The Latest
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Trial setback strikes blow to Sage antidepressant ambitions
SAGE-217 failed to meet the main goal of a Phase 3 depression study, a result that cut the drugmaker's market value by roughly $4 billion.
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The clearest picture of Biogen's Alzheimer's drug is still fuzzy
Biogen laid out its best case for aducanumab on Thursday, but even more detailed data couldn't clear up the uncertainties that have made its surprising decision to revive the drug so controversial.
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Deep DiveWill sky-high drug prices spur the US to use an obscure power over patents?
New cell therapies as well as gene-based treatments like Zolgensma benefited from NIH funding of early-stage research. Advocates say the time is now for the government to invoke its "march-in" rights.
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New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda
One Wall Street analyst expects the FDA's OK will help Tecentriq outpace Bristol-Myers Squibb's Opdivo in 2020 in the non-small cell lung cancer market.
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After FDA rejection, Immunomedics tries again with breast cancer drug
Sacituzumab govitecan would be Immunomedics' first commercial product if the biotech succeeds on its second attempt to convince the FDA.
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What to watch as Biogen presents its all-important Alzheimer's data
During what some have called the biotech event of the year, doctors will be paying close attention to how Biogen accounted for missing data in its pivotal aducanumab studies.
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Astellas joins gene therapy race with $3B Audentes buy
Manufacturing was a key draw for Astellas, which gains access to a plant owned by Audentes that can support clinical and commercial production.
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FDA denies Lexicon bid to reverse diabetes drug rejection
The biotech, which lost big pharma partner Sanofi earlier this year, isn't giving up, announcing plans to escalate its dispute to a higher division within the FDA.
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Biogen scores a rare lupus win, lending support to its new immunology focus
In a two-part study, Biogen's BIIB059 hit both primary endpoints. But statistical significance, as well as a lack of safety data, create some uncertainty about the drug's future prospects.
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Neurocrine, Xenon ink R&D deal targeting rare form of epilepsy
Working to expand its pipeline beyond the tardive dyskinesia drug Ingrezza, Neurocrine will gain access to one clinical and several preclinical treatments.
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Before 2019 closes, the FDA has 3 key approval decisions to make
The agency has been on an approval tear lately, and more may come as reviews for drugs from Amarin, Allergan and Intra-Cellular wrap up.
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Wave faces key test in bid to challenge Sarepta in DMD
Forthcoming trial results will show whether Wave's experimental drug can compete with Sarepta's Exondys 51 in Duchenne muscular dystrophy.
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Opioid makers subject of US grand jury probe
At least six companies have been subpoenaed in an investigation characterized as a wide probe into practices required under the Controlled Substances Act.
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Medicines Co. deal caps pharma's reentry into field it once abandoned
Large pharma companies like Novartis, Roche and J&J are buying back into RNAi, a technology that several retreated from in the early 2010s.
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Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo
A list price of roughly $10,000 a month puts Global Blood's Oxbryta slightly higher than what Novartis' Adakveo will cost.
UPDATED: Nov. 26, 2019 at 10:04 a.m. -
Deep DiveBankrupt biopharmas are rare. 2019 has some worried that's changing.
Eleven biopharmas declared bankruptcy in 2019, more than any other year since at least 2011. Rising market pressures, coupled with legal liabilities, risk more companies falling to zero, experts warn.
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What Novartis needs to do to make Medicines Co. deal a success
Research, sales and payer teams must execute for inclisiran to succeed in a market where would-be rivals Repatha and Praluent have faltered.
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Roche SMA therapy granted speedy FDA review; decision by May 2020
A quick approval of risdiplam, an oral therapy, could challenge Biogen and Novartis in a field that just three years ago had no treatment options.
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Karuna's 'A-ha moment': A billion-dollar stock swing and new expectations
Promising results from a schizophrenia study sent Karuna's shares soaring, putting the newly minted public biotech on the map in a difficult field.
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2 NASH drugmakers have wildly different Mondays
Shares of Intercept Pharmaceuticals rose on a positive FDA update, while CymaBay Therapeutics plummeted following a clinical trial setback.
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Novartis buys Medicines Co. in $9.7B bet on cholesterol drug
Acquiring The Medicines Company gives Novartis access to inclisiran, a lipid-lowering drug likely to win approval but facing uncertain commercial prospects.
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Deep Dive31 biopharmas at high risk of bankruptcy in 2020
BioPharma Dive dug into data from a credit monitoring firm to identify drugmakers at high risk of going bankrupt, including companies like Teva, Bausch Health and Novavax.
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'I believe the drug works.' Biogen CMO defends decision to submit Alzheimer's drug to FDA
The biotech is staking hopes for an approval of aducanumab on one Phase 3 trial it controversially declared a success last month.
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AI's impact in drug discovery is coming fast, predicts GSK's Hal Barron
The R&D chief believes researchers will discover a new drug target using machine learning within the next two or three years.
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Calquence OK boosts AstraZeneca's challenge to Imbruvica
The new FDA approval expands Calquence's use into a more common blood cancer, although doctors have already been prescribing it for that disease.
