In-Vitro, Medicine and Packaging - Clinical Research Informer

Roche announces donation of essential medicines to Ukraine

The Pharma Data

MARCH 3, 2022

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine. At the same time we are ensuring that our critical medicines and diagnostics reach the people who need them both in Ukraine and other countries impacted by the crisis. Roche vehemently condemns the violent invasion of the country.

Medicine

Medicine In-Vitro Packaging Packaging

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody

Antibody In-Vivo Medicine Vaccination

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

OCTOBER 27, 2022

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.

Life Science

Life Science Compliance Regulation Cosmetics

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg. Christoph D.

Antibody

Antibody In-Vivo Vaccination Vaccine

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

In-Vitro

In-Vitro Antibody Medicine Clinical Trials

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

JANUARY 27, 2023

This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

Marketing

Marketing Production Drugs Licensing

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, 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.

Drugs

Drugs Licensing Licensing Production

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 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.

Drugs

Drugs Vaccination Vaccine In-Vitro

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

The extension of the NDA review period will not impact the Emergency Use Authorization (EUA) or the current availability of the medicine for eligible patients. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. In the U.S.,

Drugs

Drugs Licensing Licensing Containment

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing

Licensing Licensing Drugs Manufacturing

How this biotech is ramping up its psychedelic drug discovery

Drug Discovery World

JULY 22, 2022

Psychedelic plants and fungi have been used medicinally by indigenous populations over thousands of years. In fact, psilocybin is already being deployed alongside more traditional therapies in a number of clinical trials for treatment-resistant depression, anxiety, addiction, and other indications.

Drugs

Drugs In-Vitro In-Vivo Clinical Trials

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.

Vaccination

Vaccination Vaccine Antibody Life Science

Sosei Heptares to Explore Structure-based Drug Discovery (SBDD) Approaches to Ion Channels through Strategic Technology Collaboration with Metrion Biosciences

The Pharma Data

JANUARY 31, 2021

In addition to Metrion, these collaborations with Captor Therapeutics in targeted protein degradation and with PharmEnable to access proprietary artificial intelligence-enabled and medicinal chemistry technologies are a key factor to drive our future growth ambitions.” ” About Sosei Heptares.

Drugs

Drugs Protein In-Vitro Development

Clinical Research Informer

Roche announces donation of essential medicines to Ukraine

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

Trending Sources

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

How this biotech is ramping up its psychedelic drug discovery

COVID-19 Pandemic Coverage

Sosei Heptares to Explore Structure-based Drug Discovery (SBDD) Approaches to Ion Channels through Strategic Technology Collaboration with Metrion Biosciences

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