Novo Nordisk diabetes pill wins FDA approval for first-line use

The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others.

By Jonathan Gardner • Jan. 13, 2023

California files suit against PBMs over insulin prices

The state filed suit Thursday against pharmacy benefit managers CVS Caremark, Express Scripts and OptumRx, alleging they worked with drugmakers to drive up the price of insulin.

By Hailey Mensik • Jan. 13, 2023

Explore the Trendline➔

Alzheimer's disease

Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

By BioPharma Dive staff

JPM23: Takeda tests Bristol Myers, Prime weighs spinoffs and Sanofi faces down a competitor

Prime Medicine’s CEO pondered how best to advance an expansive pipeline, while executives at the two pharmas talked up their rival autoimmune disease drugs at the J.P. Morgan Healthcare Conference.

By Ben Fidler , Jacob Bell , Gwendolyn Wu , Delilah Alvarado • Jan. 11, 2023

Bristol Myers, Bayer forecast blockbuster future for rival blood thinners

The companies forecast that annual sales of two experimental anticoagulants they’re respectively developing could exceed $5 billion later this decade.

By Christopher Newman • Jan. 11, 2023

AstraZeneca, Avillion get FDA approval for new ‘rescue’ drug for asthma

Airsupra joins a growing portfolio of new drugs that are helping the British drugmaker offset wilting sales of older respiratory medicines like Pulmicort.

By Kristin Jensen • Jan. 11, 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

JPM23: Vaccine developers as dealmakers, Gilead’s trial tea leaves and building platform companies

Arrakis CEO Michael Gilman discussed platform companies’ central challenge, while Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted at greater dealmaking to come for their companies.

By Jacob Bell , Ben Fidler , Jonathan Gardner • Jan. 10, 2023

Novavax’s Erck to depart after 12 years as CEO

The longtime company head is retiring after a trying year for the COVID-19 vaccine developer. John Jacobs, most recently CEO at Harmony Biosciences, will succeed him.

By Delilah Alvarado • Jan. 9, 2023

Arrowhead reports positive data from liver drug, but company’s shares slide

The biotech and partner Takeda also announced a Phase 3 study of the RNA medicine that is longer than anticipated, pushing out analysts’ timelines.

By Jonathan Gardner • Jan. 9, 2023

5 questions facing the pharma industry in 2023

Drug price reforms and regulatory scrutiny present challenges for large drugmakers, although successes in Alzheimer’s and obesity have brought new opportunities, too.

By Christopher Newman , Jonathan Gardner • Jan. 9, 2023

Trio of biotech buyouts jumpstarts J.P. Morgan healthcare meeting

AstraZeneca is acquiring CinCor Pharma, while Ipsen and Chiesi announced deals to buy rare disease drugmakers Albireo and Amryt Pharma, respectively. 

By Ned Pagliarulo • Jan. 9, 2023

Harmonizing site and sponsor platforms to accelerate study startup and monitoring

Tech overload is among the greatest challenges sites have when they take on new clinical trials and the average clinical research center has to manage multiple platforms daily.

Jan. 9, 2023

Eisai, in pricing new Alzheimer’s drug, tries to sidestep controversy

The pharma set the average annual cost of it and Biogen’s newly approved medicine Leqembi to $26,500, below the cost of the companies’ earlier drug Aduhelm but above one estimate of cost effectiveness.

By Ned Pagliarulo • Jan. 6, 2023

Pfizer pares back early-stage research in rare disease, cancer

The drugmaker said it is considering licensing out some assets to shorten development timelines, and will stop work on early viral-based gene therapies. 

By Jonathan Gardner • Jan. 6, 2023

Kenvue, J&J’s consumer health unit, files for an IPO in step toward split

The IPO, which one estimate said could raise as much as $5 billion, is likely to be one of the largest new stock offerings in recent years.

By Delilah Alvarado • Jan. 5, 2023

FDA sets decision date for Alvotech’s Humira biosimilar

Along with the review deadline, Alvotech also disclosed the FDA had turned back an application for interchangeability as the agency needs to reinspect a manufacturing facility.

By Jonathan Gardner • Dec. 22, 2022

Merck builds out cancer drug pipeline with Kelun-Biotech deal

The pharma will pay the Chinese drugmaker $175 million for access to seven preclinical antibody-drug conjugates, deepening ties established this year. 

By Ned Pagliarulo • Dec. 22, 2022

Roche, Biogen sign royalty deal for late-stage lymphoma drug

Roche will pay royalties to Biogen on glofitimab, part of a long-standing collaboration between the two companies that’s resulted in Rituxan and Ocrevus.

By Jonathan Gardner • Updated Dec. 26, 2022

Lilly partners with Sosei to develop drugs aimed at a key family of proteins

The pharma will pay Sosei $37 million upfront to discover new candidates for diabetes and metabolic diseases that target G protein-coupled receptors.

By Christopher Newman • Dec. 16, 2022

Lilly lays out ambitious plans for 2023

Expected increases in sales and spending will be accompanied by a lengthy clinical and regulatory agenda in diabetes, obesity and Alzheimer’s disease.

By Jonathan Gardner • Dec. 14, 2022

Roche pharma division head to depart amid CEO changeover

The drugmaker’s pharmaceuticals head Bill Anderson will leave on Dec. 31. Current diagnostics chief Thomas Schinecker will fill in on an interim basis before a replacement is found and Schinecker takes over as CEO in March.

By Christopher Newman • Dec. 12, 2022

[Podcast] Thinking Big for Small and Mid-Sized Biotechs

This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need them.to help small and mid-sized companies get innovative treatments to the people who need them.

By BioPharma Dive's studioID • Updated Dec. 15, 2022

How can growth-oriented pharma organizations ensure they are ‘fit for purpose’?

The pharmaceutical industry is dynamic and rapidly evolving. To compete, companies must learn to leverage the pace of change as an accelerator for both shareholder returns and patient outcomes.

Dec. 12, 2022

Novartis gets second trial win for blockbuster hopeful

The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.

By Kristin Jensen • Dec. 8, 2022

MEI, Kyowa stop lymphoma drug trials after FDA meeting

The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

By Jonathan Gardner • Dec. 6, 2022