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Novartis unveils new multi-trial data for CAR-T therapy Kymriah in advanced lymphoma

December 7, 2020
Research and Development, Sales and Marketing CAR-T, Kymriah, Novartis

Novartis has taken the opportunity at the 2020 American Society of Hematology Annual Meeting & Exposition (ASH) to unveil promising …

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EMA receives filing for Janssen’s twice-yearly schizophrenia jab

December 7, 2020
Sales and Marketing EMA, Janssen, schizophrenia

The European Medicines Agency (EMA) has received Janssen’s Marketing Authorisation Extension for paliperidone palmitate six-monthly (PP6M), an injectable therapy administered …

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Jakafi outperforms best available therapy in steroid-refractory/dependent chronic graft-versus-host disease

December 7, 2020
Research and Development, Sales and Marketing Incyte, Jakafi, Novartis

The first Phase 3 findings have been revealed for Jakafi (ruxolitinib) in the treatment of steroid-refractory or steroid-dependent chronic graft-versus-host disease …

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Six-year follow-up data shows Imbruvica’s benefit in high-risk chronic lymphocytic leukaemia

December 7, 2020
Research and Development, Sales and Marketing Janssen, chronic lymphocytic leukaemia, imbruvica

Janssen has revealed multiple pooled data analyses for its Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) in the first-line treatment …

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FDA approves Novo Nordisk’s Saxenda for adolescent obesity

December 7, 2020
Sales and Marketing FDA, Novo Nordisk, saxenda

The FDA has awarded US approval to Novo Nordisk’s Saxenda (liraglutide) 3mg injection to treat obesity in patients between the …

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Top Ten most popular articles on Pharmafile.com this week

December 4, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Dupixent, EMA, UK, Vaccine, top ten

As the year winds to a close, excitement is rising around the efficacy and availability of COVID-19 vaccines around the …

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New research links metformin to decreased mortality risk in female patients hospitalised with COVID-19

December 4, 2020
Medical Communications, Research and Development COVID-19, Vaccine, metformin

Researchers from the University of Minnesota Medical School (UMMS) and UnitedHealth Group have uncovered potential benefit of metformin, a generic …

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IBM uncovers “precision phishing campaign” targeting global COVID-19 vaccine cold chain supply

December 4, 2020
Manufacturing and Production, Medical Communications, Research and Development COVID-19, Vaccine, ibm

US tech firm IBM has reported that it has identified attempts by unknown parties to hack and disrupt elements of …

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FDA approves BioCryst’s Orladeyo for reducing hereditary angioedema attacks

December 4, 2020
Medical Communications, Sales and Marketing BioCryst, FDA, Orladeyo

BioCryst has scored FDA for its therapy Orladeyo (berotralstat) for reducing or preventing hereditary angioedema (HAE) attacks in patients over …

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moderna

MSD cashes in on Moderna investment as FDA mulls COVID-19 vaccine approval

December 4, 2020
Medical Communications, Sales and Marketing MSD, Moderna

Moderna has wrestled its way to the forefront of the industry amidst the COVID-19 pandemic, becoming one of its most …

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Jazz and PharmaMar’s Zepzelca combo misses main goal in small cell lung cancer sub-population

December 3, 2020
Research and Development PharmaMar, jazz pharma, trial failure

Jazz Pharma and PharmaMar have revealed that their jointly-developed therapy Zepzelca (lurbinectedin), when combined with doxorubicin, fell short of its …

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Neurogene secures EMA orphan designation for gene therapy in rare, inherited aspartylglucosaminuria

December 3, 2020
Sales and Marketing EMA, Neurogene, aspartylglucosaminuria

The European Medicines Agency (EMA) has bestowed Orphan Drug Designation (ODD) to Neurogene’s adeno-associated virus vector (AAV) gene therapy in …

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Janssen scoops up rights to Hemera’s gene therapy for retinal geographic atrophy

December 3, 2020
Sales and Marketing Hemera Biosciences, Janssen, Retina, geographic atrophy

Janssen is set to acquire the rights to Hemera Biosciences’ intravitreal gene therapy injection HMR59, the company has announced, to …

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Drug-free nasal spray could prevent COVID-19 infection, promising data show

December 3, 2020
Research and Development COVID-19, Nasal Spray, auris medical

Auris Medical has revealed promising new in vitro data for AM-301, its drug-free nasal spray, showing that the product could …

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Roche secures emergency FDA approval for COVID-19 antibody test

December 3, 2020
Sales and Marketing COVID-19, FDA, Roche

The FDA has awarded Emergency Use Authorization to Roche’s COVID-19 test to allow users in the US to analyse the …

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Pharmafile.com’s weekly COVID-19 news round-up

December 2, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Image credit: CDC, Top 5, Vaccine

EMA receives Pfizer and BioNTech’s filing for conditional approval of COVID-19 vaccine in Europe – Published on 01/12/20

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FDA greenlights Gavreto for advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer in over-12s

December 2, 2020
Research and Development, Sales and Marketing FDA, Gavreto, Roche

The FDA has awarded accelerated approval to Roche and Blueprint Medicines’ Gavreto (pralsetinib) for the treatment of advanced or metastatic …

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European approval for Janssen’s Tremfya in active psoriatic arthritis, either alone or in combo

December 2, 2020
Research and Development, Sales and Marketing Europe, Janssen, Tremfya

The European Commission has authorised Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) in the treatment of active psoriatic arthritis (PsA), either …

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Ovid’s Angelman syndrome therapy falls short at Phase 3

December 2, 2020
Research and Development Angelman syndrome, Ovid

Ovid Therapeutics has revealed disappointing results for its therapy OV101 (gaboxadol) in the treatment of Angelman syndrome, admitting that it failed …

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UK becomes first nation to approve Pfizer and BioNTech’s COVID-19 vaccine

December 2, 2020
Research and Development, Sales and Marketing COVID-19, Pfizer, UK, Vaccine

The UK has become the first country worldwide to authorise Pfizer and BioNTech’s promising COVID-19 vaccine, the UK Government has …

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