Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

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Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

Manchin also voiced concerns about the ongoing lack of permanent leadership as Dr. Janet Woodcock continues to serve as acting commissioner of the agency. Woodcock began her tenure as acting commissioner after Biden’s inauguration. She has worked at the agency since 1986.

Manchin asked Biden to make the FDA explain why it chose to ignore the advice of an external advisory committee, which had recommended that the agency not approve the drug without additional data.

Three members of that advisory committee have since…

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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.

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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.

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VoluMetrix’s venous waveform monitor wins FDA breakthrough designation

[Image from VoluMetrix]VoluMetrix announced today that it received FDA breakthrough device designation for its NIVA HF venous waveform monitor.

Nashville, Tenn.–based VoluMetrix designed the investigational NIVA HF device to monitor the venous waveform, a novel physiologic signal in heart failure patients, through its non-invasive venous waveform analysis (NIVA) technology.

According to a news release, a fast-track grant from the National Institutes of Health (NIH) supports the development of NIVA HF, which is currently being prepared for FDA de novo regulatory clearance.

NIVA technology represents a way to optimize hemodynamic assessment through signal capture with a non-invasive wrist sensor, signal deconstruction and signal decoding, VoluMetrix said. NIVA HF provides a proprietary NIVA score that corresponds to a pulmonary capillary wedge pressure (PCWP), a value that can only be obtained through invasive catheterization of the heart and vasculature at p…

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Former FDA commissioner Hahn to join VC behind Moderna

Flagship Pioneering announced that former FDA commissioner Dr. Stephen Hahn will lead its Preemptive Medicine & Health Security initiative.

A “bioinnovation platform company,” Flagship Pioneering has originated and fostered more than 100 scientific ventures totaling more than $90 billion in aggregate value, according to the company.

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Former FDA commissioner Hahn to join VC behind Moderna

Flagship Pioneering announced that former FDA commissioner Dr. Stephen Hahn will lead its Preemptive Medicine & Health Security initiative.

A “bioinnovation platform company,” Flagship Pioneering has originated and fostered more than 100 scientific ventures totaling more than $90 billion in aggregate value, according to the company.

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

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Former FDA commissioner Hahn to join VC behind Moderna

Flagship Pioneering announced that former FDA commissioner Dr. Stephen Hahn will lead its Preemptive Medicine & Health Security initiative.

A “bioinnovation platform company,” Flagship Pioneering has originated and fostered more than 100 scientific ventures totaling more than $90 billion in aggregate value, according to the company.

It has, to date, deployed more than $2.4 billion in capital toward founding and growing companies, as well as more than $19 billion of follow-on investments from other institutions. Among the 41 companies comprising Flagship’s ecosystem is Moderna, the maker of the second vaccine to receive FDA emergency use authorization under Hahn’s tenure with the agency.

Hahn, who served as FDA commissioner from 2019 to 2021, having previously held the role of chief medical executive at the University of Texas MD Anderson Cancer Center, will assume the position of chief medical officer and join Flagship’s…

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Building a new foundation for oncology clinical trials

Photo by Anna Shvets from Pexels

The COVID-19 pandemic disrupted oncology clinical trials, and drug developers and regulators, including the FDA, continue to look for ways to catalyze clinical trial innovation.  The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more open both in study design, alternative execution methods and the use of real-world evidence (RWE) and retrospective data,” said Jeff Elton, CEO of ConcertAI.

ConcertAI is now in a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. “One of the first projects is looking at cardiovascular adverse events that occur in [immuno-oncology]-treated patient populations,” Elton said.

One factor contributing to the evolution of oncology clinical trials is the change in interactions between sponsors and regulatory agencies. “It is materially diffe…

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FDA rejects Verily’s smartwatch-based Parkinson’s exam

Verily’s Study Watch [Image courtesy of Verily]The FDA issued a letter to Google’s (NSDQ:GOOGL) Verily declaring that it will not accept a letter of intent for the company’s Parkinson’s exam.

Verily submitted the LOI for drug development tool (DDT) for the virtual motor exam for Parkinson’s disease. The device measures a change in digitally assessed parameters of a subset of Parkinson’s disease motor signs from the MDS-UPDRS Part III (motor examination) through a smartwatch (Verily’s Study Watch), according to the FDA letter.

The FDA determined that the examinations provided by Verily are “limited in their capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life.”

In the letter, the FDA said a change in rigidity or finger tapping can’t be directly interpreted as meaningful to patients, while a change in speech, eating and dr…

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J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

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J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.

This comes as the latest blow to Emergent and J&J after news broke in April that a factory error…

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