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BIOCON AND MYLAN
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, Mylan launch cancer drug in CanadaFulphila, co-developed by Biocon Biologics and Mylan, was the first biosimilar pegfilgrastim to be approved in the US and was launched in J...
- Biocon, Mylan win US court ruling in favour of insulin GlargineUS District Court of New Jersey found the device patent claims (US Patent No. 9526844) asserted by Sanofi against Biocon and Mylan’s insuli...
- US FDA accepts Biocon's cancer drug application for reviewBiocon and Mylan’s proposed biosimilar bevacizumab, a cancer drug, is expected to be the third biosimilar from the partnered portfolio for ...
- 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.
- 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...
- Breast cancer biosimilar approval delayed as US FDA reviews additional information by Biocon, MylanBiocon and Mylan have together developed the trastuzumab biosimilar, which is a copy of a complex biologic drug developed by Swiss biotech ...
- Delhi High Court gives Biocon, Mylan green light to market blockbuster biosimilar for three cancersThe court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and M...
- HC allows Biocon, Mylan to sell their drug for three cancersBiocon and Mylan had appealed against the single judge order as restrictions were imposed on the use of clinical data in the package insert...
- 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 ...
- 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 Biocon and Mylan's regulatory submission for proposed breast cancer biosimilar drugBiocon and Mylan are engaged in a court battle in India against Swiss biotech firm Roche over marketing restrictions imposed on their trast...
- 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...
- Reliance Life Sciences appeals marketing restrictions on breast cancer drugThe counsel is appealing conditions including the restrictions placed on the labelling of TrastuRel as well as those placed on using Roche’...
- 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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