The Latest
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Meet the protein responsible for nearly $100B in cancer drug deals
Kinase-inhibiting drugs like Vitrakvi, Imbruvica and Rozlytrek were at the heart of 20 M&A deals over the past decade, according to a new SVB Leerink report.
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SponsoredThe quest for patient centricity: The travel conundrum
Patient enrollment is a central part of a clinical trial. But without proper transport, how can trials enroll?
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Price, safety will test blockbuster billing for AbbVie's new arthritis drug
Rinvoq adds another oral option to rheumatologists' tool kits, but at a list price of $59,000 per year.
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Novo faces shareholder suit over insulin sales disclosures
Filed in Danish court, the securities lawsuit claims Novo misled investors and demands $1.75 billion.
UPDATED: Aug. 16, 2019 at 1:41 p.m. -
Celgene wins approval for drug key to Bristol buyout
Inrebic, which Celgene acquired in 2018 via its acquisition of Impact Biomedicines, is now approved for adults with a certain type of myelofibrosis.
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Roche cancer drug the 3rd approved for pan-tumor use
Entrectinib, which will be sold as Rozlytrek, joins Bayer's Vitrakvi as a treatment for solid cancers featuring a rare genetic fusion.
UPDATED: Aug. 15, 2019 at 6:15 p.m. -
CMS chief declines to provide details on Trump healthcare plan
Seema Verma did reiterate Thursday, though, the agency is pressing forward on the proposed plan for an International Pricing Index, calling it a "top priority."
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Nonprofit under pressure to make new TB drug affordable
Doctors Without Borders is calling on the TB Alliance to set a low price for the drug, and to put money from a sale of a regulatory fast pass toward patient access.
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Regeneron gets cholesterol drug win where Praluent won't go
The experimental therapy cut "bad" cholesterol levels almost 50% compared to placebo in patients with a hard-to-treat metabolic disorder.
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Novartis replaced AveXis chief scientist, R&D head amid Zolgensma uproar
Neither Brian Kaspar nor his brother Allan has been involved in AveXis operations since early May, when the Swiss pharma says it confirmed inaccuracies in the gene therapy's data.
UPDATED: Aug. 14, 2019 at 3:18 p.m. -
Lawmakers charge Mylan, Teva obstructed 2014 drug pricing probe
Renewing demands for information, Sen. Bernie Sanders and Rep. Elijah Cummings say Teva, Mylan and Heritage coordinated to "stonewall" past inquiries.
UPDATED: Aug. 16, 2019 at 10:27 p.m. -
Lilly bests J&J, with implications for AbbVie's new immunology star
A study of psoriasis patients found Lilly's Taltz outperformed J&J's Tremfya, which works the same way as AbbVie's new-to-market offering, Skyrizi.
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Pharming deal shows there's still life in struggling cancer drug class
For $20 million, the Netherlands-based company gets access to leniolisib, a PI3K inhibitor developed by Novartis.
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Study success strengthens case for Lynparza in ovarian cancer
Lynparza, approved since December as a first-line maintenance therapy in the tumor type, is now supported by positive results from a second trial in that setting.
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Amgen resurgent as court victory for top drug eases doubts
Shares in Amgen rose to their highest level in the past year as a favorable ruling makes Enbrel sales through 2029 more secure.
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Lawmakers up pressure on Novartis in wake of data manipulation
Republican Senator Chuck Grassley demanded the Swiss pharma give a full account of its handling of faulty data used in winning approval for the gene therapy Zolgensma.
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Deciphera success sets up 2-horse race in gastrointestinal cancer
The small biotech rejoined the billion-dollar club after trial results for its experimental drug look to have bested those of a rival from Blueprint.
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As Ebola outbreak rages, researchers find promise in Regeneron drug
The antibody-based therapy yielded higher survival rates than standard of care in a large clinical trial, which is now advancing to an expansion stage.
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In rebuke of Novartis, FDA making 'statement for the world'
"This is a rapidly evolving field where there are going to be accelerated approvals," former FDA chief Robert Califf told BioPharma Dive. "The quality of the data is critical."
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AstraZeneca cancer drugs build as primary care shrinks
Top-seller Tagrisso shined in the front-line lung cancer setting, which should help offset declines to respiratory and cardiovascular drugs.
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Nektar battered over manufacturing issues and Bristol-Myers pullback
A study of skin, kidney and bladder cancer found disease progressed faster after patients received inactive doses of a Nektar drug paired with Opdivo.
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Hospitalized gene therapy patient triggers Sarepta sell off
An erroneous report of rhabdomyolysis in a patient enrolled in a Duchenne trial was the latest safety worry to send shares in a gene therapy biotech spiraling.
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FDA decision on Amarin heart drug delayed as agency to hold expert review
The biotech previously indicated an advisory committee meeting was unlikely. Investors seemed to have taken that to heart, reacting negatively to the surprise disclosure.
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Gilead's Descovy set for PrEP approval, but not without data, access concerns
An expert panel recommended the FDA extend approval of Gilead's drug for preventive use, though advisers pushed for further study in cisgender women.
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Deep DiveNumber of female biotech CEOs remains 'shockingly low,' putting spotlight on BIO
"I need more from BIO," the group's diversity chair and Halozyme chief Helen Torley told BioPharma Dive. More than 90% of CEOs running the industry's top companies are men.
