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FDA gives nod for Monjuvi combo for second-line relapsed or refractory diffuse large B-cell lymphoma

August 3, 2020 Sales and Marketing FDA, Incyte, Monjuvi, morphosys, pharma

The FDA has awarded MorphoSys and Incyte US approval for their Fc-modified cytolytic CD19-targeting monoclonal antibody Monjuvi (tafasitamab-cxix), when used …
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cbd

FDA approves CBD treatment for seizures associated with tuberous sclerosis complex

August 3, 2020 Sales and Marketing CBD, tsc

The FDA has approved Epidiolex (cannabidiol) as a treatment for seizures associated with tuberous sclerosis complex (TSC) in patients over …
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Top Ten most popular articles on Pharmafile.com this week

July 31, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Roche, UK government, Vaccine, lilly, pharma, top 10

Another week dominated by COVID-19. Among our most popular stories this week, Celltrion’s infliximab biosimilar Remsima has scored approval for …
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FDA expands Stelara indication to cover paediatric plaque psoriasis

July 31, 2020 Medical Communications, Sales and Marketing Janssen, Stelara, pharma, plaque psoriasis

Janssen’s IL-12 and IL-23 inhibitor Stelara (ustekinumab) has had its approved indications expanded by the FDA to include the treatment …
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Bavencio+Inylta combo approved or Cancer Drugs Fund in advanced renal cell carcinoma

July 31, 2020 Medical Communications, Sales and Marketing Merck, NICE, Pfizer, pharma

NICE has revealed that a combination of Merck KGaA’s Bavencio (avelumab) and Pfizer’s Inlyta (axitinib) will be made available as …
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UCB syncs up with Roche and Genentech in Alzheimer’s drug deal worth a potential $2bn+

July 30, 2020 Research and Development, Sales and Marketing Genentech, Roche, UCB, partnership

UCB Pharma is set to partner up with Roche and Genentech in a development and commercialisation deal focused on its …
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NICE shoots down Kyowa Kirin’s Poteligeo for NHS treatment of mycosis fungoides or Sézary syndrome

July 30, 2020 Sales and Marketing Kyowa Kirin, NICE, pharma

NICE has issued draft guidance that has shot down Kyowa Kirin’s therapy Poteligeo (mogamulizumab) for use on the NHS in …
News

Takeda poised to cut sales jobs in Japan as restructuring continues

July 29, 2020 Medical Communications, Research and Development, Sales and Marketing Japan, Takeda, job cuts

Japan’s biggest drug firm Takeda is said to be mulling plans to cut back its sales operations with a new …
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Pharmafile.com’s weekly COVID-19 news round-up

July 29, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, coronavirus, pharma

The once-touted COVID cure hydroxychloroquine continues its downward spiral of credibility as new data is published on its lack of …
News
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Novartis’ Piqray combo becomes first Europe-approved therapy for PIK3CA-mutated advanced breast cancer

July 29, 2020 Research and Development, Sales and Marketing Europe, Novartis, Piqray, breast cancer, pharma

The European Commission (EC) has awarded its approval for Novartis’ Piqray (alpelisib) to be made available in combination with fulvestrant …
News
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UK Government secures 60 million doses of Sanofi and GSK’s COVID-19 vaccine

July 29, 2020 Research and Development, Sales and Marketing COVID-19, GSK, Sanofi, UK government, pharma

The UK Government has sealed another deal to procure an effective COVID-19 vaccine for its citizens, partnering up with Sanofi …
News
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Eli Lilly teams up with Chi-Med for Chinese sales of Elunate capsules

July 28, 2020 Manufacturing and Production, Sales and Marketing Chi-Med, China, Eli Lilly

Eli Lilly Shanghai, an affiliate of the wider company, has enlisted the help of biopharma firm Hutchinson China MediTech, or …
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Kyowa Kirin’s Crysvita secures CHMP support in rare X-linked hypophosphataemia

July 28, 2020 Manufacturing and Production, Sales and Marketing CHMP, EMA

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has given its backing to Kyowa Kirin’s …
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Celltrion’s infliximab biosimilar Remsima secures European approval in five indications

July 27, 2020 Manufacturing and Production, Sales and Marketing celltrion, infliximab, pharma, remsima

The subcutaneous (SC) formulation of Remsima, Celltrion’s biosimilar version of infliximab, has secured approval from the European Commission covering five …
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AstraZeneca partners with Daichii Sankyo in potential $6bn cancer drug deal

July 27, 2020 Research and Development, Sales and Marketing AstraZeneca, Daiichi Sankyo, partnership, pharma

AstraZeneca and Daiichi Sankyo have joined forces to drive the development and commercialisation of the latter’s DS-1062, a trophoblast cell-surface …
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