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The Latest Breaking News from EMA

EU regulator gives green light to omicron booster vaccines

The European Medicines Agency (EMA) has backed two separate Covid-19 booster vaccines updated to target the omicron variant of Covid-19 and developed by drugmakers Moderna and BioNTech-Pfizer.

Radio France Internationale

EU states urged to roll out COVID booster shots to fend off winter infections

EU countries should start offering COVID boosters to their populations now to contain a fresh wave of infections expected this autumn and winter, the bloc's executive said in a document seen by Reuters on Friday ahead of its official release.

Reuters

EU regulator backs use of Novavax COVID shot as a booster

The European Medicines Agency (EMA) on Thursday backed the use of Novavax's COVID-19 shot as a booster for adults, ahead of an anticipated rise in infections this winter.

Reuters

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EU regulator approves Omicron vaccines

The European Union’s drug regulator has recommended the use of two Omicron-tailored vaccines developed by the Pfizer-BioNTech partnership and Moderna Inc ahead of a fresh booster programme this fall across the continent.

Bangkok Post

East Midlands Airport one of top 10 most expensive to drop off passengers

'This aims to reduce the number of vehicles travelling around the busiest area of our campus'

Nottingham Post

Recap Of Friday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ:INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. Incyte shares traded in a range of $71.38 to $72.98 on day volume of 1.25…

Benzinga

Understaffing and wellbeing weigh on business

Employees report poor health outcomes due to pressures in the workplace, with deleterious effects on the future of small businesses as well as the national happiness quotient.

Newsroom.co.nz

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

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ:PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D). Insulet shares traded in a range of $260.13 to $266.73 on day volume of 200.86 thousand shares…

Benzinga

EU backs changing monkeypox vaccine injection method to boost supply

European countries could stretch out limited supplies of the monkeypox vaccine by administering smaller doses of the shot, the European Medicines Agency (EMA) said on Friday.

Reuters

EU regulator OKs plan to increase monkeypox vaccine supplies

The European Medicines Agency said a smaller dose of the monkeypox vaccine appears to still be effective and can be used to stretch the current supply by five times, echoing a recommendation made earlier this month by the U.S. Food and Drug Administration

The Independent UK

East Midlands Airport details plans to deal with demand amid surge in passengers

The airport has seen record numbers returning after Covid restrictions

Nottingham Post

The sleepless nights, stress, and financial worries that make it near-impossible for young carers to stay in school

Dylan Thomas, 18, fell asleep in class and some teachers "didn't care" when he was absent

Wales Online

EU says Novavax COVID shot must carry heart side-effect warning

The European Medicines Agency (EMA) is recommending Novavax's COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

Reuters

Bavarian Nordic monkeypox vaccine wins EU approval

Danish biotechnology company Bavarian Nordic said on Monday the European Commission had given permission for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended last week by the European Medicines Agency (EMA).

Reuters

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360info

How the pandemic set back drug safety

The best form of inspection is an unannounced one, but the pandemic changed the game for regulators. They’ll need to work together to protect consumers.

The Independent UK

EU drug regulator recommends clearing vaccine for monkeypox

The European Medicines Agency says the smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox as an outbreak of the once-rare disease sickens people across Europe

Benzinga

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

Salon

No, boosters aren't bad for you

A conspiracy theory about booster shots resurfaced this month — here’s what experts say

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Nottingham Post

East Midlands Airport rules for baggage drop off and what you can't take on a plane

It is important to check the details

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

Nottingham Post

East Midlands Airport update on summer holiday check in times

They are keen to minimise delays

Benzinga

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

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.

The Independent UK

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

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