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China Takes Lead in CRISPR Race

China has taken the lead in CRISPR research as an oncology team in that country became the first to inject cells that contained edited genes using the technology.

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Huge study finds a billion people suffer from high blood pressure

The number of people with high blood pressure has almost doubled in 40 years to over 1.1 billion worldwide, scientists said, with the burden of the condition shifting from the rich to the poor.

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Long-lasting cholesterol lowering in drug study

A new type of heart drug developed by The Medicines Co. significantly lowered “bad” LDL cholesterol in high-risk patients with no major safety issues.

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Cholesterol drug reduces artery-clogging plaque

Amgen’s Repatha with statin therapy took “bad” LDL cholesterol down to extremely low levels and caused artery-clogging plaque decline after 18 months’ treatment.

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Puma Biotech Crashes After Diarrhea Risk is Linked to Breast Cancer Drug

Puma Biotechnology shares plummeted after the company disclosed patients taking its experimental breast cancer drug neratinib may require a second drug to prevent serious diarrhea.

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Corbus drug succeeds in scleroderma study

Corbus Pharmaceuticals Holdings Inc. said its only drug outperformed a placebo in a mid-stage study involving patients with a form of systemic sclerosis.

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FDA Approves Opdivo for Head and Neck Cancer

Bristol-Myers Squibb Co.’s immuno-oncology treatment Opdivo has now been approved in five tumor types in under two years by the U.S. FDA.

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Zika striking women at higher rates than men

Adult women in Puerto Rico were significantly more likely to develop Zika than men, researchers said, raising new questions about the potential role of sexual transmission of the virus from males to females.

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Scientists develop new HIV test on USB stick

Scientists in Britain have developed a type of HIV test using a USB stick that can give a fast and highly accurate reading of how much virus is in a patient’s blood.

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AstraZeneca drops durvalumab early approval plan

AstraZeneca has given up on the idea of seeking early approval of its immunotherapy drug durvalumab in head & neck cancer using mid-stage Phase II trials data.

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Arrowhead Hep B Study Placed on Clinical Hold

Shares of Arrowhead Pharmaceuticals were down after the company’s experimental hepatitis B drug, ARC-520, was placed on clinical hold by the U.S. FDA.

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Bone Therapeutics Taps New CEO

Shares of Bone Therapeutics dropped slightly after the company announced a change in leadership and ended plans to hold a clinical trial in the United States.

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Stanford uses CRISPR to correct sickle cell

Scientists at Stanford University School of Medicine have used the CRISPR gene-editing tool to repair the gene that causes sickle cell disease in stem cells.

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Biogen, Ionis Stocks Jump on Positive Study Data

Biogen and Ionis Pharma announced that Spinraza (nusinersen) met its primary endpoint in its Phase III trial in later-onset spinal muscular atrophy (SMA).

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Sanofi One Of Worst Culprits in Reporting Trial Data

For the second straight year, Sanofi was cited as one of the least transparent companies for clinical trial data.

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Two Deaths Linked to Yervoy-Opdivo Combo

Checkpoint inhibitors have become popular treatments for cancers, but a New England Journal of Medicine article may give physicians pause before prescribing them.

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Alzheimer’s Contender Wows in Human Clinical Trial

Merck & Co. published results from its Phase I clinical trial of verubecestat for Alzheimer’s disease in the journal Science Translational Medicine. The Phase I data provides information related mostly to the safety and activity of the drug.

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Adverse events in trial dent hopes for Roche hemophilia drug

Four patients have suffered serious adverse events in a clinical trial of an experimental hemophilia medicine from Roche, the Swiss group said, clouding prospects for its potential blockbuster product.

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Opexa Stock Tanks After Failed MS Trial, Cuts Staff

In the wake of a failed Phase IIb clinical trial, Opexa Therapeutics announced it will be laying off about 40 percent of its workforce.

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Gilead Racks Up Clinical Failures in Q3 Report

Investors were not particularly happy with Gilead’s Q3 2016 report. In addition to sagging sales and revenue, it outlined a laundry list of failed clinical trials.

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


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