Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that … [Read More...]
Sponsored Content
Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...]
Featured Posts
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...]
Phillips-Medisize is expanding in Wisconsin
Phillips-Medisize, a Molex company, has broken ground on a new manufacturing facility in Hudson, Wis., on the eastern end of the Minneapolis-St. Paul metro area. The 34-acre location at the St. Croix Meadows development will support at least … [Read More...]
Cash-strapped Aradigm declares bankruptcy
Aradigm Corp. (NSDQ:ARDM) announced last week that it's officially declaring bankruptcy. Strapped for cash, the Calif.-based company resigned to filing for Chapter 11 protection after it couldn't confirm funding from its primary investor and … [Read More...]
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that … [Read More...]
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan's (NSDQ:MYL) brand-name emergency allergy device has dominated the … [Read More...]
Medtronic wins FDA’s breakthrough status for closed-loop insulin system
Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system. The company touted its technology as enabling automated insulin delivery in a real-time, adaptable … [Read More...]
India CDSCO adds new medical devices to regulated list
By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) continues expanding oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, … [Read More...]
Senseonics partners to provide veterans with Eversense CGM
Senseonics (NYSE:SENS) this week announced that it partnered with Geo-Med to provide access to the Eversense continuous glucose monitor to more than 9 million veterans and U.S. government staff. The company's Eversense device is the first CGM … [Read More...]
Tandem wins interoperable claim for insulin pump from FDA
The FDA announced this week that it established Tandem Diabetes Care's (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called 'Alternate Controller Enabled Infusion Pumps' or ACE pumps. The newly-approved indication … [Read More...]
Ocugen wins orphan drug status for ocular gene therapy
The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease. The Malvern, Penn.-based company's OCU400 product includes an adeno-associated virum serotype 5 capsid that … [Read More...]
In case you missed it
- Insulet president & CEO Shacey Petrovic to participate in keynote interview at DeviceTalks Boston 2019
- Diabetes tech execs talk patient-centric design, device development & trust
- How suppliers are taking drug-delivery tech to the next level
- Tracking tumors with Precipio’s liquid biopsy tech
- Novo Nordisk exec: In the digital age, it’s not enough to have a better molecule
- Acorda’s CEO on failure, perseverance and the profound risks of drug development
- Going public, Provention Bio looks to tackle immune-mediated diseases
- RenovoRx sets its sights on localized treatment of pancreatic cancer
- Oyster Point takes aim at the root of dry eye disease with intranasal drug-delivery technique
- Vaccine maker PaxVax tackles the unmet need posed by chikungunya virus
- Sage Therapeutics’ chief scientist on discovering drugs and taking risks
- Sunovion looks to molecular clues, patient preferences to inform drug development
- ivWatch to integrate IV infiltration sensor into Philips’ patient monitors
- Foundation Medicine looks to expand oncology arsenal with precision drugs
- Noble aims to put patients at ease with auto-injector training devices
- AcelRx tackles acute pain with sublingual drug-delivery tech
- Medtech veteran Mir Imran wants to replace injections with the ‘robotic pill’
- Adherium looks to give doctors a window into their patients’ lives
- Here’s how Sanofi separates true innovation from all the hype in digital health
- With groundbreaking approval, Amgen launches new class of medicine for migraine patients
- PolarityTE aims to ‘wage war on skin grafts’ with regenerative tech
- Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products
- OncoSec looks to boost effects of immunotherapy with intratumoral delivery
- Fine-tuning formulation with Fluid Imaging Technologies’ FlowCam
- Dexcom CEO on ‘treading new ground’ with G6 glucose monitor
- This new technology could help surgeons clear out leftover cancer cells
- The company behind Narcan looks toward a treatment for fentanyl overdoses
- Valeritas takes on multiple daily insulin injections with wearable V-Go device
- NanOlogy looks to transform chemotherapy with localized delivery platform
- After 20 years, Paratek’s broad-spectrum antibiotic is headed to the FDA
- Portal Instruments uses speed to tackle needle-free drug delivery
- How conversations with virtual people could help mitigate the opioid crisis
- TapImmune brings therapeutic vaccines into the clinic for ovarian, breast cancer
- The ‘smart pill’ market could be worth $3B by 2025 – meet the key players
- How this biotech plans to go up against big pharma with its eye disease products
- Mass Innovation Labs expands to give startups a better way to do research
- One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how
- How Enable Injections plans to bring value to pharma with its drug-delivery device
- Aridis uses human antibodies to fight against “time bomb” of antibiotic resistance
- Q Biomed looks to dust off shelved cancer pain drug
- Startup aims to disrupt asthma, COPD space with digital inhaler
- Draper develops novel device to deliver drugs to the inner ear
- Pertinax Pharma tackles wound care, dental health and more with its controlled-release antiseptic
- Meet 5 companies developing novel drug-delivery devices
- JDRF wants to expand access to DIY diabetes tech – here’s how
- OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years
- Meet the two former Johns Hopkins residents disrupting the wound care market
- This company helps cell therapies travel around the world
- How etectRx’s “smart pill” aims to improve patient compliance trends
- Here’s how the diabetes industry’s leaders think about patient-centered R&D
- Dexcom CEO: Bringing meaningful data to the diabetes community
- Convenience, compliance & control: How Insulet is changing insulin delivery tech
- Why Takeda thinks partnerships can revive innovation in pharma
- Vericel CEO: Industry has reached ‘watershed moment’ for cell therapies
- Milestone Scientific wants to bring subcutaneous injections into the 21st century
- Capillary Biomedical takes aim at ‘the Achilles heel of diabetes’
- Navigating the regulatory and development pathways for drug-device products
- Inovio prices $65m senior notes offering
- FDA committee backs J&J’s nasal spray for depression
- West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
- Touting pricetag, Mylan launches Advair generic
Clinical Trials
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five […]
Regeneron touts one-year diabetic retinopathy data for Eylea
Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Of the 133 people […]
Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy
Pulmatrix (NSDQ:PULM) said today that the FDA approved a Phase II trial of the company’s inhaled formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in people with asthma. The Lexington, Mass.-based company plans to kick off the trial in the first half of 2019, with top-line data expected in the second […]
FDA publishes finalized guidance for buprenorphine depots
The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder. The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) […]
Audion touts Ph1 results for hearing loss drug
Audion Therapeutics touted positive results yesterday from a Phase I trial of the company’s hearing loss drug. In 15 people with mild to moderate sensorineural hearing loss, Audion tested the safety and tolerability of its LY3056480 mediated Notch inhibitor. The drug is designed to regenerate the inner ear sensory hair cells that are lost over […]
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