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COVID-19

Generales

AstraZeneca suspends leading COVID-19 vaccine trials after a participant's illness

AstraZeneca Plc said it has paused global trials, including large late-stage trials, of its...

EU expands scope of Imbruvica to include untreated CLL patients

The European Commission (EC) has expanded the marketing authorisation for Janssen's Imbruvica...

Novacyt launches two gene COVID-19 test

Novacyt (OTC:NVYTF) launches its CE-Mark'd two-gene COVID-19 test molecular test in countries...

South Korea's Celltrion to begin commercial production of COVID-19 antibody drug

South Korea’s Celltrion Inc will begin commercial production of its experimental treatment...

AbbVie puts $2B on the table for I-Mab cancer collab as biotech nabs $418M raise

It’s a good day for Shanghai-based I-Mab, which has penned a $2 billion upfront-biobucks...

SyntheticMR Receives Japanese Approval for MRI Software

Japan’s Pharmaceuticals and Medical Devices Agency has approved SyntheticMR’s SyMRI software that...

Genentech's Gavreto cleared for RET non-small cell lung cancer

US regulators have approved Genentech's Gavreto (pralsetinib) for the treatment of adults with...

Hopeful News on Parkinson's: More Than 100 Trials Underway

While there are treatments to alleviate symptoms of Parkinson's disease, there is no known cure...

Study of China "insect" vaccine for COVID-19 set to begin

China's National Medical Products Administration has signed off on a clinical trial evaluating a...

Moderna concludes advanced talks with EU for COVID-19 vaccine supply

Moderna Inc said on Monday it has concluded advanced exploratory talks with the European Commission...

Italy begins testing potential COVID-19 vaccine on volunteers

Italy kicked off human trials of a potential COVID-19 vaccine on Monday, joining a global effort to...

Drugmaker ramping up production of potential coronavirus vaccine in record time

Drugmaker AstraZeneca's potential coronavirus vaccine is now in advanced trials, and the company...

Gilead seeks U.S. approval for COVID-19 treatment remdesivir

Gilead Sciences Inc (GILD.O) has filed an application with the U.S. Food and Drug Administration...

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

The United States has entered an agreement with drugmaker Moderna Inc (MRNA.O) to acquire...

Kamada initiates early-stage study for its plasma-therapy for COVID-19

Kamada (NASDAQ:KMDA) has recruited the first patient to its Phase 1/2 trial of its anti...

Putin hails new Sputnik moment as Russia is first to approve a COVID-19 vaccine

President Vladimir Putin said on Tuesday that Russia had become the first country to grant...

COMUNICADO CANIFARMA MARZO

La industra farmaceútica apoya las acciones del gobieron para frenar el covid...

Moderna gets further $472 million U.S. award for coronavirus vaccine development

Reuters) - Moderna Inc (MRNA.O) said on Sunday it has received an additional $472 million...

Merus nabs US Orphan Drug tag for Zeno in pancreatic cancer

The FDA has designated Orphan Drug status for Merus's (MRUS -0.9%) Zenocutuzumab...

Hahn says COVID-19 vaccines will be reviewed in ‘real time’

At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus...

Head of China CDC gets injected with experimental vaccine

BEIJING (AP) — The head of the Chinese Center for Disease Control and Prevention...

MediciNova inks deal to jointly develop SARS-CoV-2 Vaccine in Japan

MediciNova (NASDAQ:MNOV) announces an agreement to jointly develop a...

Virology institute launches Russia's second COVID-19 vaccine human trial

MOSCOW (Reuters) - A Russian state virology institute has started human trials of...

PRIME status for Adaptimmune's synovial sarcoma drug

The European Medicines Agency (EMA) has awarded Adaptimmune's ADP-A2M4 PRIME...

Nearly 160 coronavirus vaccines are in the works. Here’s a closer look at the science

In the world of virology, the nomenclature of war comes easy. The human body is a citadel...

Big data graphs are playing an important role in the coronavirus pandemic

Researchers from many outlets are turning to graphs in an effort to connect pieces of data related...

Sanofi's latest investment signals long-term focus on vaccines

Sanofi on Tuesday announced plans to build a vaccine manufacturing site and a separate...

Cobra Biologics signs AstraZeneca deal to supply COVID-19 vaccine

Cobra Biologics on Tuesday said it had signed a supply agreement with AstraZeneca...

Nearly 160 coronavirus vaccines are in the works. Here’s a closer look at the science

In the world of virology, the nomenclature of war comes easy. The human...

Israel signs deal to acquire Covid-19 vaccine from Moderna

Moderna announced it was concluding its phase two testing for the vaccine and plans...

Sinovac reveals positive preliminary data for COVID-19 vaccine

Beijing, China-based Sinovac Biotech has announced that early results from its phase...

MHRA suspends COVID-19 hydroxychloroquine trials

The current recorded case count for COVID-19 (coronavirus) in the UK...

Sysmex Obtains Japan Marketing Approval for Use of Saliva With Coronavirus Kit

Sysmex said Tuesday it has obtained marketing approval in Japan for the use of....

India lifts export ban on Trump-touted drug hydroxychloroquine

India has lifted an export ban on hydroxychloroquine, the anti-malarial drug touted by U.S...

EU plans advance purchase of up to six promising covid-19 vaccines - sources

The European Commission is seeking a mandate from EU governments to buy in advance...

AstraZeneca to deliver 400M vaccine doses to Europe once approved

AstraZeneca announced Saturday that it has reached an agreement with the Inclusive Vaccines...

Gilead's next step on coronavirus: inhaled remdesivir, other easier-to-use versions

Gilead Sciences Inc (GILD.O) is developing easier-to-administer versions of its antiviral treatment...

South Korea firm says COVID-19 antiviral drug results positive

SEOUL, June 1 (UPI) -- South Korean pharmaceutical firm Celltrion announced positive results from...

MeMed Receives CE-IVD Mark for Infectious Disease Test, POC Platform

NEW YORK – Infectious disease diagnostics company MeMed said on Tuesday that it has received...

Global trial to assess chloroquine against COVID-19 in health workers

More than 50,000 healthcare workers worldwide will be enrolled in a clinical trial to...

Quidel assay wins EUA to detect COVID-19 without extraction step

Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency...

WuXi Biologics clinches deal to build first U.S. facility at Boston area hub

WuXi Biologics has angled for years to expand its manufacturing base out of China...

Oxford University and NIH COVID-19 vaccine shows success in rhesus macaques

A vaccine currently in Phase I clinical trials was effective at inducing immune responses...

New COVID-19 test allows rapid detection of past infections

Professor Wang Linfa, Director of the Duke-NUS’ Emerging Infectious Diseases programme, and...

NIH Launches Clinical Trial to Study Hydroxychloroquine Efficacy in COVID-19

The lack of treatment options for COVID-19 patients, potential promise in repurposing...

Takeda says coronavirus treatment trial using recovered patients' blood could start in July

Takeda Pharmaceutical Co Ltd could start a clinical trial as early as July for...

Takeda gets expanded EC approval for lymphoma drug Adcetris

Takeda Pharmaceutical has secured expanded approval from the European ...

Nevro Nabs CE Mark for Spinal Cord Stimulation System

Nevro’s Senza Omnia spinal cord stimulation system (SCS) has received the CE mark for...

Chinese drugmaker in talks to test virus vaccine globally

With China having largely curbed its growth of new infections, its drugmakers will need to...

Latest Abbott coronavirus antibody test receives FDA emergency use OK

Abbott on Monday announced the FDA granted emergency use authorization for...

Moderna's potential coronavirus vaccine gains FDA's 'fast track' status

Moderna Inc said on Tuesday the U.S. Food and Drug Administration granted...

Gilead signs licenses for generic companies to make and sell remdesivir in 127 countries

Seeking to blunt concerns about access to its remdesivir treatment for Covid...

Gilead Outlines Efforts to Expand Global Supply of Remdesivir for COVID-19

Gilead Sciences’ antiviral drug remdesivir is, to date, the only approved drug...

Japan approves Gilead Sciences' remdesivir as COVID-19 drug

Japan on Thursday approved Gilead Sciences Inc’s remdesivir as a treatment...

Antiviral Trio Shows Mettle Against COVID-19

A triple whammy of three antiviral drugs shows promise in fighting mild to...

Takeda's subcutaneous version Entyvio OK'd in Europe

The European Commission has granted Takeda Pharmaceutical (NYSE:TAK) a Marketing Authorization...

Coronavirus Antibody Test From Biomerica Gets CE Mark

Biomerica said on Thursday it received a CE mark for its COVID-19...

'Tuskegee always looms in our minds': Some fear black Americans, hardest hit by coronavirus, may not get vaccine

David Graham is a nurse practitioner who...

WHO launches ambitious global project to develop Covid-19 medical products

Led by the World Health Organization, a long list of countries...

Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine

The Trump administration is organizing a Manhattan Project-style effort...

Funding the development and manufacturing of COVID-19 vaccines: The need for global collective action

On February 20, the World Bank and the Coalition...

COVID-19 clinical operations

ICON has a range of existing services that will support you to keep your clinical...

Heartburn drug being studied as COVID-19 treatment

A heartburn drug is being studied as a possible treatment for COVID-19 patients in New York...

Leaked data on Gilead's remdesivir suggest drug didn't help patients with COVID-19

Patients in China who received Gilead's experimental antiviral drug remdesivir...

MDR delay official as industry calls to push back IVDR

The European Council voted 27-0 on Wednesday to adopt an amendment to delay...

If Sanofi’s coronavirus vaccine works, CEO says it can produce up to 600 million doses next year

French drugmaker Sanofi expects to produce up to 600 million doses of its coronavirus...

Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment

Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral...

Novartis, U.S. regulators agree to malaria drug trial against COVID-19

ZURICH, April 20 (Reuters) - Novartis has reached an agreement with U.S...

Guanfacine extended-release effective, safe for adult ADHD

Guanfacine extended-release was associated with significant improvement in adult...

NIH partners with 16 drug companies in hopes of accelerating Covid-19 treatments and vaccines

WASHINGTON — The National Institutes of Health on Friday announced...

DiaSorin to Launch COVID-19 Test in Italy

DiaSorin announced that it has completed studies in Italy for its COVID-19 test...

Despite COVID-19, Patients Are Interested In New Trials

When the COVID-19 pandemic hit, the pharmaceutical industry was hit along...

UPDATE 1-Congo records third new Ebola case from same infection chain -WHO

KINSHASA, April 13 (Reuters) - The Democratic Republic of Congo recorded...

Researchers studying a variety of COVID-19 treatments in the pipeline

The puzzle continues over whether much-ballyhooed drugs actually...

Moderna Zika vaccine shows promising action in early-stage study

Ahead of its Vaccines Day event today, Moderna (NASDAQ:MRNA)...

Alnylam's vutrisiran Fast Track'd for rare inherited nerve disorder

The FDA grants Fast Track status for Alnylam Pharmaceuticals...

Clinical and epidemiologic features of COVID-19 in children

Children with COVID-19 tended to have milder clinical manifestations...

China approves two experimental coronavirus vaccines to enter clinical trials

BEIJING (Reuters) - China has approved early-stage human tests for two...

Sanofi partners with GSK for developing coronavirus vaccine

Sanofi and GSK have entered an agreement to jointly create a Covid-19...

Gilead files application in Canada for HIV med for pre-exposure prophylaxis

Gilead Sciences' (NASDAQ:GILD) Canadian unit has filed a supplemental...

Novavax fast-tracks phase 1 testing of coronavirus vaccine

Novavax has announced that its primary coronavirus vaccine candidate – NVX-CoV2373...

Biotech Gilead supersizes remdesivir trials, changes primary endpoint

Gilead Sciences has made major mid-study changes to its global...

The coronavirus spreads at least 13 feet, travels on shoes: CDC

The coronavirus can travel through the air at least 13 feet — more than...

BGI Unveils Inflatable P2 Lab for Emergency COVID-19 Testing

BGI, in collaboration with the company Etopia, have jointly designed a mobile...

Tiziana develops delivery tech for COVID-19 treatment

As of this morning – Thursday April 9 – the current recorded case count for COVID-19...

Covid-19 early warning system for medical staff developed in Cork

Cork University Hospital model remotely identifies those with a rising temperature...

FDA's Hahn: No sign China has affected U.S. drug supply during coronavirus pandemic

With pharmaceutical supply chains under immense pressure due...

WHere Are All the Companies Working on COVID-19 Vaccines, Treatments, and Testing

An investor's guide to healthcare companies' coronavirus efforts...

WHO says coronavirus vaccine and treatment research has ‘accelerated at incredible speed’

More than 70 countries have joined WHO’s trial to accelerate...

Precision Bio commences study of CAR T therapy in blood cancerss

Dosing is underway in a Phase 1/2a clinical trial evaluating Precision...

Anti-Parasitic Drug Halts Coronavirus Replication in Lab-Grown Cells within 48 Hours

An anti-parasitic drug that is available around the world stops SARS-CoV-2...

BGI, Aid Genomics Partner to Build COVID-19 Testing Lab in Gaza

NEW YORK – BGI of China and Israeli medical technology company Aid Genomics...

Genetron Health Gets CE Mark for Coronavirus PCR Test

NEW YORK – Chinese cancer genomic profiling firm Genetron Health said on...

India lifted its ban on the export of hydroxychloroquine — Trump's unproven coronavirus 'cure' — hours after the president threatened 'retaliation' if it didn't do so

President Donald Trump meets and Indian Prime Minister Narendra Modi...

Pfizer sterile injectables plant in India slapped with warning letter

When Pfizer received a warning letter for an older, Hospira sterile...

Gilead ramps up production of experimental Covid-19 treatment amid criticism over access

In response to intensifying demand, Gilead Sciences (GILD) has been...

Makers of a new saliva Covid-19 test seeks EUA from FDA despite not needing it

A company with CLIA certification has developed a saliva test for Covid-19...

New BD, BioGX coronavirus test can be run on-site at hundreds of U.S. hospitals

Becton Dickinson (NYSE:BDX) and BioGX announced today that the FDA granted emergency...

Convalescent plasma transfusion shows promise for severely ill patients with COVID-19

Preliminary research has shown the potential of convalescent plasma...

Tocilizumab may be effective for patients with COVID-19, blood cancer

The immunosuppressant tocilizumab may be an effective treatment...

Regulator OKs 1st AI-based cancer diagnosis software

The Ministry of Food and Drug Safety has approved the first artificial...

Swiss and German Team to Develop Inhaled mRNA Coronavirus Treatment

The Swiss antibody specialist Neurimmune and the German RNA biotech...

Siemens Healthineers Announces Availability of Molecular Fast Track Diagnostics SARS-CoV-2 Assay Test Kit

Siemens Healthineers (Erlangen, Germany) has released its molecular...

Fresinius Medical Care names new CEO

Fresenius Medical Care Korea said Wednesday that it has appointed...

Rendu Biotechnology Gets Emergency Approval in China for Coronavirus Detection Kit

NEW YORK — Rendu Biotechnology said on Monday that it has received...

Biolidics to launch ten-minute rapid test kits for COVID-19

The medtech company has obtained provisional authorization from Singapore’s HSA...

Gilead suspends access to experimental COVID-19 drug

Gilead Sciences is temporarily suspending access to its experimental COVID-19...

AbbVie gives up patent rights to HIV med Kaletra amid COVID-19 tests: report

With international scrutiny focusing on a narrowing set of drugs currently in...

When might experimental drugs to treat Covid-19 be ready? A forecast

There is a desperate need for new medicines to treat Covid-19...

India bans export of drug being tested for coronavirus treatment

NEW DELHI (Reuters) - India said on Wednesday it had banned the export of...

DiaCarta SARS-CoV-2 Test Kit Receives CE Mark

NEW YORK – Molecular diagnostic firm DiaCarta said on Monday that its...

Real-world data (RWD) will become the bedrock that informs pharma corporate strategy

It is well known that pharma’s development cycle of more than 10 years...

AusDiagnostics Gets CE Mark for Multiplex Coronavirus, Flu, RSV Assay

NEW YORK — AusDiagnostics said on Monday that it has received CE marking for...

What are pharmaceutical companies doing to tackle COVID-19?

Pharmaceutical companies have deep scientific knowledge gained from decades...

Protecting health-care workers from subclinical coronavirus infection

Health-care workers face an elevated risk of exposure to infectious diseases...

Letter from IQVIA CEO and Leadership Team

The growing outbreak of COVID-19 has affected each one of us in multiple ways...

WHO announces trial of potential coronavirus drugs

The World Health Organization announced that it will initiate a multicountry clinical trial to test four...

COVID-19

Organizaciones Internacionales

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research...

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts...

Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies

Health Canada has followed up on the two reports of anaphylactoid reactions to Pfizer BioNTech’s...

Authorization of Pfizer-BioNTech COVID-19 Vaccine with English-only Carton and Vial Labels

On December 9, 2020, Pfizer-BioNTech COVID-19 Vaccine (COVID-19 mRNA Vaccine) (DIN 02509210) was authorized...

Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies

Health Canada has followed up on the two reports of anaphylactoid reactions to Pfizer BioNTech’s...

CBPF: Anvisa completa mais um passo para a avaliação das vacinas

Equipe finalizou as inspeções para a Certificação de Boas Práticas de Fabricação. Fim do processo ainda depende de informações complementares...

Verificación técnica de plantas en la Federación Rusa

Funcionarios/as de ANMAT viajarán la próxima semana para la verificación técnica de plantas...

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products...

FDA Sets Up Vaccine Safeguards to Counter Pressure From Trump

An unsubstantiated claim two weeks ago by President Donald Trump — that the “deep state” was slowing...

REGENXBIO on go with mid-stage study of gene therapy for diabetic retinopathy

The FDA has signed off on a Phase 2 clinical trial, ALTITUDE, evaluating REGENXBIO's (NASDAQ:RGNX)...

Lista de dispositivos médicos prioritarios en el contexto de la COVID-19, 13 de agosto del 2020

La lista de dispositivos médicos prioritarios en el contexto de la COVID-19...

ANVISA lanza informe sobre sus acciones para combatir la pandemia

ANVISA ha publicado un informe que destaca la actuación de la Agencia...

NOWDiagnostics’ COVID-19 Antibody Test Cleared in Europe

NOWDiagnostics has received a CE Mark for a 15-minute COVID-19 antibody...

Uso de emergencia de intervenciones no probadas y fuera del ámbito de la investigación

La pandemia de COVID-19 nos enfrenta a la urgencia moral de llevar a cabo...

Infografía: Ética e investigación. 10 datos claves sobre investigación durante la pandemia

Esta infografía lista los pasos a seguir cuando se conducen investigaciones durante la pandemia...

Health Canada: acciones relacionadas con el COVID-19

Respiradores N95 Falsificados/no registrados...

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The U.S. Food and Drug Administration (FDA) will host a virtual...

Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design

Scientists from the U.S. Food and Drug Administration (FDA) have identified specific...

Health Canada: acciones relacionadas con el COVID-19

Health Canada advierte sobre los riesgos del uso de respiradores N95 falsificados...

Merck, Walmart, IBM, and KPMG's FDA Blockchain Pilot: Here's What We Learned

IBM, KPMG LLP, Merck and Co. Inc., and Walmart Inc. successfully completed an FDA...

FDA names five companies recalling NDMA-contaminated metformin

The US Food and Drug Administration (FDA) announced on Thursday that five companies...

FDA Grants EUAs for Coronavirus Tests From Cue Health, Tide Laboratories, TBG Biotechnology

The US Food and Drug Administration on Wednesday issued separate Emergency...

FDA Issues Recall Alert for Metformin ER Products

On May 28, the FDA announced(www.fda.gov) that it had asked five pharmaceutical firms to voluntarily...

EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...

FDA updates COVID-19 clinical trials guidance to address serious adverse events

The US Food and Drug Administration (FDA) last week updated its guidance on...

Consideraciones regulatorias sobre la autorización del uso de plasma de convalecientes (PC) para atender la emergencia de COVID-19, 22 de abril de 2020

...

Utilización de decisiones de otras autoridades regulatorias para autorizar el uso de emergencia de medicamentos y otras tecnologías sanitarias en una pandemia (por ejemplo, COVID-19)

...

Manejo de crisis durante epidemias: orientaciones generales para las autoridades reguladoras nacionales para coordinar la respuesta de forma eficiente, mayo de 2020

...

WHO embraces plan for Covid-19 intellectual property pool

In response to the global race to combat the Covid-19 pandemic, the World Health Organization...

WHO sees "potentially positive data" on COVID-19 treatments

The World Health Organization said on Tuesday that some treatments...

NIH begins study of remdesivir with anti-inflammatory drug to treat COVID-19

The National Institutes of Health said on Friday it has started a clinical...

FDA OKs new use of AstraZeneca and Merck's Lynparza

AstraZeneca (NYSE:AZN) and collaboration partner Merck (NYSE:MRK) announce the...

First at-home saliva test for COVID-19 earns FDA approval

The U.S. Food and Drug Administration (FDA) has approved the first at-home...

COFEPRIS: acciones en COVID-19o

La Autoridad Regulatoria Nacional en Mexico (COFEPRIS) ha publicado en su pagina web sus acciones p...

ISP de Chile: acciones regulatorias relacionadas con COVID-19

El Instituto de Salud Pública de Chile ha actualizado las acciones sobre el COVID-19...

FDA: acciones actualizadas con relación al COVID-19

La información actualizada respecto a las acciones de la FDA con relación al COVID-19 se encuentranico durante una pandemia presenta un número...

Health Canada: acciones relacionadas con el COVID-19

Health Canada advierte sobre los riesgos del uso de respiradores N95 falsificados/...

ANMAT: acciones regulatorias relacionadas con el COVID-19

En su página en línea, la Autoridad Regulatoria Nacional de Argentina (ANMAT) mantiene información...

ANVISA: acciones relacionadas al COVID-19

La Agencia Regulatoria Nacional de Brasil, Anvisa, ha realizado una serie de acciones...

OMS: Ética y SRAS-CoV-2 – Medidas restrictivas y distanciamiento físico

El uso de medidas restrictivas y de distanciamiento físico durante una pandemia presenta un número...

Italy's DiaSorin gets U.S. FDA approval for COVID-19 antibody test

Italian diagnostics group DiaSorin said on Saturday it had received an Emergency Use Authorisation (EUA)...

ANMAT: acciones regulatorias relacionadas con el COVID-19

En su página en línea, la Autoridad Regulatoria Nacional de Argentina (ANMAT) mantiene...

ANVISA: acciones relacionadas al COVID-19

La Agencia Regulatoria Nacional de Brasil, Anvisa, ha realizado una serie de acciones regulatorias...

Health Canada: acciones relacionadas con el COVID-19

Health Canada advierte sobre los riesgos del uso de respiradores N95...

INVIMA: acciones relacionadas con COVID-19

Se encuentra disponible un sitio web donde podrán encontrar la información actualizada sobre las medidas...

CHILE: acciones regulatorias relacionadas con COVID-19

El Instituto de Salud Pública de Chile ha publicado las acciones sobre...

FDA: acciones actualizadas con relación al COVID-19

La información actualizada respecto a las acciones de la FDA con relación al COVID-19...

OMS: Ética y COVID-19: asignación de recursos y priorización

Los gobiernos, agencias internacionales y sistemas de salud tienen la obligación...

FDA approves Tukysa as part of combination therapy for breast cancer

The FDA approved tucatinib in combination with chemotherapy for...

FDA tightens enforcement on Covid-19 antibody tests

After loosening restrictions on antibody tests, the US Food and Drug...

FDA: acciones actualizadas con relación al COVID-19

La información actualizada respecto a las acciones de la FDA con relación al COVID-19...

ANVISA: acciones relacionadas al COVID-19

La Agencia Regulatoria Nacional de Brasil, Anvisa, ha realizado una serie de acciones...

ANMAT: acciones regulatorias relacionadas con el COVID-19

En su página en línea, la Autoridad Regulatoria Nacional de Argentina (ANMAT)...

FDA, EC Offer Guidance on COVID-19 Convalescent Plasma

The US Food and Drug Administration (FDA) and European Commission (EC)....

EMA Stands up Task Force to Oversee Regulatory Response to COVID-19

The European Medicines Agency (EMA) on Thursday stood up a new...

CHILE: acciones sobre el COVID-19

El Instituto de Salud Pública de Chile ha publicado las acciones sobre el COVID-19 en...

COVID-19: orientación e investigación en curso en las Américas

La OPS ha desarrollado una base de datos de búsqueda que brinda acceso a diretrices técnicas...

Lista anotada de Medicamentos y Dispositivos Médicos

La OPS ha lanzado MedList, el portal de medicamentos y listas de dispositivos que proporciona...

Technical Documents - Coronavirus Disease (COVID-19)

Here you can find technical Documents of the new Coronavirus Disease (COVID-19)...

COVID-19 + MT

Suggested COVID-19 information resources links related to Medicines, In-Vitro Diagnostics (IVDs) and other Medical Devices...

FDA Drug Review Times Reflective of 4 Key Features, GAO Finds

The length of review of new drug applications (NDAs) by the US Food and...

IBEROAMÉRICA frente al COVID-19

Bienvenido/a este espacio donde recogemos la respuesta de Iberoamérica...

FDA OKs new use of Acceleron and Bristol-Myers Squibb's luspatercept

Acceleron Pharma (NASDAQ:XLRN) and collaboration partner Bristol-Myers...

Google Académico

En esta sección podrás encontrar links de interés sobre el COVID-19...

After a Speedy IPO, Equillium Expands Antibody RD to Renal Disease

Equillium, a biotech that’s looking to develop an antibody drug for immuno-inflammatory diseases...

Bristol-Myers Squibb, bluebird bio submit biologics license application for advanced multiple myeloma CAR-T

Bristol-Myers Squibb and bluebird bio have submitted a biologics license...

Vizient warns medicines needed for ventilator patients are running low

Drugs used for ventilator patients—such as sedatives and neuromuscular...

New FDA Program to Accelerate Coronavirus Treatments

The US Food and Drug Administration (FDA) on Tuesday detailed a new...

EMA Backs Fluad Tetra for Influenza Prophylaxis in the Elderly

The Committee for Medicinal Products for Human Use of the European Medicines Agency...

OPS: COVID-19: orientación e investigación en curso en las Américas

La OPS ha desarrollado una base de datos de búsqueda que brinda acceso a diretrices...

OPS: Mantengase actualizado!

La OPS/OMS ha desarrollado una página online dedicada a proveer a la población...

FDA: actualización regulatoria – COVID-19

Las siguientes actualizaciones regulatorias relacionadas con el COVID-19...

2020 Medical Device Recalls

List of Medical Device recalls in 2020...

USP: recursos e información relacionada con el COVID-19

La Farmacopeia Americana (USP, por sus siglas en inglés) ha puesto a disposición...

PAHO: COVID-19 guidance and ongoing research in the Americas

PAHO has developed a searchable database that provides access to technical guidelines...

PAHO: Keep posted on COVID-19

PAHO/WHO has developed a webpage dedicated to inform the population on COVID-19...

FDA: actualización regulatoria – COVID-19

Las siguientes actualizaciones regulatorias relacionadas con el COVID-19...

2020 Medical Device Recalls

List of Medical Device recalls in 2020...

USP: recursos e información relacionada con el COVID-19

La Farmacopeia Americana (USP, por sus siglas en inglés) ha puesto a disposición...

OPS: Mantengase actualizado!

La OPS/OMS ha desarrollado una página online dedicada a proveer a la población...

OPS: COVID-19: orientación e investigación en curso en las Américas

La OPS ha desarrollado una base de datos de búsqueda que brinda acceso a diretrices...

OPS: Orientación ética sobre cuestiones planteadas por la pandemia del nuevo coronavirus (COVID-19)

El Programa Regional de Bioética de la OPS ha desarrolado un documento que da orientación...

FDA approves Roche’s Actemra COVID-19 trial

Roche has announced that the US Food and Drug Administration...

FDA Grants Experimental Coronavirus Drug Benefits For Rare Disease Treatments

The Food and Drug Administration gave an experimental medicine...

FDA Move Opens Door to Biosimilar Insulins, Other Biologics

The US Food and Drug Administration (FDA) has now officially changed...

OMS: Hay mucha información falsa alrededor. Estos son hechos!

Las personas de todas las edades PUEDEN infectarse con el coronavirus...

La OMS se ha unido a WhatsApp para responder todas sus preguntas sobre coronavirus, reventar noticias falsas

La OMS se ha unido a WhatsApp para proporcionar la información y orientación...

“La guerra” del coronavirus requiere una acción coordinada: Secretario general de la OCDE

Los esfuerzos deben tener “la ambición del Plan Marshall y la visión del New Deal”...

Anuncio acerca del ibuprofeno y COVID-19

Respecto de las informaciones surgidas sobre el peligro de usar ibuprofeno...

Información actual sobre las acciones de la FDA en respuesta a COVID-19

La FDA ha emitido una Guía de vigencia inmediata para laboratorios y fabricantes...

Eventos

Eventos