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PeptiDream Bags R&D Pact With Bayer

Peptidream Inc. scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment of multiple disease targets.

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U.S. FDA Approves Kaléo’s AUVI-Q 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

Privately held pharmaceutical company kaléo announced that the U.S. Food and Drug Administration approved its supplemental New Drug Application for AUVI-Q (epinephrine injection, USP) 0.1 mg.

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Acorda Therapeutics scraps Parkinson’s drug after deaths

Acorda Therapeutics Inc. said the company would stop developing its Parkinson’s disease drug tozadenant less than a week after reporting deaths in key studies testing the treatment.

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Zejula approved in Europe for recurrent ovarian cancer

Tesaro Inc.’s PARP inhibitor Zejula was approved by the European Commission for recurrent ovarian cancer.

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New ARV drugs, early diagnosis key to beating AIDS epidemic: UNAIDS

Developing new antiretroviral (ARV) drugs and using technology for early diagnosis are among steps needed to sustain momentum in fighting HIV/AIDS and ending the disease as a public health threat by 2030, UNAIDS said in a report.

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Roche stock up $12 billion on cancer, hemophilia trials

Roche shares were lifted by two clinical trial wins for its new cancer and hemophilia drugs, potential blockbusters that the Swiss drugmaker is counting on to offset shrinking revenue from older medicines.

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Samsung Bioepis Receives Regulatory Approval for Europe’s First Trastuzumab Biosimilar, Ontruzant

Samsung Bioepis Co. Ltd. announced the European Commission’s marketing authorization of Ontruzant – a biosimilar referencing Herceptin (trastuzumab) – for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

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SEC Filing Reveals GlaxoSmithKline’s 13 Percent Stake in Spero Therapeutics

A filing with the U.S. Securities and Exchange Commission (SEC) indicates that the UK’s GlaxoSmithKline has a 13 percent stake in Spero Therapeutics, with 1,854,006 shares in the Massachusetts biotech company.

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FDA OKs Gazyva for new lymphoma indication

The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.

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Trump administration proposes Medicare rules aimed at opioids, drug costs

The Trump administration proposed changes to Medicare drug plans including limits on opioid prescriptions and rules aimed at reducing drug costs for seniors, such as requiring health insurers to pass on discounts to consumers.

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FDA expands use for Pfizer cancer drug Sutent

The U.S. FDA approved the use of Pfizer Inc.’s cancer drug Sutent to help prevent kidney cancer from returning following surgical removal of a kidney.

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Johnson & Johnson wins California lawsuit claiming asbestos in talc caused cancer

A California jury ruled in favor of Johnson & Johnson in a lawsuit by a woman who said she developed the cancer mesothelioma after being exposed to asbestos in the company’s talc-based products including J&J’s Baby Powder.

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J&J hit with $247 million verdict in hip implant trial

A federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.

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Merit Medical Coughs Up $100 Million for Bard, BD’s Biopsy Assets

Shares of Merit Medical Systems jumped more than 9 percent after the company announced it plunked down $100 million for two product lines belonging to Becton, Dickinson and Company (BD).

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All Systems Go: Johnson & Johnson Reaches Out for Second Ionis GI Drug

Ionis Pharmaceuticals and Janssen strengthened their alliance with a second deal for gastrointestinal drugs. Janssen put up $5 million to secure the licensing of Ionis’ antisense drug, IONIS-JBI2-2.5RX.

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Kendall Square Startup Cue Biopharma Scores $374 Million R&D Pact With Merck

Immunotherapy company Cue Biopharma Inc. announced a strategic research collaboration and license agreement with Merck & Co. Inc.

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$1 million price tag in spotlight as gene therapy becomes reality

Battle lines are being drawn as the first gene therapy for an inherited condition nears the U.S. market, offering hope for people with a rare form of blindness and creating a cost dilemma for healthcare providers.

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FDA approves Roche hemophilia drug Hemlibra

The U.S. Food and Drug Administration approved Roche’s first-in-class therapy Hemlibra for hemophilia suffers.

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FDA announces comprehensive regenerative medicine policy framework

The U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

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Billionaire founder of Insys to plead not guilty to opioid bribe scheme

The billionaire founder of Insys Therapeutics Inc. appeared in federal court in Boston to plead not guilty to charges that he participated in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug.

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