Drug Delivery Business

Phillips-Medisize is offering connected health data services: Here’s how

One of the world’s largest medical device contract manufacturers, Phillips-Medisize is making a business play to provide the technological back end for connected drug delivery devices. Phillips-Medisize used to be all about the housings, assembly … [Read More...]

Insulet president & CEO Shacey Petrovic to participate in keynote interview at DeviceTalks Boston 2019

[Press Release] – WTWH Media and MassDevice.com announced today that Shacey Petrovic, president and CEO of Insulet (NSDQ:PODD), will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019, … [Read More...]

Diabetes tech execs talk patient-centric design, device development & trust

John Timberlake has been commercializing diabetes drugs and devices for 25 years. Over the course of his career, one theme has always stood out: if you want people to use your product, it has to be made with the end-user in mind. "It's really … [Read More...]

How suppliers are taking drug-delivery tech to the next level

Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery tech. Drug-eluting technologies are moving beyond stents, thanks in part to the development of polymeric hydrogels engineered to respond to a range of … [Read More...]

Tracking tumors with Precipio’s liquid biopsy tech

In the era of personalized medicine, cancer patients will often have their tumors biopsied and analyzed as doctors hunt for mutations that are driving the patient's condition. For some forms of cancer, doctors can recommend therapies that target … [Read More...]

Novo Nordisk exec: In the digital age, it’s not enough to have a better molecule

Much of Dr. Todd Hobbs' life has centered around diabetes - he was diagnosed with Type I diabetes roughly 30 years ago and now he is the father of a child with diabetes. At his Kentucky-based primary care practice, he took on diabetic patients and … [Read More...]

Acorda’s CEO on failure, perseverance and the profound risks of drug development

Dr. Ron Cohen isn't easily deterred. The physician-turned-executive has spent decades in the biotech industry and weathered a number of setbacks – he learned in his early years at the now-defunct Advanced Tissue Sciences that to succeed, he needed … [Read More...]

Going public, Provention Bio looks to tackle immune-mediated diseases

Shares in Oldwick, N.J.-based Provention Bio began trading today following the close of its $64 million initial public offering last week. The biopharmaceutical company, lead by co-founder & CEO Ashleigh Palmer, is developing a number of … [Read More...]

RenovoRx sets its sights on localized treatment of pancreatic cancer

People living with pancreatic cancer find themselves facing devastating odds - the five-year survival rate is in the single digits, according to the American Cancer Rate. Pursuing treatment often means dealing with the side effects of systemic … [Read More...]

Oyster Point takes aim at the root of dry eye disease with intranasal drug-delivery technique

Large pharmaceutical companies dominate the dry eye disease space - Allergan (NYSE:AGN) rakes in more than a billion dollars every year for its Restasis eye drops. Eight-person Oyster Point Pharma wants in on that market. But it's betting on a … [Read More...]

Vaccine maker PaxVax tackles the unmet need posed by chikungunya virus

Transmitted by the same mosquitoes that spread Zika virus and dengue fever, the chikungunya virus is named for an African word meaning "to become contorted." People infected with the alphavirus are afflicted with lasting joint pain that causes their … [Read More...]

Sage Therapeutics’ chief scientist on discovering drugs and taking risks

When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk. But around 2011, it became clear that the process for developing brain drugs was too costly and … [Read More...]

Sunovion looks to molecular clues, patient preferences to inform drug development

From discovery to commercial launch, drug development often takes years. New tools available to the industry, like the use of biomarkers and patient-reported outcomes, promise to help inform and speed up the process. "Being able to pick out the … [Read More...]

ivWatch to integrate IV infiltration sensor into Philips’ patient monitors

For decades, nurses have sent drugs surging through a patient's body using the power of the circulatory system. Catheters deliver medications destined to travel through a person's veins – but it doesn't always turn out that way. Sometimes, leaky … [Read More...]

Foundation Medicine looks to expand oncology arsenal with precision drugs

Before she was Foundation Medicine's (NSDQ:FMI) chief business executive, Melanie Nallicheri was as an advisor to an ongoing project at the Cleveland Clinic, where she was witness to the power of personalized cancer treatment. Her team was caring … [Read More...]

Noble aims to put patients at ease with auto-injector training devices

In the early days of auto-injectors, people learned how to use their devices by practicing with the skin of an orange, according to Noble's research manager, Joe Reynolds. "The rationale was 'Well, let's teach patients how to penetrate a skin-like … [Read More...]

AcelRx tackles acute pain with sublingual drug-delivery tech

While pain medicine specialist Dr. Pamela Palmer was working on the West Coast in the early 2000's, she noticed something peculiar was happening to patients undergoing surgery - many who survived their procedures were dying of opioid overdoses as a … [Read More...]

Medtech veteran Mir Imran wants to replace injections with the ‘robotic pill’

Companies have tried for decades to deliver protein-based drugs orally. Can Mir Imran and his company’s robotic pill succeed where so many have failed? Mir Imran has been building medical device companies for 40 years. Perhaps known best for his … [Read More...]

Adherium looks to give doctors a window into their patients’ lives

To control an asthma patient's symptoms, doctors will prescribe an inhaler to stop symptoms from cropping up and a rescue inhaler to be used if patients find themselves in the middle of an asthma attack. "But if your rescue inhaler doesn't give … [Read More...]

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 … [Read More...]

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 … [Read More...]

PolarityTE aims to ‘wage war on skin grafts’ with regenerative tech

PolarityTE wants to eliminate skin grafts with its platform of regenerative technology. The Utah-based biotech is still new to the industry, but co-founders Denver Lough and Ned Swanson are betting that their company can take on the clinical standard … [Read More...]

Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products

In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% … [Read More...]

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...]

FDA clears generic Narcan nasal spray

The FDA announced today that it has approved the first generic naloxone hydrochloride nasal spray, a life-saving medication that is designed to stop or reverse opioid overdose effects. The FDA also said that it is planning new steps to prioritize … [Read More...]

Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges

Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) … [Read More...]

Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study

Surmodics ticks up on renewed SurVeil DCB trial enrollment

Contracting drug delivery device development: 5 things you need to know

AdrenaCard Pharmaceuticals is a Minneapolis-based startup developing what it touts as a small, easy-to-use epinephrine injector. As with many young medical device companies, it's founders have had to rely on contracted talent. AdrenaCard's CTO … [Read More...]

Pulmatrix, Cipla Technologies ink deal for inhaled anti-fungal

Pulmatrix (NSDQ:PULM) said yesterday that it inked a deal with Cipla to co-develop and commercialize an inhaled iSperse formulation of the anti-fungal drug itraconazole, intended for treating allergic bronchopulmonary aspergillosis in asthma … [Read More...]

Egypt fast-track medical device registration pathway speeds up market access timeframes

By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers. Get the full story here at the Emergo Group’s blog. The … [Read More...]

U.K. government requests Brexit deadline extension

By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the … [Read More...]

Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown

By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure … [Read More...]

Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study

Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]

Surmodics ticks up on renewed SurVeil DCB trial enrollment

Surmodics (NSDQ:SRDX) shares have ticked up today after the company updated on the TRANSCEND clinical trial of its SurVeil drug-coated balloon, saying that it has resumed patient enrollment. Last month, the Eden Prairie, Minn.-based company paused enrollment after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease […]

PolarityTE launches two chronic wound treatment trials

PolarityTE (NSDQ:PTE) said it has begun enrolling patients in two new randomized clinical trials of its SkinTE regenerative tissue product for chronic wounds. The trials will evaluate the SkinTE’s effectiveness in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is a human cellular and tissue-based product designed to regenerate full-thickness, functional skin […]

Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy

Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome. The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer. The Boston-1 trial is slated to enroll people with BOS […]

Johnson & Johnson touts drug-releasing lens studies for itchy eyes

Contact lenses imbued with an antihistamine drug reduced itchy eyes in a pair of older studies funded by the vision business at Johnson & Johnson (NYSE:JNJ), the company said today. The Phase 3 studies, conducted in 2007, involved a total of 244 patients, divided into three cohorts. In the first patients wore a plain lens […]

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