News and Resources from the WTWH Media Life Science Network - Page 636 of 968

Rafael Holdings names chief legal officer

Rafael Holdings (NYSE:RFL), the parent of Rafael Pharmaceuticals, has announced that Ashok Marin has agreed to join the company’s management team. Ashok will support the company’s quest to become a “fully integrated cancer metabolism therapeutics company.”

Marin has also worked for Gilead, Immunomedics, Mallinckrodt Pharmaceuticals, BD and Sanofi.

Rafael Holdings appointed a new chief financial officer, Patrick Fabbio, earlier this month.

Ashok Marin

“We are continuing to build a highly experienced management team with the skillset necessary to advance the ongoing and planned clinical trial programs across multiple indications and the early-stage pipeline,” said Ameet Mallik, Rafael Holdings CEO, in a statement.

Rafael Holdings plans to merge with Rafael Pharmaceuticals to form a publicly traded, late-stage cancer therapeutics firm.

The company is prepping for the top-line data re…

Novo Nordisk settles U.S. securities class action suit

Novo Nordisk (NYSE:NVO) has agreed in principle to settle securities class action litigation in the Federal District Court of New Jersey. The Bagsværd, Denmark–based company would pay $100 million in the settlement.

That amount includes plaintiffs’ attorneys’ fees, expenses and settlement costs.

The lawsuit alleged that the company made misleading statements regarding the price of its insulin.

The agreement contains no admission of liability or wrongdoing. The company stressed in a statement that it believes the “plaintiffs’ claims are without any merit.”

“While we are confident in the facts and merits of our position, we believe that resolving this matter is the right business decision for Novo Nordisk and our shareholders,” said Tomas Haagen, general counsel at Novo Nordisk.

Purchasers of American Depository Receipts initially filed the lawsuit in 2017.

Novo Nordisk, along with Eli Lilly and Sanofi-Aventis, has faced litigation ove…

SeaSpine warns of COVID-19 hit to surgical revenue

SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business.

Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout the United States.”

“Throughout the third quarter of 2021, and most acutely starting in August, spine surgery procedure volumes were negatively impacted in many areas of the United States, including in Florida and Texas, where SeaSpine derives a meaningful portion of its revenue, due to cancellations and/or postponements of procedures as a result of the increased cases and transmissibility of COVID-19 and because hospitals and other surgical centers were experiencing staffing shortages,” the company said in the SEC disclosure.

SeaSp…

A closer look at a microrobot that could treat a rare brain malformation

Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers.

The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation.

In 1914, neurosurgeon Walter Dandy observed a toddler with a brain cyst that led to swelling in the back of the brain. In the 1940s, another neurosurgeon, Arthur Earl Walker, identified the same type of malformation, later dubbed Dandy-Walker syndrome. While the syndrome varies in severity, children with the condition may have developmental and movement disorders, vomiting or seizures.

Treatment options for the syndrome have been limited to shunt surgery, which has a significant rate of complications. A 2015 study found more than one-quarter of Dandy-Walker syndrome patients experienced complications, including infection, shun…

A closer look at a microrobot that could treat a rare brain malformation

Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers.

The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation.

In 1914, neurosurgeon Walter Dandy observed a toddler with a brain cyst that led to swelling in the back of the brain. In the 1940s, another neurosurgeon, Arthur Earl Walker, identified the same type of malformation, later dubbed Dandy-Walker syndrome. While the syndrome varies in severity, children with the condition may have developmental and movement disorders, vomiting or seizures.

Treatment options for the syndrome have been limited to shunt surgery, which has a significant rate of complications. A 2015 study found more than one-quarter of Dandy-Walker syndrome patients experienced complications, including infection, shun…

Heraeus buys Mo-Sci and ETS Technology Holdings

Mo-Sci makes glass products for medical devices. [Photo courtesy of Mo-Sci]

The Heraeus Group has a deal to acquire Mo-Sci Corp. and ETS Technology Holdings, the Germany-based conglomerate announced this week.

Mo-Sci is a supplier of glass microspheres, fibers and powders for medical devices, while ETS is the developer of bioactive glass fiber wound care product Mirragen, an FDA-cleared resorbable synthetic skin substitute.

The companies — both in Rolla, Missouri — will join Hanau, Germany-based Heraeus Group’s healthcare and medical technology portfolio. The deal is anticipated to close by the end of 2021.

“Across every treatment area, medical technology is changing rapidly,” Heraeus Head of Business Area Medical Technologies Nicolas Guggenheim said in a news release. “The acquisition of Mo-Sci and ETS gives us new capabilities to help our customers deliver innovative technologies and break…

Medical Alley appoints new CEO

The Medical Alley Association announced today that it appointed Roberta Dressen as its new president & CEO.

Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then.

Get the full story at our sister site, MassDevice.

Westfall Technik names Mark Gomulka as CEO

Westfall Technik’s board of directors has promoted Mark Gomulka to CEO.

Gomulka joined the Las Vegas-based plastics manufacturer as SVP in January 2020. Before that, he led Flex’s medical and precision plastics operations for five years and earlier spent 15 years at Nypro in various global operational and leadership roles.

In those roles before joining Westfall, Gomulka worked closely with Westfall founder Brian Jones.

“I trust Mark to lead Westfall as CEO,” Jones said in a news release. “I’ve seen executives grow up in the plastics industry for a long time, and Mark knows better than anyone how to execute the integrated vision for Westfall. We’ve worked together closely for many years, and Mark has done a masterful job maturing the Westfall organization.”

The Westfall leadership team has launched or acquired 18 companies since October 2017, when New York-based private equity firms Lee Equity Partners and BlackBern Partners sponsored the Westfall …

CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…

Medical Alley appoints new CEO

The Medical Alley Association announced today that it appointed Roberta Dressen as its new president & CEO.

Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then.

Hovard will stay on board over the next several weeks to assist with the transition as Dressen will officially begin her new role next week, according to a news release.

“The Medical Alley Association has a strong reputation of leadership and innovation,” Dressen said in the release. “I look forward to joining MAA and partnering with other global healthcare leaders to find ways to better serve our members and stimulate collaboration around how we can bridge current gaps in the healthcare industry.”

Dressen holds nearly two decades of leadership experience with some of Medical Alley’s notable healthcar…

MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD

MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon.

Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020.

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

Ayala Pharmaceuticals sees promise of gamma secretase inhibitor AL101 for desmoid tumors

Oncology-focused Ayala Pharmaceuticals (NASDAQ: AYLA) has published two positive case studies of adults with desmoid tumors treated with gamma secretase inhibitor AL101 in Current Oncology.

Desmoid tumors are noncancerous and most often appear in the abdomen, arms or legs. They can also occur in the head and neck, chest and other areas of the body. While the tumors do not metastasize, they can invade neurovascular structures and vital organs.

Wilmington, Delaware–based Ayala says the case studies point to the promise of AL101 to reduce patients with significant tumor burden.

The two patients achieved durable partial responses. The first patients had a maximal decrease in tumor size from baseline of 41% after 55 weeks of therapy. The second had a 60% decrease at 82 weeks.

AL101, the company’s investigational lead candidate, is a novel, injectable drug.

The company has a related gamma secretase inhibitor known as AL102 for the treatment…