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The Latest Breaking News from European Medicines Agency

Pfizer (PFE), BioNTech Seek EU Nod For Omicron-Based COVID Jab

Pfizer (NYSE: PFE) and its partner, BioNTech (NASDAQ: BNTX) announced that they have completed the submission of a regulatory application to the European Medicines Agency (EMA), which seeks authorization for thei

Benzinga

Recap of Monday's Biotech Catalysts - End of the Day Summary

Abbvie (NYSE: ABBV) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month.

Benzinga

Novavax (NVAX) Down As EU Adds Side Effects To COVID Jab Label

Shares of Novavax (NASDAQ: NVAX) fell 26.2% on Jul 14, after the European Medicines Agency's (TSE: EMA) Pharmacovigilance Risk Assessment Committee ("PRAC") updated the product label of Nuvaxovid, the company's COVID-19 vaccine, to include some potential side effects like severe aller

Benzinga

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EU regulator considers clearing smallpox shot for monkeypox

The European Medicines Agency says it will begin reviewing data to decide if a smallpox vaccine made by the pharmaceutical company Bavarian Nordic might also be authorized for monkeypox, amid a growing outbreak of the disease across the continent

The Independent UK

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

Sanofi-GSK's Beta-Containing COVID-19 Vaccine Shows Efficacy Against Omicron

Sanofi SA (NASDAQ:SNY) and GSK plc (NYSE:GSK) have announced positive data from their vaccine trial of adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. "Sanofi-GSK's vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation," Sanofi said in a statement. The bivalent vaccine targets the…

Benzinga

SIGA Technologies Announces $13M Worth Order For Its Monkeypox Treatment

SIGA Technologies Inc (NASDAQ:SIGA) has announced approximately $13 million in procurement orders for oral TPOXX (tecovirimat) The order includes $11 million for initial procaurement from two new international jurisdictions and an approximate $2 million order from a country in the Asia Pacific region with an established contract for oral TPOXX. "We expect a…

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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

Popular holiday destinations still with strict Covid restrictions for Brit travellers

With summer upon us, plenty of Brits are looking to get abroad into the sunshine for a short while, but some places still operates some strict Covid-19 restrictions

Daily Mirror

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Nod For Kids As Young As Six Months

The FDA has granted emergency use authorization (EUA) to Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ:BNTX) COVID-19 Vaccine as a three 3-µg dose series for children six months through 4 years of age. Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under five. The EUA…

Benzinga

Jet2, easyJet, Ryanair and TUI: Latest travel rules for Spain, Turkey, Portugal, Italy and more

Leeds Live has collated a list of the travel requirements for popular holiday destinations in Europe this summer

Leeds Live

In Eli Lilly's Lebrikizumab Atopic Dermatitis Study, Majority Of Patients Maintained Skin Clearance At One Year

Eli Lilly And Co (NYSE:LLY) announced topline results from one-year analyses of the efficacy and safety of lebrikizumab for moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 trials (ADvocate 1 and 2) showed that 8/10 of patients who achieved clinical response with lebrikizumab monotherapy at 16 weeks maintained skin clearance…

Benzinga

Veru Seeks FDA Emergency Use Nod For Its COVID-19 Treatment

Veru Inc (NASDAQ:VERU) has submitted an emergency use authorization (EUA) for sabizabulin application to FDA for COVID-19 treatment. The application covers moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS). The EUA submission is based on the positive results from the Phase 3 COVID-19 clinical trial…

Benzinga

Spain, Greece, France and Portugal travel rules for UK holidaymakers

As many of us flock abroad to enjoy a long-awaited holiday, here are all the rules you need to know for some of the most popular destinations we'll no doubt be flying to

Glasgow Live

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Belfast Live

Spain, Portugal, Greece, Italy and France travel rules for holidaymakers

Everything you need to know

Benzinga

EMA's Advisory Committee Recommends Eiger's Zokinvy In Premature Aging Disorder

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending Eiger BioPharmaceuticals Inc's (NASDAQ:EIGR) Zokinvy for Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PL). HGPS and PL are ultra-rare and fatal pediatric diseases that cause dramatically accelerated aging and premature death. The CHMP…

Benzinga

CHMP Supports Approval Of Merck's Keytruda As Adjuvant In Post Surgery Melanoma Setting

European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending Merck & Co Inc (NYSE:MRK) Keytruda in melanoma setting. The opinion covers Keytruda as a monotherapy adjuvant treatment for adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have…

Benzinga

Europe's CHMP Backs Approval Of PTC Therapeutics' Gene Therapy In Rare Neurometabolic Disorder

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of PTC Therapeutics Inc's (NASDAQ:PTCT) Upstaza (eladocagene exuparvovec, PTC-AADC). Once ratified by the European Commission, Upstaza will be the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency for patients 18 months and older…

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Benzinga

The Daily Biotech Pulse: CDC Recommends COVID-19 Boosters For Kids 5-11, Foghorn's Blood Cancer Trial On Clinical Hold, Bayer Intends To Bow Out From CAR-T Therapy Pact With Atara

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

Benzinga

Calliditas' Kinpeygo Receives CHMP Backing For Kidney Disease

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional approval for Calliditas Therapeutics AB's (NASDAQ:CALT) Kinpeygo for primary immunoglobulin A (IgA) nephropathy (IgAN). The opinion covers adult patients at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Also See: Calliditas…

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).

Manchester Evening News

Portugal holidays: Entry requirements, passport validity, Covid vaccine and booster rules explained

Portugal is open to holidaymakers - but you have to meet certain passport and Covid-19 vaccination requirements

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…

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

Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose…

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