LONDON – Family-owned Angelini Pharma is to buy Swiss startup Arvelle Therapeutics GmbH for $960 million, acquiring full European rights to the epilepsy drug cenobamate. The first tranche, of $610 million, will be paid following the EMA’s recommendation to approve cenobamate, which is expected at either the January or February meeting of the Committee for Medicinal Products for Human Use.
LONDON – The COVID-19 vaccine developed by Astrazeneca plc and Oxford University has been approved by the U.K regulator, with the first doses being shipped on Dec. 30 and a mass vaccination program due to begin on Jan. 4. AZD-1222, now named COVID-19 Vaccine Astrazeneca, is authorized for emergency use and will require two doses for durable effect.
LONDON – The pharmaceutical industry exhaled sharply and prepared to labor over the fine print in 1,246 pages of text after the EU and U.K. announced they had agreed a post-Brexit trade deal on Christmas Eve. The EU/U.K. Trade and Cooperation Agreement means the risk of a crash-out Brexit on Dec. 31 is over, and there will be no tariffs or quotas on the import and export of goods.
LONDON – The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use. The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27.
LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products. That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX.
DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.
DUBLIN – The European Medicines Agency’s human medicines committee, the CHMP, all but closed out the year by issuing positive opinions on eight marketing authorization applications during its December meeting. Its work for 2020 is not quite yet done, however. It has scheduled an extraordinary meeting for Dec. 29 to review an application from Pfizer Inc. and Biontech AG for their mRNA COVID-19 vaccine BNT162b2.
LONDON – A study of genetic variants in patients with life-threatening COVID-19 has shed light on the mechanisms that underpin severe disease, uncovered new drug targets and pointed to approved drugs, including JAK inhibitors and phosphodiesterase type 4 inhibitors, as therapies that could aid recovery.
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
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