Marketing
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RiverNorthPhotography via Getty Images
FTC wades into dispute between Supernus, generic competitor
The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.
By Kristin Jensen • March 22, 2023 -
Permission granted by Pear Therapeutics
Pear, tight on cash, considers strategic alternatives
The digital therapeutics firm is considering a sale, merger or other deal following struggles to market its app-based treatments.
By Elise Reuter • March 17, 2023 -
iStock via Getty Images
VA to cover Leqembi for veterans with early Alzheimer’s
The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.
By Christopher Newman • March 14, 2023 -
Permission granted by Amylyx Pharmaceuticals
ALS drug developmentAmylyx’s ALS drug sales impress Wall Street
In its first full quarter on the market, Amylyx’s Relyvrio generated nearly $22 million in revenue, or about five times what some analysts forecast last month.
By Jacob Bell • March 13, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA clears first at-home flu and COVID test, days after its developer files for bankruptcy
The test’s maker, Lucira, said the agency’s “protracted” authorization process caused it to miss out on test sales in the latest flu season.
By Nick Paul Taylor • Feb. 27, 2023 -
Courtesy of Eisai
Medicare maintains limits on Eisai’s new Alzheimer’s drug
Eisai and Biogen have data showing Leqembi slows cognitive decline, but CMS won’t budge until FDA converts its approval from accelerated to full.
By Jonathan Gardner • Feb. 23, 2023 -
Permission granted by Amgen
Doctors largely comfortable with biosimilar drugs, but question economics: report
Weeks after the first Humira copycat launched in the U.S., a survey by Cardinal Health suggests insurer mandates will drive biosimilar adoption.
By Jonathan Gardner • Feb. 22, 2023 -
Courtesy of GSK
GSK wins full approval for cancer immunotherapy, looks to expand use
The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors.
By Jonathan Gardner • Feb. 10, 2023 -
Permission granted by Amylyx Pharmaceuticals
ALS drug development
Cigna restricts coverage of new ALS drug, deepening fears about access
The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.
By Jacob Bell • Feb. 7, 2023 -
Courtesy of Leqembi
Eisai gives first glimpse into Alzheimer’s drug launch
In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.
By Jacob Bell • Feb. 6, 2023 -
Courtesy of Roche
Roche writes off $3B on lower sales forecasts for gene therapies, cancer drugs
Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics.
By Jonathan Gardner • Feb. 3, 2023 -
Lilly reports fast sales for new diabetes drug
Still, fourth quarter sales for Mounjaro were slightly below high Wall Street forecasts and didn’t offset falling revenue from Lilly’s COVID-19 antibodies.
By Jonathan Gardner • Updated Feb. 2, 2023 -
Bill Oxford via Getty Images
Court rules for drugmakers in 340B fight over contract pharmacies
The decision is a win for Sanofi, Novo Nordisk and AstraZeneca. The drugmakers sued HHS after regulators ordered them to stop restricting sales of 340B drugs to contract pharmacies.
By Rebecca Pifer • Jan. 31, 2023 -
Amgen Inc.
Patent thicketsHumira biosimilars arrive in the US, as Amgen launches first copycat to AbbVie’s blockbuster drug
The world’s best-selling drug will face pricing pressure as rivals try to steal share from AbbVie’s $20 billion-a-year flagship product in the U.S.
By Jonathan Gardner • Jan. 31, 2023 -
Jonathan Gardner / BioPharma Dive
BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca
The drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.
By Jonathan Gardner • Jan. 20, 2023 -
Ridofranz via Getty Images
Sponsored by Kwello by Acceleration PointHow social listening can boost your Medical Affairs strategy for 2023 and beyond
Digital innovation continues to transform the healthcare and biopharmaceutical landscape, and as it does, the role of Medical Affairs is changing.
Jan. 17, 2023 -
Win McNamee via Getty Images
Patent thicketsLooking past Humira, AbbVie boosts sales forecasts for successor drugs
Competition to Humira will weigh on AbbVie, but the pharma has laid out ambitious expectations for fast growth from its medicines Skyrizi and Rinvoq.
By Jonathan Gardner • Jan. 11, 2023 -
Pharma companies boost drug prices to start year, but hikes lag inflation
Analysts noted hundreds of list price increases, including dozens by Pfizer. Many checked in around 5%, roughly in line with hikes taken in recent years.
By Jonathan Gardner • Jan. 3, 2023 -
artJazz via Getty Images
European regulators back hemophilia gene therapy
The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti.
By Jacob Bell • Dec. 16, 2022 -
Photo: Will Warasila for Industry Dive
Deep Dive // ALS drug developmentFor ALS patients, doctors, a new medicine reignites concerns about healthcare access
Relyvrio, a drug developed by Amylyx Pharmaceuticals, is in high demand in ALS clinics across the U.S. Though some patients are already getting it, insurance coverage and out-of-pocket costs remain a source of anxiety.
By Jacob Bell , Shaun Lucas • Dec. 15, 2022 -
Permission granted by Bluebird bio
Gene therapy approval won, Bluebird takes on next challenge: selling it
The biotech is still waiting to treat its first commercial patient with Zynteglo, but says it has not seen insurers deny coverage for the beta thalassemia drug.
By Ned Pagliarulo • Dec. 12, 2022 -
Hinterhaus Productions via Getty Images
Sponsored by First Republic BankLife science investment outlook: thinking beyond the pandemic
Learn about the investment landscape for life science companies, heading into 2023.
Dec. 12, 2022 -
Ivan-Balvan via Getty Images
Esperion, without data, says cholesterol pill lowered heart risk in study
The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.
By Ned Pagliarulo • Dec. 7, 2022 -
Courtesy of GSK
GSK to pull blood cancer drug from US market after study failure
The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.
By Ned Pagliarulo • Nov. 22, 2022 -
Drazen_ via Getty Images
Sponsored by Ogilvy HealthHow brands can tap into wellness – lessons from influencers
Our latest research uncovers new insights on how brands can truly close the wellness gap and grow within their industry sectors.
By Marion McDonald, Managing Director, Ogilvy Health • Nov. 21, 2022
