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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.
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Ultragenyx boosted by trial data for 2nd gene therapy
One analyst called the results, which sparked a 30% jump in Ultragenyx's stock price, better than expected. The biotech is now preparing a Phase 3 trial.
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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.
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Amag CEO to step down as troubled pharma looks to sell 2 drugs
Emerging from an activist investor fight, Amag announced a restructuring plan and 2020 sales estimates that fell short of Wall Street expectations.
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AbbVie to house Allergan Botox business in separate unit
Allergan's eyecare and specialty drugs, however, will be folded into the existing AbbVie organization once its $63 billion acquisition is complete.
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5 trends to watch at the FDA in 2020
With Stephen Hahn confirmed as commissioner, the regulator is better positioned to more firmly address political pressures and a rising tide of complex medicines.
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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.
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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.
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GSK's plan to take over the HIV drug market hasn't worked out
An FDA rejection and modest sales for two marketed products are challenging GSK's argument that two-drug treatments are a better way to treat HIV.
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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.
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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.
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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.
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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.
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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.
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Pfizer, AbbVie and Gilead among drugmakers boosting prices to start 2020
List prices rose on some of the top-selling medicines in the U.S., including Humira, Opdivo, Prevnar 13 and Biktarvy.
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Illumina scraps $1.2B PacBio takeover amid regulatory pushback
The FTC's action to block the deal comes amid heightened scrutiny of life sciences deals, most notably Roche's now completed buyout of Spark.
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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.
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5 FDA approval decisions to watch in the 1st quarter
Aimmune's peanut allergy therapy and Esperion's cholesterol offering could be among the new drugs cleared in the first few months of the new decade.
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AstraZeneca and Merck's Lynparza cleared by FDA for pancreatic cancer
The pill is the second targeted treatment approved for pancreatic cancer, although its use is limited to only a small share of patients.
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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.
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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.
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Daiichi, AstraZeneca breast cancer drug joins bumper crop of early FDA approvals
AstraZeneca bet big on the Japanese pharma's HER2-targeting therapy, a gamble that paid off with a speedy approval for Enhertu.
UPDATED: Dec. 23, 2019 at 10:35 a.m. -
FDA rejects GSK's HIV therapy in setback to two-drug strategy
The British drugmaker said the Complete Response Letter was unrelated to product safety, but the delay could hamper GSK's bid to challenge rival Gilead.
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FDA approves Merck's Ebola vaccine, a historic first against deadly virus
The pharma giant has already given 275,000 doses of the vaccine to fight an outbreak in central Africa. Other drugmakers, including J&J and Regeneron, are also developing vaccines.
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Dive Awards
The BioPharma Dive Awards for 2019
A busy year brought an upswing in a storied pharma's fortunes, an industry-shaking mega-merger and the surprise revival of an Alzheimer's drug.
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