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49943 items
1:40 PM, Feb 12, 2018  |  BC Extra | Company News

Poxel finds U.S., European partner for imeglimin

Poxel S.A. (Euronext:POXEL) added €0.65 (10%) to €6.87 on Monday after granting Roivant Sciences GmbH (Basel, Switzerland) rights to late-stage Type II diabetes candidate imeglimin (PXL008). Poxel will receive an upfront payment of $35 million...
12:28 PM, Feb 12, 2018  |  BC Extra | Company News

Liquid biopsy group releases first open access data set

The Blood Profiling Atlas in Cancer Consortium (BloodPAC), a nonprofit seeking to spur development of cancer liquid biopsy technology, released to the public its first data set on its BloodPAC Data Commons. The BloodPAC Data Commons...
8:45 AM, Feb 12, 2018  |  BC Extra | Preclinical News

HDAC3 inhibition promotes peripheral remyelination

A study published in Nature Medicine identified histone deacetylase 3 (HDAC3) as a target for boosting remyelination in peripheral neuropathies. Following demyelination in a mouse model of sciatic nerve injury, researchers from Cincinnati Children’s Hospital Medical...
4:56 PM, Feb 09, 2018  |  BC Extra | Financial News

Biotech index gains erased, fund flows into the red

The return of drug pricing rhetoric and global stock market volatility have rocked biotech indexes over the last two weeks, wiping out most of what had been strong year-to-date gains. Fund flows into the space...
4:55 PM, Feb 09, 2018  |  BC Extra | Politics & Policy

CEA recommends pricing reforms at home and abroad

The Council of Economic Advisers issued a white paper proposing ways that the U.S. government can reduce drug prices while also fostering innovation. The paper included recommendations to reform policies that hinder price competition at...
3:52 PM, Feb 09, 2018  |  BC Extra | Politics & Policy

American College of Rheumatology recommends biosimilars for rheumatic disease

In a white paper published in Arthritis & Rheumatology, the American College of Rheumatology now recommends the use of biosimilars to treat rheumatic disease, saying they should be incorporated into the U.S. healthcare system. The authors...
3:48 PM, Feb 09, 2018  |  BC Extra | Financial News

InnoCare raises $55M

InnoCare Pharma Ltd. (Beijing, China) raised $55 million in a financing led by Vivo Capital. Existing investor Jianxin Capital also participated. InnoCare is developing through R&D and in-licensing a pipeline of immune-modulating therapies to treat autoimmune...
3:23 PM, Feb 09, 2018  |  BC Extra | Politics & Policy

FDA unveils system to facilitate patient meeting requests

FDA launched a new system to make it easier for non-industry stakeholders -- such as patient advocacy groups and providers -- to request drug-related meetings with the agency's Center for Drug Evaluation and Research, according...
3:08 PM, Feb 09, 2018  |  BC Extra | Politics & Policy

CFDA releases submission guidelines for anti-PD-1, PD-L1 mAbs

China FDA's Center for Drug Evaluation (CDE) said single-arm trials with objective response rate (ORR) as the primary endpoint are sufficient for sponsors wanting to submit rolling NDAs for checkpoint inhibitors. The country has yet...
2:20 PM, Feb 09, 2018  |  BC Extra | Clinical News

Sarepta's DMD trial halted in U.K. on safety signal

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said it halted dosing at U.K. study sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045) to treat Duchenne muscular dystrophy. Sarepta shares were off $2.03 to...