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New Roche hemophilia drug prevents bleeds

The investigational hemophilia drug emicizumab cut the bleed rate by 87% in patients with resistance to standard therapy versus those receiving another treatment.

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Investors Relieved as Seattle Genetics Pulls Out Win for Phase III Lymphoma Trial

Seattle Genetics and Takeda Pharmaceutical Company announced positive results from the Phase III ECHELON-1 clinical trial in previously untreated advanced classical Hodgkin lymphoma.

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EU regulators greenlight U.S. biotech Aveo’s kidney cancer drug

European regulators recommended the approval of Aveo Pharmaceuticals Inc.’s drug to treat kidney cancer, marking a big victory for the U.S. biotech that has faced a number of setbacks in bringing the drug to the market.

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EU backs second biosimilar copy of Humira

European regulators recommended approval of a second copy of AbbVie’s rheumatoid arthritis drug Humira, the world’s top-selling medicine.

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Germany’s Merck gets EU backing for oral MS drug

Merck KGaA won a key recommendation to become an entrant to the oral MS drug market in Europe, six years after its first attempt to launch the cladribine pill failed.

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Novartis breast cancer drug Kisqali wins European panel backing

A European Medicines Agency (EMA) panel recommended approving Novartis’s Kisqali drug, bolstering the Swiss drugmaker’s bid to challenge rival Pfizer’s Ibrance against tough-to-treat breast cancer.

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FDA Calls Cara Therapeutics’ Kidney Disease Drug a Breakthrough, Stock Soars

Shares of pain-relief company Cara Therapeutics were up more than 16 percent after the company grabbed the Breakthrough Therapy Designation for its chronic kidney disease treatment CR845.

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bluebird bio Touts Impressive Data From Late-Stage Gene Therapy Study

bluebird bio’s interim data for its Phase III gene therapy LentiGlobin trial showed promising results in reducing a patient’s need for blood transfusions after one month after treatment, but the data also raised some concerns.

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FDA Approves Rituxan Hycela for Subcutaneous Injection in Certain Blood Cancers

The U.S. FDA approved Genentech’s Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of adults with certain blood cancers.

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Mylan shareholders vote against executive pay, re-elect board

Mylan NV shareholders voted against the generic drugmaker’s executive pay policy but re-elected the board at its 2017 annual meeting despite a shareholder campaign in the wake of a scandal over high prices for its EpiPen emergency allergy treatment.

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Senate Republicans reveal Obamacare replacement bill with tough debate expected

A seven-year push by U.S. Republicans to dismantle Obamacare and kill the taxes it imposed on the wealthy reached a critical phase when Senate Republican leaders unveiled a draft bill they aim to put to a vote.

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Novartis heart drug success opens up new care option

A Novartis anti-inflammatory drug cut cardiovascular risk for heart attack survivors in a pivotal trial, potentially changing ideas about treatment.

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BIO2017: Biotech Dealmaking Will Be Robust in 2017, But Remain Below 2015 Highs

A well-known business book is called “The Art of the Deal” and dealmaking in the biotech sphere has certainly become an art form. Since the booming year of mergers and acquisitions in 2015, the rate of dealmaking in the pharma industry has declined.

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OvaScience Slashes Workforce, Replaces CEO

OvaScience named a new chief executive officer and slashed its employee count by half.

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FDA Slaps Hold on IND for Vadastuximab Talirine

The U.S. FDA placed a hold on Seattle Genetics’ Investigational New Drug Application for vadastuximab talirine.

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Kamada Withdraws MAA For Inhaled Alpha-1 Antitrypsin

Kamada Ltd. withdrew the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency with the EMA.

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Missouri AG sues opioid manufacturers

Missouri became the third U.S. state to accuse major drug manufacturers of fraudulently misrepresenting the risks of opioid painkillers.

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GSK presents positive revaccination study results

Shingrix induced a strong immune response in older adults previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine.

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U.S. FDA moves to prevent Pharma from ‘gaming’ generic drug system

The U.S. Food and Drug Administration moved to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.

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Drugmaker Mylan gets boost from unlikely source: coal

Mylan N.V. is best known for producing EpiPen emergency allergy treatments and generic drugs. But a non-pharmaceutical offering – refined coal – has quietly generated hundreds of millions of dollars of tax credits for the company over the last six years that have boosted its bottom line, according to a Reuters review of company filings.

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