Drug Delivery Business

OncoSec looks to boost effects of immunotherapy with intratumoral delivery

Thousands of cancer patients have been treated with immune checkpoint inhibitors since the first of its kind was approved in 2011. The product is designed to block the production of proteins that prevent the body's immune system from acting in the … [Read More...]

Fine-tuning formulation with Fluid Imaging Technologies’ FlowCam

After seven people died in 2013 from serious allergic reactions to Omontys, an injectable anemia drug marketed by Takeda Pharmaceutical (TYO:4502) and Affymax, the companies recalled the product and regulators launched an investigation to find out … [Read More...]

Dexcom CEO on ‘treading new ground’ with G6 glucose monitor

Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes. This week, Dexcom … [Read More...]

This new technology could help surgeons clear out leftover cancer cells

In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew … [Read More...]

The company behind Narcan looks toward a treatment for fentanyl overdoses

Despite growing attention from lawmakers and doctors, the opioid crisis is not slowing up in the U.S. A new report published last week by the Centers for Disease Control and Prevention showed that emergency room visits for opioid overdoses jumped 30% … [Read More...]

Valeritas takes on multiple daily insulin injections with wearable V-Go device

There are millions of Americans with Type II diabetes and many of them take multiple daily injections of insulin, using two injection pens - one for mealtime insulin and one for insulin throughout the day. But studies have found that people with Type … [Read More...]

NanOlogy looks to transform chemotherapy with localized delivery platform

Paclitaxel revolutionized cancer treatment when it was first used as a chemotherapeutic in the 1990s. But although the product is a powerful cancer killer, patients taking systemic doses of paclitaxel have to endure side effects such as peripheral … [Read More...]

After 20 years, Paratek’s broad-spectrum antibiotic is headed to the FDA

More than two decades after it was first synthesized in a lab, omadacycline is finally being reviewed by the FDA for its potential as a broad-spectrum antibiotic. It's a long-awaited milestone for Dr. Evan Loh, who serves as president, COO and CMO … [Read More...]

Portal Instruments uses speed to tackle needle-free drug delivery

Nobody likes to be on the receiving end of a shot. Studies have found that needle anxiety keeps people from getting important medications, like the flu vaccine, and can even stop people from taking self-injected drugs to manage chronic … [Read More...]

How conversations with virtual people could help mitigate the opioid crisis

It often starts in the doctor's office or the emergency room. A patient has broken their leg and will be in pain for weeks. Another patient has had back surgery and is on their way home, but it will take time before they're fully recovered. A third … [Read More...]

TapImmune brings therapeutic vaccines into the clinic for ovarian, breast cancer

In the past decade, new innovations and well-funded research have heralded in the era of immunotherapy. The pace of change within the field has amazed Peter Hoang, the chief executive of a Jacksonville, Fl.-based company working to develop … [Read More...]

The ‘smart pill’ market could be worth $3B by 2025 – meet the key players

The "smart pill" market is expected to nearly quadruple in value to $3 billion by 2025, according to Grand View Research. Driving this growth is an increasing demand for minimally-invasive procedures, as well as better patient monitoring … [Read More...]

How this biotech plans to go up against big pharma with its eye disease products

Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena - after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to … [Read More...]

Mass Innovation Labs expands to give startups a better way to do research

At the 124,000-square foot Cambridge headquarters of Mass Innovation Labs, co-founder & CEO Amrit Chaudhuri points to a cluster of tables and identifies them one by one: This startup went public and did a massive deal with Merck (NYSE:MRK), he … [Read More...]

One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how

When Jeff Dachis was diagnosed with Type I diabetes four years ago, he remembers leaving the doctor's office with a sinking feeling in his chest. "I had about six minutes with a nurse practitioner and was given an insulin pen and a prescription … [Read More...]

How Enable Injections plans to bring value to pharma with its drug-delivery device

Mike Hooven is no stranger to the medical device industry - he has spent the last 30 years launching companies and developing technologies for a variety of clinical applications. So when he ventured into drug delivery, he knew that he needed to find … [Read More...]

Aridis uses human antibodies to fight against “time bomb” of antibiotic resistance

Although antibodies have gained plenty of ground in recent years as vehicles for cancer therapies, Aridis Pharmaceuticals wants to use them as nature intended - to fight infection. "These are human monoclonal antibodies being investigated as … [Read More...]

Q Biomed looks to dust off shelved cancer pain drug

Denis Corin has spent the last 13 years in the biopharmaceutical industry watching and learning from scientists and companies that fail. "I've seen so many promising and innovative young technologies really struggle along or die on the vine … [Read More...]

Startup aims to disrupt asthma, COPD space with digital inhaler

Formed just two years ago, pharma startup Pneuma Respiratory is developing a digital inhaler that it touts as the first of its kind. The company is looking to bring its technology to the more than 40 million people who suffer from asthma or … [Read More...]

Draper develops novel device to deliver drugs to the inner ear

Millions of people around the world are losing their hearing thanks to inner ear disorders and the pharmaceutical industry has spent years working to develop therapeutics to help address this patient population. But Jeff Borenstein, lead scientist … [Read More...]

Pertinax Pharma tackles wound care, dental health and more with its controlled-release antiseptic

For nearly a decade, Michele Barbour and her team of researchers at the University of Bristol have been developing controlled-release salts of a commonly-used chemical called chlorhexidine. Barbour believed her technology had enormous potential - so … [Read More...]

Meet 5 companies developing novel drug-delivery devices

At the 7th annual Partnership Opportunities in Drug Delivery event, presented by The Conference Forum, device companies gathered to tout their drug-delivery technologies and learn from each other's mistakes and successes. Among them were … [Read More...]

JDRF wants to expand access to DIY diabetes tech – here’s how

As companies race to develop the first fully-automated insulin delivery system, a group of tech-savvy patients are hacking their own artificial pancreas systems. And industry is just starting to take notice of this highly motivated grassroots … [Read More...]

OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years

Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule … [Read More...]

Meet the two former Johns Hopkins residents disrupting the wound care market

Ned Swanson and Denver Lough were plastic surgery residents at Johns Hopkins when they made a choice that would change the course of their lives - they decided to drop out and start a business. Lough had a technology that they thought could help … [Read More...]

This company helps cell therapies travel around the world

With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T therapies use a patient's own cells to … [Read More...]

How etectRx’s “smart pill” aims to improve patient compliance trends

When Harry Travis first met Neil Euliano and learned about his medication adherence technology, the pharmaceutical industry was beginning to usher in the age of pricey drugs with Hepatitis C therapies that hit the market at prices like $500 or $1,000 … [Read More...]

Here’s how the diabetes industry’s leaders think about patient-centered R&D

Designing devices centered around patients is a goal espoused by nearly all device companies nowadays, as they aim to make products that people want to use and can incorporate into their everyday lives. Underscoring those products is often years of … [Read More...]

Dexcom CEO: Bringing meaningful data to the diabetes community

Kevin Sayer describes Dexcom's (NSDQ:DXCM) history as punctuated by "firsts" - its continuous glucose meter was the first to connect to a phone. Last year, the company's tool became the first approved by the FDA as one from which a patient with … [Read More...]

Convenience, compliance & control: How Insulet is changing insulin delivery tech

Shacey Petrovic spent nearly a decade trying to convince her diabetic father to switch to an insulin pump, rather than inject himself multiple times each day. But he was wary of the tubing and other challenges that come with constantly wearing a … [Read More...]

Why Takeda thinks partnerships can revive innovation in pharma

Takeda Pharmaceutical (TYO:4502) has been on a partnership spree lately, inking at least 65 collaborations and deals in the last 18 months. Fueling those agreements is a fundamental belief that to reinvigorate the pharmaceutical industry, access … [Read More...]

Vericel CEO: Industry has reached ‘watershed moment’ for cell therapies

Shares in Cambridge-based Vericel Corp (NSDQ:VCEL) surged last year after the FDA approved its bioresorbable scaffold for cartilage repair. The product, Maci, is the first FDA-approved implant to use healthy cartilage tissue from a patient's own … [Read More...]

Milestone Scientific wants to bring subcutaneous injections into the 21st century

As a dentist, Mark Hochman gave countless injections to his patients and watched as many of them would cringe from pain. Frustrated with a technology that he said hasn't improved in decades, he decided to take a different approach to the common … [Read More...]

Capillary Biomedical takes aim at ‘the Achilles heel of diabetes’

Major players in the medical device realm are in a heated race to develop the first artificial pancreas to help patients with diabetes manage the chronic condition. Just last year, Medtronic (NYSE:MDT) won FDA approval for its MiniMed 670G … [Read More...]

Navigating the regulatory and development pathways for drug-device products

David Lee began his path to CEO of Lumicell in 1999, when his wife was diagnosed with cancer. She passed away in 2003, while Lee was working in the semiconductor industry. He decided it was time for a career change. More than a decade later, Lee … [Read More...]

Livongo Health acquires weight-management, disease-prevention dev Retrofit

Livongo Health said yesterday it acquired weight-management and disease-prevention program developer Retrofit for an undisclosed amount. With the acquisition, Mountain View, Calif.-based Livongo Health said it will make Retrofit's Diabetes … [Read More...]

Report: Amazon abandons drug distribution and supply plans

Amazon's (NSDQ:AMZN) Business division has dropped plans to sell and distribute pharmaceutical products to hospitals, according to a new report from CNBC. The shift comes due to the online mega-retailer being unable to convince large hospital … [Read More...]

Glooko names digital health veteran as CEO | Personnel Moves – April 17, 2018

Glooko named health tech veteran Russ Johannesson as its new chief executive this month, adding that the diabetes data management company's former CEO, Rick Altinger, is slated to become EVP of corporate development. Johannesson previously served … [Read More...]

How these Boston Marathon runners kept their diabetes in check with Abbott’s FreeStyle Libre monitor

When Courtney Duckworth was first diagnosed with Type I diabetes, her glucometer was the size of a cell phone and she pricked her fingers nearly 12 times each day to keep track of her blood sugar. "I couldn't feel the things that I touched because … [Read More...]

AstraZeneca inks outcomes-based contract with Highmark for COPD, asthma drug

Health insurer Highmark inked an outcomes-based contract with AstraZeneca (NYSE:AZN) for Symbicort, the pharmaceutical company's drug designed to treat asthma and chronic obstructive pulmonary disease. Highmark said its contract with AstraZeneca … [Read More...]

Valeritas inks distro deal in Australia, New Zealand for V-Go insulin delivery device

Valeritas (NSDQ:VLRX) said today that it inked an exclusive distribution deal with AMSL Diabetes and NZMS Diabetes for the commercialization of its V-Go wearable insulin delivery device in Australia and New Zealand. According to the terms of the … [Read More...]

Novocure touts top-line data from Ph2 mesothelioma trial

Johnson & Johnson’s global pharma sales up 19% in Q1

Johnson & Johnson (NYSE:JNJ) today reported first-quarter sales and earnings results, topping analysts' expectations on Wall Street. The company's pharmaceutical business delivered "robust growth," chairman & CEO Alex Gorsky said in a … [Read More...]

Health Canada launching new unit for digital health technology licensing

By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. Get the full story here at the Emergo Group’s … [Read More...]

Novocure touts top-line data from Ph2 mesothelioma trial

Novocure (NSDQ:NVCR) today touted positive top-line data from its Phase II pilot mesothelioma trial and revealed that it plans to submit a humanitarian device exemption application to the FDA for approval. The St. Helier, N.J.-based company reported that patients who received treatment with its “Tumor Treating Fields” system plus chemotherapy experienced clinically meaningful improvements in overall […]

Avita Medical touts pivotal trial of ReCell burn injury device

Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints. The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted. “Treatment with the ReCell device […]

AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers

Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]

FDA refuses to review application for Alkermes’ depression drug

Alkermes (NSDQ:ALKS) shares tumbled this morning after the company revealed that the FDA will not review its application for an investigational depression drug. The U.S. regulatory issued a refusal to file letter to Alkermes, writing that it can’t review the drug’s application based on “insufficient evidence of overall effectiveness for the proposed indication,” and that […]

Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease

Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]

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