國際新聞精選周三（2017年2月15日）

2017年2月16日 | Filed under: | Posted by: 編輯 D

Incyte Takes on Global Responsibility for Agenus' GITR and OX40 Antibody Programs

Incyte and Agenus have amended an existing license, development, and commercialization agreement for Agenus’s GITR (glucocorticoid-induced tumor necrosis factor receptor) and OX40 antibody programs, to give Incyte responsibility for funding global development and commercialization of resulting antibody candidates. The amended deal converts the agreements from development co-funding and profit sharing to royalty generating, with Incyte paying Agenus 15% royalties on global net sales for each approved product.【閱讀全文】

Lilly/Incyte’s Olumiant bags first approval with EU nod

Eli Lilly's Olumiant has picked up its first regulatory approval with a nod from the European Commission to treat moderate-to-severe active rheumatoid arthritis.

The decision allows the drug's use either as a monotherapy or in combination with methotrexate to treat adult patients with the condition who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).【閱讀全文】

Gilead and Glaxo’s HIV battle intensifies

The first phase II data with Gilead’s HIV integrase inhibitor bictegravir have set up a showdown with Glaxosmithkline/Viiv Healthcare’s marketed product dolutegravir. But Glaxo is already one step ahead with data from a two-drug combo that could reduce the side-effect burden for HIV patients.

Glaxo believes that this doublet could “reshape the whole game”, the group's chief executive, Andrew Witty, said on its fourth-quarter earnings call. HIV has been one of the group’s main drivers in recent quarters as it has taken market share from Gilead, which is becoming increasingly reliant on HIV as its hepatitis C franchise slows. 【閱讀全文】

Onxeo Receives USPTO Notice of Allowance for a new AsiDNATM-Related Patent, Expanding Its IP Protection in the U.S.

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent (n° 15/232,844) relating to the Company’s candidate AsiDNA?, a first-in-class product that prevents tumor cells from repairing their DNA.【閱讀全文】

Amgen Submits Supplemental Biologics License Application For BLINCYTO (Blinatumomab) In Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BLINCYTO^? (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study, supporting the conversion of BLINCYTO's accelerated approval to full approval. The sBLA also includes new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The application aims to broaden BLINCYTO's indication for the treatment of patients with relapsed or refractory B-cell precursor ALL.【閱讀全文】

Intercept strikes at the heart of the Nash problem

Changing the design of a pivotal trial rarely augurs well. But on Friday Intercept made a clever pitch that amending Ocaliva’s pivotal Regenerate study in Nash would increase its chances of success as well as cutting the recruitment burden, and the sellside was sold, with upgrades pushing the stock up 5%.

True, much of what the group has done is simply a response to the low bar set by Intercept’s Nash competitors. But the changes raise serious questions about whether Nash is even a disease whose treatment might realistically appear as an indication on Ocaliva’s label.【閱讀全文】

The E100: Biotech execs are bullish about 2017, but fret about drug pricing and the FDA under Trump

The biotech industry is feeling bullish about its own prospects at the beginning of 2017, largely satisfied with the financial support that’s been flowing in to the field with most execs ready to hire through the year as the tempo on deal-making remains upbeat.

But it’s not all coming up roses.

The industry is in a funk about the Trump administration after a few weeks of headlines over a travel ban controversy and a rolling series of outspoken tweets, with a large segment of these execs worried that a new head of the FDA could come in ready to reduce if not actually discard standards on drug development.【閱讀全文】

Celgene co-founder Sol Barer bags a Johns Hopkins immuno-oncology spinout in buyout

A few weeks ago, Johns Hopkins Professor Jonathan Schneck published new research showing how the biomimetic nano beads he had created in the lab could work with a checkpoint inhibitor in fighting cancer. These beads were designed to act as antigen presenting cells aimed at whipping up a full scale killer T cell attack on cancer as the checkpoint stripped the cancer cells of their built-in defense system.【閱讀全文】

Double-whammy for Aviragen as lead drug trial ends in failure

It's been a torrid few days for antiviral drug developer Aviragen as a second phase 2 trial ended in failure, all but decapitating its R&D pipeline.

The phase 2b SPIRITUS trial of vapendavir in moderate to severe asthma patients failed to hit its main objective of curbing breakthrough symptoms and attacks in asthmatics with rhinovirus (RV) infections, according to a statement from Aviragen.【閱讀全文】

That was fast: Days after launching a strategic review, Teva's eyeing a branded generics sale or spinoff

Teva’s strategic review launched only last week, but the company is reportedly already weighing asset sales.

The company is considering a sale of its branded generics business, Bloomberg’s sources say. That’s a deal that could fetch several billion dollars, which Teva could use to cut down its heavy debt load.【閱讀全文】

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