Go to our sister site Medical Design & Outsourcing to read what they said.
Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia’s Therapeutic Goods Administration for its Preserflo MicroShunt.
The San Clemente, Calif.-based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or where glaucoma progression needs surgery.
Get the full story on our sister site, Medical Tubing + Extrusion.
The U.S. Supreme Court has turned back a third Republican challenge to the Affordable Care Act (ACA), this time by a 7-2 vote.
The latest challenge to the law popularly known as Obamacare came from Texas and other states, backed by the administration of former President Donald Trump. The justices ruled that the challengers lacked legal standing for their case. They did not address part of the law known as the “individual mandate,” which requires Americans to have health insurance and which the complainants sought to overturn as unconstitutional.
Get the full story on our sister site, Medical Design & Outsourcing.
Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.
Get the full story on our sister site Drug Discovery & Development.
Hologic (NSDQ:HOLX) today announced that it has completed its $795 million acquisition of diagnostic developer Mobidiag Oy.
France-based Mobidiag develops PCR-based tests for acute care conditions, including gastrointestinal and respiratory infections, antimicrobial resistance management and healthcare-associated infections. Its Amplidiag and Novodiag platforms can deliver results in 50 minutes to two hours.
Marlborough, Mass.-based Hologic announced the deal in April when it said it would make a cash payment of approximately $714 million for Mobidiag’s equity and net debt of approximately $81 million.
“Closing the acquisition of Mobidiag enables us to become a broader, more diversified global diagnostics leader,” Jan Verstreken, international president at Hologic, said in a news release. “Together, we can accelerate development and adoption of Mobidiag’s innovative products globally and drive Hologic’s growth.”
Hologic previously said that …
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.
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.
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.
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.
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.
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…
Merck (NYSE: MRK) spinoff Organon (NYSE:OGN) today announced the completion of its acquisition of Alydia Health for up to $240 million.
Alydia Health develops treatments centered around preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding. The company designed its Jada system to control and treat abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Jersey City, N.J.-based Organon announced an agreement for the acquisition in March. Total consideration amounts to $240 million, including a $215 million cash payment, of which Merck paid $50 million upon signing. Organon paid the remaining $165 million at closing and the final $25 million will potentially arrive as a contingent milestone payment.
“Organon’s acquisition of Alydia Health expands our portfolio into the medical device category and underscores our commitment to identify options for women’…