The Latest
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Q&AReata's new CFO on M&A, weathering a recession and biotech's quirks
Manmeet Soni helped execute multi-billion dollar sales as CFO of Ariad and Pharmacyclics. He's now moving from Alnylam to a small, Texas-based biotech.
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Aimmune faces crucial FDA panel vote on first peanut allergy drug
The allergy-focused biotech faces a critical test today. Here's what to expect from the FDA advisory committee's review.
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In a 'make or break' moment, Tocagen falls short
The San Diego biotech's lead drug failed to extend survival in a pivotal study for an aggressive type of brain tumor, setting back the company's plans.
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Drug companies pay for exclusive access to UK genetic data
Amgen, AstraZeneca, GSK and J&J will get nine months to pour over the first wave of whole genome data coming out of UK Biobank before the global research community gets a chance to look.
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ICER dings Novo's new oral diabetes drug
The semaglutide pill is less effective than Jardiance and more expensive if priced similarly to the drug's injectable form, ICER said in a draft report.
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Deep DivePublic trust in drugmakers is at an all-time low. Can biopharma recover?
Leaders are grappling with how to improve the industry's reputation at a time when the broader business world is under increased scrutiny.
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Sanofi paying Lexicon $260M to exit diabetes alliance
Lexicon had argued Sanofi violated the companies' contract when providing notice in July that it would terminate a research partnership on Zynquista.
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BioMarin talks down worries on gene therapy data differences
BioMarin's R&D head said timing of steroid treatment impacted interim Phase 3 data, which had spurred questions on valrox's durability.
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Medicare would negotiate prices for 250 drugs under House Democrats' plan
Speaker Nancy Pelosi's proposal also finds common ground with the president in pegging U.S. prices to an international index.
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Survey suggests Ionis is losing battle against Pfizer and Alnylam
Physician preferences between the company's respective drugs appear to be emerging in the year since Ionis' Tegsedi won approval.
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Biomarker data help Merck case for wide use of Keytruda combo
"In the setting of chemo combinations, it does not appear that PD-L1 or TMB influences the outcome," said Merck development head Roy Baynes.
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After scandal, Novartis pledges faster action on data integrity
CEO Vas Narasimhan committed to informing the FDA within five business days of any credible data integrity issues tied to a pending drug application.
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Cancer drug data back up Lilly's Loxo buyout
Updated study results show striking efficacy for LOXO-292 in an uncommon form of lung cancer, clearing the path for Lilly to file for approval this year.
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Trial win could drive Acadia's Nuplazid to new use
A data monitoring board stopped study of dementia-related psychosis patients early due to positive efficacy, setting Nuplazid up for another FDA filing.
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Amgen update shows promise, limits of KRAS cancer drug
A 54% response rate among lung cancer patients will encourage, but several relapses could temper sky-high expectations for AMG 510.
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Pfizer touts successor to Prevnar 13
Phase 2 data showed Pfizer's experimental pneumococcal vaccine to be safe, boosting confidence in what Pfizer hopes will be a follow-on to Prevnar 13.
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Roivant offloads biotech stakes in $3B alliance with Japanese pharma
The deal transfers ownership in five Roivant subsidiaries to Sumitomo Dainippon, along with a stake in Vivek Ramaswamy's parent company.
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MD Anderson official emerges as top choice to run FDA, reports say
Nominating Stephen Hahn, an oncologist and chief medical executive at the Texas cancer center, would be a change of course from acting agency head Ned Sharpless.
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Alexion suffers another Soliris patent setback
Just a week after the U.S. patent office took up an Amgen challenge, Alexion now faces patent struggles in Europe as well.
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ColumnPharmacquired: Vertex has an appetite for deals. Gene therapy is on the menu
CEO Jeffrey Leiden told BioPharma Dive that one or two gene therapy deals wouldn't be surprising as the biotech builds out what he calls its tool kit of technologies.
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With third pharma deal, IFM's unorthodox approach paying off
An inflammatory disease partnership with Novartis is IFM's second this year with the Swiss pharma and follows a 2017 deal with Bristol-Myers Squibb.
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Ultragenyx gene therapy data disappoints investors
The biotech said the current dose of DTX401 will be taken into Phase 3 testing, although a less potent dosage level showed similar efficacy.
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Mallinckrodt plunges after report it's mulling bankruptcy amid opioid trial
Staring down more than 2,000 opioid lawsuits, the pharma has maxed out its borrowing capacity, raising the possibility of bankruptcy, per Bloomberg.
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Skyrizi looks ready to soar after strong launch
Dermatologists expect Skyrizi prescriptions to accelerate, according to a new survey that has some analysts now forecasting $300 million in 2019 sales for the psoriasis drug.
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Aclaris to lay off 86 employees in restructuring to extend cash
The biopharma is moving away from selling its dermatology products and will focus on its immuno-inflammatory pipeline, company execs said Thursday.
