Biocon-Mylan’s Cancer Treatment Drug Accepted for Review by European Medicines Agency
Biocon Ltd. and Mylan NV announced that Mylan's Marketing Authorisation Application for biosimilar Trastuzumab has been accepted for review by the European Medicines Agency. Mylan and Biocon have co-developed the proposed biosimilar.
This may be the first MAA for a trastuzumab biosimilar to be accepted by the EMA for review, according to a joint press release by both companies on the Bombay Stock Exchange.
Trastuzumab is used to treat certain HER2 (a type of protein) positive breast and gastric cancer, the release adds.
The companies view Europe as a vital market for the product with the government there “striving to reduce healthcare costs” and aim at launching the drug in the market, they said in the release.
The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biological therapy for the treatment of HER2-positive breast cancer.Arun Chandvarkar, CEO and Joint MD, Biocon
In July 2016, Mylan's MAA for Pegfilgrastim biosimilar was accepted for review by the EMA, the release adds.
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High US Salaries, No Green Card Certainty: The Financial Calculation Facing Indian H-1B Families
The suspension of PERM processing at eight technology employers does not cancel existing H-1B visas. What it does is force a question many Indian families have been avoiding: is the US salary worth tying your career and family plans to one employer?
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Swiggy vs Eternal: Food Delivery's Two Rivals Are No Longer In The Same Race
Eternal is building a private AI assistant, dark.ai. Swiggy is still working out how to make Instamart pay, with an operating loss of Rs 895 crore in the July-September quarter while Blinkit stayed profitable.
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Where You Live Shapes How You Get To Work | The Reason Why
Two-wheelers are the most popular way to get to work in India, accounting for nearly 43% of workplace commutes.
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Unhedged Position: Can India See An Indonesia-Style Time Correction?
The Nifty is trading below levels it first clocked in 2024. Is there, then, as I have suggested in the headline, potential that the current time correction drags on painfully for the next three-five, even ten years?
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Navigating Friction And Energy Realities: An Analysis Of Marco Rubio's October Visit To India
Occurring at a critical juncture marked by stalled trade negotiations and escalating geopolitical pressures over global energy supplies, the visit offers a profound window into modern US-India relations.
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India Exports Capital. Why Not Export Trusteeship?
The big question, then, is whether India can build an institution that global borrowers, investors, banks, and lawyers can trust, even without an Indian connection.
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France's Economy & Politics Are In Crisis | The Reason Why
Let's look at how the French economy and politics evolved under Nicolas Sarkozy, Franois Hollande and Emmanuel Macron.
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You May Inherit The Business. You Must Earn Its Credibility.
Succession tests the founder's ability to share authority as much as it tests the next generation's readiness to assume it.
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Signing Deals Is One Thing; Making Them Work Is Another | The Week In Whys
Sometimes, things don't turn out as planned. Indian companies have lost some bids to rivals, some projects won't produce until 2030.
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FOMC Wall, PERM Suspension, Hospital Stocks | Talking Points This Week
A PERM suspension would directly affect green-card sponsorship rather than H-1B visas, so the near-term earnings impact could remain relatively limited. The key question is whether this marks a new phase in US scrutiny of Indian IT.
