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

Merck adds to lung cancer wall with Otsuka deal

The $50 million deal with two Japanese biotechs is a small bet to match challengers in Amgen and Mirati, who are advancing agents targeting KRAS mutations.

By Jonathan Gardner • Jan. 6, 2020

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

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

Intra-Cellular approval keeps focus on FDA's neuroscience review process

Lumateperone, to be sold as Caplyta, had conflicting results in late-stage trials​. Its approval suggests the FDA is using a "glass half full lens" to review neuroscience drugs, said one analyst.

By Jacob Bell • Dec. 23, 2019

Roche hands $1B to Sarepta in major return to gene therapy deals

The Swiss pharma acquired a muscular dystrophy treatment for markets outside the U.S. in a pact that could reach a value of $10 billion.

By Jonathan Gardner • Dec. 23, 2019

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

Paratek wins US contract to develop anthrax treatment

A BARDA contract will provide Paratek with up to $285 million, some of which would go toward to acquiring the biotech's antibiotic for a national stockpile.

By Kristin Jensen • Dec. 19, 2019

Bladder cancer approval gives Seattle Genetics its second drug

Padcev, an antibody-drug conjugate developed jointly with Astellas, will expand Seattle Genetics' business beyond Adcetris.

By Ned Pagliarulo • Dec. 19, 2019

Global Blood taps Syros for its next act in blood disorders

Fresh off a sickle cell approval, Global Blood is looking to Syros' technology to keep up with the rapid innovation happening there and in beta thalassemia.

By Jacob Bell • Dec. 18, 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

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

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

In stunning twist, FDA approves Sarepta's Duchenne drug it rejected

Following an August rejection of Vyondys 53, Sarepta appealed the FDA's decision through a formal dispute resolution process that led to the agency's about-face.

By Ned Pagliarulo , Jonathan Gardner • Dec. 12, 2019

Value-based pricing for gene therapy? Maybe not ready for hemophilia

A small patient population plus large potential savings could make blood-clotting gene therapies an easier sell to payers, biotech executives say.

By Jonathan Gardner • Dec. 11, 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

For an 'acquisitive' Gilead, 2020 will be key test for CAR-T plans

Dealmaking, whether partnering or acquiring, is on the mind of Christi Shaw, the new CEO of Gilead's Kite. "Really we have one or two competitors," she told BioPharma Dive. "All of these other ones want us to buy them."

By Ned Pagliarulo • 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

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

Merck's ArQule buy showcases pharma appetite for targeted cancer drugs

The biotech's experimental drug targeting the BTK protein is of particular interest to Merck & Co., which is acquiring ArQule at more than a 100% premium.

By Jacob Bell • Dec. 9, 2019

Biotech of the Year: Galapagos

The Belgian drugmaker pulled off a rare feat, retaining its independence while collecting a multibillion-dollar investment from Gilead. Now it needs to prove its partner's bet was well placed.

By Jacob Bell • Dec. 9, 2019

Disruptor of the Year: The Federal Trade Commission

A more active FTC, suggested by the surprise delay for Roche's takeover of Spark, could slow dealmaking in an industry that relies on big pharma buyouts.

By Jonathan Gardner • Dec. 9, 2019