Egalet wins tentative FDA nod for intranasal abuse-deterrent pain-killer

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Egalet (NSDQ:EGLT) said today that the FDA tentatively approved an expanded label for its Arymo extended-release pain-relief tablets. The new label includes data from a intranasal human abuse potential study and an intranasal abuse-deterrent claim.

The FDA previously excluded this data from Arymo ER’s label due to exclusivity given to another company, Egalet reported. The FDA is slated to give full approval to Arymo ER’s new label when that exclusivity period ends on Oct. 2, 2018.

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

pSivida touts pilot osteoarthritis trial for Durasert implant

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pSividapSivida (NSDQ:PSDV) touted results today from a Phase I safety and efficacy pilot trial of its sustained-release Durasert implant in patients with osteoarthritis of the knee.

The company’s Durasert tech, combined with an implantable device from the Hospital for Special Surgery, was designed to continuously deliver a low dose of dexamethasone into the knee joint. Six patients with osteoarthritis of the knee were followed throughout the study for six months.

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

Teva to slash 14,000 jobs in restructuring effort

  • 7 medical devices combating the opioid crisis

    Opioid-related deaths have become an epidemic in the US, garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from a drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause […]

  • Companion Medical launches smart insulin pen in U.S.

    Companion Medical started selling its smart insulin pen in the U.S. today, according to the San Diego, Calif.-based company. The InPen system, which combines an insulin injector pen and a smartphone app, is compatible with Eli Lilly‘s (NYSE:LLY) Humalog and Novo Nordisk‘s (NYSE:NVO) Novolog fast-acting insulin. Get the full story at our sister site, Drug Delivery Business News. […]

  • Manufacturing companies form collaborative for advancing product development capabilities

    A group of manufacturing services companies said today they created a collaboration, called the Medical Device Development Collaborative, to help improve access to a full range of product development capabilities for concept-to-market solutions. The collaboration is based in the Medical Alley region and aims to help small to mid-size OEMs by offering experience and expertise […]

  • Millar offloads telemetry product line to Kaha Sciences

    Medical device and OEM company Millar said today it is selling its lifesciences telemetry product division to New Zealand-based Kaha Sciences. Houston-based Millar said the divestiture comes as the company looks to focus its efforts on the clinical and OEM business segments in a strategy that emerged earlier this year. Kaha Sciences has picked up a handful […]

  • InstruSafe and Senhance Surgical Robotic System partner to launch instrument trays

    Summit Medical’s InstruSafe and TransEnterix’s Senhance Surgical Robotic System  have forged a partnership to launch two new surgical instrument trays for use with the robotic platform. The two new trays will include an instrument tray an an endoscopic adapter tray, both of which have been validated for the Senhance instrumentation. “We are excited to expand our product offering […]

  • New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies

    By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

  • Researchers create ultrasound-sensor powered prosthetic hand with individual digit control

    Researchers are one step closer to creating a prosthetic hand that allows users to have full control over each finger, according to a new report from Georgia Tech. Researchers at the university say they have created an ultrasonic sensor which allows amputees to control individual fingers on a prosthetic hand, with enough sensitivity to play […]

  • Medline acquires Centurion Medical Products

    Medline recently completed its previously announced acquisition of Centurion Medical Products – boosting offerings around the Medline Erase BSI line access and dressing change bundles. Financial terms of the deal were not disclosed. Medline’s Erase BSI is meant to standardize best practices around central lines post-insertion, reducing cases of bloodstream infections. On top of its minor procedure trays, Centurion makes vascular insertion […]

  • Cadence expands laser processing capabilities

    Cadence has expanded its laser processing technologies with a new CL900 Cincinnati laser cutting machine. The new 4,000W fiber laser cutter adds to Cadence’s modified tube cutting lasers and completely custom flat sheet cutting lasers, Cadence announced yesterday. It also has the ability to cut 1,000 in. per minute (IPM) with a positioning accuracy of +/-0.001 […]

  • These artificial heart muscle patches can repair dead heart muscles

    A team of biomedical engineers have developed a fully functioning artificial human heart muscle that can be used as a patch to repair dead heart muscle. Duke University biomedical engineers developed the patch to be used in human patients who have previously suffered a heart attack. “Right now, virtually all existing therapies are aimed at […]

  • How to think outside the box with medtech innovation

    Innovation is important in medtech and many other industries. But what does it really mean – and can it be done with speed? That was the question that a panel of experts – moderated by William Betten of Betten Solutions – grappled with today at DeviceTalks West in Orange County, Calif. It turns out that […]

  • Shire taps Rani Therapeutics’ oral delivery tech for hemophilia therapy

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    ShireShire (NSDQ:SHPG) said this week that it is collaborating with Rani Therapeutics to combine the company’s Rani Pill technology for the delivery of factor VIII therapy in patients with hemophilia A.

    According to the terms of the deal, Shire has the exclusive option to negotiate a license to develop and commercialize the technology as a delivery mechanism for FVIII therapy after the companies conduct feasibility studies. Shire also made an equity investment into Rani Therapeutics as part of the collaboration.

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

    Appeal board to review Sanofi’s Lantus insulin injection patents

  • 7 medical devices combating the opioid crisis

    Opioid-related deaths have become an epidemic in the US, garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from a drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause […]

  • Companion Medical launches smart insulin pen in U.S.

    Companion Medical started selling its smart insulin pen in the U.S. today, according to the San Diego, Calif.-based company. The InPen system, which combines an insulin injector pen and a smartphone app, is compatible with Eli Lilly‘s (NYSE:LLY) Humalog and Novo Nordisk‘s (NYSE:NVO) Novolog fast-acting insulin. Get the full story at our sister site, Drug Delivery Business News. […]

  • Manufacturing companies form collaborative for advancing product development capabilities

    A group of manufacturing services companies said today they created a collaboration, called the Medical Device Development Collaborative, to help improve access to a full range of product development capabilities for concept-to-market solutions. The collaboration is based in the Medical Alley region and aims to help small to mid-size OEMs by offering experience and expertise […]

  • Millar offloads telemetry product line to Kaha Sciences

    Medical device and OEM company Millar said today it is selling its lifesciences telemetry product division to New Zealand-based Kaha Sciences. Houston-based Millar said the divestiture comes as the company looks to focus its efforts on the clinical and OEM business segments in a strategy that emerged earlier this year. Kaha Sciences has picked up a handful […]

  • InstruSafe and Senhance Surgical Robotic System partner to launch instrument trays

    Summit Medical’s InstruSafe and TransEnterix’s Senhance Surgical Robotic System  have forged a partnership to launch two new surgical instrument trays for use with the robotic platform. The two new trays will include an instrument tray an an endoscopic adapter tray, both of which have been validated for the Senhance instrumentation. “We are excited to expand our product offering […]

  • New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies

    By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

  • Researchers create ultrasound-sensor powered prosthetic hand with individual digit control

    Researchers are one step closer to creating a prosthetic hand that allows users to have full control over each finger, according to a new report from Georgia Tech. Researchers at the university say they have created an ultrasonic sensor which allows amputees to control individual fingers on a prosthetic hand, with enough sensitivity to play […]

  • Medline acquires Centurion Medical Products

    Medline recently completed its previously announced acquisition of Centurion Medical Products – boosting offerings around the Medline Erase BSI line access and dressing change bundles. Financial terms of the deal were not disclosed. Medline’s Erase BSI is meant to standardize best practices around central lines post-insertion, reducing cases of bloodstream infections. On top of its minor procedure trays, Centurion makes vascular insertion […]

  • Cadence expands laser processing capabilities

    Cadence has expanded its laser processing technologies with a new CL900 Cincinnati laser cutting machine. The new 4,000W fiber laser cutter adds to Cadence’s modified tube cutting lasers and completely custom flat sheet cutting lasers, Cadence announced yesterday. It also has the ability to cut 1,000 in. per minute (IPM) with a positioning accuracy of +/-0.001 […]

  • These artificial heart muscle patches can repair dead heart muscles

    A team of biomedical engineers have developed a fully functioning artificial human heart muscle that can be used as a patch to repair dead heart muscle. Duke University biomedical engineers developed the patch to be used in human patients who have previously suffered a heart attack. “Right now, virtually all existing therapies are aimed at […]

  • How to think outside the box with medtech innovation

    Innovation is important in medtech and many other industries. But what does it really mean – and can it be done with speed? That was the question that a panel of experts – moderated by William Betten of Betten Solutions – grappled with today at DeviceTalks West in Orange County, Calif. It turns out that […]

  • Report: Investors review hedge fund involvement in wake of harassment allegations against Orbimed founder Isaly

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    OrbiMedInstitutional investors with positions in OrbiMed are reportedly reviewing their involvement with the healthcare hedge fund after sexual harassment allegations surfaced against founder and managing partner Sam Isaly.

    Six former employees of biotech hedge fund accused Isaly, a 72-year-old investor long revered in the biotech community for his ability to pick stocks, of routinely demeaning and harassing women with hardcore pornography and sex toys, STAT reported Dec. 5. Isaly has denied the allegations. The sixth accuser contacted the outlet after that story, requesting anonymity for fear of reprisal by the hedge fund. Best thing you can do is to stop watching porn and start from pornaddiction.co.uk to help you.

    The story roiled Wall Street, prompting investment firm Eaton Vance to review its arrangement with OrbiMed, which provides it with investment advice, according to STAT.

    “We were not aware of any of these allegations, which we take very seriously,” an Eaton Vance spokesperson told the outlet via email. “We are reviewing the matter now.”

    OrbiMed’s code of ethics requires that “all personnel must conduct themselves in a professional and ethical manner that will reflect favorably on OrbiMed and the profession, and should encourage others to do the same,” Eaton Vance said in a regulatory filing, according to STAT.

    Another large investor, the CalPERS California public pension fund, also invests in OrbiMed via an externally managed “fund of funds.” CalPERS told the site that it plans to alert its manager on the matter.

    “While we have no control over external manager investment decisions or underlying portfolio holdings, we will certainly bring this matter to the attention of our external manager,” a CalPERS spokeswoman told the site.

    OrbiMed said it’s hired an independent law firm to investigate the allegations but did not respond to requests for comment, STAT reported.

    The story is closely followed in the financial circles in the U.K., where Isaly manages the $1.2 billion Worldwide Healthcare Trust. Although a representative declined to comment, the fund said yesterday acknowledged the scandal and said it would “keep shareholders informed of any relevant developments.” The British fund’s website prominently features a video of Isaly touting his firm’s healthcare investing acumen.

    Isaly was scrubbed from the speaker list at an upcoming CNBC heathcare conference, where he was billed as “one of the world’s most recognized healthcare fund managers.” The television network declined to comment to STAT. He also skipped an investor event in New York City last night, the site reported, citing an attendee at the Evercore ISI event.

    Harrassment allegations

    Isaly’s former assistant, Delilah Burke told STAT that he repeatedly showed her hardcore pornography just to laugh as she reacted in disgust.

    “I’m scarred,” Burke said. “I still have anxiety from that job — now, years later.”

    In August of 2010, Isaly allegedly summoned Burke into his office and asked her to get a file from his briefcase. She opened the briefcase only to find a flesh-colored vibrator, Burke told STAT. Isaly laughed at her reaction, but for Burke it was the last straw.

    “The vibrator thing is when I quit,” Burke said. “It was just, ‘You’re disgusting. I’m leaving. This is it.’”

    Of the five original accusers, four said they repeatedly complained about Isaly’s behavior to OrbiMed executives, who expressed sympathy but did not pursue the matter. Four of the five former OrbiMed employees spoke on condition of anonymity, citing non-disclosure agreements and a fear of retaliation. Burke reportedly received a printed copy of her non-disclosure agreement last week with a letter reminding her of what she signed.

    The sixth accuser contacted the website yesterday after reading the site’s first scoop on Isaly to corroborate the account’s original five accusers.

    None of the accusers said Isaly touched them in a sexual way. Instead, he promoted and took part in a toxic culture of sexually-charged jokes that made some of his female colleagues uncomfortable, they alleged.

    The firm brushed off some of the allegations, including one that Isaly kept a set of breast implants on his desk and would touch them during conversations with employees. Those devices, OrbiMed said, were keepsakes from the firm’s investment in Sientra (NSDQ:SIEN).

    Court dismisses class action suits against Novocure

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    NovocureTwo class action lawsuits filed against Novocure (NSDQ:NVCR) and some of its directors and executives in January were dismissed after the court established that it lacked personal jurisdiction over any of the defendants.

    In mid-January, Joseph Donahue, Stephen Rosen and Susan Rosen filed two putative class action suits in a New Hampshire court against Novocure, its directors, some of its officers and the underwriters of its October 2015 initial public offering. The plaintiffs alleged that the company misstated or omitted information in Novocure’s initial public offering materials, violating federal securities law.

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

    Mixed migraine results for PFO closure study

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    St. Jude MedicalPercutaneous closure of patent foramen ovale did not significantly lessen the frequency of migraines in patients with episodic migraines, according to a study published yesterday in the Journal of the American College of Cardiology. 

    Although the Premium trial missed its primary endpoint, the study met the secondary endpoint of reducing migraine days after PFO closure.

    A sub-group analysis also found that patients with frequent aura experienced a significant reduction in migraine attacks with PFO closure. One of the trial’s investigators told Medscape that there is validity to right-to-left shunt closure, as long as researchers can identify the subset of patients who are most likely to respond.

    The 230-patient trial focused on patients with six to 14 migraine days per month. The participants also had failed at least three migraine preventive medications and showed significant right-to-left shunt in ultrasonography scans. Researchers randomized patients to receive medication with a sham procedure or medication and PFO with St. Jude Medical‘s Amplatzer PFO Occluder.

    The primary efficacy endpoint was met in 45 of 117 patients in the PFO group and 33 of 103 patients in the control group. Data from the study also showed that 10 patients in the PFO group experienced complete cessation of migraine attacks for one year compared to one patient in the control group.

    Patients in the PFO group had 3.4 fewer migraine days per month compared to baseline, while participants in the control group had two fewer migraine days per month.

    Although previous work has shown an association between patients with migraines and the presence of PFO, there is still an ongoing debate whether PFO closure can lessen the frequency of migraine attacks. The mixed results of the Premium trial underscore that debate and some see it as highlighting the need to focus PFO-closure trials on patients with frequent aura.

    In a subgroup analysis of patients with aura as a consistent feature of their migraines, 49% of patients in the PFO group saw a >50% reduction in migraine days compared to 23% of patients in the control group.

    “Because this subgroup was not prespecified, these observations can be used only to generate the hypothesis that a future clinical trial of PFO closure might be beneficial in subjects where aura is a frequent component (>50%) of the migraine episodes,” the researchers wrote.

    Acorda resubmits NDA for inhaled Parkinson’s disease therapy

  • Solvay releases new PEEK polymer for implantable devices

    Solvay has launched its new Zeniva ZA-600 CF30 polyetheretherketone (PEEK) designed for use in implantable device applications. Zeniva ZA-600 CF30 PEEK is a 30% carbon fiber-reinforced, radiolucent polymer that offers modulus that is similar to cortical bone. The polymer helps implants minimize bone density reduction while maintaining normal stress on surrounding bone tissues. The polymer […]

  • Lexington Biosciences moves forward with its affordable heart diagnostic device

    Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device. The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial […]

  • Tobii and RightEye partner to create eye-tracking system

    RightEye and Tobii announced that they have forged a partnership to develop new hardware solutions for RightEye vision tests and training games for healthcare, vision and sports markets. “We’re excited to be partnering with Tobii to advance our product and offer customers a more portable, integrated eye-tracking system to further enhance their users’ experience with […]

  • How Smith & Nephew’s InVentures program is promoting innovation

    For nearly a decade, Smith & Nephew’s InVentures program has worked with surgeons who have innovative ideas but aren’t starting their own companies. The program provides a third innovation route on top of the major two for big medical device companies: internal R&D and acquisition of smaller companies with new technologies. “A company the size of Smith […]

  • Promenade Software to showcase medical device software at DeviceTalks West

    Promenade Software is a company comprised of highly skilled and experienced medical device software engineers with expertise spanning from low-level firmware to embedded applications, mobile applications and cloud services. Its engineers are on-site in Irvine, Calif. Featured technology and services: Parlay, professional services, cybersecurity Parlay: Parlay accelerates the development of medical device software, while simultaneously enabling testing and […]

  • Zeiss launches new imaging software

    Zeiss has launched its newest imaging software called the Zeiss Zen 2 core for improving laboratory workflow and efficiency. Zeiss Zen 2 core is a lab infrastructure solution designed to connect systems, data and workflows, helping laboratories become more efficient. The imaging software is used as a tool for image analysis and interactive control of […]

  • Overmolding: 2 types to know

    MTD Micromolding Some micro projects require specialty micro injection molding processes, such as overmolding. Overmolding involves two or more materials molded together to become one part. Examples include molding plastic over plastic or molding plastic over a preformed part, such as a metal insert. (See examples of common polymers and substrates below.) MTD specializes in […]

  • 3D printed organ models are getting way better: Here’s how

    University of Minnesota researchers are taking 3D printed organ models to the next level: They look and feel like the real thing, and integrated sensors help surgeons train. There’s even the potential that such artificial models may someday become the real deal – “bionic organs” used to replace damaged biological organs. The Minnesota researchers published […]

  • How BioSig is using plug and play as a medtech startup strategy

    Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during […]

  • PEEK formulations for new implantable devices

    Since the late 1990s, polyether ether ketone has become a go-to material for companies that manufacture orthopedic implants, thanks to its radiolucency and anatomical properties. Now, custom formulations of PEEK are enabling new potential applications for the polymer. Lawrence Acquarulo, Foster Corp. Polymers have always played a role in modern implantable medical devices. But until […]

  • Materialise and Formlabs want to bring more 3D printing labs to hospitals

    Materialise (Leuven, Belgium) and Formlabs (Somerville, Mass.) have forged a partnership to help deliver cost-effective solutions to hospitals that want to start in-house 3D printing labs. The partnership combines Materialise’s Mimics inPrint medical imaging software with Formlabs’s Form 2 printers to create a complete 3D printing package that will help implement patient-specific care that is an affordable price-per-print. Using […]

  • Stryker pledges $662m cash for Entellus Medical

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    Stryker acquires Entellus MedicalEntellus Medical (NSDQ:ENTL) said today that it struck a deal to be acquired by Stryker (NYSE:SYK) for $662 million in cash.

    Plymouth, Minn.-based Entellus, founded in 2006, makes a family of minimally invasive balloon device products, including its flagship Xpress device, that are designed to treat blocked sinuses. Earlier this year it closed the $81 million buyout of Spirox and its Latera absorbable nasal implant.

    The company’s shareholder must still approve the $24-per-share deal.

    “The combination of Stryker’s established commitment to making healthcare better and Entellus’ innovative products within the ENT segment will continue to provide our customers the tools they need for cost effective solutions,” president & CEO Robert White said in prepared remarks. “I look forward to the additional progress we will make together.”

    “Entellus is a leader in the ENT segment and offers a comprehensive portfolio of products that enable physicians to conveniently and comfortably perform a broad range of ENT procedures,” added Stryker medsurg & neurotech president Timothy Scannell.

    In September the FDA released an April warning letter sent to Entellus over a study of the Xpress device in pediatric patients, involving use of a dilator in patients under age 12 in frontal and sphenoid sinuses; the trial’s approved protocol only allowed treatment in the maxillary sinus for patients that young, according to the federal safety watchdog.