Biopharmaceutical News week 5 2015
January 28, 2015
The European Commission agrees on Novartis-GSK deal
The European regulators have given approval to the deal between GlaxoSmithKline and Novartis, under which the firms will exchange assets in the vaccine and the oncology field and form a new consumer healthcare joint venture, on the condition that Novartis divests two of its cancer therapies LGX818 and MEK162.
January 29, 2015
Valeant announces the acquisition of Dendreon for $296 Mio in cash
The Canadian drugmaker Valeant indicates that it has reached an agreement to acquire Dendreon and its prostate cancer vaccine Provenge, for $296 million. The deal is subject to a bankruptcy court approval, since Dendreon had filled a Chapter 11 protection in November 2014.
January 28, 2015
Novartis intends to sell its UK Horsham R&D site to Brighton University
Novartis has entered into exclusive negotiations with the University of Brighton on the purchase of the R&D site in Horsham (UK). The University of Brighton is now looking to buy the site where it plans to open “an innovative, high-quality centre for higher education” and provide around 3,500 places for students.
January 29, 2015
AstraZeneca signs four deals to apply genome editing technology CRISPR
Just three weeks after Novartis signed CRISPR agreements with Intellia Therapeutics and Caribou Biosciences, Astra Zeneca announces the signature of four CRISPR collaborations deals with the Wellcome Trust Sanger Institute, the Innovative Genomics Initiative, the Broad Institute and Whitehead Institute in Massachusetts and Thermo Fisher Scientific. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a genome-editing tool, which allows scientists to make changes in specific genes. The collaborations are expected to yield new drug targets in preclinical models of disease.
Amgen sales to exceed $20 billion in the coming year
The California based company Amgen has now become one of the industry’s top selling drug company with expected sales of $21.3 billion in 2015. The company is expecting further strong growth from its myeloma drug Kyprolis, which Amgen accessed through the Onyx acquisition. Nevertheless Neupogen sales, which reached $1.45 million in 2014, could see the approval of the first biosimilar competitor, developed by Sandoz, later this year in the US.
January, 30, 2015
Pfizer terminates its development agreement with Repligen for compounds to treat spinal muscular atrophy
Approval of drugs, diagnostics, vaccines and devices
January 23, 2015
NPS Pharmaceuticals gets FDA approval for Natpara to treat hypoparathyroidism, a rare disease
NPS Pharmaceuticals (USA), which is in the process of being acquired by Shire in a $5.2 billion deal, has obtained the FDA's approval to market Natpara, a recombinant human parathyroid hormone, for use in controlling low blood calcium levels in hypoparathyroidism patients. Hypoparathyroidism, is a rare disease associated with long-term complications such as kidney damage, kidney stones, development of cataracts and calcification of soft tissues.
January 27, 2015
China FDA approves Agilent's microarray scanner for in vitro diagnostics
Agilent Technologies announced that its SureScan Dx microarray scanner has been approved by the China Food and Drug Administration as a medical device for use in in vitro diagnostics. China is very keen to promote medical device equipment for its fast-growing network of hospitals. The SureScan Dx microarray scanner was first CE-marked and launched in Europe, in 2013, and Agilent has expressed intentions to file for 510(k) clearance in the United States.
January 29, 2015
Two HIV combination drugs get FDA approval
The FDA has granted marketing approval for Evotaz and Prezcobix. Both are fixed-dose, once-daily oral drugs to treat HIV-1 infection. Evotaz (Bristol-Myers Squibb), is a combination of atazanavir, a protease inhibitor, and cobicistat. Prezcobix (Johnson & Johnson) is a combination of cobicistat and the protease inhibitor darunavir.
Drugs at clinical stage
January 22, 2015
Samsung Bioepis'application for Enbrel biosimilar accepted by EMA
A marketing application submitted by Samsung Bioepis, the joint venture between the Samsung and Biogen Idec, for SB4, its biosimilar of Amgen and Pfizer’s anti-TNF Enbrel (etanercept), has been accepted by the European Medicines Agency. If SB4 gets approved it will be produced and sold in Europe by Biogen Idec.
Pharnext’s Pleotherapy Drug PXT-864 Shows Synergistic Effects in Alzheimer’s Disease
Pharnext (Paris, France) announced the publication of preclinical results in Nature’s Scientific Reports for its lead pleodrug, PXT-864, in Alzheimer’s. The pleotherapy approach is based on a proprietary network pharmacology platform that identifies synergic combinations of drugs already approved for other diseases. PXT-864, a combination of baclofen and acamprosate, demonstrated synergistic effect in various animal models.
The “Institut Curie” (Paris, France) announces that circulating tumoral ADN, obtained from blood samples, can be as accurate, in identifying tumoral molecular abnormalities, as the one obtained from classical biopsies.
January 23, 2015
An Ebola vaccine trial involving 27,000 people will start in Liberia
The National Institutes of Health (NIH) announced that it will test two experimental Ebola vaccines from Merck and GlaxoSmithKline in Liberia.
January 26, 2015
Executive of the biopharmaceutical sector support the idea that FDA should review clinical AND economic value
According to a report from PricewaterhouseCoopers' Health Research Institute, 43% of senior executives at pharmaceutical and life sciences companies said they would be willing to have their products evaluated, by the FDA, on economic and clinical value. This compares to just 14% in a 2010 poll carried out by PwC's Health Research Institute. The PwC report adds that 71% believe that the FDA can still accelerate approval programmes by balancing swifter approval with increased post-market surveillance.
Gout Disease Treatment Market Value to increase by 18%
According to a Global Data Report, the acute gout segment of the six major markets will double in size over the forecast period, reaching $337m in 2018 at a CAGR of 15%. The chronic gout market, which encompasses urate-lowering and prophylactic anti-inflammatory therapies, will experience even faster growth at a CAGR of 18.8%, and it will more than double in size, reaching over $1.9 billion in 2018.
Author : Jean-Claude MULLER, Special Advisor, Innovation & International Relationship (I&IR)
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