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MYLAN AND BIOCON
Biocon jumps 4% on launch of drug Fulphila in CanadaBiocon has shared or co-exclusive commercialisation rights with Mylan for the product in the rest of the world.- Biocon rises 5% after launch of Ogivri in US marketBiotechnology major Biocon and drug firm Mylan NV on Monday announced the launch of biosimilar Ogivri, used for treatment of certain breast...
- Biocon, Mylan launch cancer drug in US marketOgivri, available in a 420mg multi-dose vial and a 150mg single-dose vial, will be used for treatment of all types of breast cancer and met...
- Biocon, Mylan launch insulin biosimilar in AustraliaThe biotechnology major and pharmaceutical company Mylan N V announced the launch of their insulin biosimilar Semglee.
- Biocon puts arthritis drug on backburnerBiocon and Mylan have been working for a decade on a biosimilar version of the drug, originally sold by Amgen under brand name Enbrel.
- Biocon-Mylan's cancer drug gets USFDA nodFulphila is expected to contribute to Biocon’s revenue in FY19, as well as to its profits through a profitshare arrangement with Mylan.
- Mylan-Biocon’s insulin biosimilar faces FDA hurdleFirms have been asked to share details about a change in the manufacturing site for glargine from Bengaluru to a new facility in Malaysia.
- USFDA okays Mylan, Biocon's biosimilar of cancer drug HerceptinOgivri is the first USFDA approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the...
- USFDA issues CRL for proposed biosimilar Pegfilgrastim: BioconThe company said it does not expect the CRL to impact the timing of the launch of biosimilar Pegfilgrastim in the US market.
- Big boost for Biocon as USFDA Onco committee approves company's first breast cancer biosimilar drugThe USFDA's Oncology Drugs Advisory Committee voted 16-0 in support of the eligible indications of the original product.
- USFDA accepts Mylan's BLA for proposed biosimilar PegfilgrastimThe proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the ...
- Biocon climbs 3% as USFDA accepts BLA for Mylan’s anti-cancer drug“This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months”, said Rajiv Mali...
- US FDA accepts Biocon-Mylan biosimilar application for proposed anti-cancer bio-similarBiocon said that the FDA's acceptance for review of this biosimilar is an outcome of the company’s strong R&D and manufacturing capabilitie...
- USFDA accepts Mylan's application for proposed biosimilar TrastuzumabThis is Mylan and Biocon's "first US regulatory submission through the 351(k) pathway and reinforces the strength of collaboration."
- European Medicines Agency accepts marketing application of Biocon, Mylan productMylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients.
- EMA accepts marketing application of Biocon, Mylan productMylan and Biocon, who co-developed the proposed biosimilar, received EMA's acceptance of the submission for review, Biocon said in a statem...
- Biocon, Mylan challenge ban on using Roche dataBangalore-based Biocon and US generic drugmaker Mylan have challenged Delhi High Court’s interim order which barred them from using Roche’s...
- Biocon gets DCGI nod to market biosimilar trastuzumab in IndiaBiocon today said it has received approval from the Indian drug regulator to market its biosimilar trastuzumab developed jointly with Mylan.
- Biocon gets DCGI nod to market biosimilar trastuzumab in IndiaBiocon said it has received approval to market its biosimilar trastuzumab developed jointly with Mylan for treating breast cancer.
- Biocon Inks Pact with Mylan for generic insulinIn 2009, Mylan and Biocon had come together to develop five blockbuster biologic drugs in cancer and pain areas.
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