Biotech: Page 85
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Ultragenyx wins early approval for rare disease drug
Dojolvi, as Ultrangenyx's drug will be sold, is the first FDA-approved treatment for a group of genetic disorders that affect several thousand people in the U.S.
By Kristin Jensen • July 1, 2020 -
Permission granted by Gilead Sciences
Gilead pricing suggests it will make a business out of COVID-19 drug
Even at the lower end of its price range, remdesivir could earn Gilead a billion dollars. How well the drug's price is received will be an important test for other companies working on coronavirus treatments.
By Jacob Bell • June 30, 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 -
Jacob Bell/BioPharma Dive
Intercept's NASH drug faces its biggest delay yet
The FDA rejected obeticholic acid, asking for more data. If the agency ends up requiring outcomes results too, it could set Intercept's approval hopes back by two years or more.
By Jacob Bell • June 29, 2020 -
Permission granted by Gilead Sciences
Gilead sets price for COVID-19 drug remdesivir
A typical course of treatment with remdesivir will cost between $2,340 and $3,120 in the U.S., a price range that likely ensures Gilead earns a profit on sales of the drug.
By Ned Pagliarulo • June 29, 2020 -
By $4M, La Jolla outbids Melinta for struggling Tetraphase
La Jolla's cash offer is the third attempt to take out Tetraphase, an antibiotic specialist once valued at nearly $2 billion but now worth less than $20 million.
By Jonathan Gardner • June 24, 2020 -
Permission granted by Gilead Sciences
Gilead, in latest cancer bet, puts $275M into immunotherapy startup Pionyr
The drugmaker's investment in California-based Pionyr follows other recent cancer-focused deals with Forty Seven and Arcus Biosciences.
By Jonathan Gardner • June 23, 2020 -
Permission granted by Gilead Sciences
Gilead to launch studies of inhaled version of COVID-19 drug remdesivir
Remdesivir's benefit appears greatest when given early on. But the drug is administered intravenously, making early or outpatient treatment more difficult.
By Ned Pagliarulo • June 22, 2020 -
Getty / Edited by BioPharma Dive
Sarepta tries to fine-tune its gene therapy approach
Research deals with Codiak Biosciences and Selecta Biosciences could help Sarepta work around a key challenge in gene therapy development.
By Jacob Bell • June 22, 2020 -
In big year for microbiome drugs, a small biotech sets the bar
Data from Finch Therapeutics will likely be held up against two rivals planning to present their own clinical results later this year.
By Jacob Bell • June 19, 2020 -
Biogen loses patent dispute with Mylan, putting its top drug's future in doubt
Despite an upcoming appeal from Biogen, Mylan wants to launch its copycat drug as soon as possible and says it's working with the FDA to bump up the Nov. 16 target approval date.
By Ben Fidler • Updated June 18, 2020 -
AbbVie puts $60M into ex-Dendreon CEO's company in autoimmune drug pact
The deal gives AbbVie an option to license a drug Alpine Immune Sciences — a company run by one-time Dendreon CEO Mitch Gold — is developing for autoimmune diseases.
By Ben Fidler • June 18, 2020 -
Neurocrine bets $2B on Takeda's psychiatry drugs
The deal provides Neurocrine with three clinical-stage drugs and a more diversified pipeline, while Takeda gets more bandwidth to work on its other neuroscience projects.
By Jacob Bell • June 16, 2020 -
Getty / Edited by BioPharma Dive
Magenta's technology attracts another gene therapy developer
A freshly inked research pact will test one of biotech's antibody drug conjugates as a conditioning treatment for patients receiving Beam Therapeutics' gene editing therapies.
By Jacob Bell • June 15, 2020 -
Kendall Davis / BioPharma Dive/BioPharma Dive
CureVac gets German backing for coronavirus vaccine, but says it's independent
An investment of 300 million Euros gives the German government a 23% stake in CureVac, but won't grant the country exclusive national rights to a vaccine nearing human testing.
By Jonathan Gardner • June 15, 2020 -
Jonathan Gardner/BioPharma Dive
Agios, seeking a new strategy, touts positive data and marketing deal
The company has sold off royalty rights to one of its drugs amid a push to focus on a wholly owned medicine it's developing for several blood diseases.
By Jacob Bell • June 12, 2020 -
AstraZeneca spinout wins first FDA approval 2 years after launch
Viela Bio can now call itself a commercial-stage company, but its new drug Uplizna will compete with existing therapies in the rare neurological disease it just got approved to treat.
By Jonathan Gardner • June 12, 2020 -
Moderna to start in July what could be first late-stage coronavirus vaccine trial
The Phase 3 study, which would be run in collaboration with the NIH, is expected to enroll 30,000 participants in the U.S. Other similarly large studies of candidates from AstraZeneca and J&J could quickly follow.
By Ben Fidler • June 11, 2020 -
Regeneron brings first COVID-19 antibody 'cocktail' into human tests
The biotech has begun a pair of clinical trials testing a two-drug combination in COVID-19 patients. Two other studies, starting later this month, aim to prove the therapy can prevent coronavirus infections.
By Ben Fidler • June 11, 2020 -
Courtesy of Genmab A/S
AbbVie hands Genmab $750M in latest bid to grow cancer drug business
Best known for Humira, AbbVie has made a concerted effort to build its cancer drugs business, with mixed results. The Genmab alliance could take the Illinois drugmaker in a new direction.
By Ben Fidler • June 10, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Drug regulators in agreement on coronavirus vaccine trials, FDA official says
Health agencies will be under pressure to clear promising vaccines quickly. But Peter Marks, a top FDA official, said regulators will still want to see large trials to provide proof of safety.
By Jonathan Gardner , Ben Fidler • June 9, 2020 -
China's Innovent buys rights to Roche cancer technology
The deal covers research into cell therapies and bispecific antibodies, and grants Roche an option to develop any resulting product outside of China.
By Jonathan Gardner • June 9, 2020 -
Lundbeck to cut more than 100 jobs as it remodels R&D
The roughly 130 to 160 positions are in R&D and R&D-related functions, a company spokesperson confirmed, and the majority of them are in Lundbeck's Denmark offices.
By Jacob Bell • June 9, 2020 -
Alnylam details data for kidney disease drug under FDA review
Treatment with lumasiran significantly lowered levels of a key chemical correlated with kidney failure, paving the way for what would be Alnylam's third drug approval.
By Jonathan Gardner • June 8, 2020 -
Getty / Edited by BioPharma Dive
Sarepta, with new data, plans final push for limb-girdle gene therapy
New results show a higher dose of Sarepta's gene therapy outperformed a lower one, a finding its CEO believes should build confidence in several of its other experimental treatments.
By Ben Fidler • June 8, 2020 -
Fresh off ASCO myeloma data, Legend Bio gets $424M in biotech's biggest IPO of 2020
The China-based cell therapy developer, whose myeloma therapy is a rival to one from Bristol Myers and Bluebird, outraised this year's previous top initial biotech stock offering.
By Ben Fidler • June 5, 2020
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