Lilly looms over Blueprint as the biotech files targeted cancer drug

Positive results in certain lung cancer patients support Blueprint's decision to submit pralsetinib, a RET-inhibitng drug, for approval in the first quarter.

By Jacob Bell • Jan. 8, 2020

US cancer death rate drops by most on record

Reductions in smoking and earlier cancer detection have driven death rates lower, but newer treatments could be playing a larger role, too.

By Ned Pagliarulo • Jan. 8, 2020

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

Merck's Keytruda falls short of rivals in 1 lung cancer type

Mixed results could put Merck at a disadvantage in small cell lung cancer, a tumor type which has proved responsive to Roche's Tecentriq and AstraZeneca's Imfinzi.

By Jonathan Gardner • Jan. 7, 2020

Alexion's blockbuster Soliris bested by Apellis in Phase 3 trial

The study result sent shares in Apellis up by more than 20%, as investors saw potential for the Massachusetts biotech to take on Alexion's top-seller. 

By Andrew Dunn • Jan. 7, 2020

Pfizer, Merck KGaA show immunotherapy's survival benefit in bladder cancer

While cancer immunotherapy hasn't proved as effective in urothelial carcinoma as in other tumor types, Monday's result suggests some success.

By Andrew Dunn • Jan. 6, 2020

Trial failure keeps Incyte searching for its next act

A setback for Incyte's experimental drug itacitinib adds to a list of pipeline disappointments for the Delaware biotech. 

By Ned Pagliarulo • Jan. 3, 2020

Wave's Huntington's drug shows effect but falls short of mark set by Roche and Ionis

The gene-targeting drug lowered levels of a damaging mutant protein, but the therapy's modest effect disappointed investors.

By Jonathan Gardner • Jan. 2, 2020

Stealth's rare disease drug falls short in study, sinking shares

The setback could also put in jeopardy an option Stealth recently granted to Alexion to partner on elamipretide following the Phase 3 readout.

By Ned Pagliarulo • Dec. 20, 2019

AstraZeneca lupus drug shows potential, but it may not be enough for FDA

If approved, anifrolumab would compete against GlaxoSmithKline's Benlysta, the first lupus drug to reach the market in decades.

By Jonathan Gardner • Dec. 19, 2019

Muscle data doesn't help Solid build faith in its gene therapy

A regulatory delay due to an adverse event, meanwhile, has put Solid further behind Sarepta in the pursuit of a Duchenne muscular dystrophy gene therapy.

By Jonathan Gardner • Dec. 18, 2019

Homology unveils first data for PKU gene therapy, marking early milestone

Data presented Tuesday are from just three patients, but set the pace in a field that includes BioMarin and, most recently, Sangamo Therapeutics.

By Andrew Dunn • Dec. 17, 2019

GSK advances blood cancer drug to FDA, but rivals threaten

Belantamb mafodotin, a crucial drug for GSK's ambitions in oncology, could be the first anti-BCMA therapy approved. But new data show it's at risk of being outclassed.

By Ned Pagliarulo • Dec. 17, 2019

With trial win, Alnylam to seek approval for first treatment of rare kidney disease

The biotech's RNAi therapy lumasiran appears positioned to become the first drug for primary hyperoxaluria. Potential rivals, though, are close behind.

By Andrew Dunn • Dec. 17, 2019

BeiGene's Brukinsa bet falls short against Imbruvica

The Chinese biotech's recently approved cancer drug wasn't able to beat out Imbruvica in a rare lymphoma, raising questions about its next regulatory filing.

By Jonathan Gardner • Dec. 16, 2019

Novartis shutters late-stage asthma program, spelling trouble for Gossamer

After four Phase 3 trials fell short, the Swiss pharma is ceasing development of fevipiprant in asthma.

By Andrew Dunn • Dec. 16, 2019

Gilead's NASH ambitions buckle under the weight of ATLAS

The Phase 2 ATLAS study was Gilead's last chance to stay in the pack of companies leading the charge toward a first-ever drug for NASH, a fatty liver disease.

By Jacob Bell • Dec. 16, 2019

Wave cancels its Exondys competitor and heads back to the lab in muscular dystrophy

Suvodirsen failed to stimulate production of a muscle-building protein, a finding that prompted suspension of development of a second Duchenne drug.

By Jonathan Gardner • Dec. 16, 2019

BioMarin drug for dwarfism meets goal in late-stage study

Positive data in hand, BioMarin plans to soon discuss with regulators filing vosoritide for approval, setting up a consequential year ahead for the biotech.

By Ned Pagliarulo • Dec. 16, 2019

How to implement risk-based quality management into your clinical trial

Change isn't easy in the pharmaceutical industry, but it's necessary to accommodate the diversity of data sources and study designs.

Dec. 16, 2019

Biogen's Alzheimer's drug gets caught in Sarepta's spotlight

The unexpected approval of Sarepta's Vyondys 53 has some wondering how lenient the FDA might be in reviewing aducanumab. Others, however, see little impact.

By Jacob Bell • Dec. 13, 2019

UniQure, Pfizer updates hint at gene therapy potential in hemophilia B

The two companies are advancing toward market one-time treatments for the blood disorder, with Takeda about to begin clinical testing of its own therapy.

By Jonathan Gardner • Dec. 10, 2019

Leukemia rivals try to stay ahead as Merck, Lilly chase

Merck's surprise buyout of ArQule will heat up competition in a class of cancer drugs that includes AbbVie and J&J's Imbruvica and AstraZeneca's Calquence.

By Jonathan Gardner • Dec. 10, 2019

Get ready for 2020: What to know about the 15 most important trends impacting healthcare

New report reveals the critical trends and market changes impacting biopharmaceutical companies in the year ahead.

Dec. 10, 2019

New drugs for sickle cell excite but, at ASH, a recognition that more is needed

Approvals for Adakveo and Oxbryta double the number of treatment options for sickle cell disease in the U.S., bringing hope that more may soon follow.

By Ned Pagliarulo • Dec. 9, 2019

As CAR-T presses ahead in multiple myeloma, alternative approaches gain supporters

Three different ways of attacking the blood disease are emerging, raising hopes for life-extending drugs for the sickest patients.

By Jonathan Gardner • Dec. 9, 2019