Lilly sells emergency diabetes drug for $500M

The divestment of Baqsimi to Amphastar could net Lilly more than $1 billion if sales goals are met.

By Jonathan Gardner • April 24, 2023

Supreme Court maintains access to abortion pill, blocking restrictions on its use

The stay suspends a Texas judge’s order that invalidated the FDA’s approval of mifepristone, keeping it available while a circuit court hears the case.

By Delilah Alvarado • Updated April 22, 2023

Explore the Trendline➔

Pharma, new drugs and market strategy

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Supreme Court delays decision in battle over abortion pill

An administrative stay of a Texas district court ruling will remain in place through Friday, pushing out a Supreme Court decision in the closely watched case over the drug mifepristone.

By Delilah Alvarado • April 19, 2023

FDA again knocks back Alvotech’s Humira biosimilar

The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.

By Jonathan Gardner • April 14, 2023

Novo boosts sales outlook on strong demand for obesity drug

The Danish drugmaker nearly doubled the 2023 forecasts for Wegovy and Ozempic in the latest indicator of the sales potential of an emerging and competitive class of weight loss drugs. 

By Kristin Jensen • April 13, 2023

Federal judge invalidates FDA approval of abortion pill

The April 8 decision by a district court judge in Texas set off a high-profile chain of litigation that has now reached the Supreme Court, whose decision could carry ripple effects for drug regulation more broadly.

By Delilah Alvarado • April 8, 2023

FDA withdraws preterm birth drug’s approval, denying maker’s request for delay

Commissioner Robert Califf and Chief Scientist Namandjé Bumpus determined there was “no justification” for keeping Covis Pharma’s controversial treatment Makena on the market.

By Ned Pagliarulo • April 6, 2023

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

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

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

Amylyx’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

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

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

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

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

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

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

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

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

Humira 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

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

How 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

Looking 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