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 FDA’s action plan. The first AdCom was critical of the study’s robustness.

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pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

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Legacy MEDSearch

MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. 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.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. This leads to a question; “where does it end?” Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. ” Why are the costs so high? .”

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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.” ” InTandem is anticipated to be available soon in select market segments. .

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pharmaphorum

NOVEMBER 2, 2022

The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms. The potential for a digital solution.

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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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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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pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. Many FDA-cleared drugs have pharmacogenomics data on the label, which indicate the biomarker information to help guide decisions regarding the use of the therapeutic in individual patients.

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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.” FDA, 2022. . About the authors.

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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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PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. How can data itself play a larger role in addressing adherence? Jason Burum.

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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. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

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Evolve Your Success

JANUARY 31, 2023

A lot of organizations that may have a sales model don’t probably follow the prescription that we deliver or the method that we deliver to them, which is why they contract us. From a management perspective, what happens is that you see managers who begin to believe that they can lead their team from behind their desks.

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PM360

NOVEMBER 21, 2022

The two retail pharmacy giants have announced their intention to settle lawsuits regarding inappropriate opioid prescriptions at $5 billion each. Ketamine is FDA approved for anesthesia and pain management but not for depression or any other psychiatric disorder. Local and U.S. over the past two decades. The pandemic led the U.S.

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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). She said, “I wish the data were more persuasive”.

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Cadensee

JULY 20, 2021

So, you see on one side, there's a special body of the FDA trying to listen to patients to find new targets for health and for pharmaceutical technology. And second of all, you should see who leads the anti-vaxxer; it's usually doctors. They brought food for vaccine; people vaccinated for a piece of food.

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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 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

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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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. Food and Drug Administration (FDA). While the media is focused on drug costs, which are a problem, only 12% of every healthcare dollar is spent on prescription drugs.

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