PM360

NOVEMBER 29, 2022

Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA. Example: Top Pharma Company Using NLP to Explore Drug Label Data.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

pharmaphorum

DECEMBER 20, 2022

The road to the development of treatments for non-alcoholic steatohepatitis (NASH) is littered with failed projects, but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. Although, so far efforts to bring a therapy to market have failed.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. This is before a drug can be approved for public use.

Side effects 52

Side effects Medical sales reps Insurance Pharmacology 52

Pharmaceutical Technology

MAY 16, 2023

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. The approval also includes clearance for a Phase I clinical trial protocol of NXP900.

Food and Drug Administration 52

Food and Drug Administration Pharma FDA Pharmacology 52

European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

Food and Drug Administration 79

Food and Drug Administration Manufacturing Engineering Pharmacology 79

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105

FDA Pharmacology Patients Pharmaceutical 105

Pharmaceutical Technology

MARCH 17, 2023

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. Securing reimbursement for digital therapeutics also continues to impede its uptake.

Prescription 111

Prescription Pharmacology Pharma Medical 111

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.

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FDA Healthcare Healthcare Medicine 78

Pharmaceutical Technology

DECEMBER 16, 2022

Spearheaded by collaborations between non-profit groups and pharma players, new treatments are edging closer to late-stage trials in malaria and neglected tropical diseases such as sleeping sickness. The company now expects to complete its submission for a BLA with the FDA by the end of the year.

Pharmacology 105

Pharmacology Pharma Pharmaceutical Manufacturing 105

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. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

OCTOBER 10, 2022

After more than a decade in development, Freya Pharma Solutions plans to advance an oral tablet dubbed Lybrido into Phase III trials to treat female sexual interest/arousal disorder (FSIAD). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

MARCH 16, 2023

For example, Ontario, Canada-based Verity Pharmaceuticals’s Trelstar was FDA approved for palliative treatment of advanced prostate cancer and the other two are indicated for treating central precocious puberty and endometriosis, respectively.

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Ethics Prescription Safety Healthcare 144