Prescribed Reading: Deals sputter in, warning letter frenzy

Small bolt-on deals and acquisitions keep trickling in, unloved therapeutic areas get positive data, and CDER warnings letters rise under Gottlieb. 

By Lisa LaMotta • Feb. 23, 2018

Oral form of Novo's Ozempic hits primary endpoint in first Phase 3

Novo Nordisk's oral GLP-1 drug improves long term blood glucose control in a six-month trial.

By Suzanne Elvidge • Feb. 23, 2018

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

Apellis touts new data for eye drug hopeful

Further follow-up of AMD patients treated with Apellis' drug appeared to support earlier Phase 2 results.

By Suzanne Elvidge • Feb. 23, 2018

Gilead taps Sangamo to expand cell therapy after Kite buy

The big biotech is trying to expand its know-how and pipeline in its recently acquired area of cell therapies.

By Lisa LaMotta • Feb. 22, 2018

AbbVie fibroids drug meets Phase 3 endpoint

In the primary analysis of the late-stage study, AbbVie's elagolix reduced heavy menstrual bleeding.

By Suzanne Elvidge • Feb. 22, 2018

Aimmune knocks down DBV with positive peanut results

The peanut allergy space heats up as Aimmune reports strong data for its late-stage treatment.

By Lisa LaMotta • Feb. 20, 2018

CAR-T growing up with big pharma's big bet

Major acquisitions by Celgene and Gilead should catalyze further investment into the technology needed to make CAR-T work smoothly. Yet cell therapy's commercial potential remains an open question.

By Ned Pagliarulo • Feb. 20, 2018

$690M deal in peril after Lilly ends mid-stage studies

Lilly shuts the door on rheumatoid arthritis for its BTK collaboration project; what's next remains to be seen.

By Suzanne Elvidge • Feb. 20, 2018

AstraZeneca's Imfinzi wins FDA lung cancer nod

The British big pharma snaps up the first FDA approval of a therapy for unresectable stage 3 patients with non-small cell lung cancer.

By Suzanne Elvidge • Feb. 20, 2018

Prescribed Reading: Landscape-changing deals and Alzheimer's shake-ups

A relatively large research collaboration could change the deal landscape. Elsewhere, the Alzheimer's development picture is getting a makeover. 

By Lisa LaMotta • Feb. 16, 2018

FDA pushes pharma to continue efforts in Alzheimer's

In new guidance to industry, the regulator signaled greater flexibility around the use of biomarkers in studying the neurodegenerative disease.

By Suzanne Elvidge • Feb. 16, 2018

Biogen shares fall after unexpected 'variability' in Alzheimer's studies

Company executives insisted the pre-planned check did not change their confidence in aducanumab, which has become Biogen's key pipeline asset.

By Ned Pagliarulo • Feb. 15, 2018

Pfizer, Merck KGaA lung cancer drug fails

The duo's checkpoint inhibitor Bavencio failed to beat out chemotherapy in the key setting of non-small cell lung cancer. 

By Lisa LaMotta • Feb. 15, 2018

Fresh data sets up showdown for Lilly's Taltz vs Cosentyx

In the highly competitive IL-inhibitor space, securing new indications has been a key strategy for drugmakers looking to gain an edge.

By Jacob Bell • Feb. 14, 2018

Merck delivers latest Alzheimer's disappointment

The big pharma discontinued another trial, acknowledging its drug doesn't work in early-stage patients. 

By Lisa LaMotta • Feb. 14, 2018

New approval helps Vertex's 'cleanest growth story in biotech'

Symdeko, a combination treatment for cystic fibrosis, holds a price tag of $292,000 and could provide Vertex up to $200 million in revenue by year's end.

By Jacob Bell • Feb. 13, 2018

Trump pitches changes to 180-day generic exclusivity

The administration's budget includes a proposal to prevent generic drugmakers from abusing the current system.

By David Lim • Feb. 13, 2018

Despite trial win, Roche's new eye drug can't escape Eylea's shadow

While positive, the latest data for Roche's RG7716 doesn't answer how it will compete with Regeneron's market heavyweight.

By Jacob Bell • Feb. 12, 2018

Aveo, Eusa tout promise of tivozanib combo in kidney cancer

Early results from a trial testing tivozanib together with Opdivo showed enough merit to further explore combo treatment — in the companies' eyes, at least. 

By Suzanne Elvidge • Feb. 12, 2018

Fewer regs could lower drug costs: White House council

The Council of Economic Advisers also suggested creating an independent agency to oversee the 340B prescription drug program.  

By Les Masterson • Feb. 12, 2018

Boehringer ends Alzheimer's research for PDE9 blocker

After Phase 2 trials of the drug failed to show a cognitive benefit in Alzheimer's, Boehringer will refocus its work on PDE9 inhibition around schizophrenia.

By Ned Pagliarulo • Feb. 9, 2018

Prescribed Reading: Earnings point to restructuring, not M&A

As pharma companies continued to report full-year earnings, the M&A spree has stopped and the focus has shifted to fixing up the pipeline. 

By Lisa LaMotta • Feb. 9, 2018

Madrigal shares slide despite Phase 2 success

Although Madrigal touted its candidate's prospects in hypercholesterolemia, the market took a different take and sent shares in the biotech tumbling.

By Suzanne Elvidge • Feb. 9, 2018

Biogen drops Tysabri stroke program after Phase 2 miss

A study known as ACTION 2 showed treatment with the MS drug failed to improve clinical outcomes versus placebo in acute ischemic stroke.

By Suzanne Elvidge • Feb. 8, 2018

Array's stock zooms as melanoma combo beats out Zelboraf

With its target action date approaching, a combo drug from Array and Pierre Fabre shows it can cut the risk of death in BRAF-mutant melanoma.

By Suzanne Elvidge • Feb. 7, 2018