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The Pulse of the Pharmaceutical Industry

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Medtronic misses revenue estimates, shares dip

Medical device maker Medtronic Plc reported Q1 fiscal 2018 revenue fell short of analysts’ estimates, hurt by lower sales in its diabetes-related device business.

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Clinical Study Shows That Retinal Imaging May Detect Signs of Alzheimer’s Disease

A study led by researchers at Cedars-Sinai and NeuroVision Imaging LLC provides the scientific basis for using noninvasive eye imaging to detect the pathological hallmarks of Alzheimer’s. The experimental technology, developed by Cedars-Sinai and NeuroVision, scans the retina using techniques that can identify beta-amyloid protein deposits that mirror those in the brain.

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Novartis launches first large-scale research study in multiple sclerosis that allows participants to contribute from smartphones

Novartis announced the launch of a mobile research study for people with multiple sclerosis (MS) that collects data via their smartphone, without the need for clinic visits.

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J&J ordered to pay $417 million in trial

A California jury ordered Johnson & Johnson to pay $417 million to a woman who claimed she developed ovarian cancer after using the company’s talc-based products.

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It’s Time for Healthcare Brands to Get Personal

Marketers need to dig deeper to facilitate communications that are dynamic enough to reach and engage patients on a more personal, emotional level.

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New Tool Identifies Diabetes Patients at Risk for Low Blood Sugar Emergencies

A team led by Kaiser Permanente researchers has developed and validated a practical tool for identifying diabetes patients who are at the highest risk for being admitted to an emergency department or hospital due to severe hypoglycemia, or very low blood sugar.

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FDA approves Duzallo for treating hyperuricemia

The U.S. FDA approved Ironwood Pharmaceuticals Inc.’s Duzallo as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone.

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Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder

Alkermes plc announced the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration, seeking marketing approval of ALKS 5461. The once-daily, oral vestigational medicine with a novel mechanism of action is intended for the adjunctive treatment of major depressive disorder MDD).

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AstraZeneca Jumps Deeper Into mRNA Drugs With Ethris Deal

AstraZeneca is diving deeper into messenger RNA research to develop new therapies for one of its core focuses – respiratory disease. The company is investing about $30 million into a partnership with mRNA specialist Germany-based Ethris GmbH to develop new stabilized non-immunogenic modified RNA therapies.

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Samsung Bioepis teams up with Takeda to develop original biotech drugs

Samsung Bioepis Co. Ltd. said it will fund and develop multiple original drugs in partnership with Japan’s Takeda Pharmaceutical Co. Ltd., expanding its business scope beyond copies of existing biologic drugs.

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Hikma’s U.S. unit raises medicine prices

Hikma Pharmaceuticals Plc’s U.S. subsidiary raised the price of a common diarrhea drug by more than 400 percent and is charging more for five other medicines.

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NIH scientist to head up Pfizer unit

Thomas Wynn, after serving 26 years as a senior investigator at the National Institutes of Health (NIH), left to lead Pfizer’s inflammation and immunology unit.

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Bayer, J&J win another Xarelto U.S. trial

A federal jury cleared Bayer and J&J of liability in the third case to go to trial out of thousands of lawsuits claiming their blood thinner Xarelto led to severe internal bleeding.

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The Greater Than One Group Appoints Jim Plattner Global Chief Financial Officer

The Greater Than One Group (GTO) announced that James P. Plattner joined the firm as Global Chief Financial Officer.

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Insys agrees to resolve Illinois opioid lawsuit

Insys Therapeutics Inc. agreed to pay $4.45 million to resolve a lawsuit by Illinois’ attorney general claiming it deceptively marketed an addictive fentanyl-based cancer pain drug for off-label uses.

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Philippines reports second outbreak of bird flu

The Philippines found a second outbreak of bird flu in another province in the main Luzon island, Agriculture Secretary Emmanuel Pinol said, a week after reporting the country’s first case of the poultry disease.

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FDA expands use of ovarian cancer drug

The FDA expanded the use of Lynparza, sold by AstraZeneca Plc and Merck & Co. Inc., and approved a new two-tablet regimen for the drug.

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FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection

As an additional measure in the fight against Zika virus, the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.

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FDA approves rare blood cancer drug

The U.S. Food and Drug Administration approved Pfizer Inc.’s rare blood cancer drug Besponsa with a boxed warning.

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Deficiencies in early brain activity linked to delinquent behavior in teens

Lower levels of brain activity during childhood may lead to decreased self-control and, eventually, delinquent behavior in adolescence, according to a new study published by a team of researchers from FIU and the University of Michigan.

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