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Richter’s Esmya drug may have contributed to liver damage cases: EMA

Hungarian drugmaker Richter’s Esmya medicine used to treat benign tumors of the womb may have contributed to some cases of serious liver damage, European health regulators said after a months-long review.

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Roche immunotherapy combination increases lung cancer survival — study

Roche’s immunotherapy Tecentriq, given with the company’s older drug Avastin and chemotherapy, improved survival of advanced lung cancer patients by about 30 percent over the combination without Tecentriq, according to interim results of a late stage trial.

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FDA Gives Genentech’s Tecentriq Priority Review for Triple-Combo Lung Cancer Treatment

The FDA granted Genentech’s Tecentriq triple combination with Avastain, paclitaxel and carboplatin Priority Review for the first-line treatment of patients with metastatic NSCLC.

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FDA approves Novartis combo therapy for aggressive type of thyroid cancer

The U.S. Food and Drug Administration approved Novartis AG’s Tafinlar and Mekinist combination therapy to treat an aggressive type of thyroid cancer.

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Breast cancer screening failure may have shortened 270 lives in England

As many as 270 women in England may have died prematurely of breast cancer because of an IT failure that led to 450,000 patients missing out on routine screening appointments.


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Stock Dives as Celldex Cuts 20% of Staff After Phase II Breast Cancer Failure

Celldex Therapeutics reported that the company’s Phase IIb trial of glembatumumab vedotin (glemba) failed in a trial of metastatic triple-negative breast cancer. Celldex has filed with the U.S. Securities and Exchange Commission that it’s cutting about 20 percent of staff.

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FDA declines to approve Pfizer biosimilar

Pfizer Inc. said on Monday U.S. regulators declined to approve the company’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin, and sought additional technical information.

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AstraZeneca wins U.S. approval for 1st-line use of lung cancer drug

U.S. regulators expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation.

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Eli Lilly Shows Off More Verzenio Data at AACR

Eli Lilly unveiled final data from the MONARCH 3 study that helped the drug garner FDA approval in February 2018 for the treatment of some breast cancer patients.

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Pharma Sales Drive J&J’s 2018 First Quarter

Johnson & Johnson reported a strong first-quarter 2018 with $20 billion in sales that was fueled by significant growth in the company’s pharmaceuticals business.

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General Electric Creates Ready-Made Viral Drug Factories for Pharma and Biotech Companies

General Electric is diving deeper into the world of biotechnology. The conglomeration is launching prefabricated manufacturing units to product virus-based gene and cell therapies, Reuters reported.

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Shire Sells Oncology Business to France’s Servier for $2.4 Billion

Shire, a global biotechnology company focused on rare diseases, sold its oncology business to France’s Servier for $2.4 billion.

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Survival data boosts Keytruda lead in lung cancer

Merck & Co.’s immunotherapy Keytruda plus chemotherapy significantly improved overall survival versus chemotherapy alone in newly diagnosed patients with advanced non-small cell lung cancer in a highly anticipated study.

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As cancer drug prices climb, value not keeping pace

The cost of new anti-cancer drugs increased more than five-fold from 2006 to 2015, but a new analysis suggests that cancer patients and insurers may be getting less for their money.

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Roche Secures U.K. NHS Coverage Nod for Tecentriq, Completes Flatiron Acquisition

Swiss pharma giant Roche has completed the acquisition of Flatiron Health and secured a big win with the United Kingdom’s healthcare provider for the lung cancer drug Tecentriq.

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European Medicines Agency to review Sanofi-Regeneron’s Dupixent, Cemiplimab

The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said.

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FDA Orphan Drug Designation Granted to TTAC-0001

The U.S. Food and Drug Administration granted orphan drug designation to PharmAbcine Inc.’s leading clinical compound TTAC-0001 for the treatment of glioblastoma multiforme.

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Outcome Health And The Colorectal Cancer Alliance Announce Campaign To Support Patient Education

Outcome Health, a technology company that provides health education at the moment of care to improve patient outcomes, announced a partnership with the Colorectal Cancer Alliance to make patients aware of the signs and symptoms of colorectal cancer.

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Genentech’s Late-Stage Trial Data Shows Combination of Tecentriq and Avastin Helps NSCLC Patients Live Longer

Genentech Inc. is planning to seek regulatory approval for a blended lung cancer treatment following positive interim results from a late-stage trial that showed a combination of Tecentriq and Avastin plus chemotherapy enabled patients to live longer.

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Novartis drug Tasigna approved by FDA to treat children with rare form of leukemia

Novartis announced that the U.S. Food and Drug Administration expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

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April 2018 Focus: Agency Profiles, Manny Awards and Annual Review


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