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in Clinical Research

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in Clinical Research




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Executives On The Move: Operations Change At Khondrion And A Promotion At Grunenthal

Thu, 12/19/2019 - 2:41am

Khondrion BV, developer of therapies for mitochondrial disease, has appointed a former Novartis SVP as COO, and pain and inflammation...

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Patent Pool Strikes Deals with Cipla, Pfizer For New HIV, TB Drugs

Wed, 12/18/2019 - 7:09pm

The Medicines Patent Pool, a UN-backed public health organization, has announced deals with two major global pharma firms aimed at...

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Astellas, Seattle Genetics Break Ground With US ADC Approval

Wed, 12/18/2019 - 7:03pm

Co-developers gain nod for novel antibody-drug conjugate that provides new option for patients with advanced form of bladder cancer.

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Tech Transfer Roundup: MD Anderson Inks Set Of IO Deals Covering US, UK, Japan, China

Wed, 12/18/2019 - 1:09pm

Three separate agreements team the innovative cancer research center with Takeda, Artios/ShangPharma, and Ziopharm. Hoth continues busy deal-making year by...

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Can Low LSD Doses Address Alzheimer’s Disease?

Wed, 12/18/2019 - 7:18am

The CEO of Eleusis tells Scrip how the privately held biotech plans to progress low-dose lysergic acid diethylamide (LSD) to...

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FDA Panel Tentative Yes To AZ’s Lynparza In Pancreatic Cancer

Wed, 12/18/2019 - 6:04am

Lynparza doubled PFS in metastatic patients with germline mutations in BRCA but the FDA usually wants to see OS data...

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First Generic Of Gilead’s Biktarvy In India Debuts

Tue, 12/17/2019 - 10:20pm

Hetero launches cut-price version of Gilead’s Biktarvy in India but 20 other India-based firms also hold licenses for the product...

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Podcast: Significant Approvals, Diabetes And NASH In India, Japan M&A

Tue, 12/17/2019 - 3:37pm

Join the Asia-based content team for Scrip and the Pink Sheet for their first podcast as they take a look at...

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Alnylam Seeking Lumasiran Approvals Soon, But Has Two Rivals On Its Heels

Tue, 12/17/2019 - 3:13pm

Phase III results support early 2020 filings for what could be the RNAi specialist’s third commercial product, but two competing...

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Intercept’s Early NASH Efforts Will Stress Advanced Fibrosis

Tue, 12/17/2019 - 12:12pm

Intercept said its commercial groundwork in NASH centered on identifying doctors who treat patients with advanced fibrosis and talking to...

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Pipeline Watch: The ASH Bumper Edition

Tue, 12/17/2019 - 7:26am

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...

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GSK Files Its BCMA Drug In Multiple Myeloma

Tue, 12/17/2019 - 7:05am

GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate...

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Axsome Soars After Depression Trial Success

Tue, 12/17/2019 - 6:44am

Axsome is set to file for approval in the second half of 2020.

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Wave Crashes Down On Duchenne Fail

Tue, 12/17/2019 - 4:37am

Having spectacularly failed even to match Sarepta’s Exondys 51 in the restoration of dystrophin in Duchenne muscular dystrophy patients, Wave's...

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EU Approval Delay for Janssen’s Spravato?

Tue, 12/17/2019 - 2:57am

The EMA has received written interventions from third parties relating to its CHMP opinion that the controversial antidepressant should receive...

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Roche/Spark Deal Clears FTC In A Sigh Of Relief For Pharma Dealmakers

Mon, 12/16/2019 - 3:31pm

US Federal Trade Commission says it conducted an "exhaustive" 10-month investigation and determined Roche would not have incentive to delay...

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