Mylan
Fosun's sale of Gland Pharma to become India's biggest pharma deal: Report
With the acquisition, Gland pharma may also get access to global companies like AstraZeneca, Sanofi, Mylan, and Organon
 "Fosun's sale of Gland Pharma to become India's biggest pharma deal: Report")
Biocon in talks with Mylan to merge biosimilar businesses: Report
Indian drugmaker Biocon Ltd is in talks with generic drugmaker Mylan for a merger of their biosimilar businesses, a report said
 "Biocon in talks with Mylan to merge biosimilar businesses: Report")
USFDA informs Biocon, Mylan of deferred action on biosimilar license plea
Biocon said its arm, Biocon Biologics, and Mylan have been informed by the USFDA of a deferred action on the biologics license application for a biosimilar to drug Avastin
 "USFDA informs Biocon, Mylan of deferred action on biosimilar license plea")
Biocon-Mylan launch insulin Glargine at lowest price in US market
The commercialisation in the US of the drug, which already has approval in 45 countries, gives a boost to Biocon's ambitious target of $1 billion in sales through its biologics division by FY22
 "Biocon-Mylan launch insulin Glargine at lowest price in US market")
Indian drug makers gear up to make Gilead's remdesivir for Covid-19 therapy
Domestic players will be free to price it; Dutch firm Mylan also to make the drug in India; no royalty for Gilead as yet
 "Indian drug makers gear up to make Gilead's remdesivir for Covid-19 therapy")
Biocon, Mylan launch Fulphila, a biosimilar Pegfilgrastim in Australia
CEO of Biocon Biologics, Dr Christiane Hamacher said, Fulphila, co-developed by Biocon Biologics and Mylan, is the third biosimilar to be commercialised in Australia
 "Biocon, Mylan launch Fulphila, a biosimilar Pegfilgrastim in Australia")
Malaysia plant boosts Biocon prospects in US and other key markets
Firm seen benefiting from operating leverage, biologic sales by FY22
 "Malaysia plant boosts Biocon prospects in US and other key markets")
Build to last
In the second part of a series, the author notes down some lessons for start-ups
Biocon, Mylan win patent case for insulin device against Sanofi in US
Development takes Biocon a step closer to commercialise its glargine biosimilar Semglee in America
 "Biocon, Mylan win patent case for insulin device against Sanofi in US")
USFDA accepts Biocon-Mylan's Avastin biosimilar application for review
The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments
USFDA accepts proposed biosimilar application by Mylan, Biocon for review
The application seeks approval of Bevacizumab for the first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy
 "USFDA accepts proposed biosimilar application by Mylan, Biocon for review")
US launch of second oncology biosimilar to boost Biocon's earnings
Even as the Street will monitor product ramp-up, commercialisation of more biosimilars will drive prospects further
 "US launch of second oncology biosimilar to boost Biocon's earnings")
Biocon and Mylan launch Trastuzumab biosimilar Ogivri in US market
Ogivri will be launched at a competitive discount for customers to help ensure access and increase treatment options for patients
 "Biocon and Mylan launch Trastuzumab biosimilar Ogivri in US market")
Pfizer may be talks to merge off-patent drugs business with Mylan
Separation of Pfizer's off-patent business would be a tax-free spin-off
 "Pfizer may be talks to merge off-patent drugs business with Mylan")
Mylan partnered Indian drug firms to keep R&D costs low
Homegrown firms saw R&D spend, as percentage of sales, rise in past 5 years
 "Mylan partnered Indian drug firms to keep R&D costs low")
Mylan looks to sell off Vizag formulations unit it acquired in 2012
BS ReporterHyderabad, 6 September: American generics drug major Mylan is looking for a buyer for its formulations manufacturing facility in Vizag Pharma City for some business considerations. While there was no official conformation either on the decision or the reasons behind it from Mylan's Indian subsidiary, sources aware of the matter said the plant has been on the block for some time now.Entered India ten years ago on the back of its maiden acquisition of Hyderabad-based Matrix Laboratories in 2007, Mylan has built a huge global manufacturing base in the country, mostly through inorganic route, since then. 25 out of its 40 manufacturing facilities as well as one of the three global R&D centers of the company are located in India.Mylan had acquired Vizag facility in 2012 from Hyderabad-based SMS Pharma for $ 32.5 million. SMS Pharma had built this plant for products related to cancer therapy.While there are no concrete details available on why Mylan wants to dispose of this ..
US FDA issues warning letter to Mylan for Nashik facility
The pharma firm also failed to establish an adequate quality control unit
 "US FDA issues warning letter to Mylan for Nashik facility")
US FDA warns Mylan over quality concerns at India facility
US FDA's concerns stem from an inspection in September of a facility located in Maharashtra
 "US FDA warns Mylan over quality concerns at India facility")
USFDA accepts Mylan's BLA for proposed biosimilar Pegfilgrastim
Proposed biosimilar is one of the six products co-developed by Mylan and Biocon for global market
 "USFDA accepts Mylan's BLA for proposed biosimilar Pegfilgrastim")
Mylan to pay $465 million over EpiPen Medicaid rebate dispute
Lawmakers were trying to determine whether Mylan made more money on EpiPen than warranted from state Medicaid programmes
 "Mylan to pay $465 million over EpiPen Medicaid rebate dispute")
