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The Latest Breaking News from European Medicines Agency

EMA Backs Amgen Drug For Rare Autoimmune Disorder

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the therapeutic indication of Amgen Inc.’s (NASDAQ:AMGN) Uplizna (inebilizumab) to include the treatment of adult patients with active immunoglobulin G4-related disease (IgG4-RD).

Benzinga

Drug regulator investigating suicidal thoughts among some weight-loss jab users

The European Medicines Agency is looking at Wegovy (semaglutide), Saxenda (liraglutide) and other similar drugs used to control appetite.

The Independent UK

European drug agency opposes Amsterdam’s erotic centre plans

EMA says relocation of sex workers to area near its HQ could bring problems associated with red light district

The Guardian - UK

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2 Pharma Stocks to Buy Right Now and 1 You Might Want to Consider Selling

The pharmaceutical industry is evolving with personalized medicines and the rapid adoption of RPM technology, which should boost growth. Moreover, with a recession lurking, fundamentally strong pharma stocks AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) might be ideal buys. However, SNDL (SNDL) might be best avoided. Keep reading to know why.

StockNews.com

EU regulator recommends clearing Takeda's dengue vaccine

The European Medicines Agency is recommending that a dengue vaccine made by the Japanese pharmaceutical Takeda be authorized, in a move that could provide a new tool for millions worldwide against the potentially fatal disease

The Independent UK

EU health regulator says COVID pandemic not over

An official at the European Union's drugs regulator said on Tuesday the COVID-19 pandemic was not over, contradicting U.S. President Joe Biden, and that a planned vaccination campaign in the region during the cold season was key to fighting it.

Reuters

Important Biotech Catalysts For September 15, 2022 - End Of The Day Summary

Pfizer (NYSE:PFE) announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints. Pfizer shares traded in a range of $45.7…

Benzinga

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Take whatever COVID booster you can get, says head of EU drugs watchdog

People in Europe should take whatever COVID-19 booster is available to them in the coming months, Emer Cooke, Executive Director of the European Medicines Agency (EMA), said in a Reuters Next Newsmaker interview ahead of an expected autumn rise in infections.

Reuters

EU Regulator Backs Pfizer's BA.4/5-Adapted COVID Booster

The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5, days after endorsing a pair of boosters tailored to target the older BA.1 variant. The latest recommendation is for a so-called bivalent vaccine developed by Pfizer and BioNTech, which targets BA.4/5 as well…

Asharq Al-Awsat

EU regulator clears Pfizer-BioNTech's tweaked COVID booster

The European Medicines Agency has recommended the authorization of a tweaked booster dose of the Pfizer-BioNTech coronavirus vaccine that includes protection against two of the latest versions of omicron, as countries look to bolster their immunization programs ahead of winter

The Independent UK

Boost high-risk people with Omicron-tailored shots first - EU officials

EU officials on Tuesday recommended that the two Omicron- tailored vaccines recently endorsed by the European Medicines Agency (EMA) be first deployed in high-risk individuals.

Reuters

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

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

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ:NTLA) lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in a range of $56.52 to $60.06 on day volume of 901.43 thousand shares, closed regular trading session at $59.97. The company…

Benzinga

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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The Independent UK

EU regulator clears tweaked versions of COVID vaccines

The European Medicines Agency has recommended the authorization of two coronavirus vaccines made by Pfizer-BioNTech and Moderna Inc., tweaked to include protection against an early version of the omicron variant

Benzinga

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…

The Independent UK

Pfizer asks EU drug regulator to OK tweaked COVID vaccine

Pharmaceuticals Pfizer and BioNTech say they have asked the European Medicines Agency to authorize their updated coronavirus booster vaccine that includes the most recent omicron subvariants

The Independent UK

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

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Benzinga

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

The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ:KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB). The regulatory agency has granted Priority Review designation and assigned a target actin date of February 17,…

Benzinga

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

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ:MDWD) recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. MediWound shares traded in a range of $1.6 to $1.76 on a day…

Benzinga

Recap of Wednesday's Biotech Catalysts - End of The Day Summary

IDEAYA Biosciences (NASDAQ:IDYA) has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397 with Amgen's AMG 193 in a Phase 1 clinical trial. IDEAYA shares traded in a range of $14.59 to $15.82 on a day volume of 130.58…

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).

Benzinga

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

Bristol Myers Squibb (NYSE:BMY) received European Medicines Agency (EMA) Positive CHMP Opinion recommending approval for Opdualag (nivolumab and relatlimab) for treatment of patients with Unresectable or Metastatic Melanoma based on results from the Phase 2/3 RELATIVITY-047 trial. Bristol Myers shares traded in a range of $72.48 to $73.61 on a…

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

StockNews.com

Ready to Retire? These 3 Stocks Could Help You Do It Earlier

Investors planning their retirement finances could benefit from investing in equities with stable return potential and consistent dividend payouts amid the current market volatility. On that front, investing in quality dividend-paying stocks Philip Morris (PM), Flowers Foods (FLO), and AbbVie (ABBV) could be rewarding. Read on….

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