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The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a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 The draft guidance also does not address clinical trial use.

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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). However, stakeholders should be aware that the leaked review contains no such analysis.

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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?

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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.

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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.,

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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. ,

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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.

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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.

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The Pharma Data

DECEMBER 5, 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. (..)

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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.

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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.

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The Pharma Data

JUNE 18, 2021

Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Concomitant use of preparations containing St. 7 VENCLEXTA (venetoclax) [Package Insert]. and by AbbVie outside of the U.S. John’s wort as Venclyxto efficacy may be reduced.

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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.

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The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers.

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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.

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Drug Discovery World

AUGUST 24, 2023

As of February 2023, there are no approved therapeutic products containing psilocybin in Canada. The insititute’s current clinical trials include PSIL201, PSIL201 LTFU, PSIL102 TQT, and PSIL102 – Food Effect (Part 2). One such focus is psilocybin.

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Drug Discovery World

MARCH 27, 2023

The UK government endorses TREs, having recently announced an investment package of up to £200 million in TREs and digitally enabled clinical trials 4. A robust environment will contain secure access controls that can prevent and detect misuse of data.

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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.

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Pfizer

NOVEMBER 23, 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 November 23, 2022. Our Commitment to Access. Disclosure Notice.

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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

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