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U.S. FDA raises concerns over Teva’s plant in China

The U.S. Food and Drug Administration raised concerns over manufacturing controls at a Teva Pharmaceutical Industries plant in China, Israel’s biggest company said in a regulatory filing.

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Icon Bioscience Submits NDA for Dexycu, a Potential Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery

Icon Bioscience Inc., a specialty biopharmaceutical company focused on utilizing its Verisome drug-delivery platform to develop unique intraocular eye-care therapeutics, announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration for the company’s lead pipeline product Dexycu (IBI-10090).

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BioMarin Announces Kuvan (sapropterin dihydrochloride) Patent Challenge Settlement

BioMarin Pharmaceutical Inc. announced that it has entered into a settlement agreement with Par Pharmaceutical that resolves patent litigation in the United States related to BioMarin’s Kuvan (sapropterin dihydrochloride) 100mg oral tablets and powder for oral solution in 100mg packets.

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Tech Giant Apple Hires Secret Team of Biomedical Engineers for Treating Diabetes

In yet another example of tech companies getting involved in healthcare, Apple is quietly moving into the area of diabetes management.

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Roche launches antibody test to aid in diagnosis of challenging prostate cancer cases

Roche announced the global launch of the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody2 for prostate cancer diagnosis.

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NextGen Healthcare Announces Agreement to Acquire Entrada Inc.

NextGen Healthcare Information Systems LLC, a wholly owned subsidiary of Quality Systems Inc., announced an agreement to acquire Entrada Inc.

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Japan automakers look to robots to keep elderly on the move

Japanese automakers are looking beyond the industry trend to develop self-driving cars and turning their attention to robots to help keep the country’s rapidly graying society on the move.

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Trump Taps Congressman as Next ‘Drug Czar’

President Trump, hoping to take on the opioid epidemic sweeping parts of America, tapped U.S. Rep. Tom Marino to head up the Office of National Drug Control Policy.

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FDA approves movement disorder drug

The U.S. FDA approved Neurocrine Biosciences Inc.’s drug to treat tardive dyskinesia, an uncontrolled movement side effect of antipsychotic medications.

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Maryland lawmakers approve bill to fight drug price gouging

Maryland lawmakers have passed a first-in-the-nation measure that lets the state attorney general sue generic drug makers that sharply raise prices in a move aimed at fighting “price gouging.”

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FDA warns Mylan over quality concerns at India facility

The U.S. Food and Drug Administration raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency.

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U.S. guidelines relax opposition to prostate cancer screening

An influential physician task force backed by the U.S. government is softening its opposition to routine prostate cancer screening.

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India’s Strand Life Sciences launches blood test to detect cancer

A small Indian company launched on Tuesday a blood test to detect a wide range of cancers at a fraction of the cost of similar diagnostics available in the United States.

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The Human Vaccines Project, Vanderbilt And Illumina Join Forces To Decode The Human Immunome

The Human Vaccines Project and Vanderbilt University Medical Center announced that they joined forces with Illumina Inc. to decipher the human immunome, the genetic underpinnings of the immune system.

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SEC Cracks Down on “Fake Biotech News”

The Securities and Exchange Commission singled out four biotech companies for allegedly promoting “fake news” in an attempt to manipulate share prices.

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Austrian biotech Themis launches Zika vaccine clinical trial

Austrian biotech company Themis Bioscience said it had started a clinical trial of an experimental Zika vaccine in healthy volunteers, opening up another front in the race to prevent the spread of the mosquito-borne disease.

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FDA Picks Emulate for Organ Chip Technology

The U.S. FDA’s Office of Foods and Veterinary Medicine entered into a cooperative R&D agreement to “evaluate and qualify” Emulate Inc.’s organ-on-a-chip technology.

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UK cost agency turns down Bristol drug

Britain’s healthcare cost-effectiveness watchdog NICE said Bristol-Myers Squibb’s immunotherapy drug Opdivo was not worth using on the state health service for treating head and neck cancer due to its high price.

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Pancreatic Cancer Pathway Identified; Discovery May Broach New Era of Effective Immunotherapies for the Deadliest Major Cancer

Pancreatic Cancer Action Network (PanCAN) grantee George Miller, MD, and his research team at NYU Langone Medical Center discovered a novel and potentially targetable way that pancreatic cancer cells hide themselves from the immune system. The findings, published in the journal Nature Medicine, have the potential to broach a new era of effective immunotherapies for pancreatic cancer.

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OncoMed sinks as cancer drug fails

OncoMed Pharmaceuticals is discontinuing a trial testing its experimental drug demcizumab as an initial therapy for advanced pancreatic cancer.

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