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The Latest Breaking News from EMA

East Midlands Airport update on summer holiday check in times

They are keen to minimise delays

Nottingham Post

InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19

InflaRx N.V. (NASDAQ:IFRX) provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19. The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG. PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.…

Benzinga

Adverum Biotech Receives EMA's Priority Medicines Status For Chronic Eye Disorder Candidate

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Adverum Biotechnologies’ (NASDAQ: ADVM) lead drug ADVM-022 for the treatment of wet age-related macular degeneration (wet AMD).

Benzinga

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BioNTech Gets EMA's Priority Medicines Status For Testicular Cancer Drug

BioNTech (NASDAQ: BNTX) received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its product candidate BNT211 in the third- or later-line treatment of testicular germ cell tumors.

Benzinga

EU regulator authorizes COVID shot made by France's Valneva

The European Medicines Agency says it is recommending the authorization of the coronavirus vaccine made by French pharmaceutical Valneva, making it the sixth shot to be given the green light in Europe

The Independent UK

Nasr to make Spa 24 Hours debut in EMA Porsche

Ex-Formula 1 driver Felipe Nasr will make his Spa 24 Hours debut next month as part of an all-factory driver line-up in a Porsche fielded by Australian entrant EMA Motorsport.

Motorsport

Ex-F1 driver Nasr to make Spa 24 Hours debut in EMA Porsche

Ex-Formula 1 driver Felipe Nasr will make his Spa 24 Hours debut next month as part of an all-factory driver line-up in a Porsche fielded by Australian entrant EMA Motorsport.

Autosport

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Legend Biotech Shares Move Higher After Bullish BMO Pitch

BMO Capital Markets initiated coverage on Legend Biotech Corporation (NASDAQ:LEGN) with a price target of $77, and an Outperform rating. The analyst says the company's recently approved Carvykti for multiple myeloma is best-in-class late-line CAR T therapy. Related: EMA's CHMP Clears Janssen, Legend's Multiple Myeloma CAR-T Therapy Though the analyst expects a gradual increase in sales due…

Benzinga

East Midlands Airport announces summer changes to deal with huge number of passengers

“We want our passengers to have the best possible start to their trips and holidays"

Nottingham Post

East Midlands Airport joint statement after flights divert over 'drone sightings' at Download

Police patrols have increased

Nottingham Post

Giant fungus spreading into rivers near East Midlands Airport being investigated

Concerns have been raised about the impact of the process

Nottingham Post

Thousands sign petition demanding 35 kids with Cystic Fibrosis be given life-saving drug Kaftrio

'The lives of our children are at stake here, and we need to have this drug'

Irish Mirror

The Daily Biotech Pulse: Valneva's COVID-19 Vaccine Filing Accepted By EMA, Enanta's RSV Candidate Fails, Orphan Drug Tag For Mersana's Gastric Cancer Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD

The European Medicines Agency (EMA) has classified Tetra Bio-Pharma Inc.’s (OTCQB: TBPMF) (TSX:TBP) (FRA:JAM1) PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB).

Benzinga

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Benzinga

Why Valneva's Shares Are Plunging Today Premarket

Valneva SE (NASDAQ:VALN) warned it might have to reconsider its FY22 financial guidance after the European Commission informed the company of its intent to terminate an advance purchase agreement (APA) for its VLA2001 COVID-19 candidate vaccine. In November, the company signed the APA with the European Commission to supply up to 60 million doses of…

Nottingham Post

East Midlands Airport statement as 3000 passengers affected by incident

Flights were also delayed

Benzinga

Dupixent, Consumer Healthcare Lifts Sanofi's Q1 Earnings, Backs FY22 Guidance

Sanofi SA (NASDAQ:SNY) posted a net profit of €2 billion for Q1 FY22, up from €1.57 billion a year ago. Sales reached €9.67 billion, up from €8.59 billion in Q1 FY21. Eczema drug, Dupixent, and consumer healthcare drove the growth. Dupixent alone grew by 45.7% to €1.6 billion, driving Sanofi's specialty care…

Benzinga

Novartis - BeiGene's Tislelizumab Aces Late-Stage Esophageal Cancer Trial

Novartis AG (NYSE:NVS) has announced topline results from an interim analysis of the Phase 3 RATIONALE 306 study of tislelizumab plus chemotherapy in esophageal squamous cell carcinoma (ESCC). Data showed that tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic…

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Benzinga

AstraZeneca's COVID-19 Antibody Provides Protection For At Least Six Months In High-Risk Individuals

AstraZeneca plc (NASDAQ:AZN) shared detailed results from the PROVENT Phase 3 pre-exposure prophylaxis (prevention) trial of Evusheld (tixagevimab and cilgavimab), formerly AZD7442. The data showed that Evusheld reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and 83% in the six-month follow-up analysis, compared to placebo. There were no…

Benzinga

Valneva Shares Jump As Its COVID-19 Vaccine Receives Conditional Approved In UK

The Healthcare products Regulatory Agency (MHRA) of the U.K. has granted Conditional Marketing Authorization for Valneva SE's (NASDAQ:VALN)COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age. MHRA found that VLA2001 meets safety, quality, and effectiveness standards. This new marketing authorization comes in addition to the emergency use authorization,…

Benzinga

ProQR Therapeutics Pulls Plug On Inherited Retinal Disease Programs, Cuts 30% Workforce

ProQR Therapeutics N.V. (NASDAQ:PRQR) has decided to prioritize the development of genetic eye disease candidates and the Axiomer RNA base-editing technology platform. The Company will suspend the development of QR-1123 for autosomal dominant retinitis pigmentosa, QR-504a for Fuchs endothelial corneal dystrophy, and all other Inherited Retinal diseases (IRD)-related research activities. ProQR will implement…

Benzinga

Europe Holds Second COVID-19 Booster Dose For People Aged Under 80 Years

European Medicines Agency concluded that it is too early to consider using the fourth dose of either Pfizer Inc (NYSE:

Nottingham Post

East Midlands Airport set for 'busiest weekend since Covid restrictions were lifted'

It said it is putting in plans to cope with the extra demand

Benzinga

Biophytis Shares Fall As It Stops Enrollment In Sarconeos COVID-19 Trial, Data Expected In Q3 2022

Biophytis SA (NASDAQ:BPTS) said that it is currently assessing FDA comments and recommendations and preparing to submit Phase 2-3 trial designs for sarconeos (BIO101) trial in sarcopenia. Enrollment is expected to start in 2H of 2022 in the SARA Phase 2 trial. In October 2021, sarconeos at the highest dose of 350 mg…

Asharq Al-Awsat

No Evidence to Support Widespread Use of Fourth COVID Shot, Say EU Agencies

EU health agencies said on Wednesday there was no evidence to support the use of a fourth dose of COVID-19 vaccines developed by Pfizer and Moderna in the general population, but they recommend a second booster for people aged 80 and above. There is no clear evidence in the European…

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