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Herceptin

Showing 15 posts of 53 posts found.

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China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers

August 18, 2020
Manufacturing and Production, Sales and Marketing China, Henlius, Herceptin, Roche, biosimilar

China’s National Medical Products Administration (NMPA) has given the green light to Shanghai’s Henlius for its biosimilar version of Roche’s …

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roche

Roche’s subcutaneous Perjeta/Herceptin combo proves non-inferior to IV formulation in HER2-positive early breast cancer

December 12, 2019
Research and Development Cancer, Herceptin, Perjeta, Roche, breast cancer, pharma

New Phase 3 data from Roche has shown that its subcutaneously-delivered formulation of Perjeta (pertuzumab) and Herceptin (trastuzumab), in combination …

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samsung

FDA approves third Herceptin biosimilar with Samsung Bioepis’ Ontruzant

January 22, 2019
Manufacturing and Production, Sales and Marketing FDA, Herceptin, Samsung Bioepis, biosimilar, pharma

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), …

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Celltrion and Teva’s Herceptin biosimilar secures FDA approval in breast cancer

December 18, 2018
Manufacturing and Production, Sales and Marketing Herceptin, Herzuma, Teva, celltrion, pharma

Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by …

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Pfizer notches two EU approvals, including Herceptin biosimilar

August 1, 2018
Research and Development, Sales and Marketing Cancer, EMA, EU, Genetech, Herceptin, Pfizer, Trazimera, Xeljanz, biosimilar, breast cancer, pharma

Pfizer is patting itself on the back after securing two new approvals in Europe within 24 hours: Xeljanz (tofacitinib citrate) …

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Study finds Herceptin use can be halved

May 17, 2018
Medical Communications, Research and Development Herceptin, Roche, biosimilars, biotech, drugs, pharma, pharmaceutical

A team of researchers from the University of Cambridge and Warwick Clinical Trials have revealed that Roche’s Herceptin is just …

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EMA’s CHMP backs Roche’s Perjeta combo in HER2-positive breast cancer

April 30, 2018
Sales and Marketing Cancer, Herceptin, Perjeta, Roche, breast cancer, pharma

Roche’s Perjeta has edged one step closer to approval as a combo therapy after the EMA’s Committee for Medicinal Products …

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Top Ten most popular articles on Pharmafile.com this week

March 9, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AbbVie, Biogen, Celgene, EMA, Gilead, HIV, Herceptin, Japan, NHS, Ontruzant, Sanofi, opioid crisis, opioids, pharma, real world data, top ten, zinbryta

After a particularly jarring bout of cold weather and snow, we may just have seen off the worst of winter …

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samsung_bioepis

Ontruzant launches to become first Herceptin biosimilar available in the UK

March 8, 2018
Sales and Marketing Cancer, Herceptin, MSD, Ontruzant, Roche, Samsung Bioepis, pharma

Ontruzant, the biosimilar version of Herceptin (trastuzumab ) originally developed by Korean firm Samsung Bioepis, has launched for patients in …

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celltrion1

Celltrion’s Herceptin biosimilar seals EU approval

February 15, 2018
Sales and Marketing EU, Europe, Herceptin, Herzuma, celltrion, pharma

Herzuma, Celltrion’s biosimilar version of Roche/Genentech’s blockbuster immunotherapy Herceptin, has been awarded approval from the European Commission, the company has …

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mylan_building

Mylan and Biocon biosimilar approval expands to Brazil

January 2, 2018
Manufacturing and Production, Sales and Marketing Biocon, Herceptin, Mylan, biosimilar, biotech, drugs, pharma, pharmaceutical

Since Mylan and Biocon managed to gain US FDA approval for its Herceptin (Trastuzumab) biosimilar, it has forged ahead in …

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roche

FDA grants breast cancer approval to Roche’s Perjeta/Herceptin combo therapy

December 21, 2017
Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma

Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) …

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fdaoutsideweb

Mylan’s Ogivri becomes first and only FDA-approved Herceptin biosimilar

December 4, 2017
Sales and Marketing Biocon, Cancer, FDA, Herceptin, Mylan, Roche, biosimilar, pharma

The FDA has announced the approval of Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar version of Roche’s Herceptin to be authorised …

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samsung_bioepis

Samsung Bioepis’ Ontruzant becomes first Herceptin biosimilar approved in Europe

November 20, 2017
Sales and Marketing EMA, Herceptin, Roche, Samsung Bioepis

Samsung Bioepis has announced that Ontruzant, the company’s biosimilar version of Roche’s Herceptin, has been awarded marketing authorisation in Europe …

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rocherooflr

FDA awards Roche priority review in HER2-positive breast cancer

October 2, 2017
Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma, pharmaceutical

Roche has revealed that its monoclonal antibody Perjeta (pertuzumab) has been awarded priority review by the FDA as an adjuvant …

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