The EMA officially vacates its London HQ — next stop Amsterdam; CHMP backs approval of 8 drugs
→ The EMA officially said goodbye to its Canary Wharf headquarters in London on Friday, to set up shop in Amsterdam — a decision triggered by Britain’s 2016 decision to leave the EU.
Today we are closing our London offices after almost a quarter of a century. Thank you, London for being such a gracious host! https://t.co/R8LXjfzvp3 pic.twitter.com/8abqMcbROJ
— EU Medicines Agency (@EMA_News) March 1, 2019
→ The EU regulator also issued positive recommendations for a slate of treatments, listed below:
EMA’s human medicines committee recommends 8 #medicines for approval at its February 2019 meeting https://t.co/VCEdeqiAar #CHMP pic.twitter.com/0Z1cCNfkng
— EU Medicines Agency (@EMA_News) March 1, 2019
- Sanofi/Regeneron‘s Dupixent for severe asthma, setting up the expansion of the medicine’s label, which currently covers atopic dermatitis
- Sanofi $SNY had another endorsement, for its diabetes drug sotagliflozin, to be sold under the brand name Zynquista
- BioMarin Pharmaceuticals $BMRN has won backing for pegvaliase, which has been dubbed Palynziq, for phenylketonuria, a rare but potentially serious inherited metabolic disease
- The agency endorsed granting a conditional marketing authorization for Akcea’s volanesorsen — to be sold as Waylivra — as the first medicine to treat familial chylomicronaemia syndrome, a rare genetic disease that thwarts the body from breaking down fats
- Another condition approval was recommended for Portola Pharmaceuticals’ $PTLA andexanet alfa, branded as Ondexxya — an antidote for patients on certain clot-fighters, when the use of the anticoagulants leads to life-threatening or uncontrolled bleeding
- AbbVie $ABBV secured recommendation for risankizumab — branded as Skyrizi — for plaque psoriasis
These recommendations followed two others from Thursday:
- GSK’s $GSK zanamivir — to be sold as Dectova— for complicated and potentially life-threatening influenza
- Pfizer $PFE secured backing for conditional approval of lorlatinib — branded as Lorviqua — to treat a form of non-small cell lung cancer
→ Under fire from Starboard and Wellington — which have made their opposition against the $74 billion buyout of Celgene $CELG abundantly clear — Bristol-Myers $BMY has been trying to shore up investor support behind-the-scenes, CNBC reported on Friday. The report suggested Bristol had sent executives to New York to meet with institutional investors several times over the last two weeks and met with investors in Boston on Wednesday and Thursday, citing a person briefed on the meetings.
→ UK-based AdoRx Therapeutics has tied up with J&J $JNJ to develop lung cancer drugs in a deal with undisclosed financial terms.
