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The Latest Breaking News from EMA

Governments want COVID vaccine developers to aim higher in hunt for better shots

As governments prepare to live with COVID-19, some are questioning how much to rely on drugmakers to adapt vaccines to ward off future virus variants amid signs of tension between companies and regulators over the best approach, according to several sources familiar with the matter.

Reuters

EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE:GSK) application seeking conditional authorization for their COVID-19 vaccine. The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be…

Benzinga

EU drug watchdog approves AstraZeneca Covid prevention jab

The Hague (AFP) - The EU's drug watchdog on Thursday recommended for approval AstraZeneca's Covid-19 prevention cocktail, which can be used for patients with immune system problems or severe reactions to other coronavirus vaccines.

AFP

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EU regulator advises AstraZeneca's COVID drug be cleared

The European Union's drug regulator says it's recommending that an antibody drug developed by AstraZeneca be authorized to help people avoid getting sick with the coronavirus

The Independent UK

EMA Recommends Approval Of AstraZeneca's COVID-19 Therapy, Evusheld

EMA's human medicines committee (CHMP) has

Benzinga

Evelo Biosciences Shares Gain After Positive Data On Faster Release EDP1815 Capsule, Q4 Earnings

In the Q4 earnings release, Evelo Biosciences Inc (NASDAQ:EVLO) shared results from an ongoing Phase 1 single-center trial in healthy volunteers that showed that a capsule with an improved release profile could deliver EDP1815 higher up in the small intestine.

Benzinga

Moderna Says Infant Covid Vaccine Succeeded in Trial

US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response. Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated…

Asharq Al-Awsat

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AstraZeneca's COVID-19 Vaccine Expected To Win European Approval This Week: Reuters

European Medicines Agency is expected to approve AstraZeneca Plc's (NASDAQ: AZN) antibody-based COVID-19 vaccine for preventing COVID-19 infections,

Benzinga

Moderna says infant Covid vaccine succeeded in trial

Washington (AFP) - US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response.

AFP

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

Calliditas Therapeutics AB (NASDAQ:CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an…

Benzinga

East Midlands Airport announces new flights with Flybe airline

Daily flights to Amsterdam will start in April and the twice daily EMA-Belfast service commences in July

Nottingham Post

NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC

NeuroSense Therapeutics Ltd (NASDAQ:NRSN) has received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects. PrimeC is a novel extended-release oral formulation composed of a fixed-dose combination of ciprofloxacin and celecoxib. PrimeC targets several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration,…

Benzinga

BTAI: Final Countdown to April 5, 2022 PDUFA Date for BXCL501…

By David Bautz, PhD NASDAQ:BTAI READ THE FULL BTAI RESEARCH REPORT

Benzinga

Dynavax Adjuvanted Clover Bio's COVID-19 Vaccine Booster Shows Durable Protection Against Omicron

Clover Biopharmaceuticals Ltd's follow-up analysis for efficacy in the SPECTRA Phase 2/3 trial of SCB-2019 COVID-19 vaccine provided high and durable protection in individuals five months after the second dose. The follow-up analysis involved 26,400 individuals. Against any variant, efficacy was maintained at 100% against severe COVID-19 and 95% against COVID-19 associated…

Benzinga

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France 24

Did the European Medicines Agency say we should stop using Covid-19 boosters?

After a clip from a press conference was published online, questions were raised on social media about the European Medicines Agency's opinion on Covid-19 booster vaccines. Elements of the presser were taken out of context and the EMA's full message got lost in some of the posts. FRANCE 24's Georgina…

Benzinga

Orphazyme Calls For Court-Mediated Restructuring, Lays Off 50% Workforce

Orphazyme A/S's (NASDAQ:ORPH) board of directors has called for a court-mediated restructuring, prompting the second round of layoffs in less than a year. The in-court restructuring will determine whether any operations can continue if the Company can raise any capital or if it is prudent to sell all or some parts of…

Benzinga

European Recommendation On Valneva's COVID-19 Shot Pushed Into April

Valneva SE (NASDAQ:VALN) now expects a positive recommendation from the European Medicines Agency (EMA) for its VLA2001 COVID-19 candidate vaccine in April. Earlier, the Company expected the European recommendation by the end of March. As announced in February, Valneva received a list of questions as part of the CHMP's initial assessment, to which…

Benzinga

Amryt Pharma's Q4 FY21 Sales, FY22 Guidance Shy Of Street Consensus

Amryt Pharma Plc's (NASDAQ:AMYT) Q4 FY21 sales increased 29% Y/Y to $54.8 million, missing the consensus of $56.81 million. The growth was driven by metreleptin revenues that increased 44% to $31.9 million. Cash of $113 million at December 31, 2021 (2020: $118.8M) The Company reported a wider operating loss of $(50.5) million…

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The Guardian - UK

Covid: Iceland to lift all remaining curbs; coronavirus isolation rules end in England – as it happened

Latest updates: Iceland confirms no extra restrictions for unvaccinated; people in England who test positive for Covid no longer have to self-isolate

Birmingham Post

Training provider moves into ex-Derby Telegraph offices

EMA Training has created three floors of collaborative workspace, break-out areas, exam suites and meeting rooms

StockNews.com

5 Best Healthcare Stocks to Buy as a Hedge Against Inflation

The healthcare sector has historically provided a better hedge against inflation than gold because of the inelastic demand for its products and services. Rising healthcare needs of an aging population, integration of advanced technologies, and breakthroughs in clinical trials brighten the sector’s prospects. Therefore, fundamentally-sound and undervalued healthcare stocks Sanofi…

Nottingham Post

East Midlands Airport TUI, Jet2, Ryanair: What airlines fly from there?

Travel restrictions have eased and flight demand is rising from EMA

Benzinga

Menstrual Irregularities Cases After mRNA COVID-19 Vaccine - EMA Reviews Cases

The European Medicines Agency's safety committee is reviewing reports of heavy menstrual bleeding and absence of menstruation af

Nottingham Post

East Midlands Airport gives holiday message to anyone flying abroad this half term

The airlines that serve EMA are, between them, flying to more than 30 destinations for the remainder of February

Benzinga

Amryt Shares Fall After Oleogel-S10 EMA Regulatory Update

The European Medicines Agency

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