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Daily Brief: Cellectis gains Novartis scientist, EU label updates for Janssen and Otsuka

The latest from pharma, biotech and healthcare

Cellectis

Cellectis gains senior scientist from Novartis

France’s CAR-T therapy contender Cellectis has hired a senior Novartis scientist to be its head of clinical development.

Dr. Stefan Scherer, M.D., Ph.D. is to take on the role of senior vice president clinical development and deputy chief medical officer, and joins from Novartis, where he was the head of early development, strategy and innovation for the big pharma’s US oncology division.

Dr Scherer’s move is just the latest in a growing trend of big pharma scientists being attracted into biotech roles, no doubt reflecting the exciting science being led by these companies, plus a greater freedom from big pharma’s cumbersome R&D infrastructures.

He is joining an ambitious effort by Cellectis: it is aiming to be the first to bring an ‘off the shelf’ or allogeneic CAR-T to market – which if it can be proven to be as safe and effective as the autologous CAR-Ts – will prove to be a faster, more convenient approach.

Dr. Scherer is based in New York and will report to Prof. Stéphane Depil, M.D., Ph.D., executive vice president of R&D and chief medical officer.

Andre

Cellectis CEO Dr. André Choulika

“Stefan’s deep medical expertise, strong track record of alliance- and relationship-building and previous C-level experience, all position him to make an immediate impact on the development and long-term strategic planning for Cellectis’ innovative product portfolio,” said Dr. André Choulika, Cellectis chief executive.

“As we continue to evolve our efforts to accelerate the access to patients of our off-the-shelf, gene-edited CAR T-cell product candidates, Stefan will be a key driver in the advancement of our product pipeline and programs overall.”

Dr. Scherer commented: “I look forward to contributing my experience and expertise to further the development of Cellectis’ innovative CAR T product candidates that address what are truly some of the biggest health challenges of our time."

Janssen boosted by Invokana label change

Europe’s key medicines decision-maker the CHMP committee has issued a positive opinion to update Invokana’s label to show the drug can reduce the risk of heart attacks and strokes.

Janssen’s type 2 diabetes treatment is in a battle with rival drugs (especialy in its SGLT2 inhibitor class), where proof of cardiovascular benefits are now vital for future market share.

The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to grant approval of the updated label. The CHMP decision is based on the results of the CANVAS programme, the largest completed CV outcomes trial to date for any of the SGLT2 inhibitors.

The label update will help Invokana keep pace with the emerging market leaders. The first SGLT2 inhibitor to gain this EU label update was Boehringer and Lilly’s Jardiance in January last year.

The CHMP decision adds to further good news for Invokana: it has bounced back after earlier CANVAS data suggested the drug raised the risk of amputations in patients. Janssen recently released an analysis which suggested there were no such worrying patterns in real-world patients.

Otsuka gains European nod for Jinarc extension

The European Commission has approved a label extension for Jinarc (tolvaptan) to include adult patients with CKD stage 4 Autosomal Dominant Polycystic Kidney Disease (ADPKD).

The drug was approved three years ago to treat ADPKD in adults with CKD stage 1-3 at initiation of treatment and evidence of rapidly progressing disease. The decision to include stage 4 within the licence follows the submission of extra data supporting its safety and efficacy in patients with more advanced renal disease.

Jinarc is the only drug treatment approved to slow the progression of cyst development and renal insufficiency in ADPKD patients with evidence of rapidly progressing disease.

Article by
Andrew McConaghie

3rd August 2018

From: Marketing

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