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Pharming preps filing for rare disease drug leniolisib after trial win

pharmaphorum

Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal trial, setting up regulatory filings in the coming months. For comparison, Takeda reported sales of around $415 million in the first six months of the 2021-22 fiscal year.

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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

The Pharma Data

Moderna lifts COVID-19 vaccine sales forecast to $19.2 Taking double Covid-19 hits, Merck writes off $170M for scrapped drug, highlights $600M in missed sales ( Endpoints ). In Belgium, too many clinical trial sponsors waffle about reporting required results ( STAT ). OcuWho? .

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Generic pill could be alternative to oral antivirals in COVID-19

pharmaphorum

There were also numerically fewer deaths with the antidepressant – 17 out of 741 treated with fluvoxamine and 25 out of 756 allocated to placebo – in the TOGETHER trial, which has now been published in The Lancet. The post Generic pill could be alternative to oral antivirals in COVID-19 appeared first on.

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Update: FDA clears first generic of AZ’s blockbuster Symbicort

pharmaphorum

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. The company is comprised of several units, and the largest is Johnson & Johnson’s pharma unit which generated $52.56 billion in pharmaceutical sales from 2021. billion the drug generated in 2021. billion, a 42.74

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.