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Molnupiravir holds up to omicron in lab studies

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro.

The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the UK, Taiwan, Japan, India and Australia.

“Based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including omicron, we anticipate that molnupiravir will continue to be active against variants of concern and an important tool in the fight against COVID-19,” said Wendy Holman, Ridgeback Biotherapeutics CEO, in a statement. “We are grateful for the efforts of the investigators and look forward to continuing our work to help address the pandemic.”

The recent lab studies were conducted by independent researchers using cell…

Eli Lilly to build $1B manufacturing facility for injectable products, devices in North Carolina

Eli Lilly (NYSE:LLY) announced today that it plans to invest more than $1 billion to create a new manufacturing site in North Carolina.

Indianapolis-based Eli Lilly’s new facility, which it expects to bring with it nearly 600 jobs in Concord, North Carolina, will manufacture parenteral (injectable) products and devices while increasing the company’s manufacturing capacity.

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

Eli Lilly to build $1B manufacturing facility for injectable products, devices in North Carolina

Eli Lilly (NYSE:LLY) announced today that it plans to invest more than $1 billion to create a new manufacturing site in North Carolina.

Indianapolis-based Eli Lilly’s new facility, which it expects to bring with it nearly 600 jobs in Concord, North Carolina, will manufacture parenteral (injectable) products and devices while increasing the company’s manufacturing capacity.

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

Eli Lilly to build $1B manufacturing facility for injectable products, devices in North Carolina

Eli Lilly (NYSE:LLY) announced today that it plans to invest more than $1 billion to create a new manufacturing site in North Carolina.

Indianapolis-based Eli Lilly’s new facility, which it expects to bring with it nearly 600 jobs in Concord, North Carolina, will manufacture parenteral (injectable) products and devices while increasing the company’s manufacturing capacity.

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

Stryker earnings miss by a penny in Q4

Stryker (NYSE:SYK) posted mixed fourth-quarter results, with the COVID-19 omicron variant pressuring elective procedure volumes in December.

The Kalamazoo, Michigan–based ortho device giant reported profits of $662 million, or $1.73 per share, on sales of $4.701 billion for the three months ended Dec. 31, 2021. The results, posted yesterday evening, represented a bottom-line gain of 16.5% and sales growth of 10.3% compared with Q4 2020.

Adjusted to exclude one-time items, earnings per share were $2.71, a penny behind The Street, where analysts were looking for EPS of $2.72 on sales of $4.61 billion.

Investor Relations VP Preston Wells told analysts yesterday evening that it wasn’t just omicron affecting procedure volumes: Ongoing nursing staffing shortages disrupted hospital scheduling. Hospital staffing challenges also delayed the installation of high-demand capital equipment from Stryker, and the company also had to grapple with raw materials sho…

FDA accepts label update for Suneva’s handheld plasma energy device

Suneva Medical announced today that the FDA accepted updates to its Plasma IQ handheld plasma energy device.

San Diego-based Suneva designed the Plasma IQ for the removal and destruction of skin lesions and coagulation of tissue. The company touts Plasma IQ as the first handheld, FDA-cleared plasma energy device with such indications.

According to a news release, the updated label includes the removal of the product’s eye contraindication, due in part to literature provided to the FDA that showed the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. The new label update allows Suneva to address treatment around the eye for patients in the U.S.

Plasma IQ delivers focused, controlled energy to create micro-injuries on skin, renewing and restoring it. The platform is prescription only, owned and manufactured by Neauvia with Suneva responsible for North American distribution.

Suneva earlier this month e…

NeuroMetrix dips on Q4 losses

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) shares dipped slightly before hours today on fourth-quarter results that included a bottom-line slide.

The Woburn, Massachusetts-based neurostimulation technology developer posted losses of $1 million, or 15¢ per share, on sales of $1.8 million for the three months ended Dec. 31, 2021, for a bottom-line dip deeper into the red on sales growth of 0.6%.

NeuroMetrix develops the Quell system, which it designed as a wearable, non-invasive neuromodulation technology enabled by a proprietary microchip. The device automatically adjusts stimulation through position and motion sensing while supporting Bluetooth low energy (BLE) to communicate with smartphone and smartwatch apps to control and personalize the treatment.

“We accomplished a great deal in 2021 and are now positioned to focus on our growth strategy,” NeuroMetrix CEO Dr. Shai N. Gozani said in a news r…

FDA clears Insulet’s next-generation Omnipod 5 wearable insulin delivery patch

The Insulet Omnipod 5 [Photo courtesy of Insulet]Insulet (NSDQ:PODD) announced today that it received FDA clearance for its Omnipod 5 automated insulin delivery system.

FDA clearance for the next-generation version of the company’s wearable insulin delivery patch system covers individuals aged six years and older with type 1 diabetes. The platform provides easier glucose management, with no multiple daily injections, no tubes and zero fingersticks.

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

Biogen to sell equity stake in Samsung Bioepis joint venture for up to $2.3B

After moving to accelerate a confirmatory clinical trial of the Alzheimer’s drug Aduhelm, Biogen (NSDQ:BIIB) plans on selling its equity stake in the Samsung Bioepis joint venture for up to $2.3 billion.

The deal would give Biogen $1 billion in cash and $1.25 billion to be paid in two installments after that. In addition, Biogen could receive an additional $50 million if agreed-upon commercial milestones are met.

Samsung Bioepis has one of the largest portfolios of biosimilars in the industry.

Samsung Biologics and Biogen announced the joint venture in 2012.

Under the terms of the agreement, Biogen will retain rights to BYOOVIZTM (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab) and the investigational biosimilar candidate SB15 (aflibercept), a proposed biosimilar referencing EYLEA.

BIIB shares increased 2.31% to $224.00 in after-hours trading.

Pfizer’s Paxlovid wins positive opinion from CHMP

The Committee for Medicinal Products for Human Use (CHMP) has recommended that Pfizer’s (NYSE:PFE) COVID-19 pill be granted conditional marketing authorization.

Specifically, CHMP recommended that the antiviral, comprising PF-07321332 and ritonavir, be used in adults not requiring supplemental oxygen who face an elevated risk of severe COVID-19.

If the European Commission signs off on the drug, it could be the first oral antiviral available in the region.

The organization provided guidance on the potential use of the drug in December.

To reach its recent recommendation, CHMP scrutinized clinical data from a study demonstrating the drug significantly reduced the risk of hospitalization or death in patients at risk of developing severe COVID-19. That study found that 0.8% of Plaxovid recipients required more than 24 hours of hospitalization compared to 6.3% of those who got placebo. There were no deaths in the Plaxovid group, which comprised 1,039 p…

The future of pharmacovigilance: Assessing the role of ML, NLP and other technologies

Image from Roberto Sorin via Unsplash

The field of pharmacovigilance has evolved significantly in recent years. While regulatory authorities have long favored technologies such as artificial intelligence and machine learning for monitoring patient safety, the trend has accelerated during the pandemic. “I’ve never seen as much advancement as I have in the last two years,” said Marie Flanagan, director, offering management, Vigilance Detect at IQVIA.

Flanagan predicted that regulators’ interest in AI and ML for pharmacovigilance will catalyze growing interest across the pharma industry in 2022 and beyond. The pandemic has demonstrated to regulators and life science companies that the technologies can help make sense of exploding volumes of pharmacovigilance data points.

“If we look at just the user vigilance database in the past two years — as of last week, 64% of all infor…

Polaris Pharmaceuticals extends operations in Northern California

Vacaville Mayor Ron Rowlett (right) meets with Vacaville’s Polaris Principal Engineer Mary Scomona, Business Development Manager Jose Ortiz and Facility Director Matt Mitchell (left to right).

San Diego–based Polaris Pharmaceuticals has purchased 15 acres from the City of Vacaville, California, within the Vaca Valley Business Park.

Polaris already has a contract development and manufacturing site in the city in addition to operations in San Diego and Chengdu, China.

In Vacaville, the company plans to construct an additional biopharmaceutical manufacturing facility.

Polaris established the Vacaville site in 2002, adding a cGMP facility for biologics in 2005

“We are excited to expand our manufacturing and process research capabilities in Vacaville,” said Chris Huxsoll, senior vice president of operations of Polaris Pharmaceuticals, in a statement.

Home to the non-profit C…