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Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

Get the full story from our sister site, Drug Discovery & Development.

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

In its letter, Public…

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

Get the full story from our sister site, Drug Discovery & Development.

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

Smiths Medical recalls some insulin syringes over skewed graduation marking

[Image from Smiths Medical]Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes.

Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward by approximately 20 degrees.

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

Dabir Surfaces forges deal with Vizient

Dabir Surfaces (Harwood Heights, Ill.) recently announced that it has landed a contract with group purchasing firm Vizient.

Dabir also announced a deal with Premier this month.

The contract with Vizient, effective April 1, 2021, involves both OR products and patient care products. Dabir will provide powered overlay surfaces for patients at risk of developing pressure injuries in perioperative care and inpatient care, among other settings.

The contract provides the purchasing company’s members access to negotiated pricing and terms for the Dabir Surfaces’ products.

Westfall Technik opens new medical molding plant in Chicago

Westfall Technik announced that it opened a new facility near Chicago to boost its clean-room capabilities.

Las Vegas-based Westfall said in a news release that it completely refitted a brownfield structure and opened it as a purpose-built, 40,000-square-foot facility with three Class 8-certified clean rooms and one white space certified for meeting Good Manufacturing Practices (GMP).

The facility features clean rooms that can accommodate up to 23 injection molding machines and Westfall expects them to gain ISO 13485 certification by September of this year. The GMP-compliant space currently has the room to take up to 15 molding machines, with press sizes ranging from 35 tons to 400 tons in clamping force.

Additionally, the new site in suburban Chicago (Antioch, Ill.) features a fully functional tool room with dedicated, climate-controlled mold storage space. On top of all the capabilities at the new site, Westfall said it has tripled its clean room space…

JMI Equity invests $120M in Greenlight Guru

Greenlight Guru announced that it has received a roughly $120 million investment from JMI Equity to support further development and sales growth for its medical device quality management software.

The news comes half a year after Indianapolis-based Greenlight Guru launched its AI-powered Halo for Change Management, which provides recommendations of items impacted by a change order and real-time visibility to discover, assess and manage the impact of a change.

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

JMI Equity invests $120M in Greenlight Guru

Greenlight Guru announced that it has received a roughly $120 million investment from JMI Equity to support further development and sales growth for its medical device quality management software.

The news comes half a year after Indianapolis-based Greenlight Guru launched its AI-powered Halo for Change Management, which provides recommendations of items impacted by a change order and real-time visibility to discover, assess and manage the impact of a change.

“We listened to the needs of the medical device industry and chose JMI Equity as a strategic partner because they are experts at achieving growth by putting the customer first,” Greenlight Guru CEO David DeRam said in a news release posted yesterday.

“We’ve been extremely deliberate when taking on investment because we wanted to ensure we found the right partner for us and our customers. This partnership will allow us to accelerate the value we provide to our customers as we remain committed to help…

U.S. government buys 200M more doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) announced today that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine.

The government’s purchase agreement with Moderna also includes the option to purchase other COVID-19 vaccine candidates to come out of the company’s pipeline.

Get the full story at our sister site, Pharmaceutical Processing World.

U.S. government buys 200M more doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) announced today that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine.

The government’s purchase agreement with Moderna also includes the option to purchase other COVID-19 vaccine candidates to come out of the company’s pipeline.

Cambridge, Mass.-based Moderna said in a news release that the purchase brings the U.S. government’s confirmed order commitment to 500 million doses, including 110 million expected to be delivered in the fourth quarter of 2021 and 90 million planned for the first quarter of 2022.

Moderna said that, as of June 14, 2021, it has supplied the U.S. with 217 million released doses of the vaccine. The company is currently seeking full FDA approval for the two-dose vaccine, which in December became one of three to receive FDA emergency use authorization in the U.S.

“We appreciate the collaboration with the U.S government for these additional doses of the M…

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Digital disruption – and opportunity

We’ve seen the rapid expansion of digital technology continue to disrupt every aspect of how primary care physicians, healthcare providers, and practice administrators operate. Digital technology is reshaping how healthcare gets done. This includes organizations efficiently and seamlessly procure the products they need to run their facilities.

In fact, now, 93 percent of all U.S. companies are already doing some portion of their B2B business online.

However, when it comes to digital sourcing, professional buyers acknowledge there are challenges – especially when borders are crossed. Ensuring quality, and giving buyers access to more choices from different suppliers to find products at a price that works for them and their needs, meet their strict requirements, and managing smooth and fast delivery rank among the most important hurdles fo…