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The Pulse of the Pharmaceutical Industry

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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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Imprimis receives FDA warning

The U.S. FDA issued a warning letter to Imprimis Pharmaceuticals Inc. accusing it of making false or misleading claims that its compounded eye medications had the agency’s approval.

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FDA expects IV fluid shortage to improve in coming weeks, months

The U.S. FDA expects a shortage of intravenous saline fluids for hospitals due to damage to key manufacturing facilities in Puerto Rico to improve over the coming weeks and months.

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New Biotech Hub Emerging in Bay Area

It’s no secret the Bay Area has been a stronghold of biotech innovation. Now it appears the area is about to get stronger as more space for pharma and biotech companies will soon be available down the Peninsula south of San Francisco in the city of San Carlos.

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U.S. healthcare uninsured rises most in near decade: Gallup

The number of Americans without healthcare insurance rose by 3.2 million people between 2016 and 2017 – or 1.3 percentage points to 12.2 percent – according to a Gallup poll, the biggest jump in the uninsured rate in nearly a decade.

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FDA to speed review of military medical products

The U.S. FDA and Department of Defense launched a program to speed up the development of drugs that could be used by military personnel.

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Eiger to abandon blood pressure drug

Eiger BioPharmaceuticals Inc. will stop development of a drug to treat pulmonary arterial hypertension after it failed in a mid-stage study.

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FDA approves new indication for Gilotrif

The U.S. FDA approved a supplemental NDA for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test.

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Keytruda extends lung cancer survival in study

A cocktail of Merck & Co. Inc.’s blockbuster drug Keytruda and two chemo medicines helped lung cancer patients live longer and stopped the disease from advancing.

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Novartis new data reinforces superiority of Cosentyx versus Stelara in achieving skin clearance for psoriasis patients

Novartis announced results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx (secukinumab) compared to Stelara (ustekinumab) in delivering clear and almost clear skin in adults with moderate to severe plaque psoriasis at 12 weeks.

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Rigel Pharma Awaits FDA Approval for Tavalisse, Builds Commercial Org for Drug Launch

The first half of 2018 will be pivotal for Bay Area-based Rigel Pharmaceuticals Inc. as the company awaits regulatory approval for its rare blood disorder drug and builds out the internal infrastructure to commercialize the product.

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Ironshore Laid Off Staff, Quietly Closed Down

Almost one year after filing a New Drug Application for an ADHD drug and less than one year after announcing it secured $200 million in financing, Ironshore Pharmaceuticals closed its doors.

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German watchdog calls for direct comparison of cancer immunotherapies

Germany’s drug assessment body criticized a lack of data directly comparing drugs in a promising new class of cancer immunotherapy, saying physicians could be overwhelmed or misled by the available information.

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U.S. FDA Approves Teva’s Trisenox

Trisenox (arsenic trioxide) injection was approved in combination with tretinoin for treating adults with newly diagnosed low-risk acute promyelocytic leukemia.

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