FDA OKs first generic under new approval pathway

The "Competitive Generic Therapy" designation was created to speed review for copies of single-source drugs — part of the FDA's broader plan to boost competition.

By Suzanne Elvidge • Aug. 8, 2018

Regeneron eyes DTC for its top-seller

While Eylea continues to dominate eye disease markets, its manufacturer is looking to reach more diabetic macular edema patients.

By Jacob Bell • Aug. 8, 2018

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

5 takeaways from payer Q2 earnings reports

Health insurers found success in Medicare, Medicaid and even the ACA exchanges.

By Les Masterson • Aug. 8, 2018

Vertex's Orkambi approved for kids with CF

A label expansion should strengthen Vertex's grip on the cystic fibrosis market.

By Suzanne Elvidge • Aug. 8, 2018

CMS to allow step therapy in Medicare Advantage plans

A CMS senior adviser said the move could save 15-20% of the $12 billion spent annually by MA plans on pricey Part B drugs. Not all analysts buy that estimate.

By David Lim • Aug. 8, 2018

Express Scripts drops Mavyret from 2019 formulary in blow to AbbVie

The PBM will exclude 48 drugs, including AbbVie's fast-selling hepatitis C medicine, from its list of preferred drugs next year.

By Ned Pagliarulo • Aug. 7, 2018

Teva confident migraine drug will launch this year despite new manufacturing woes

On Tuesday, contract manufacturer Celltrion disclosed it received a Form 483 for its plant in Incheon, South Korea, which makes Teva's fremanezumab.

By Jacob Bell • Aug. 7, 2018

ICER update gives boost to Tremfya, risankizumab for psoriasis

Revisiting an earlier report, the cost watchdog also called for payers to limit or eliminate step therapy approaches to coverage of psoriasis drugs.

By Suzanne Elvidge • Aug. 6, 2018

Acorda gets reprieve as Ampyra generic is delayed

Generic competition for the company's best-selling drug is put on hold as Mylan agrees to a deal.

By Suzanne Elvidge • Aug. 6, 2018

Acorda looks to Inbrija launch as Ampyra court battle continues

After losing several rounds of litigation in a bid to stave off generic rivals, the biotech will shift its focus to new opportunities. 

By Lisa LaMotta • Aug. 3, 2018

Drugs make up more US health spending than thought, report suggests

Research published in Health Affairs finds drugs accounted for 15% of total U.S. healthcare spending in 2016, higher than the oft-cited 10% figure.

By Ned Pagliarulo • Aug. 3, 2018

Allergan sues Pfizer over legal fees tied to opioid marketing

Allergan alleges its fellow big pharma hasn't lived up to contractual obligations requiring Pfizer pay for certain damages related to the marketing and sale of the painkiller Kadian.

By Jacob Bell • Aug. 3, 2018

AbbVie surprised investors with its hepatitis C success. Will it last?

Sales of Mavyret, approved last year, have widely beat expectations. But in a declining market the drug looks to have peaked, leaving investors hungry for other sources of growth.

By Ned Pagliarulo • Aug. 2, 2018

With diabetes competitive as ever, Novo launches Ozempic DTC campaign

The Danish drugmaker is relying on the success of GLP-1 analogs like Victoza and recently approved Ozempic to carry it through rough times.

By Jacob Bell • Aug. 1, 2018

Gilead spotlights Truvada ads as preventive use grows

A DTC campaign for the drug rolled out late in the second quarter, aiming to boost awareness of pre-exposure prophylaxis, or PrEP.

By Ned Pagliarulo • Aug. 1, 2018

Pfizer CEO sees drug rebates 'going away' in US

Weeks after President Trump confronted Ian Read on Pfizer price hikes, the pharma chief is on board with the administration's plans for major changes to how drugs are paid for.

By Ned Pagliarulo • July 31, 2018

Progenics picks up radiotherapeutic approval for rare cancers

Azedra is the first drug specifically developed for metastatic pheochromocytoma or paraganglioma, two uncommon adrenal gland tumors.

By Suzanne Elvidge • July 31, 2018

With CHMP thumbs up, Alynlam's RNAi moves a step closer to EU market

The drugs committee of the EU regulator this month recommended a slate of new drugs for approval, including the newly named Onpattro from Alnylam.

By Suzanne Elvidge • July 30, 2018

AbbVie faith in Humira, future growth remains ironclad

Biosimilars to the world's best-selling drug are coming to Europe this year and are on the horizon in the U.S. AbbVie's confidence, however, is running high.

By Ned Pagliarulo • July 27, 2018

Sales of Roche new drugs are surging. Will that be enough?

If Roche is to grow through biosimilar competition as it hopes, drugs like Ocrevus and Hemlibra will need to extend strong market launches. 

By Ned Pagliarulo • July 26, 2018

Pharma, medtech spending accounted for 28% of CME funds in 2017

2017 marked the fourth consecutive yearly increase in medical education spending from companies in those sectors.

By Rebecca Pifer Parduhn • July 25, 2018

GSK secures US approval of new malaria drug

The pharma also plans to secure regulatory OKs in malaria-endemic countries, where it says it will sell the treatment at a "not-for-profit" price.

By Ned Pagliarulo • July 25, 2018

Chiesi adds US rights to Fabry disease drug in Protalix deal

While the upfront payment is small, Protalix could receive nearly $800 million in milestone payments if the late-stage candidate is successfully marketed. 

By Suzanne Elvidge • July 25, 2018

Payers, doctors weigh AI's disruptive prescribing potential

The disruption won't happen overnight, though, as big tech firms try to not only develop healthcare AI tools, but show they'll enhance, rather than upend, the doctor-patient relationship.

By Jacob Bell • July 23, 2018

Agios gets to prove its marketing abilities with new approval

The biotech expects that its time helping Celgene roll out Idhifa will benefit the commercialization of Tibsovo, Agios' first wholly-owned product.

By Jacob Bell • July 23, 2018