Novartis pulls Arzerra outside US markets amid rising CLL competition

In all markets except the U.S., the leukemia drug will only be available on a compassionate use basis. 

By Ned Pagliarulo • Jan. 24, 2018

NYC seeks $500M in suit aimed at opioid manufacturers

The Big Apple joins a chorus of cities, states and counties seeking retribution from prescription painkiller developers, including J&J and Purdue Pharma.

By Jacob Bell • Jan. 24, 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

Novartis predicts growth pick-up on back of Cosentyx, Entresto

Incoming CEO Vas Narasimhan will soon step into the role, as the Swiss pharma looks to rebound from several years of declining operating profits.

By Ned Pagliarulo • Jan. 24, 2018

Drug price hikes drive health spending up

The Health Care Cost Institute found healthcare spending grew 4.6% last year.

By Jeff Byers • Jan. 23, 2018

J&J signals new tax laws won't change its M&A strategy

Despite a more favorable tax rate, J&J leadership said the company is still focused largely on early-stage acquisitions after a busy year of dealmaking.

By Jacob Bell • Jan. 23, 2018

FDA to speed public notification of product recalls

The move is part of the FDA's efforts to strengthen its enforcement of potentially unsafe food and medical products.

By Ned Pagliarulo • Jan. 19, 2018

Pharma, payers clash over CMS Part D drug rebate plan

The drug, PBM and insurance industries differ on a CMS proposal to require Part D sponsors to pass on a percentage of rebates to consumers.

By David Lim • Jan. 18, 2018

Shire's latest approval won't save it from Hemlibra

The EC thumbs up for Adynovi should bolster Shire's hemophilia business, yet Roche's new drug still threatens bottom lines. 

By Jacob Bell • Jan. 17, 2018

Novartis aims for US approval of Humira biosimilar

If OK'd by the FDA, the Swiss pharma's drug would be the third copycat version of the top-selling biologic product in the U.S.

By Suzanne Elvidge • Jan. 17, 2018

Price for Spark gene therapy too high, ICER says

Even considering indirect societal benefits, the group found Luxturna's $850,000 price tag would need to be cut in half to meet its cost-effectiveness thresholds.

By Ned Pagliarulo • Jan. 16, 2018

Novartis goes 2-0 against J&J in psoriasis

Fresh data support Cosentyx's superiority to Stelara in treating plaque psoriasis.

By Jacob Bell • Jan. 16, 2018

AstraZeneca's PARP inhibitor gains market edge with breast cancer approval

Lynparza, already one of AstraZeneca's fastest growing products, now holds a new indication over rival therapies from Clovis and Tesaro.

By Jacob Bell • Jan. 12, 2018

BioPharma Dive's 3 predictions for 2018 and beyond

What trends will shape the biopharma industry in 2018? BioPharma Dive's editors took a stab at predicting how the year may unfold for AI, oncology and neuroscience.

By Ned Pagliarulo • Jan. 12, 2018

Drug charity group bites back at HHS

Patient Services Inc. filed a lawsuit claiming recent guidance from the department violated the organization's First Amendment rights.

By Jacob Bell • Jan. 10, 2018

FDA slaps down Amneal bid to stop Forteo generics

The agency has rejected a citizen petition from the copycat drugmaker.

By Jacob Bell • Jan. 10, 2018

Price competition to hit oncology next: BioPharma Dive's 2018 predictions

Cancer drugs routinely command a premium price. A crowded pipeline of me-too rivals could change that. 

By Ned Pagliarulo • Jan. 10, 2018

JPM18: Allergan says no Restasis generic before second quarter

Allergan has fought hard against generic competitors to its blockbuster eye drug.

By Suzanne Elvidge • Jan. 10, 2018

Azar talks list prices, mandatory Medicare pilots

The HHS nominee identified high drug prices and shifting payment models to reward health outcomes as top priorities.

By David Lim • Jan. 9, 2018

FDA rejects Allergan's latest bid to block Restasis copies

Allergan could face generic competition to Restasis as soon as this year, bringing with it a potential blow to the company's bottom line.

By Ned Pagliarulo • Jan. 5, 2018

Drug approvals surged in 2017. What does that mean for pharma?

The FDA approved more novel medicines in 2017 than in any year since 1996.

By Ned Pagliarulo • Jan. 3, 2018

Big drugmakers ring in new year with price hikes

Allergan, Amgen and Biogen are just a few of the companies charging more for their meds in 2018.

By Jacob Bell • Jan. 3, 2018

Spark sets precedent with outcomes models, $850K gene therapy price tag

After winning approval of Luxturna in December, the biotech revealed the blindness treatment's cost, along with plans for outcomes-based rebate contracts.

By Lisa LaMotta • Jan. 3, 2018

Allergan to cut 1,000 jobs as generic competition threatens

The big question for 2018 is whether copies of Allergan's eye drug Restasis will enter the market. But the pharma also faces loss of exclusivity for several other products.

By Ned Pagliarulo • Jan. 3, 2018

Inovio reworks immunotherapy deal with eye to China

Under an amended agreement, ApolloBio will pay $23 million upfront for exclusive rights within Greater China for Inovio's HPV immunotherapy. 

By Suzanne Elvidge • Jan. 3, 2018

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