Trump efficiency guru Ramaswamy could benefit from crusade against FDA
Vivek Ramaswamy owns about $670 million in shares of Roivant Sciences, which is pursuing studies for three drugs that could land before the FDA during Donald Trump’s second term.
Pharmaceutical
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New FDA rules for TV drug ads: Simpler language and no distractions
TV remains the drug industry’s primary advertising format, with more than $4 billion spent in the past year, led by blockbuster drugs like weight-loss treatment Wegovy, according to ispot.tv, which tracks ads.
UPDATE: Lilly shares tumble on earnings report that falls short of Wall Street expectations
The Indianapolis-based drugmaker missed expectations on sales of two popular drugs, diabetes treatment Mounjaro and weight-loss treatment Zepbound, which it attributed to inventory decreases in the wholesaler channel.
UK regulator approves Lilly’s new Alzheimer’s drug but government won’t pay for it
Britian’s National Institute for Health and Care Excellence said more evidence was needed to prove Kisunla’s worth. Lilly says a year’s worth of treatment is $32,000.
Elanco gets FDA approval for third new product this year
The product, called Credelio Quattro, is designed to protect against fleas, ticks, heartworms, roundworms, hookworms and three different species of tapeworms.
Lilly weight-loss drug copycat makers sue FDA for taking drugs off shortage list
The plaintiffs allege that the shortage of Lilly’s drugs isn’t actually over, and that the agency’s decision deprives patients of important medicines by restricting compounding.
Eli Lilly’s weight-loss drugs no longer in shortage, FDA says
Lilly has been making the case since August that its tirzepatide-based drugs are now “commercially available,” which the FDA agreed on. But the agency warned that patients and prescribers might still experience “localized supply disruptions.”
Lilly to invest another $4.5B in Lebanon site for new ‘medicine foundry’
The new funding, for an advanced manufacturing and drug development center, will bring the Indianapolis-based drugmaker’s total investment in the Boone County site to more than $13 billion.
Roche has more than five weight-loss companion medicines, CEO says
The the Swiss drugmaker will face off in the obesity area with leaders Novo Nordisk A/S and Indianapolis-based Eli Lilly and Co.
Weight-loss drugs are supposed to be forever … until they run out
Recurrent shortages, shifting insurance coverage, indecision and a lack of guidance about side effects and dosing have led to challenges for some patients prescribed Mounjaro, Ozempic, Zepbound or Wegovy.
Lilly seeks court ruling that could mean big money for new weight-loss drug
The Indianapolis-based drugmaker filed a suit in federal court this month, challenging the U.S. Food and Drug Administration’s ruling that the company’s experimental obesity treatment not a biological product.
Eli Lilly requests records of people who took copies of its weight-loss drug
The letter is the latest sign that the battle between the brand-name drug manufacturers and the companies that make and sell the compounded versions has intensified.
Elanco’s dermatology treatment for itchy dogs gets FDA approval
Zenrelia is one of several drugs Elanco has in its pipeline that it predicts could reach blockbuster status, which in animal health means more than $100 million in annual sales.
Lilly to make $1.8B investment in two Ireland manufacturing facilities
The expansion projects will boost production of medicines for Alzheimer’s disease, diabetes and obesity.
Lilly names new chief financial officer
Lucas Montarce, who has been with Lilly since 2001 and most recently served as president for its Spain, Portugal and Greece operations, is now the company’s CFO and executive vice president.
Nearly 2,000 drug plants overdue for FDA checks after COVID delays, analysis finds
Last year’s inspection numbers were down almost 40% from the pre-pandemic period, when the FDA averaged about 4,300 annual inspections.
Eli Lilly ramps up fight against imitation weight-loss drugs
Lilly and rival Novo Nordisk have been battling the emerging industry making copies of their top-selling diabetes and weight-loss drugs, a situation without modern precedent.
Fishers-based Flexware acquires North Carolina-based engineering services firm
Fishers-based Flexware Integration LLC, a fast-growing IT services provider, has acquired Castle Hill Technologies LLC, a North Carolina-based company that provides engineering services to the pharmaceutical industry.
Lilly now selling vials of blockbuster Zepbound at 50% discount
Lilly said its new option will help millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance.
MBX Biosciences files intention to go public
The five-year-old, clinical-stage drugmaker has already raised more than $213 million to develop therapeutics to treat rare endocrine disorders, a huge amount for a startup.