Eisai’s Alzheimer’s drug Leqembi approved in Japan

Eisai and Biogen’s anti-amyloid drug is still undergoing regulatory reviews in the EU, U.K. and elsewhere.

By Ned Pagliarulo • Sept. 25, 2023

New RSV vaccines can be powerful tools, but rollout poses test

Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID-19 and flu.

By Delilah Alvarado • Sept. 18, 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

FDA approves GSK’s new bone cancer drug, helping validate a billion-dollar bet

The drug, known scientifically as momelotinib, is now cleared to treat myelofibrosis and will compete against rival medicines sold by Incyte and Bristol Myers Squibb.

By Jacob Bell • Sept. 18, 2023

J&J to phase out Janssen name in corporate rebrand

Janssen will be recast as Johnson & Johnson Innovative Medicine, melding the drugs division’s identity more closely with its parent.

By Ned Pagliarulo • Sept. 15, 2023

Insulin pump-makers grapple with questions about GLP-1s

New weight loss drugs have sparked a stock selloff for some device makers, but medtech analysts don’t see them a likely to undermine the companies’ business — yet. 

By Elise Reuter • Sept. 14, 2023

Akili cuts 40% of workforce, plans shift to non-prescription model

The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

By Elise Reuter • Sept. 13, 2023

CDC endorses new COVID boosters as focus turns to rollout

This fall will now feature vaccination campaigns for COVID-19, influenza and respiratory syncytial virus.

By Delilah Alvarado • Sept. 13, 2023

Do not miss the return to growth

The signals of a return to growth are emerging. As commercial leaders gear up for 2024 planning, they must prepare to fight for resources in a budget constrained environment.

By Alexander Group • Sept. 5, 2023

FTC allows Amgen’s $28B deal for Horizon to go through, with conditions

The settlement between Amgen and the FTC may reassure those in the industry who feared a more activist regulator would gum up dealmaking.

By Jonathan Gardner • Sept. 1, 2023

FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

Urged by a judge, the antitrust regulator said it wants to start discussions “regarding the proper resolution of this matter” — a potential prelude to a settlement.

By Jonathan Gardner • Aug. 28, 2023

AstraZeneca the latest pharma to challenge drug pricing law

The drugmaker's lawsuit follows similar legal challenges from Merck & Co., Bristol Myers Squibb and Johnson & Johnson, among others. 

By Ned Pagliarulo • Aug. 25, 2023

FDA approves Novartis’ copycat of blockbuster Biogen drug

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

By Jacob Bell • Updated Aug. 25, 2023

Boehringer sues to block US drug price program

The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.

By Ned Pagliarulo • Aug. 22, 2023

Amazon Pharmacy expands insulin manufacturer coupons

The new coupons include some of the most commonly prescribed diabetes drugs from Eli Lilly, Novo Nordisk and Sanofi.

By Rebecca Pifer • Aug. 17, 2023

Dexcom, Abbott ramp up DTC marketing in fight for growing diabetes market

As insurers cover continuous glucose monitors for more people, device makers are taking a page from the pharma marketing playbook.

By Elise Reuter • Aug. 17, 2023

Amylyx ALS drug sales tick higher after fast US launch

In Europe, however, the biotech is appealing a negative decision from regulators that has for now blocked its path to market there.

By Ned Pagliarulo • Aug. 11, 2023

Novartis sickle cell drug’s approval formally revoked by EU regulators

The company said it would withdraw the drug, Adakveo, from the EU market after the European Commission endorsed an earlier EMA recommendation.

By Ned Pagliarulo • Aug. 4, 2023

With OTC birth control approved, access battles have just begun

Perrigo received the first FDA approval for an over-the-counter birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.  

By Karissa Waddick • July 31, 2023

Apellis faces safety doubts for fast-selling eye drug

At a medical meeting, the company confirmed seven cases of a rare, but severe, side effect have been reported following treatment with its geographic atrophy drug Syfovre.

By Ben Fidler • Updated July 31, 2023

Apellis shares sink on reports of rare side effects with new vision loss drug

An organization of retinal specialists flagged six cases of severe eye inflammation from commercial use of Syfovre. Apellis says the drug’s safety profile is consistent with testing.

By Ben Fidler • July 17, 2023

More convenient form of Roche MS drug succeeds in study

The under-the-skin formulation of Ocrevus can be administered in 10 minutes, versus a longer period for the current intravenous version.

By Kristin Jensen • July 13, 2023

EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

By Kristin Jensen • July 12, 2023

Illumina hit by EU with maximum fine for Grail acquisition

The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.

By Susan Kelly • July 12, 2023

Bausch + Lomb bulks up OTC business with J&J deal

The eye care company has become an active acquirer under new CEO Brent Saunders, buying an eye drop product line one week after purchasing several medicines from Novartis.

By Ned Pagliarulo • July 6, 2023

With FDA approval in hand, BioMarin lays out plan to sell $2.9M gene therapy

The agency granted a long-awaited clearance last Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.

By Jacob Bell • June 30, 2023