U.S. Sen. Elizabeth Warren (left) and FDA Commissioner nominee Dr. Robert Califf (right)
Sen. Elizabeth Warren, D-Massachusetts, announced today that she has secured what she described as significant ethics commitments from FDA Commissioner nominee Dr. Robert Califf.
In a letter dated Jan. 27 to Warren, Califf made several promises as he seeks to secure Democratic votes for his Senate confirmation.
Read the full story on our sister site MassDevice.
U.S. Sen. Elizabeth Warren (left) and FDA Commissioner nominee Dr. Robert Califf (right)
Sen. Elizabeth Warren, D-Massachusetts, announced today that she has secured what she described as significant ethics commitments from FDA Commissioner nominee Dr. Robert Califf.
In a letter dated Jan. 27 to Warren, Califf made several promises as he seeks to secure Democratic votes for his Senate confirmation.
Read the full story on our sister site MassDevice.
Sen. Elizabeth Warren, D-Massachusetts, announced today that she has secured what she described as significant ethics commitments from FDA Commissioner nominee Dr. Robert Califf.
In a letter dated Jan. 27 to Warren, Califf made several promises as he seeks to secure Democratic votes for his Senate confirmation:
He’ll recuse himself from matters involving his former employers and clients for four years, two years longer than what is required in the Biden administration’s ethics pledge. He does not intend to seek a waiver from his recusals. For four years after his tenure, he won’t seek employment or compensation — including board seats — from pharmaceutical and medical device companies he interacts with while he is commissioner.“I intend to pursue opportunities in higher education to help educate the next generation of medical leaders. I have, and always…
When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin.
At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study.
“I’ve seen a lot of innovation,” said Kaufman, chief medical officer at continuous glucose monitoring technology developer Senseonics (NYSE:SENS).
She’s been involved in innovation as well, the latest being the 180-day Senseonics Eversense continuous glucose monitor (CGM), for which FDA approval could be coming very soon.
Get the full story at our sister site, Drug Delivery Business News.
Artivion (NYSE:AORT) today announced positive results from a clinical trial for its On-X mechanical mitral valve replacement (MVR).
Atlanta-based Artivion (formerly CryoLife) published results in The Annals of Thoracic Surgery. The Proact clinical trial, a multicenter, non-inferiority, two-arm study assessed whether, after an On-X MVR, patients could be safely managed with lower-intensity warfarin plus aspirin.
The trial observed patients after their On-X mechanical MVR followed by at least three months of standard anticoagulation. In total, 401 patients across 44 North American centers were randomized to low-dose warfarin (target INR of 2.0 to 2.5) or standard-dose warfarin (target INR of 2.5 to 3.5). All patients were prescribed aspirin (81 mg daily) and encouraged to use home INR testing. Mean patient follow-up was 4.1 years with a maximum follow-up of eight years.
Artivion observed no differences in bleeding, valve thrombosis or thromboembolism rates…
Pfizer Inc. (NYSE:PFE) is abandoning plans to develop an investigational antisense therapy known as vupanorsen for potential use for cardiovascular indications and severe hypertriglyceridemia (SHTG).
The company had projected that vupanorsen could generate up to $3 billion in peak sales.
Pfizer is returning development rights of the drug to Ionis Pharmaceuticals (NSDQ:IONS), from whom it licensed the drug in 2019.
“While this outcome is disappointing, the clinical and scientific knowledge derived from the vupanorsen program will hopefully contribute to a greater understanding of cardiovascular risk reduction and severe hypertriglyceridemia and the current gaps in treating these conditions,” said Dr. James Rusnak, senior vice president and chief development officer, internal medicine and hospital of Pfizer, in a statement.
Pfizer, which led the development of vupanorsen, made the decision after reviewing data from the global TRANSLATE-TIMI 70 Phase…
Janssen (NYSE:JNJ) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of a T-cell redirecting, bispecific antibody to treat relapsed or refractory multiple myeloma (RRMM).
Known as teclistamab (JNJ-64007957), the bispecific antibody targets the B-cell maturation antigen (BCMA) and CD3.1.
In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA for approval of teclistamab to treat relapsed or refractory (R/R) multiple myeloma.
That same month, EMA granted accelerated assessment for teclistamab.
In the EMA application, Janssen included data from the MajesTEC-1 study testing teclistamab in adults with RRMM.
“We are pleased to announce the submission of teclistamab to the European Medicines Agency. Once again, this shows our commitment to continue to provide innovative, transformative therapies for patients with relapsed or refractory multiple myeloma,” said …
Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]
Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.
Get the full story at our sister site, Pharmaceutical Processing World.
Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.
FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.
Get the full story at our sister site, Pharmaceutical Processing World.
Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.
FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.
“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in an FDA release. “While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to indivi…
Ulbrich Stainless Steels & Special Metals agreed to acquire ATI Specialty Rolled Products’ distribution facility in Pico Rivera, California.
North Haven, Connecticut-based Ulbrich announced earlier this month that, effective today (Jan. 31, 2022), the facility will operate under the name “Ulbrich of California” and, as of today, all shipments from the Pico Rivera facility will become orders serviced by Ulbrich Steel and its personnel while ATI will continue supplying Ulbrich with the nickel, titanium and specialty alloy products upon which their customers rely.
Ulbrich and ATI are working closely together to transition the facility and ensure product quality and service remains at or above customer expectations, with no expected changes or interruptions to service from the location. Ulbrich also plans to have the facility’s Pratt-Whitney Laboratory Controlled at Source (LCS) certification recertified under its own name by mid-Februar…
Their technique — called Hierarchical Phase-Contrast Tomography (HiP-CT) — relies on X-rays from the European Synchrotron Research Facility particle accelerator in Grenoble, France. Following its Extremely Brilliant Source upgrade (ESRF-EBS), European Synchrotron can produce X-rays 100 billion times brighter than a hospital X-ray. They’re the brightest X-rays in the world, according to the researchers.
The result is that researchers can view blood vessels that are five microns in diameter — a tenth of the diameter of a hair — in an intact, donated human lung. The tiny size is 100 times smaller than th…