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U.S. FDA Grants Priority Review for Daratumumab

The U.S. FDA granted Priority Review to daratumumab as a combination treatment for patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant.

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Little-Known Life Science Hedge Fund Dethroning Ackman’s Pershing Square

Biotech investing is a volatile business as 2018 has seen a little-known hedge fund with a focus on biotech and the life sciences beat out a couple of heavy hitters, David Einhorn and Bill Ackman.

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Teva’s Job Cuts Hit 208 Philadelphia Employees

Cuts implemented by Israel-based Teva Pharmaceutical hit the shores of the United States. The company is laying off 208 people in the Philadelphia area.

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Why AstraZeneca’s New Drug Strategy Seems to be Bearing Fruit

Pharma giant AstraZeneca has seen a fourfold increase in research productivity following a narrowing of disease focus and cuts in laboratory and staff over the past seven years, Reuters reported.

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U.S. health agency to issue religious objection regulations

The HHS is issuing new regulations aimed at protecting healthcare workers’ civil rights based on religious and conscience objections.

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Lynparza Receives Approval in Japan for Treating Advanced Ovarian Cancer

AstraZeneca and Merck announced that the Japanese Ministry of Health, Labour and Welfare approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy.

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FDA: New drug compounding priorities

The FDA head is preparing a new, more restrictive policy targeting which drugs compounding pharmacies can produce that do not go through the regulatory agency’s approval process.

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European Commission Approves Mvasi For Treating Certain Types Of Cancer

Amgen Inc. and Allergan plc. announced that the European Commission granted marketing authorization for Mvasi (biosimilar bevacizumab).

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Celgene to Create Biopharma Incubator on New Jersey R&D Site

Fresh off its $7 billion acquisition of San Diego-based Impact Biomedicines and its JAK inhibitor program targeting myelofibrosis, Celgene is planning to open a biopharma incubator on its corporate campus in New Jersey.

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5 Healthcare Systems Launching Generics Company

The U.S. Department of Veterans Affairs and Intermountain Healthcare, Ascension, SSM Health and Trinity Health are forming a not-for-profit generic drug company.

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Homology Inks Deal for New Massachusetts HQ

Backed by financing from a collaboration with Novartis and an $83 million financing round, Homology Medicines is moving to a new facility with more than triple the space of its headquarters.

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Toothpaste ingredient could fight malaria, research shows

Research carried out in part by an artificially intelligent ‘robot scientist’ found that a common ingredient of toothpaste could be developed to fight drug-resistant strains of malaria.

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U.S. court invalidates patent on J&J cancer drug Zytiga

A U.S. administrative court invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions.

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U.S. Senate committee advances Azar nomination as health secretary

A U.S. Senate committee voted to move forward the nomination of Alex Azar, a former drug industry executive and lobbyist whom President Donald Trump has tapped to be the next secretary of Health and Human Services.

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Chemo organ bath improves ovarian cancer survival

A heated chemotherapy organ bath circulated throughout the abdomen after surgery can significantly prolong a woman’s survival with advanced ovarian cancer.

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Juno Explodes on Celgene Takeover Rumors

Rumors that Celgene Corporation is in talks to acquire Juno Therapeutics caused Juno’s stock to rocket more than 50 percent to $68.80 in premarket trading.

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Biggest Winners and Losers of JPM 2018

Some analysts have picked “winners and losers” from the 2018 J.P. Morgan Healthcare Conference. CNBC’s Jim Cramer made his picks related to stock performance.

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Physician burnout takes a toll on U.S. patients

Nearly two-thirds of U.S. doctors feel burned out, depressed, or both – and those feelings affect how they relate to patients, according to a survey conducted by Medscape.

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Kymriah wins speedy reviews in U.S., Europe

Novartis was granted fast-track reviews of its cell therapy Kymriah for blood cancers in the United States and Europe.

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Exelixis and Ipsen Announce Phase 3 Trial Results of Cabozantinib

Cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival at the planned second interim analysis for the population of second-line and third-line patients enrolled in the CELESTIAL study.

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