Stevanato Group (NYSE:STVN) announced today that it will begin construction on a new U.S. facility in Fishers, Indiana.
Piombino Dese, Italy-based Stevanato Group will begin construction on the new facility this month with expectations for the site to be operational in 2023.
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Cambra was previously a vice president at Zimmer Biomet (NYSE:ZBH), “leading product management for their $5 billion global reconstruction business,” SpinaFX said in a news release. He served in that role from November 2020 to June 2021, according to his LinkedIn page.
He ended a nearly 11-year career at Medtronic (NYSE:MDT) in 2020, ultimately serving as vice president and general manager of interventional therapies. SpinaFX said he “led a successful turnaround of their $400 million vertebral augmentation and oncology business through new technology innovation, strategic partnerships, acquisitions and expanding margins.”
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The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%.
One potential hurdle for the drug is whether unvaccinated individuals will accept the treatment, given their higher likelihood of contracting severe COVID-19. According to McKinsey, unvaccinated individuals tend to be most concerned about the potential of COVID-19 vaccines to cause long-term side effects.
The lack of long-term safety data concerning molnupiravir could be an obstacle for skeptical patients. That’s especially the case given early conclusions that there are “persistent side-effect concerns with mutagenic molnupiravir,” as a Clinical Trials Arena article observed. That article goes on to cite Ron Swanstrom, a professor at the University of North Carolina, Chap…
The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%.
One potential hurdle for the drug is whether unvaccinated individuals will accept the treatment, given their higher likelihood of contracting severe COVID-19. According to McKinsey, unvaccinated individuals tend to be most concerned about the potential of COVID-19 vaccines to cause long-term side effects.
The lack of long-term safety data concerning molnupiravir could be an obstacle for skeptical patients. That’s especially the case given early conclusions that there are “persistent side-effect concerns with mutagenic molnupiravir,” as a Clinical Trials Arena article observed. That article goes on to cite Ron Swanstrom, a professor at the University of North Carolina, Chap…
At the European College of Neuropsychopharmacology (ECNP), Janssen presented data on the Phase 3 trial for the recently approved schizophrenia treatment Invega Hafyera, paliperidone palmitate 6-month (PP6M).
“We hope that this continues to change the paradigm in treating schizophrenia with long-acting injectables,” said Dean Najarian, associate field director, neuroscience medical affairs at Janssen. “Non-adherence is a major contributor of relapses and associated hospitalizations, and certainly costly to the healthcare systems as well as social dynamics.”
The prospect of a six-month schizophrenia injection can “offer patients and caregivers the potential for a life less defined by their schizophrenia medication,” Najarian said.
Invega Hafyera is the only twice-yearly, long-acting injectable.
Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ), announced the FDA approval of the formulation on Sept. 1. Approvals in other countries are pending…
Insulet (NSDQ:PODD) last week presented positive pivotal trial data for its Omnipod 5 automated insulin delivery system.
Acton, Massachusetts-based Insulet’s Omnipod 5 — which it touts as the world’s first tubeless wearable system for continuously adapting insulin delivery based on glucose levels and trends — significantly improved time in range and reduced HbA1c in the trial.
Get the full story at our sister site, Drug Delivery Business News.
The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial.
If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S.
To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration.
Merck intends to file an EUA for the oral therapy soon.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” Merck CEO Robert M. Davis said in a statement.
The molnupiravir study focused on initially non-hospitalized adults with mild-to-moderate COVID-19. It found that 7.3% of molnupiravir recipients were hospitalized within 29 days. By contrast, 14.1% of placebo …
Headquartered in Jena, Germany, QInstruments was founded by CEO Olaf Simmat and Christian Stange in 2003. It’s a developer, manufacturer and supplier of advanced sample preparation automation for clinical diagnostics and biomedical and life science research.
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Erik Gatenholm is the CEO of BICO Group. [Photo courtesy of BICO]
BICO Group has a deal to acquire QInstruments for $71 million, the life sciences holding company said Friday.Headquartered in Jena, Germany, QInstruments was founded by CEO Olaf Simmat and Christian Stange in 2003. It’s a developer, manufacturer and supplier of advanced sample preparation automation for clinical diagnostics and biomedical and life science research.
BICO plans to close the deal “as soon as reasonably possible,” according to a news release. QInstruments will operate as a standalone company in BICO’s bioautomation business area to strengthen BICO’s ability to improve workflows for its other subsidiaries and customers.
“Our team invents user-friendly and intuitive systems that enable multidisciplinary research in a cost and time efficient manner,” Simmat said in the news release. “With BICO, we share a common vision o…
Coherus BioSciences (NSDQ:CHRS) has announced that FDA has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate referencing the blood vessel growth inhibitor Lucentis (ranibizumab).
Developed by Genentech, Lucentis first won FDA approval in 2006 to treat wet age-related macular degeneration. Other indications followed, including macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.
FDA has chosen August 2, 2022, as the Biosimilar User Fee Act action date for CHS 201.
Besides CHS-201, Coherus has a range of other biosimilars in its portfolio.
In 2019, it won FDA backing for Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar used to decrease the incidence of infection. The FDA label for the drug describes its use in treating patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs.
<…Miach Orthopedics this week announced that it has appointed Christopher Joyce as VP and chief financial officer and has appointed Kevin Sidow to the board of directors.
Joyce will be responsible for leading the financial operations. He has more than 30 years of experience in finance and most recently served as consulting CFO for several biotech and medical device startups. Prior to that, he was on the founding teams as a CFO of FRX Polymers and Elemé Medical and Percardia.
Sidow is also a medical device industry veteran with more than 35 years of experience in orthopedics. He has served as president and CEO for Moximed and St. Francis Medical Technologies and held numerous leadership roles at Johnson & Johnson’s Depuy.
“We are thrilled to welcome Chris, who has an impressive background in managing finance and operations for medical device startups, and Kevin, a highly accomplished and well-respected leader in bringing orthopedic products to mar…
Cambra was previously a vice president at Zimmer Biomet (NYSE:ZBH), “leading product management for their $5 billion global reconstruction business,” SpinaFX said in a news release. He served in that role from November 2020 to June 2021, according to his LinkedIn page.
He ended a nearly 11-year career at Medtronic (NYSE:MDT) in 2020, ultimately serving as vice president and general manager of interventional therapies. SpinaFX said he “led a successful turnaround of their $400 million vertebral augmentation and oncology business through new technology innovation, strategic partnerships, acquisitions and expanding margins.”
Get the full story at our sister site Medical Design & Outsourcing.