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FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

Pharmaceutical Technology

In addition, for doctors who do use Lucentis, there will be added pressure from payers to switch to Cimerli with its direct interchangeability with Lucentis approved. The post FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity appeared first on Pharmaceutical Technology.

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Age-related macular degeneration market expected to grow to $22.8bn in 2031

Pharmaceutical Technology

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The therapy received FDA approval in October last year.

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FDA approves Bayer/Merck & Co heart failure drug

pharmaphorum

Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. But the drug is entering an increasingly competitive market, where Novartis and AstraZeneca are vying for supremacy.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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Communicating with HCPs via email

World of DTC Marketing

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. Also, one message to ALL doctors sold not make sense. That should, however, not discourage the use of email to HCPs.

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FDA approves Alnylam’s ultra-rare disease drug Oxlumo

pharmaphorum

Oxlumo (lumasiran) was also approved in the European Union last week, making it the third from Alnylam’s pipeline of RNA interference therapeutics to make it to market. The disease is also difficult to diagnose and often takes around six years before doctors correctly identify it.

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Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.