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FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. Sustainable biosimilar competition in Europe: can it be achieved? US sales of Stelara totalled $6.4

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The debate on DTC marketing is going to heat up again

World of DTC Marketing

The FDA needs to study what people do when they see a DTC ad. Drug pricing is done by internal teams who look at what the market will bear and the competitive landscape. Some DTC budgets are only released when certain sales targets are hit. SUMMARY: DTC marketing is not the reason why prescription drugs cost so much.

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Biogen: It’s a cruel business world

World of DTC Marketing

In trying to save the product, Biogen’s reputation was trashed by FDA advisors, HCPs, and the healthcare media. 2wo: The competition’s MS drugs were better – The MS market is lucrative, and competitors launched products that were better than Biogen’s with fewer side effects discussed by the MS community online.

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Unveiling the Roadmap: Navigating Medical Sales Rep Requirements

Rep-Lite

Medical sales representatives are the medium through which medical companies sell their healthcare products to providers like hospitals and clinics. Medical sales rep requirements include technical knowledge of medical equipment and technologies, sales skills, and interpersonal abilities. Why Pursue a Career in Medical Sales?

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Mirati challenges Amgen with FDA okay for KRAS drug

pharmaphorum

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year. and 10 months, respectively.

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Novartis takes aim at MS blockbuster Tysabri in US and Europe

pharmaphorum

The looming competition piles further pressure on Biogen, whose MS franchise is already beset by generic competition to oral therapy Tecfidera (dimethyl glutamate), while its attempt to build a market for Alzheimer’s therapy Aduhelm (aducanumab) has ended in failure.

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Amgen splashes out on ChemoCentryx and its blockbuster hopeful

pharmaphorum

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 Currently, ANCA vasculitis is treated with rituximab combined with corticosteroids, which can have serious side effects when administered over prolonged periods.