Pharmaceutical Technology

MAY 25, 2023

Pushing back an initial deadline, the US Food and Drug Administration (FDA) has proposed a new regulatory action date of 22 June, by which time the agency will assess the logistics of a possible approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy.

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Pharmaceutical Technology

MARCH 3, 2023

Albireo’s pipeline includes its lead asset, Bylvay (odevixibat), a potent, once-a-day, oral, non-systemic, ileal bile acid transport inhibitor (IBATi). Last month, the US Food and Drug Administration (FDA) accepted Bylvay for Priority Review to treat Alagille syndrome (ALGS) in paediatric and adult patients.

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Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics licence application for Abecma. This will lead to cytokine secretion, CAR T cell proliferation and subsequent cytolytic killing of BCMA-expressing cells.

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Legacy MEDSearch

MARCH 15, 2023

Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. A chief reason for the speedy turnaround was a decision the federal government made to expedite delivery of the vaccine — which has nothing to do with the scientific validity of the drug itself.

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Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Potential benefits include: Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure. ” For more information, visit: www.propriovision.com.

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The first AdCom was critical of the study’s robustness.

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Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). This important milestone enables the world’s first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors.” The burden on patient functioning is also profound.

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European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1.

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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”

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Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

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Cadensee

JULY 20, 2021

It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? Do you listen to them to improve your marketing and the way they should take the drug or the drug should be administered and so on so forth?

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Pharmaceutical Technology

APRIL 26, 2023

Explore the top companies in the development and manufacturing of primary packaging and medical devices Pharmaceutical Technology has listed some of the leading companies in the development and manufacturing of primary packaging for pharmaceuticals and medical devices based on its intel, insights, and decades of experience in the sector.

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Pharmaceutical Technology

MAY 15, 2023

In a closely contested debate, a US Food and Drug Administration Advisory Committee (AdCom) panel voted eight to six in favour of the accelerated approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene transfer therapy delandistrogene moxeparvovec (SRP-9001).

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Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.

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World of DTC Marketing

SEPTEMBER 22, 2020

Under no circumstances can ANY pharma company allow this administration to fastback a COVID vaccine for political purposes. To do so would derail our drug safety and lead to patients and HCP’s to question all prescription drug data. Pharma has to fight with everything in their arsenal.

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World of DTC Marketing

APRIL 7, 2022

The seventh leading cause of death in the United States, diabetes costs $327 billion in medical costs and lost work and wages. Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018.

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World of DTC Marketing

AUGUST 25, 2020

grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. For the first time, I am now in fear of FDA drug approvals.

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