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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 -
Sponsored by Crossix
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 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineCommercialization
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 -
Sponsored by ZS
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 -
Sponsored by ZS
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Sponsored by Syneos Health
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 -
CMS proposes lifting restrictions on next-gen sequencing tests for cancer
The agency revised its proposed national coverage determination after receiving more than 80 comments, with plans to extend coverage of next generation sequencing tests to earlier-stage and hereditary cancers.
By Nick Paul Taylor • Oct. 30, 2019 -
Gilead CAR-T sales slow, renewing growth doubts
Yescarta, the cell therapy Gilead acquired in its $12 billion deal for Kite, appeared to hit a snag, with sales from July to September declining versus the second quarter.
By Ned Pagliarulo • Oct. 25, 2019 -
Vertex clears its biggest commercial hurdle: UK insurance coverage
After months of testy negotiations, Vertex and English health authorities have created a reimbursement plan for the company's cystic fibrosis drugs.
By Jacob Bell • Oct. 24, 2019