Amylyx’s ALS drug gets pushback from European regulators

An EMA committee expressed concern with the main study meant to show Amylyx’s drug is safe and effective. The company now plans to ask for a re-examination of its approval application.

By Jacob Bell • June 23, 2023

As Illumina’s deSouza departs, will Grail go next?

The CEO’s resignation signals a change of direction, as anti-trust regulators order Illumina to divest the liquid biopsy unit.

By Susan Kelly • June 12, 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

Bayer launches precision health unit in latest digital health venture

The pharma company said it will work with startups and other digital health companies as it builds out the consumer-focused business unit.

By Emily Olsen • June 1, 2023

2023 Veeva trends in HCP omnichannel engagement report

Boost campaign effectiveness by 23% by synchronizing sales and marketing.

May 30, 2023

House lawmakers, PBM lobby spar over committee hearing

At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.

By Rebecca Pifer • May 25, 2023

Amylyx’s ALS drug again surpasses Wall Street expectations

Revenue from the biotech’s ALS therapy Relyvrio totaled $71.4 million in the first quarter, well above analyst estimates and helping the company turn a profit only months into the drug’s launch.

By Jacob Bell • May 11, 2023

Here’s what will change when the COVID public health emergency ends

Vaccines, which have been crucial to curbing the virus’ spread, will remain free for the vast majority of people in the U.S., but over-the-counter tests will no longer be covered for most.

By Shannon Muchmore • May 10, 2023

Abortion providers in 3 states sue over mifepristone restrictions

The lawsuit seeks to remove safety restrictions on mifepristone or, alternatively, prevent further altering of access to the drug.

By Sydney Halleman • May 9, 2023

Pfizer turns focus to new drugs as COVID vaccine revenue falls

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

By Jonathan Gardner • May 2, 2023

Lilly plans dash to market for weight loss drug after trial win

The drugmaker will use a priority review voucher in a bid to secure FDA approval of Mounjaro in obesity by late this year or early next.

By Jonathan Gardner • April 27, 2023

Roche’s new eye drug pressures Eylea with strong launch

One year after its market debut, the company’s AMD drug Vabysmo is on track for blockbuster sales as Regeneron’s rival treatment faces new threats.

By Jonathan Gardner • April 26, 2023

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

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 decision imperils access to the drug more than two decades after its U.S. approval, and could carry consequences for the FDA’s authority over prescription medicines.

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