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Lilly has a new blockbuster

World of DTC Marketing

Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?

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Is it too late for Biogen?

World of DTC Marketing

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s

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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. US sales of Stelara totalled $6.4

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EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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Blue Water Vaccines agrees to buy Veru’s Entadfi capsules business

Pharmaceutical Technology

The remaining $80m component of the deal is based on the achievement of annual sales milestones. Entadfi, a combination of finasteride and tadalafil, is administered as an oral, once-a-day drug to provide a safe and effective treatment option for benign prostatic hyperplasia (BPH), often referred to as enlarged prostate, in men.

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NICE recommends AbbVie’s/J&J’s Imbruvica for combo use in untreated CLL

Pharmaceutical Technology

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. While Imbruvica sales were $3.78 billion in the same year.

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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.