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May 2015

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GSK and Theravance receive FDA approval for asthma drug Breo Ellipta
01 May 2015 GlaxoSmithKline (GSK) and Theravance have received approval from the US Food and Drug Administration (FDA) for the Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as the once-daily...

Mylan offers to acquire Perrigo for $34bn
01 May 2015 US-based Mylan has increased its offer to acquire all of outstanding shares of Ireland-based over-the-counter (OTC) and nutritional products maker Perrigo....

April 2015

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Takeda to pay $2.4bn to settle Actos drug claims in US
30 April 2015 Japan-based Takeda Pharmaceutical Company and its US subsidiary have entered an agreement to settle multiple product liability lawsuits pending against Actos (pioglitazone HCl) in America....

FDA grants approval for generic version of antipsychotic drug Abilify
30 April 2015 The US Food and Drug Administration (FDA) has granted approval for the first generic versions of Abilify (aripiprazole), which is an atypical antipsychotic drug to treat schizophrenia and...

AstraZeneca’s heart drug Brilinta receives FDA priority review designation
29 April 2015 The US Food and Drug Administration (FDA) has accepted AstraZeneca's supplemental new drug application (sNDA) and granted priority review designation for its Brilinta (ticagrelor) tablets to...

Genzyme’s GZ/SAR402671 receives FDA fast-track designation for Fabry disease
29 April 2015 Sanofi company Genzyme has received fast-track designation from the US Food and Drug Administration (FDA) to develop its GZ/SAR402671, a new investigational oral substrate reduction therapy...

Celgene to buy drug discovery firm Quanticel for $485m
28 April 2015 US-based Celgene has signed a share purchase agreement to acquire biotechnology firm Quanticel Pharmaceuticals in a $485m deal....

Astellas introduces aspergillosis and mucormycosis treatment Cresemba in US
28 April 2015 Pharmaceutical firm Astellas has introduced its prodrug for isavuconazole, Cresemba (isavuconazonium sulfate), in the...

Innate Pharma and AstraZeneca to develop IPH2201 for immuno-oncology
27 April 2015 AstraZeneca with its global biologics research and development arm MedImmune has entered a co-development and commercialisation agreement with France-based Innate Pharma....

Mylan and Teva’s proposed combination can transform generic drugs area, says GlobalData
27 April 2015 Israel's Teva Pharmaceutical Industries potential $40bn offer to acquire drugmaker Mylan can transform the generic drugs segment, according to research and consulting firm GlobalData's...

Astellas and Potenza partner to develop immune-oncology therapeutics
24 April 2015 Japan-based Astellas Pharma has entered an exclusive research and development collaboration agreement with Potenza Therapeutics to develop a portfolio of immune-oncology therapeutics....

Mylan introduces generic Sofosbuvir 400mg tablets in India
24 April 2015 Mylan Pharmaceuticals has launched the generic version of Sofosbuvir 400mg tablets under the brand name of MyHep in India....

CymaBay MBX-8025 receives FDA orphan drug designation for hyperlipoproteinemia
23 April 2015 Clinical-stage biopharmaceutical firm CymaBay Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its MBX-8025 to treat patients...

Pfizer’s Xalkori gets FDA breakthrough therapy designation for ROS1-positive NSCLC
23 April 2015 Pfizer has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Xalkori (crizotinib) to treat patients with ROS1-positive non-small cell lung...

AstraZeneca to use Roche’s Bina GMS in its drug development programmes
22 April 2015 AstraZeneca has signed an agreement with Roche Group subsidiary Bina Technologies to join the Bina Alliance Programme and advance development of the Bina Genomic Management Solution (GMS)....

Teva offers $40bn to acquire US drugmaker Mylan
22 April 2015 Israel-based Teva Pharmaceutical Industries has made an offer of around $40bn to acquire US-based generic and specialty pharmaceuticals firm Mylan....

Lupin introduces hepatic encephalopathy treatment Zaxine in Canada
21 April 2015 India-based drugmaker Lupin has introduced its first brand product, Zaxine, in Canada....

Daiichi Sankyo sells its entire stake in India’s Sun Pharma for $3.25bn
21 April 2015 Japan-based drugmaker Daiichi Sankyo has completed the divestment of its entire share in India-based Sun Pharmaceutical Industries for around $3.25bn....

Takeda and CiRA partner for iPS cell research
20 April 2015 Japan-based Takeda Pharmaceutical Company has entered a ten-year collaboration with Centre for iPS Cell Research Application (CiRA) of Kyoto University to develop clinical applications of...

RXi’s samcyprone receives FDA orphan drug designation to treat malignant melanoma
20 April 2015 RXi Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its second clinical candidate samcyprone to treat malignant melanoma stage IIb to IV....

AstraZeneca's tremelimumab receives FDA approval to treat mesothelioma
17 April 2015 British-Swedish drugmaker AstraZeneca has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its anti-CTLA-4 monoclonal antibody, tremelimumab to treat...


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