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The Latest Breaking News from EMA

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

From analysis to the latest developments in health,
read the most diverse news in one place.

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…

Benzinga

East Midlands Airport statement as 3000 passengers affected by incident

Flights were also delayed

Nottingham Post

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…

Benzinga

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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:

Benzinga

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

Nottingham Post

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…

Benzinga

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…

Asharq Al-Awsat

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StockNews.com

3 Top-Rated Stocks for Value Investors to Consider

The recent stock market correction has created a few attractive opportunities for investors because many stocks are now trading at reasonable valuations. Thus, it could be wise now to invest in fundamentally solid stocks Bristol-Myers (BMY), McKesson (MCK), and AGCO (AGCO). These names are currently trading at discounts compared to…

Benzinga

Clovis Oncology's Rubraca Significantly Improves PFS In Ovarian Cancer Regardless Of Biomarker Status

Clovis Oncology Inc (NASDAQ:CLVS) announced positive topline data from the monotherapy arm of Phase 3 ATHENA-MONO trial of Rubraca (Rucaparib) as first-line maintenance treatment in ovarian cancer. Rubraca achieved the primary endpoint of significantly improved progression-free survival (PFS) compared with placebo (20.2 months vs. 9.2 months). The median PFS for the HRD-positive patient…

Reuters

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.

Benzinga

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…

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The Independent UK

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

Benzinga

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.

Asharq Al-Awsat

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…

Benzinga

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

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…

Nottingham Post

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

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