CDC panel to discuss COVID, hepatitis B shots in meeting next month

A federal register notice confirmed dates for the anticipated advisory meeting, which will follow an FDA decision to narrow COVID boosters' approval and comes as CDC leadership is in turmoil.

By Delilah Alvarado • Aug. 28, 2025

MAHA may take aim at pharma DTC ads

RFK Jr. has his sights set on increasing oversight and enforcement against drugmakers that run afoul of advertising laws.

By Amy Baxter • Aug. 20, 2025

Explore the Trendline➔

Commercialization

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

HHS revives defunct task force on childhood vaccine safety

The panel’s reinstatement is one of a series of controversial moves made by Robert F. Kennedy Jr. to put vaccines under new scrutiny.

By Delilah Alvarado • Aug. 15, 2025

BioNTech ends patent fight with mRNA rival CureVac ahead of buyout deal

The complex settlement, which hands payouts and royalties to CureVac and partner GSK, comes as BioNTech is inching toward an acquisition of its one-time COVID-19 vaccine competitor.

By Jonathan Gardner • Aug. 8, 2025

Novo pushes back against obesity drug compounders as competition intensifies

The company hopes an important CVS deal and broader legal action against the makers of knockoff Wegovy can solidify its slipping position in the lucrative market for weight loss drugs.

By Jonathan Gardner • Aug. 6, 2025

Experts ousted from CDC panel warn of damage to US vaccine policy

The 17 advisers fired in June by Robert F. Kennedy Jr. urged alternatives to ACIP be organized to limit further degradation in vaccine guidelines.

By Delilah Alvarado • July 31, 2025

Alnylam reaches new highs on strong sales of closely watched rare disease drug

Despite battling drugs from BridgeBio and Pfizer, Amvuttra beat Wall Street expectations with results Alnylam’s CEO claimed were “not a flash in the pan.”

By Ben Fidler • July 31, 2025

J&J tests direct CAR-T marketing with first Carvykti ad

The new direct-to-consumer ad signals J&J’s confidence in its capacity to meet demand for the cell therapy after earlier manufacturing struggles.

By Ned Pagliarulo • Updated July 30, 2025

In reversal, European regulators take positive view on Lilly Alzheimer’s drug

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug, Kisunla, one step closer to European market entry.

By Jacob Bell • July 25, 2025

RFK Jr. adopts CDC panel recommendation to remove thimerosal from flu shots

The action will remove from use the very few flu shots that contain the contested preservative, elevating unproven fears it poses health risks.

By Delilah Alvarado • July 23, 2025

Bristol Myers, Pfizer to offer Eliquis at a discount for some patients

The program is the latest example of pharmaceutical companies bypassing traditional drug distribution channels for people who aren’t insured or are willing to pay cash for their medications. 

By Ben Fidler • July 17, 2025

Soleno sales of new Prader-Willi drug rise faster than expected

Preliminary quarterly sales figures for Vykat surpassed Wall Street estimates, but shares fell on concerns the company may not be courting a buyer.

By Ben Fidler • July 10, 2025

Lilly gets FDA OK of modified dosing for Alzheimer’s drug

A slower ramp-up of Kisunla dosing lowers the rate of dangerous brain swelling, a risk that has made doctors reluctant to prescribe Lilly’s amyloid-busting drug.

By Jonathan Gardner • July 9, 2025

Medical groups, pregnant doctor sue RFK Jr. over vaccine changes

The complaint argues Kennedy’s actions to remove the COVID vaccine from the CDC's immunization schedule for pregnant people and healthy children were unlawful.

By Delilah Alvarado • Updated July 8, 2025

Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline

Industry veteran Catherine Owen Adams expects external innovation will be key to getting the brain-focused drug developer to “the next level.”

By Jacob Bell • July 2, 2025

FDA takes major step to ease access to CAR-T therapy

The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ post-treatment movement.

By Ned Pagliarulo • June 27, 2025

Supreme Court upholds ACA preventive services mandate

The high court preserved a key part of the Affordable Care Act requiring private insurers cover a range of preventive healthcare services without cost sharing.

By Emily Olsen • June 27, 2025

Congress should reconsider breaking up PBMs, experts say

Many proposals to reform the PBM industry miss the forest for the trees, experts said this week. Instead, Congress should go after the oligopoly enjoyed by the “Big Three” companies.

By Rebecca Pifer • June 27, 2025

RFK Jr.-appointed panel recommends flu shots be free of contested preservative

Thimerosal, targeted by activists who claim it’s linked to autism, shouldn't be used in vaccines given in the U.S. this coming flu season, the CDC panel said.

By Jonathan Gardner • Updated June 27, 2025

Recast CDC panel recommends new RSV antibody for infants

By a 5-2 vote, the Advisory Committee on Immunization Practices endorsed Merck’s Enflonsia for babies born during or entering their first RSV season.

By Ned Pagliarulo • June 26, 2025

Novo abruptly ends obesity drug deal with Hims

The Wegovy maker says the telehealth company didn't stop selling compounded versions of the blockbuster drug after Novo resolved its shortage.

By Jonathan Gardner • Updated June 23, 2025

RFK Jr. reveals picks for influential vaccine panel

Days after firing all 17 members of the CDC's Advisory Committee for Immunization Practices, the HHS Secretary named a small new committee that includes multiple vaccine critics.

By Kristin Jensen • June 12, 2025

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

The drug, Ibtrozi, will now vie for market share in an indication where multiple large pharmaceutical companies have already struggled to grow sales.

By Ben Fidler • June 11, 2025

AI tool could help doctors ID breast cancers vulnerable to Enhertu

Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.

By Ned Pagliarulo • May 22, 2025

Judge shuts down drugmakers’ 340B rebate plans, for now

A district court ruled HHS has the power to review drugmakers’ plans to pay hospitals rebates on 340B medications. But it left the door open to the controversial reforms.

By Rebecca Pifer • May 19, 2025