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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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Agios Pharmaceuticals Scores FDA Approval For Tibsovo

The U.S. FDA approved Agios Pharmaceuticals’ oral leukemia treatment Tibsovo (ivosidenib).

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Bayer to phase out Essure birth control device in U.S.

Bayer will discontinue the sale of the healthcare company’s birth control product Essure in the United States.

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Swiss, German drugmakers join U.S. price freeze

European drugmakers Roche, Bayer and Merck KGaA became the latest companies to freeze prices in the United States following criticism by the Trump administration of the cost of medicine.

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EU drug regulators step up work to prepare for ‘no deal’ Brexit

Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit.

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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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Roche gets breakthrough status for Alzheimer’s test Elecsys

The U.S. Food and Drug Administration granted Roche an accelerated review for the Swiss drugmaker’s Elecsys product used to diagnose Alzheimer’s disease.

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Wiley’s Science Talks with Dr. Peter Halfmann: Tackling Ebola

  Wiley, in partnership with the World Federation of Science Journalists (WFSJ) and Association of Health Care Journalists (AHCJ), is offering an educational webinar series for journalists called Science Talks. These complimentary, one-hour sessions are brought to you by The Wiley Network and provide an on-going training option for journalists. Science Talks with Dr. Peter […]

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PTC Therapeutics to Acquire Agilis Biotherapeutics

PTC Therapeutics Inc. announced an agreement to acquire Agilis Biotherapeutics Inc., a biotechnology company advancing an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system.

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Galapagos, MorphoSys Ink Potential $1.1+ Billion Deal With Novartis

Galapagos and MorphoSys signed an exclusive development and commercialization deal with Novartis for a drug compound being developed for the treatment of inflammatory diseases.

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FDA Launches Biosimilars Action Plan

The U.S. Food and Drug Administration released the regulatory agency’s Biosimilars Action Plan.

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Ogilvy CommonHealth Worldwide promotes Paula Huntzinger to chief talent officer

Ogilvy CommonHealth Worldwide, a WPP Health & Wellness company, announced the promotion of Paula Huntzinger to chief talent officer, Ogilvy CommonHealth US.

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Chinese pharma firm recalls heart drug in U.S. after possible impurity

The Chinese bulk manufacturer of the common blood and heart drug valsartan said it was recalling the product from consumers in the United States and would halt supplies to the country, after an impurity linked to cancer had been detected.

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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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Allergan, Molecular Partners eye drug abicipar meets main goal in two studies

Allergan and Molecular Partners’ drug for neovascular age-related macular degeneration met the main goal in two late-stage studies.

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Mersana’s cancer drug trial put on hold by FDA; shares halted

Mersana Therapeutics said on Thursday an early-stage trial testing the company’s lead cancer drug was put on partial hold by the U.S. FDA after a patient’s death was possibly linked to the treatment.

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AngioDynamics to pay $12.5 million over false claims allegations: U.S. Justice Department

AngioDynamics Inc. agreed to pay the U.S. government $12.5 million to resolve allegations that the company caused healthcare providers to submit false claims to federal healthcare programs over the use of two medical devices, the Justice Department said.

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Novartis Halts Planned Price Increases For Drugs Amid Scrutiny of Relationship With Trump Attorney

Novartis is halting planned price increases on the Swiss pharma giant’s medications after President Donald Trump took Pfizer to task over price hikes, with Pfizer subsequently agreeing to roll back the company’s price increases.

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Revolution Medicines Reaches Potential $500 Million Oncology Collaboration With Sanofi

In April 2018, Bay Area biotech Revolution Medicines completed its pivot from a company focused on antifungal treatments to an oncology business. Revolution’s shift paid off with a development deal worth up to $500 million with Sanofi.

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Abbott Labs tops Q2 2018 profit estimates

Abbott Laboratories raised its 2018 full-year earnings forecast and reported a quarterly profit that beat analysts’ estimates, powered by higher sales across its businesses.

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