 111

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

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Production Trials Medicine 40

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

Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. On 15 March, Eli Lilly (Indianapolis, Indiana) suspended the export of 'non-essential medicines' to Russia.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

XTalks

MAY 18, 2023

The wireless charger — the transmitter — contains a metallic coil that converts electrical energy into a magnetic field, which is then collected and reverted into electricity by the receiver inside the implanted device. Resonant Link’s medical device chargers are undergoing animal trials this year.

Development 96

Development Packaging Packaging Manufacturing 96

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.

Gene 100

Gene Marketing Vaccination Vaccine 100

Camargo

AUGUST 22, 2021

The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC. A trial summary dataset (ts.xpt) containing the study start date in YYYY-MM-DD format is present. Where Are the Technical Rejection Criteria for Study Data Applied?

Containment 190

Containment Bioavailability Cosmetics Packaging 190

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production 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. £11.99.

Drugs 87

Drugs Production Branding Medicine 87

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Trials 52

Pfizer

AUGUST 15, 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. FDA Emergency Use Authorization Statement. No dosage adjustment is needed in patients with mild renal impairment.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

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

FDA Law Blog

SEPTEMBER 20, 2021

Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments. Part 1 can be submitted as much as 2 months (but no more than 3 months) before completing the application with the submission of Part 2, containing the finalized clinical study reports and summaries.

Development 52

Development Gene Therapy Production Drugs 52

The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., Concomitant use of preparations containing St.

Medicine 40

Medicine HR Trials Production 40