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U.S. FDA Approves Pfizer’s Biosimilar Nivestym

Pfizer Inc. announced that the U.S. FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.

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PureTech Health Announces Collaboration with Roche to Advance Technology for Oral Administration of Antisense Oligonucleotides

PureTech Health plc entered into a multiyear collaboration with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. to advance PureTech’s milk-derived exosome platform technology for the oral administration of Roche’s antisense oligonucleotide platform.

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Kite and Gadeta Announce Strategic Collaboration to Advance Gamma Delta T Cell Receptor Technology for Solid Tumors

Kite Pharma Inc. and Gadeta B.V. entered into a strategic collaboration to develop novel gamma delta TCR therapies in various cancers.

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Publicis Health Acquires Payer Sciences

Publicis Health announced the acquisition of Payer Sciences, an innovative data-and-analytics-driven health marketing agency.

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Pfizer to Organize for Future Growth

Pfizer Inc. announced that the company will organize into three businesses: Innovative Medicines, Established Medicines, and Consumer Healthcare.

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Anti-PD-L1 Immunotherapy Plus Abraxane Significantly Reduced Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer

Celgene Corporation today announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival.

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Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program

Seattle Genetics Inc. and Astellas Pharma Inc. announced completion of enrollment for the enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1).

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Cleara Biotech Announces Three Collaborations to Develop New Therapeutics Targeting Senescent Cells and Cancer

Cleara Biotech B.V., a Netherlands-based biopharmaceutical company, announced the creation of three public-private partnerships to discover and develop new therapeutics.

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Europe Approves Expanded Indication for Sprycel

The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.

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Catalent Signs Agreement to Acquire Juniper Pharmaceuticals

Catalent Inc. announced that the drug delivery company agreed to acquire Juniper Pharmaceuticals Inc., including its Nottingham, U.K.-based Juniper Pharma Services division.

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Interpublic Group to purchase Acxiom Marketing Solutions for $2.3 Billion

Data foundation Acxiom announced a definitive agreement to sell its Acxiom Marketing Solutions business to Interpublic Group for $2.3 billion in cash.

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FDA Grants Priority Review to Merck’s Supplemental BLA for Keytruda in Combination with Chemo as First-Line Treatment for Metastatic Squamous NSCLC

The U.S. FDA accepted for review Merck’s supplemental Biologics License Application for the anti-PD-1 therapy Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.

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Xeljanz Wins EU Approval for Active Psoriatic Arthritis

The European Commission approved Pfizer’s Xeljanz in combination with methotrexate for treating active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

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FDA Grants Priority Review to Genentech’s Baloxavir Marboxil for the Treatment of Influenza

The U.S. FDA accepted a New Drug Application and granted Priority Review for Genentech’s baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older.

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European Commission Approves Gilead’s Biktarvy

The European Commission granted Marketing Authorization for Gilead Sciences Inc.’s Biktarvy as a once-daily single tablet regimen for the treatment of HIV-1 infection.

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Boehringer Ingelheim bolsters biologics R&D

Boehringer Ingelheim announced a 230 million euro investment into a new biologicals development center at the company’s research and development site in Biberach, Germany.

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Anika Reports Results from Knee Osteoarthritis Study

Anika Therapeutics Inc. announced results from the company’s CINGAL 16-02 clinical trial, an active-comparator Phase III study being conducted to support U.S. registration.

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Alexion Submits Application for U.S. Priority Review and Approval of ALXN1210 as Treatment for PNH

Alexion Pharmaceuticals Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for approval of ALXN1210, the company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).

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Heartbeat Certified as Veeva Level 4 Multichannel Content Partner

Leading healthcare marketing agency Heartbeat has earned Level 4 certification status with Veeva Systems Inc., a leader in cloud-based software for the global life sciences industry.

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FDA Approves Avastin for Advanced Ovarian Cancer

The U.S. FDA approved Genentech’s Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with advanced ovarian cancer following initial surgical resection.

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June 2018 Focus: Biotech, Payer Access, DTC and more!


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