European Commission

Local Covid vaccines fill gap as UN Covax scheme misses target

India, Egypt and Cuba among first states to develop and make their own vaccines as Covax falls behind Developing countries are increasingly turning to homegrown Covid vaccinations as the UN-backed Covax programme falls behind. While western countries roll out booster jabs to their own populations, Covax, which was set up by UN agencies, governments and …

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BioMarin stands tall with first approved drug for rare disease that causes dwarfism

The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.

Another hurdle down as EU clears AstraZeneca’s Alexion takeover

The European Commission has given competition clearance to the $39 billion acquisition of Alexion by AstraZeneca, leaving the UK as the last remaining obstacle to getting the deal across the line. The EU approval comes after the merger has already been okayed by the US, Japan and a number of other countries around the world, …

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EU and AZ both claim victory in COVID jab supply lawsuit

A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer than the amount sought by the European Commission. The EU had requested 120 million doses by the end of this month and 300 million by end-September, but the judge in …

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Has Marks and Spencer really got it right at last? | Nils Pratley

We’ve heard the argument before, but now it does seem the moment of maximum danger has passed Green shoots at M&S? That was chairman Archie Norman’s boast as he peered through the thicket of exceptional charges that dominated yet another set of annual results and turned a small headline pre-tax profit of £41.6m into a …

Has Marks and Spencer really got it right at last? | Nils Pratley Read More »

EU asks court to fine AstraZeneca over missing COVID jab shipments

Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious”  failure to meet the terms of its contract to supply COVID-19 vaccines to the EU. Rafael Jafferali Counsel for the Commission – Rafael Jafferali – insisted during the hearing at the Brussels Court of First …

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ViewPoints Interview: Ipsen’s Dr. Med. Steven Hildemann Shares Insight on the EC’s Approval of Cabometyx + Nivolumab for Advanced Renal Cell Carcinoma

In an interview with PharmaShots, Prof. Dr. Med. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs, and Patient Safety of Ipsen share his views on the approval of the combination regimen for aRCC. He also shed light on the company’s near-term goals in the coming years. Shots: The EC approval …

ViewPoints Interview: Ipsen’s Dr. Med. Steven Hildemann Shares Insight on the EC’s Approval of Cabometyx + Nivolumab for Advanced Renal Cell Carcinoma Read More »

EU wants to mass produce three ‘course-changing’ Covid drugs from October

Health commissioner says plan is to reduce hospitalisation and tackle long-term impact of Covid Coronavirus – latest updates See all our coronavirus coverage Three Covid medicines with the potential to “change the course” of the pandemic will be authorised for mass production and use in the EU by October under a European Commission plan. Stella …

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Roche’s Tecentriq Receives EC’s Approval as 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: improvement in OS in people with high PD-L1 expression (20.2 vs 13.1mos.), safety was consistent with its known safety profile …

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Biocon Biologics and Viatris Receive European Commission Approval for Abevmy (biosimilar, bevacizumab)

Shots: The EC has approved the Abevmy (100 & 400mg) for the treatment in metastatic colorectal carcinoma, metastatic breast cancer, NSCLC, glioblastoma, ovarian, cervical, and renal cancer as part of a specific regimen The approval follows CHMP’s positive opinion and is valid in all EU Member States as well as in the EEA countries Iceland, …

Biocon Biologics and Viatris Receive European Commission Approval for Abevmy (biosimilar, bevacizumab) Read More »

EU starts legal action against AstraZeneca over vaccine shortfalls

Firm says it will ‘strongly defend itself’ against claim it breached agreement to supply Covid jab Coronavirus – latest updates See all our coronavirus coverage AstraZeneca said it would “strongly defend itself in court” and highlighted its supply of 50m Covid vaccine doses to European countries as Brussels launched legal action against the pharmaceutical company …

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EU seeking ‘urgent clarification’ on Johnson & Johnson Covid vaccine delay

Company has said it is postponing deployment in Europe following concerns about blood clots in US Coronavirus – latest updates See all our coronavirus coverage The European commission is seeking “urgent clarification” from Johnson & Johnson after the company’s “completely unexpected” announcement that it has decided to delay the deployment of its coronavirus vaccine across …

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UK ministers silent on AstraZeneca vaccine shipment to Australia

Downing Street will not confirm or deny report that more than 700,000 Covid jabs were sent after EU blocked export Coronavirus – latest updates See all our coronavirus coverage British ministers and officials did not deny that more than 700,000 shots of the AstraZeneca vaccine were secretly dispatched from the UK to Australia a few …

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Why a fresh AstraZeneca fightback is required in Covid vaccine info row | Nils Pratley

Drugmaker isn’t entirely blameless but making it a political football for EU’s failures is simply ugly The European Union ought to be delighted. The “discovery” of a “stockpile” of 29m vaccine doses in Italy is really a non-discovery. The consignment is held at an authorised plant, available for inspection, and is merely awaiting quality sign-off. …

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AstraZeneca dismisses claim 29m vaccine doses in Italy were bound for UK

Batches were found when Italian police searched factory at request of European commission Coronavirus – latest updates See all our coronavirus coverage AstraZeneca has dismissed as “inaccurate” a report in the Italian press that 29m doses of its Covid-19 vaccine found in factory near Rome were destined for the UK. La Stampa reported on Wednesday …

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Boris Johnson slammed for saying “greed” is behind UK vaccine success

Boris Johnson’s sense of humour seems to have got him into trouble again, at the most delicate of times. The Prime Minister reportedly told Conservative backbench MPs on a Zoom call that “capitalism” and “greed” was behind the success of the UK’s COVID-19 vaccination programme, before backtracking after realising he had made a blunder and …

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AZ COVID jab efficacy debate is hindering EU’s vaccine drive

The spat between the EU and AstraZeneca over access to the company’s COVID-19 shot led to scathing remarks about its efficacy that now threaten to undermine the EU’s vaccination targets.  The European Commission approved AZ’s AZD1222 vaccine for use in the EU in all adults aged over 18 at the end of January, more than …

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Solidarity Is Not an Easy Sell as E.U. Lags in Vaccine Race

Europe’s collective vaccine purchase is an experiment in deeper integration. Despite a rocky start, many countries still stand to benefit, but it’s the most powerful who have least to gain.

Solidarity Is Not an Easy Sell as E.U. Lags in Vaccine Race

Europe’s collective vaccine purchase is an experiment in deeper integration. Despite a rocky start, many countries still stand to benefit, but it’s the most powerful who have least to gain.

Solidarity Is Not an Easy Sell as E.U. Lags in Vaccine Race

Europe’s collective vaccine purchase is an experiment in deeper integration. Despite a rocky start, many countries still stand to benefit, but it’s the most powerful who have least to gain.

Top E.U. Official Comes Under Fire in Vaccine Wars

Ursula von der Leyen has largely stayed away from the limelight while driving the handling of a crisis and letting subordinates take the blame.

Top E.U. Official Comes Under Fire in Vaccine Wars

Ursula von der Leyen has largely stayed away from the limelight while driving the handling of a crisis and letting subordinates take the blame.

AstraZeneca to supply nine million more vaccines to EU

The diplomatic row that broke out last week over the supply of AstraZeneca’s vaccine to Europe appears to have cooled after the UK pharma agreed to supply an extra nine million doses. At the end of last week, the European Commission was forced into an embarrassing U-Turn when it tried to impose restrictions on COVID-19 …

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EU Covid incompetence leaves governments wanting vaccines, not excuses | Larry Elliott

Centralised approach was meant to underline Europe’s solidarity but has had opposite effect The EU has made an almighty hash of procuring treatments for Covid-19. Vaccine centres are running short of supplies as a result. National governments want jabs rather than excuses for what has gone wrong. The search for scapegoats is on. Stripped of …

EU Covid incompetence leaves governments wanting vaccines, not excuses | Larry Elliott Read More »

EU to publish revised rules after Covid vaccine border fiasco

Commission plans to rush through regulations that ‘ensure Northern Ireland protocol remains unaffected’ Coronavirus – latest updates See all our coronavirus coverage Explainer: what is article 16 of the Northern Ireland protocol? Brussels will publish a revised regulation to potentially block vaccine exports out of the EU on Saturday, after an international outcry over its …

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EU eyes tighter COVID-19 vaccine exports as access gets ugly

The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where supplies have been delivered so far.   Moreover, it plans to rush through legislation requiring that all companies producing vaccines against COVID-19 in the EU have to notify the Commission …

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EU’s Covid vaccination debacle is down to institutional inflexibility

Supply delays underline there was no legal or economic justification for central planning A storm is raging over the EU’s failure to have ordered more of the approved Covid-19 vaccines ahead of time. Stéphane Bancel, the CEO of the US pharmaceutical company Moderna, which gained approval for its vaccine shortly after Pfizer/BioNTech, claims that the …

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Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were …

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS Read More »

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with an option to request an additional 100M doses Deliveries are anticipated to start by the end of 2020, following clinical success and regulatory authorization. The companies expect to produce ~1.3B …

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EU ramps up supply of COVID-19 vaccine, drugs

The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate. The agreement is the third for coronavirus vaccine supply for the EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and …

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The Dawn of a European Health Data Space – Opportunities

At the beginning of 2020, the European Commission introduced a “European strategy for data.” The document proposes to bolster and advance the data economy in Europe with a view towards capturing “the benefits of better use of data, including greater productivity and competitive markets, but also improvements in health and well-being, environment, transparent governance and …

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