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Lilly pushing for accelerated FDA approval of Alzheimer’s drug donanemab

Eli Lilly (NYSE:LLY) has received breakthrough therapy designation from FDA for the investigational antibody donanemab for Alzheimer’s disease.

The company plans to file a biologics license application for the drug under the accelerated approval pathway later this year.

Like Biogen’s (NSDQ:BIIB) recently approved aducanumab, donanemab is a monoclonal antibody clearing sticky amyloid plaques. Donanemab clears a modified form of beta-amyloid known as N3pG.

The FDA’s decision to grant donanemab accelerated approval underscores the regulator’s support for the so-called “amyloid hypothesis,” which has divided researchers for decades.

In a Phase 2 study known as TRAILBLAZER-ALZ published in NEJM, donanemab recipients had a better composite score for cognitive function than placebo recipients after 76 weeks of treatment. The study authors, however, included that more substantial clinical data are needed to assess its safety and efficacy.

The compa…

Medtech gets behind breakthrough device law for seniors

Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation.

Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that the Centers for Medicare and Medicaid Services (CMS) has delayed implementing with a final rule.

Get the full story on our sister site, Medical Design & Outsourcing.

Bigfoot Biomedical diabetes management program rolls out in some U.S. states

[Image from Bigfoot Biomedical]Bigfoot Biomedical announced today that made its Bigfoot Unity diabetes management program available in select U.S. markets.

Milpitas, Calif.-based Bigfoot’s program is now available in California, Texas, Florida, Pennsylvania, Ohio, New York, New Jersey, Massachusetts and other New England states. The program is offered as a bundle of devices, supplies and services and delivered as a 30-day subscription to eliminate upfront costs. Bigfoot Unity is eligible for insurance coverage and generally should be covered by insurance, although copays vary.

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

No connection between Pfizer COVID-19 vaccine and Bell’s palsy, study finds

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A case-control study in Israel found no association between recent vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNtech (NSDQ:BNTX) and facial nerve (Bell’s) palsy. JAMA published the study.

Clinical trials for Pfizer-BioNtech and Moderna COVID-19 vaccines revealed numerical imbalances regarding peripheral facial nerve (Bell’s) palsy. In the former Phase 3 trial, which involved approximately 38,000 patients, four patients in the vaccine group developed Bell’s palsy while none in the placebo group did. FDA concluded in a briefing document that the four cases did not rise above the expected rate in the general population but recommended that health officials monitor mRNA vaccine recipients for Bell’s palsy.

To analyze whether the BNT162b2 vaccine resulted in an …

FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.

The conditions appear to be more common in males.

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care.

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

An inside look at GSK’s digital twin initiative

A GSK vaccine facility. Image courtesy of GSK.

Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase.

GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of the entire vaccine manufacturing process.

A year in the making

The project, which launched a year ago, has already shown promise in reducing manufacturing timelines, optimizing product quality and other areas. The use of digital twins has enabled GSK to optimize vaccine-related experiments. “With digital twins, you’re able to do huge amounts of digital experiments and minimize the number of wet experiments that you do,” said Matt Harrison, head of sciences, digital innovati…

How contract manufacturer Minnetronix decided to make its own medical device

Medtech contract manufacturers such as Minnetronix often avoid making their own devices. But CEO Jeremy Maniak had a different idea.

Minnetronix’s first product — the MindsEye Expandable Port — earned the “Best New Technology Solution – Surgical” award from MedTech Breakthrough, an independent market intelligence. [Image courtesy of Minnetronix]Minnetronix Medical (St. Paul, Minn.) is closing on its quarter-century mark, and Jeremy Maniak has been with the company more than half of that time. Promoted into the corner office in early 2020, he has some unique ideas about how to position the medtech contract manufacturer for growth over the next 25 years.

An electrical engineer who entered the medical device industry directly out of Purdue University, Maniak explained to our DeviceTalks Weekly Podcast about how Minnetronix saw an opportunity to create its own line of medical devices. It was a move that some might see as a potential conflict with larger manufacturers …

How contract manufacturer Minnetronix decided to make its own medical device

Medtech contract manufacturers such as Minnetronix often avoid making their own devices. But CEO Jeremy Maniak had a different idea.

Minnetronix’s first product — the MindsEye Expandable Port — earned the “Best New Technology Solution – Surgical” award from MedTech Breakthrough, an independent market intelligence. [Image courtesy of Minnetronix]

Minnetronix Medical (St. Paul, Minn.) is closing on its quarter-century mark, and Jeremy Maniak has been with the company more than half of that time. Promoted into the corner office in early 2020, he has some unique ideas about how to position the medtech contract manufacturer for growth over the next 25 years.

An electrical engineer who entered the medical device industry directly out of Purdue University, Maniak explained to our DeviceTalks Weekly Podcast about how Minnetronix saw an opportunity to create its own line of medical devices. It was a move that som…

FDA approves Oticon Medical’s Neuro cochlear implant system

Oticon Medical today said the FDA has granted premarket approval for the company’s Neuro Cochlear Implant System.

Somerset, N.J.-based Oticon Medical designed the Neuro system to treat people 18 years or older with bilateral severe-to-profound sensorineural hearing loss and who have limited benefits from fitted hearing aids.

“At Oticon Medical, we are passionate about using our combined expertise and resources to open up the world of sound to as many people as possible,” John Sparacio, Oticon Medical North America president, said in a news release. “We are committed to ongoing innovation in hearing implant technology and support now and in the future for cochlear implant candidates, users and professionals. The Neuro system is an outstanding example of that commitment. Our thoroughly trained and experienced team is now ready to bring a leading-edge, highly reliable implant system to the US market.”

People in 51 countries have already benefited from…

Integra Lifesciences CEO steps down to succeed GE Healthcare CEO Murphy

Integra LifeSciences (NSDQ:IART) announced today that Peter Arduini will step down as CEO to accept a new role at GE Healthcare (NYSE:GE).

Princeton, N.J.-based Integra said in a news release that Arduini will step down at the end of 2021 to assume the role of president & CEO at GE Healthcare. Current president and CEO of GE Healthcare, Kieran P. Murphy, this week expressed his intention to retire, according to a separate release.

“It has been a privilege and honor to serve as Integra’s President and CEO since 2012 and to work alongside this talented and passionate team. Together, we have accomplished much, including global leadership in neurosurgery with some of the most recognized brands in plastic and reconstructive surgery, and an innovative pipeline to accelerate future growth,” Arduini said in Integra’s release. “I want to personally thank Stuart and the Board for their invaluable guidance and unwavering partnership over the years, as well as ou…

FDA accepts biologics license application for Genentech’s drug-eluting eye implant

Genentech’s PDS implant. [Image from Genentech]Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab.

PDS, a permanent, refillable eye implant standing at the approximate size of a grain of rice offers continuous delivery of a customized formulation of ranibizumab over a period of months with the intention of reducing the treatment burden associated with frequent eye injections.

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

Boston Scientific pulls trigger on Farapulse acquisition

Boston Scientific (NYSE:BSX) announced today that it exercised its option to acquire the remaining shares of Farapulse.

Marlborough, Mass.-based Boston Scientific first announced its intent to acquire Farapulse when it signed an investment agreement with an option to acquire the pulsed-field ablation (PFA) technology developer in September 2020.

Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27%. The transaction to acquire Farapulse includes an upfront payment of approximately $295 million for the 73% stake not yet owned, plus up to $92 million upon the achievement of certain clinical and regulatory milestones and additional revenue-based payments over the next three years, according to a news release.

The company said that, preceding consideration of current equity ownership, debt and other closing adjustments, the total transaction price amounts to $450 million upfront, up to $125 mil…