Galapagos' progress won't rattle CF markets, analysts say

Pipeline progress, including positive Phase 2 data, didn't sway some analyst beliefs that Vertex will continue to dominate the cystic fibrosis market.

By Jacob Bell • Jan. 3, 2018

Top 10 stories that had pharma execs talking

From CAR-T to potential deals, BioPharma readers dove into these pieces.

By Lisa LaMotta • Jan. 3, 2018

Explore the Trendline➔

Commercialization

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 drops boxed warning for combo asthma drugs

A review of four safety studies found pairing long-acting beta agonists and inhaled corticosteroids did not present a greater safety risk.

By Suzanne Elvidge • Dec. 22, 2017

Kymriah, Yescarta could be cost-effective, ICER finds

Despite steep prices for both CAR-T therapies, a draft report from the watchdog group suggested the clinical benefit they deliver could be worth the cost.

By Ned Pagliarulo • Dec. 21, 2017

Spending on prescription drugs has almost doubled since the '90s, report finds

About 12% of personal healthcare service spending in 2015 went toward prescription medicine sold at retail pharmacies, up from 7%. 

By Jacob Bell • Dec. 19, 2017

Hikma to sell Celltrion's Rituxan biosimilar in Africa, Middle East

The London-based generics company already markets in the MENA region two other copycat biologics developed by Celltrion.

By Lisa LaMotta • Dec. 19, 2017

Aerie eyes glaucoma market after early FDA win

Approval of Rhopressa could make Aerie a more attractive takeout option for ophthalmology-focused biopharmas. 

By Ned Pagliarulo • Dec. 19, 2017

Shire looks to stall Hemlibra impact with court injunction

Through a recently filed motion for injunction, Shire is requesting a federal court restrict Roche's ability to manufacture and sell its disruptor hemophilia drug.

By Jacob Bell • Dec. 18, 2017

Novartis buys regulatory fast pass for $130M

Ultragenyx sold the Swiss pharma a Priority Review Voucher it had received last month for the approval of its pediatric rare disease drug Mepsevii. 

By Ned Pagliarulo • Dec. 18, 2017

Positive news from the EMA for Herceptin biosimilar

Celltrion's Herzuma, its biosimilar of Roche's Herceptin, has snagged a positive opinion from the EMA, bringing the copycat drug a step closer to the market.

By Suzanne Elvidge • Dec. 17, 2017

FDA OK's new Remicade copycat but no launch planned

Pfizer has snagged a U.S. approval for Ixifi, its second Remicade biosimilar, but won't be taking it to market any time soon.

By Suzanne Elvidge • Dec. 15, 2017

Vertex licenses its first drug from CRISPR collaboration

CTX001 is a preclinical, ex vivo therapy that the biotechs are looking to push into Phase 1/2 testing for blood disorders in 2018.

By Jacob Bell • Dec. 13, 2017

After a decade of work, Otsuka and GW part ways on Sativex

A fizzled licensing agreement means GW will regain U.S. rights to its cannabinoid drug, which could be more of an albatross than a blessing.

By Jacob Bell • Dec. 13, 2017

Sanofi's Humalog follow-on gets FDA nod

With its diabetes unit on the decline, Sanofi is banking on a "more affordable" treatment to help prop up revenue.

By Jacob Bell • Dec. 12, 2017

Ardelyx signs a Chinese commercialization deal for GI drug

Fosun is continuing its mission to bring biotech to a Chinese domestic market.

By Suzanne Elvidge • Dec. 12, 2017

PwC: Opioids and Medicare pressures will challenge industry in 2018

BioPharma Dive Senior Editor Lisa LaMotta sat down with the US Pharma and Life Science Leader from PwC to discuss issues to watch in 2018. 

By Lisa LaMotta • Dec. 12, 2017

Mylan, Biocon's biosims back on track in EU after manufacturing snag

In August, Biocon had withdrawn two applications for approval of proposed biosimilars after the EMA said it would need to reinspect a drug facility.

By Suzanne Elvidge • Dec. 7, 2017

Lilly's Taltz gains new indication, improving position versus Cosentyx

Both drugs are now approved to treat psoriatic arthritis, which could help Taltz make up some of the ground Novartis' drug gained by being quicker to market.

By Jacob Bell • Dec. 6, 2017

Biogen inks outcomes-based contract for MS meds

A deal with Prime Therapeutics will link the cost of several of the biotech's multiple sclerosis drugs to patient adherence and clinical value. 

By Ned Pagliarulo • Dec. 6, 2017

FDA clears Amgen's Repatha for heart protection

Amgen can now market the PCSK9 inhibitor as an effective treatment to reduce heart attack and stroke, a potential edge to win over reluctant payers.

By Suzanne Elvidge • Dec. 6, 2017

Spark CEO Marrazzo hints at million dollar price tag

As potential approval of the first gene therapy for a rare form of blindness approaches, the problem of pricing still lacks an easy solution.

By Lisa LaMotta • Dec. 4, 2017

Mylan wins first US approval of Herceptin biosimilar

Earlier this year, the generics maker reached a settlement with Roche to market the biosimilar, although launch timing in the U.S. remains unclear.

By Ned Pagliarulo • Dec. 4, 2017

J&J jumps in on Actelion spinout's hypertension drug

Through a collaboration deal, Idorsia is handing over rights to aprocitentan in exchange for a $230 million milestone payment.

By Jacob Bell • Dec. 4, 2017

Most Impressive Drug Launch: Roche's Ocrevus

The first drug to win approval for primary progressive multiple sclerosis, Ocrevus' strong launch has already put the drug on a blockbuster trajectory. 

By Ned Pagliarulo • Dec. 4, 2017

Disruption of the Year: Long-Acting Hemophilia Drugs

Longer-acting treatments and gene therapies are likely to steal away hundreds of millions of dollars worth of revenue from established products in the coming years.

By Jacob Bell • Dec. 4, 2017