Prescribed Reading: M&A slow ahead of BIO, ASCO

With two of the industry's biggest conferences coming up, the biopharma deal space took a breath. 

By Lisa LaMotta • June 1, 2018

Gilead's filgotinib clears mid-stage test in arthritis

Separately, the big biotech also revealed a data monitoring panel had recommended the JAK inhibitor advance into Phase 3 testing for ulcerative colitis. 

By Ned Pagliarulo • May 31, 2018

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

What you need to know about NASH

BioPharma Dive is taking a deeper look at how this market is changing, the challenges drugmakers will face if they reach commercialization and the shifting market sentiment.

By Lisa LaMotta • May 31, 2018

Vertex, CRISPR gene-editing therapy hit with clinical hold

Though CTX001 now faces a delay in the U.S., CRISPR and Vertex still plan to initiate a Phase 1/2 study of it in Europe later this year.

By Jacob Bell • May 31, 2018

Madrigal scores in mid-stage NASH study

The closely watched results could give a boost to the emerging market for the liver disease. 

By Lisa LaMotta • May 31, 2018

AstraZeneca won't submit lung drug for COPD after 2nd study miss

​In the second of two Phase 3 trials, Fasenra failed to help patients with the pulmonary disease, crimping the pharma's plans to expand the drug's market. 

By Ned Pagliarulo • May 30, 2018

Novo's oral semaglutide outperforms Jardiance in late-stage study

Treatment with Novo's GLP-1 delivered superior improvement of HbA1c levels versus Jardiance. But results comparing the effect on weight loss were mixed. 

By Suzanne Elvidge • May 30, 2018

Tecentriq trial wins boost Roche bid to compete with Merck

Combining the PD-L1 blocker with chemo helped advanced lung cancer patients live longer in a Phase 3 study, the third to show an OS benefit to Roche's drug. 

By Ned Pagliarulo • May 29, 2018

Genmab stumbles after J&J dumps Darzalex combo trial

After an imbalance of patient deaths in a combo study of Darzalex and Tecentriq, Genmab partner Janssen is re-evaluating further combo studies. 

By Suzanne Elvidge • May 29, 2018

AstraZeneca's Imfinzi delivers survival benefit in Stage 3 lung cancer

While the British pharma still lags rivals in the metastatic lung cancer market, Imfinzi has carved out a leading position in the earlier, Stage 3 setting. 

By Ned Pagliarulo • May 25, 2018

Prescribed Reading: J&J seen with most M&A potential; Drug pricing plan ripples

The pharma giant has the greatest flexibility to ink a deal, according to a recent Leerink report. Elsewhere, drug pricing remained center stage in D.C. 

By Lisa LaMotta • May 25, 2018

Genmab hits roadblock in non-Hodgkin lymphoma

Results from a Phase 3 study of Arzerra didn't turn up positive for Genmab and partner Novartis, dimming prospects for the cancer biologic. 

By Suzanne Elvidge • May 25, 2018

Cancer drug spending climbs, with top winners earning lion's share

Iqvia found the top 35 cancer drugs accounted for 80% of the roughly $110 billion the world spent on oncology therapeutics last year. 

By Ned Pagliarulo • May 24, 2018

From IND to FPI: How to set up your US study for success

Clinical trials are complicated, but following certain planning and management strategies can equal study success. 

By Lauren Neighbours, PhD, RAC, US Head Regulatory, PSI CRO • May 23, 2018

Esperion talks cholesterol drug pricing after third positive study

The biotech's cholesterol-lowering therapy could fill the gap between statins and high-cost PCSK9 inhibitors.

By Suzanne Elvidge • May 23, 2018

Right to Try bill clears House, headed for Trump signature

FDA chief Scott Gottlieb had expressed reservations about the impact on agency authority.

By David Lim • May 22, 2018

Momentum grows for hemophilia gene therapies

One-time treatments developed by BioMarin and the team of Spark and Pfizer promise to transform how hemophilia A and B, respectively, are treated. 

By Ned Pagliarulo • May 22, 2018

Pharma turn to NASH unlikely to mirror meteoric rise of hep C

Hopes of a hepatitis C-sized market could be dashed by the complexity of and challenges in diagnosing the lesser-known liver disease. 

By Ned Pagliarulo • May 21, 2018

NASH drug pipeline headed toward uncertain market

The fatty liver disease has dozens of treatments in the global pipeline. But investors are treading lightly, casting doubt on the market opportunity.

By Jacob Bell • May 21, 2018

Nabriva ready for FDA, EMA filing for antibiotic candidate

The biotech has plans for a New Drug Application after a second positive Phase 3 study.

By Lisa LaMotta • May 21, 2018

Brain Talk: Cracking the code of Alzheimer's and dementia

Alzheimer's is one of the most challenging diseases to treat. Researchers face an uphill battle when it comes to developing new treatments and finding a cure.

May 21, 2018

Hemlibra's latest HAVEN results impress

Fresh late-stage data reinforced the Roche drug's strong efficacy profile, and offered reassurance that its safety and dosing support patient switches from other treatments.

By Jacob Bell • May 21, 2018

Liver safety the death knell for J&J Alzheimer's drug

Another BACE inhibitor bites the dust after safety signals push the pharma to discontinue development. 

By Suzanne Elvidge • May 21, 2018

Prescribed Reading: FDA, CMS take aim at drug pricing

Government agencies announced moves to bring down high drug prices, though the market doesn't seem worried just yet.

By Lisa LaMotta • May 18, 2018

5 takeaways from the first look at cancer's biggest conference

Study abstracts released ahead of the ASCO annual meeting gave investors new data to pore over for dozens of key cancer drugs.

By Ned Pagliarulo • May 17, 2018