Biotech: Page 103
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Biogen finds $75M home for Pfizer Alzheimer's drug
Having stepped back from neuroscience research, Pfizer will sell off an early-stage therapy to Biogen, which has made the space its central focus.
By Jonathan Gardner • Jan. 13, 2020 -
Incyte turns to German Morphosys to refresh cancer pipeline
A licensing deal for Morphosys' near-to-market lymphoma drug will pad a pipeline that was recently weakened by a surprising study setback for Incyte.
By Ned Pagliarulo • Jan. 13, 2020 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging 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 -
Blueprint wins 1st FDA approval with targeted cancer drug
The Boston-area biotech advanced Ayvakit from initial human testing to regulatory approval in just four years, a rapid timeline reflective of the drug's gene-targeted profile.
By Ned Pagliarulo • Jan. 10, 2020 -
5 biotech trends to follow in 2020
Enthusiasm for new drugs and burgeoning companies will collide with an election year spotlight.
By Ned Pagliarulo • Jan. 9, 2020 -
Moderna, though early in development, prepares its vaccine for market
The vaccine just began mid-stage testing, but Moderna is already preparing for the next steps, which include a large Phase 3 study and hiring of sales associates.
By Jacob Bell • Jan. 9, 2020 -
Solid cuts one-third of staff, goes all in on delayed gene therapy
Re-starting a halted muscular dystrophy trial is Solid's priority as it puts a second drug and an assistive device on the backburner.
By Jonathan Gardner • Jan. 9, 2020 -
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 -
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 -
Retrieved from National Cancer Institute on September 27, 2019
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 -
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