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Cristiana Bernini

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Umeclidinium bromide in pulmonary disease

The European Commission granted a marketing authorisation valid throughout the European Union for Incruse (umeclidinium bromide) on 28 April 2014. It is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Incruse is used for maintenance (regular) treatment. Umeclidinium bromide is a muscarinic receptor antagonist.

G1T28-1 in oncology treatments

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US-based pharmaceutical firm G1 Therapeutics has started a randomized, placebo-controlled, single ascending dose Phase I clinical trial of G1T28-1, a highly potent and selective CDK4/6 inhibitor with broad potential in multiple oncology indications. The trial is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of G1T28-1 in healthy volunteers, who are currently being enrolled in the Netherlands. G1T28-1 is a first-in-class therapy for protecting the bone marrow from chemotherapy-induced myelosuppression in patients with CDK4/6-independent tumors, and has the potential to be best-in-class as an antineoplastic agent in patients with CDK4/6-dependent tumors. Preclinical data suggests that G1T28-1 is differentiated from currently available therapies for myelosuppression in that it protects all hematopoietic lineages, including red cells, platelets, granulocytes and lymphocytes, before damage is done by chemotherapy.

 

New data on asfotase alfa in pediatric patients

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01733FRHAlexion Pharmaceuticals has announced that researchers presented new data from an integrated analysis of survival from two open-label, Phase 2 studies of asfotase alfa in pediatric patients (ages ≤5 years at enrollment) with hypophosphatasia (HPP) compared with data from a retrospective natural history study of untreated historical control patients matched for age and disease severity. HPP is a genetic, chronic and progressive ultra-rare metabolic disease that can lead to progressive damage to multiple vital organs,

Clinuvel’s phase II vitiligo study commences in Singapore

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Clinuvel Pharmaceuticals Limited announced a Phase II study of its drug SCENESSE® (afamelanotide 16mg implant) in Singapore (CUV103) had received the necessary approvals and commenced recruitment. Sixty adults with vitiligo will be recruited to the seven month, double‐blind, placebo controlled study at the National Skin Centre, the leading dermatology hospital in Singapore. The CUV103 study will evaluate SCENESSE® as a combination treatment with narrow ba

New CMO at Kiadis

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Jeroen Rovers is the newly named chief medical officer of biopharma company Kiadis Pharma. Prior to this position, he was CMO at Ceronco Biosciences. Rovers is an expert in cell based therapeutics. His experience will support Kiadis in the development of its T-cell immunology treatment for cancer, currently undergoing phase II with the leading candidate ATIR. “I believe ATIR is a truly innovative product and has the potential to become a key part of the next generation treatments of blood cancers”, said Rovers.

New alliance to fight Alzheimer

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AstraZeneca and Eli Lilly announced an agreement to jointly develop and commercialise AZD3293, an innovative potential treatment for Alzheimer’s disease. Lilly will pay AstraZeneca up to $500 mln in development and regulatory milestone payments. The companies will share all future costs equally for the development and commercialisation of the new medicine, as well as net global revenues post-launch.

AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. Accumulation of amyloid plaques in the brain is a typical sign of the progression of Alzheimer’s disease.

The companies aim to progress the candidate medicine rapidly into a Phase II/III clinical trial in patients with early Alzheimer’s disease.

Roche still leader in DJ Sustainability Indices

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For the sixth consecutive year, Roche is the Group Leader company in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry Dow Jones Sustainability Indices (DJSI). The Swiss pharma is amongst the top 10 percent of companies across all surveyed industries. Roche received top scores in several areas, i.e. manages customer relationships, supply chain management, the way it address healthcare burden through the value of its products and services, and in employee engagement.

DJSI have become the key reference for investors who integrate sustainability considerations into their portfolios. S&P Dow Jones Indices and RobecoSAM maintain the Dow Jones Sustainability™ Indices collaboratively. They annually identify the top company in each of the 24 industry groups. Over 3,300 publicly traded companies, including 800 companies in emerging markets, have been invited to participate the analysis this year.

Shire merges with AbbVie

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Born in 2013 from the separation from Abbott, AbbVie recently acquired Shire for $ 53,52 bln. Shire’s stakeholders will maintain control over the 25 per cent of the new company. The combined market cap counts for $ 137 bln, covering more than 170 countries, with 14 manufacturing facilities, 9 R&D centres and more than 30K employees.

The merger will give raise to six combined areas of expertise, including oncology, immunology, neuroscience, liver disease/virology and rare diseases. The combination of the portfolios account for nine leading products in the market, more that twenty projects in late phase or registration and more than thirty early development projects.

Google enters pharma R&D in ageing

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The web giant Google moves its first steps in the pharma business through the alliance between its controlled R&D company Calico and AbbVie. The partnership aims to develop a project to find new therapies for diseases associated with ageing, such as neurodegeneration and cancer. The two companies are investing a total of $ 1,5 bln; Calico shall built a new R&D facility in the San Francisco Bay area where to handle drug discovery and early drug development projects through phase IIa trials. AbbVie will take the lead once projects pass the proof-of-concept stage and continue development towards commercialisation. Profits and costs will be split between the two companies.

Calico, established by Google in 2013 to focus on ‘health, wellbeing and longevity’, is led by former Genentech chairman and chief executive Art Levinson who just resigned from the board of Genentech parent Roche to avoid any conflict of interest. Hal Barron, former Roche chief medical officer, also joined Levinson in the management team.

Research on rare genetic diseases in Tirana

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The new centre for blood collection and research in rare genetic diseases has been launched in Tirana, Albania, on September 13th. The centre is the result of an health cooperation project between Albania and Italy, a partnership including the MAGI-onlus, the Albert Schweitzer Association, MAGI-Euregio Coop. Soc and the Albanian DHVGJ blood donors association, with the support of the Albanian Ministry of Health. The new labs are equipped with PCR in order to rapidly diagnose collected blood for the presence of diseases such as thalassemia, cystic fibrosis or hemochromatosis. A new Preventive Medicine Centre shall also open in the near future. The project aims to fight genetic diseases, specifically those linked to blood donations and collection and to the production of hemo- and plasma-derivatives, such as albumin, immunoglobulines and coagulation factors.

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