Biopharmaceutical News Week 48 2014


Management changes in Pharma


Management Shake-up in Pharma

This was a month a major management shake-up. End of October Sanofi announced that it had ousted Chris Viehbacher. Earlier this week news came that Ulf Wiinberg, CEO of Lundbeck, resigned from his position because of a breach of company’s code conduct. Then Takeda announced the departure of Doug Cole, the US President of the Japanese company. And a few days later Novo Nordisk indicated that it shrinked its executive team, as Executive Vice-President Lise Kingo, in charge of human resources and corporate communication, was making an exit.


November 30, 2014

GlaxoSmithKline is planning a major reorganization

GlaxoSmithKline (GSK) is supposed to announce a major workforce restructuring that will include hundreds of job cuts, in particular in the US, where sales are flagging.


Acquisitions /Mergers/Joint-ventures

November 26, 2014 

BioMarin makes a $680 million bid for Prosensa

BioMarin Pharmaceutical, located in California, has made a proposal to buy Prosensa of the Netherlands for $680 million in cash. BioMarin is mainly involved in developing products for rare diseases. Prosensa’s Duchenne muscular dystrophy product (DMD) drisapersen, is currently under review at the US Food and Drug Administration. If drisapersen obtains approval in the US no later than 15 May 2016, and approval in Europe no later than 15 February 2017, two milestone payment of about $80 million will be paid to Prosensa.



November 22, 2014 

LabCorp and CareDx stop their on partnership on lupus test

LabCorp and CareDx have stopped their collaboration to develop a lupus flare predictor test after completing the first phase of their study.


Illumina and bioMérieux are developing an innovative sequencing system for infectious diseases

Illumina is entering a four years collaboration with French diagnostic company bioMerieux to develop a next-generation sequencing (NGS) system that can identify infection bacteria in hospital settings and service laboratories.


November 27, 2014 

Glaxo stops a development deal with Dynavax

GlaxoSmithKline does not exercise its option to license Dynavax's DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after it failed to meet its expected endpoints.


Approval of drugs

November 25, 2014

European Commission approves Lilly diabetes drug Trulicity

The European Commission has approved Trulicity (dulaglutide) from Eli Lilly, a once-weekly glucagon-like peptide-1 receptor agonist, in combination with other diabetes treatments and as monotherapy for the treatment of type 2 diabetes. Trucility will have to compete with AstraZeneca’s Bydureon and GlaxoSmithKline’s Eperzan.


European Commission approves Boehringer Ingelheim for lung cancer

The Europe's Committee for Medicinal Products for Human Use (CHMP) approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of non-small cell lung cancer (NSCLC). Nintedanib is an oral pan-angiokinase inhibitor which inhibits endothelial growth factor receptors (VEGFR), platelet derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. Earlier this month, the Europe's Committee has adopted a positive opinion supporting approval of nintedanib, for the treatment of ideopathic pulmonary fibrosis (IPF). A few months ago, the FDA has already approved the drug, branded as Ofev, for the IPF indication in the United States.



Drugs at clinical stage

November 25, 2014 

Phase 3 brodalumab psoriasis trial successful

Amgen and partner AstraZeneca announce that the Amagine-2 Phase 3 trial evaluating two doses of brodalumab, in patients with moderate-to-severe plaque psoriasis, met its primary endpoints at week 12.



November 26, 2014 

Experimental Ebola vaccine from GSK and NIH appears safe in early test

An experimental Ebola vaccine from GlaxoSmithKline and the National Institutes of Health (NIH) was well tolerated and produced an immune response in all 20 healthy volunteers who received it. The results were published in the New England Journal of Medicine.


Merck acquires rights to NewLink's Ebola vaccine candidate

Merck enters into an exclusive worldwide license agreement with NewLink Genetics to develop and commercialize investigational rVSV-EBOV (Ebola) vaccine candidate. The vaccine was created by scientists at the Public Health Agency of Canada's National Microbiology Laboratory.



November 23, 2014 

A 'hybrid vehicle' that delivers DNA

A new hybrid vehicle, under development, based on a small part of a microbe’s genes, gives DNA vaccines new potential.



November 23, 2014 

AstraZeneca invests $200M to expand US biologics site

AstraZeneca has announced plans to expand its US biologics manufacturing centre in Frederick, Maryland, spending more than $200 million to increase production in support of its "maturing pipeline". The company says the investment will help it keep pace “with a growing demand for the development and use of biologics, which currently represent nearly 50% of AstraZeneca’s overall pipeline”. The expansion, which should be complete in 2017, will add 40,000 square feet of manufacturing, laboratory and administrative space and bring 300 new jobs to the site.


November 28, 2014

Italian drug regulator suspends two batches of Novartis flu vaccine after deaths

After the sudden death of three patient who received Novartis' Fluad influenza vaccine, Italy's drug regulator AIFA suspends two lots of the product.


Author : Jean-Claude MULLER, Special Advisor,Innovation & International Relationship (I&IR)



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