FDA approves Aimmune drug as first treatment for peanut allergy

Aimmune's next challenge will be securing insurance coverage as people allergic to peanuts still have to avoid exposure to the food.

By Jonathan Gardner • Jan. 31, 2020

Amgen, Pfizer biosimilar sales pressure top drugs

Competition is heating up for copycats to Roche's top-selling cancer drugs, as the U.S. biosimilar market shows some modest signs of shifting.

By Jonathan Gardner • Jan. 31, 2020

Explore the Trendline➔

Commercialization

New drugs for obesity are becoming blockbusters, while Trump administration pressure is reshaping pharma marketing strategies ahead of looming patent cliffs.

By BioPharma Dive staff

Novartis gives up on Advair generic, leaving Mylan as sole competitor

Development delays and an uncertain path forward led Novartis to discontinue further work on its knockoff version of the GlaxoSmithKline lung drug.

By Ned Pagliarulo • Jan. 29, 2020

Pfizer hits its biosimilar stride

The big pharma, which has criticized other companies for stifling the U.S. biosimilars market, is now poised to launch three of these copycat biologics in as many months.

By Jacob Bell • Jan. 27, 2020

Google's call for change and what it means for advertisers

Last week, Google Chrome announced a vision for a future without third-party cookies. How will upcoming changes impact health marketers?

Jan. 23, 2020

Alternate sites of care: The changing face of healthcare delivery

As the care setting evolves and diversifies, stakeholders throughout the healthcare ecosystem have to evolve in kind.

By Parijat Sharma & Matt Ruple • Jan. 21, 2020

Orchard isn't for the picking, Biohaven's Allergan headache, and who's on Vascepa?

Amarin CEO John Thero had one question for investors eager to hear about his company's plans for its heart pill, while Orchard made a case for independence.

By Jacob Bell • Jan. 16, 2020

Lilly expands half-price insulin offerings

Like rivals Novo and Sanofi, Lilly has introduced lower cost insulin alternatives to head off criticism of list price increases it's taken on its branded versions.

By Ned Pagliarulo • Jan. 15, 2020

Nektar quickly drops opioid drug after FDA panel rejection

After a decade of research, the biotech said it will withdraw its application for oxycodegol and make no further investment in the drug.

By Kristin Jensen • Jan. 15, 2020

Amag CEO to step down as troubled pharma looks to sell 2 drugs

Emerging from an activist investor fight, Amag announced a restructuring plan and 2020 sales estimates that fell short of Wall Street expectations.

By Andrew Dunn • Jan. 9, 2020

GSK's plan to take over the HIV drug market hasn't worked out

An FDA rejection and modest sales for two marketed products are challenging GSK's argument that two-drug treatments are a better way to treat HIV.

By Jacob Bell • Jan. 6, 2020

Pfizer, AbbVie and Gilead among drugmakers boosting prices to start 2020

List prices rose on some of the top-selling medicines in the U.S., including Humira, Opdivo, Prevnar 13 and Biktarvy.

By Andrew Dunn • Jan. 2, 2020

Ultragenyx sells European royalty stake in rare disease drug for $320M

Royalty Pharma will add another stake to its expansive collection, while the California biotech gets an immediate injection of cash.

By Andrew Dunn • Dec. 18, 2019

Data alone can't make health improvements happen

Big tech could soon be playing the role of big brother in monitoring our health-related behaviors, with or without consumers' explicit buy-in.

By Pratap Khedkar • Dec. 3, 2019

Before 2019 closes, the FDA has 3 key approval decisions to make

The agency has been on an approval tear lately, and more may come as reviews for drugs from Amarin, Allergan and Intra-Cellular wrap up.

By Jacob Bell • Nov. 27, 2019

FDA's rapid review pace nets an early approval for Alnylam's second drug

Givosiran, which will be sold as Givlaari, is the second RNAi therapeutic cleared by the agency after Alnylam's Onpattro.

By Jonathan Gardner • Nov. 20, 2019

France clears way for wide use of Vertex's Orkambi

By agreeing to reimburse the drug beyond compassionate use, France opens up access to one of the largest cystic fibrosis populations outside the U.S.

By Jonathan Gardner • Nov. 20, 2019

Nascent digital therapeutics group lays out best practices, ethics

The two-year-old group is looking to differentiate higher-risk products that claim to treat disease from more general digital health and wellness apps.

By Susan Kelly • Nov. 13, 2019

Sage's new drug starts slow, as Wall Street waits for depression data

Few expected Sage's postpartum depression drug Zulresso to start fast. Sales of $1.5 million in its first full quarter on market confirmed those expectations.

By Ned Pagliarulo • Nov. 13, 2019

Walgreens reportedly mulling massive private equity buyout

The drugstore retailer is exploring a possible go-private deal, which would be the largest leveraged buyout in history, according to multiple media reports. 

By Ben Unglesbee • Nov. 6, 2019

AstraZeneca's China ambitions grow with new R&D investments

Already a leader in China, the British pharma is doubling down with plans to open two new centers and launch a $1 billion biotech investment fund.

By Jonathan Gardner • Nov. 6, 2019

Third Neulasta biosimilar on its way as Sandoz wins long-delayed FDA approval

Novartis' drug will be third to market, but copycat drugs have already taken a chunk of the market away from Amgen's branded version.

By Jonathan Gardner • Nov. 5, 2019

Five recent developments radically re-shaping new drug commercialization

Emerging companies and drug developers need a new game plan and new resources as their pipelines mature, often choosing to go solo where previous players partnered with others.

By Dominic Marasco, RPh • Nov. 1, 2019

Sanofi pays $315 million to settle Lemtrada go-slow claims

The administrator of a contingent value right tied to Sanofi's buyout of Genzyme argued the pharma slowed Lemtrada's progress to dodge billions in potential payouts.

By Jonathan Gardner • Oct. 31, 2019

FDA panel backs withdrawal of Amag drug to prevent preterm birth

An advisory committee narrowly recommended the FDA rescind approval for Makena, which showed no benefit in a confirmatory study.

By Ned Pagliarulo • Oct. 30, 2019