Here’s how Sanofi separates true innovation from all the hype in digital health

Recognizing that digital technology is here to stay in the business of healthcare, pharmaceutical companies have not shied away from collaborating with the folks in Silicon Valley.

Sanofi (NYSE:SNY), for instance, has dove in feet first, striking deals with major tech players like Verily. But weeding out true disruptions from all the noise isn’t easy.

“There’s a lot of hype,” said Rachel Sha, VP of Sanofi’s digital business development & licensing unit. “We work really hard to identify companies that don’t just have nice slides, but actually have early experience and data showing the impact of their technology.”

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Valeritas touts new data for insulin delivery device

Valeritas (NSDQ:VLRX) touted data today from two new studies of its V-Go wearable insulin delivery device in patients with Type II diabetes.

In one three-month evaluation of 60 people with Type II diabetes, researchers assessed if using V-Go could improve glycemic control in patients who were uncontrolled on prior treatment regimens.

Get the full story at our sister site, Drug Delivery Business News.

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With groundbreaking approval, Amgen launches new class of medicine for migraine patients

Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults.

The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) and Teva Pharmaceuticals (NYSE:TEVA) are working on their own CGRP product, but Amgen’s is the first to hit the market.

Get the full story at our sister site, Drug Delivery News.

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West Pharmaceutical boosts its analytical services with new technology

West Pharmaceutical Services (NYSE:WST) has expanded its analytical services capabilities with new equipment to help address the pharmaceutical industry’s packaging and drug-delivery concerns, the company said today.

West specifically highlighted its addition of an ion mobility quadrupole time-of-flight mass spectrometer – an instrument that combines chromatography, ion mobility and mass spectrometry.

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Here are the pharma companies accused of blocking generic competition

To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer.

But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could potentially even keep a generic version of the drug from ever reaching the market.

If companies developing generics have trouble accessing the samples they need, they can file a complaint with the FDA. Today, the FDA published a list of 39 pharmaceutical companies that have been the subjects of such complaints.

Get the full story at our sister site, Drug Delivery Business News.

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Cerus lands additional $15m in government funding

Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million.

The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology.

Get the full story at our sister site, Drug Delivery Business News.

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Neovasc continues pursuit of 1-for-100 reverse stock split

Neovasc (NSDQ:NVCN) said today that it will proceed with plans for a reverse stock split with a ratio of up to 1-for-100, with board members and management urging shareholders to vote for the proposal at an upcoming special meeting.

The Vancouver-based company will vote on the proposition on June 4, according to a recently posted SEC filing, as the company looks to regain compliance with the NASDAQ minimum bid requirement.

Neovasc warned that failure to approve the move could lead to a reduction in the liquidity in trading of its shares, difficulty raising capital from US-based institutional funds and an increase in interest on $28.6 million in outstanding senior secured convertible notes.

“Remaining on the Nasdaq Capital Market is a critical piece of the company’s turnaround strategy. Without reaching a minimum bid price above US $1.00 for a minimum of 10 consecutive days before July 2, 2018, the company may be delisted from the Nasdaq, which would have serious consequences for the company as further outlined in this press release. In short, a vote against a reverse stock split will decrease liquidity for existing shareholders, increase the cost of capital for the company, and significantly worsen the terms of the last financing. With an affirmative vote in hand we will then approach the Nasdaq for an extension to the July 2, 2018 deadline to give us more flexibility on the timing of the reverse split to best meet the needs of the company and the shareholders. Without the affirmative vote for a reverse stock split, we believe it is unlikely we will be granted such an extension. Management believes that it is in the best interest of the company and its stakeholders to remain on the Nasdaq, and that the reverse stock split is the only tool available to get the share price of the company above the minimum US$1.00 bid price before that deadline. As such, the Board and I urge the company’s shareholders to vote “FOR” granting the company the ability to effect a reverse stock split,” prez & CEO Fred Colen said in a press release.

“A reverse stock split is a process by which a company’s shares are effectively consolidated to form a smaller number of proportionally more valuable shares. Despite contrary notions, a reverse stock split has zero economic impact as an independent action. For example, under a 1-for-10 reverse stock split, rather than 100 million shares at US$0.50, a company would have, all else being equal, 10 million shares at US$5.00 at the time of the split. In either case, the market value of the example company is the same before and after,” board chair Paul Geyer said in a prepared release.

Last week, Neovasc saw shares fall after it missed Wall Street expectations and posted growing losses in its first quarter earnings release and announced initial plans for the reverse split.

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Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions

Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease.

The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part of Medtronic’s post-approval study of its Resolute Onyx device.

Get the full story at our sister site, Drug Delivery Business News.

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HHS secretary calls on drug companies to ‘stop the price hikes’

After President Donald Trump’s drug pricing speech last week was deemed a “non-event” by analysts, all eyes turned to the secretary of the U.S. Dept. of Health & Human Services, Alex Azar, to see what the former pharma executive viewed as the administration’s top concerns.

Azar called on the industry to “stop the price hikes” and cautioned that Trump would not hold back from calling out drug manufacturers by name – an effort echoed by FDA chief Dr. Scott Gottlieb who told STAT that the agency would publish the names of companies that are hindering generic drugs from reaching the market.

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Mazor Robotics shares rise on Street-beating Q1

Shares in Mazor Robotics (NSDQ:MZOR) rose today after the surgical robotic platform maker beat expectations on Wall Street with its first quarter 2018 earnings.

The Caesarea, Israel-based company posted losses of $1.3 million, or 2¢ per share, on sales of $15.5 million for the three months ended March 31, seeing losses shrink 75.6% while sales grew 32.3% compared with the same period during the previous fiscal year.

Losses per share were ahead of the 8¢ consensus on Wall Street, where analysts expected to see sales of $15.1 million for the quarter, which the company topped.

“Our record first quarter revenue reflects clinical adoption, as we surpassed 33,000 cases performed, and the continued global demand for the Mazor X and Renaissance systems. Commercially, we successfully expanded into a new international market with the Mazor X and making progress penetrating into the ambulatory surgery center market in the U.S. with the Renaissance.  Our performance, coupled with the growing number of peer-reviewed papers, presentations and the interim data from our prospective studies, is transforming spine surgery in markets around the world.  Finally, we are also advancing and expanding our technology development efforts with Medtronic, and I am pleased to share that commercialization of the Mazor X platform, which integrates Medtronic’s Stealth navigation and offers a unique robot-guided implant solution that eliminates the need for guidewires, is expected at the end of 2018,” CEO Ori Hadomi said in a press release.

Shares in Mazor Robotics re up 6.4% so far today, at $59.13 as of 12:54 p.m. EDT.

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