BioCentury | Mar 27, 2020
Regulation

CHMP decisions set stage for approval of Novartis’ SMA gene therapy, Celgene’s Zeposia for MS, Sanofi’s comeback cancer drug

EMA’s CHMP backed conditional approval of an MAA for Zolgensma to treat spinal muscular atrophy in its March set of recommendations, which were made via a virtual meeting because of the COVID-19 outbreak. The agency...
BioCentury | Mar 26, 2020
Regulation

FDA finally approves ozanimod for MS, satisfying first criterion for Bristol-Celgene CVR; launch delayed due to COVID-19

FDA’s approval of Celgene’s multiple sclerosis drug Zeposia ozanimod represents the first domino to fall among three that could lead to a big payout for Celgene’s former shareholders, who would be owed a contingent value...
BioCentury | Mar 19, 2020
Product Development

Trials, in-hospital treatments and guidances hit snags in the wake of COVID-19

As vaccine and therapeutic companies ramp up clinical trials for COVID-19, other biotechs are halting trials to protect patients and to preserve hospital resources. The ripple effects of the pandemic are also beginning to play...
BioCentury | Mar 14, 2020
Politics, Policy & Law

Patient access to new Alzheimer’s drugs will depend on diagnostic innovation and payment reform

If Biogen’s Alzheimer’s disease therapy aducanumab gets approved this year, it will set off a payment time bomb given the huge patient population, and the fact it almost exclusively falls in the Medicare age group....
BioCentury | Feb 28, 2020
Distillery Therapeutics

Boosting OSM and TIMP1 levels to treat demyelinating diseases

DISEASE CATEGORY: Autoimmune disease INDICATION: Multiple sclerosis (MS) Promoting expression of OSM or its downstream mediator TIMP1 could treat demyelinating diseases such as MS. In cultures of oligodendrocyte precursor cells, which differentiate into the myelinating...
BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application...
BioCentury | Feb 25, 2020
Distillery Therapeutics

Inhibiting necroptosis to treat ischemic stroke

DISEASE CATEGORY: Neurology INDICATION: Stroke Preventing neuronal necroptosis by disrupting the interaction between ASIC1A, an acid-sensing ion channel, RIPK1 and NSF could treat ischemic stroke. During acidosis, the interaction between ASIC1A’s C- and N-termini is...
BioCentury | Feb 21, 2020
Product Development

T regs are back - promising to do for autoimmunity what CAR Ts have done in cancer

Drug developers are giving regulatory T cells a second look as treatments for autoimmune disease. The difference this time is that they can leverage orthogonal benefits from CAR T cells in cancer, capitalizing on new...
BioCentury | Feb 20, 2020
Emerging Company Profile

C. Light opens retinal window to neurological disease

UC Berkeley spinout C. Light thinks its retina tracking technology could capture early signs of neurological diseases and variability across different patients. “We’re looking to change neurology from a reactionary area of medicine to a...
BioCentury | Feb 8, 2020
Product Development

Feb. 7 Product Development Quick Takes: Myriad tumbles on revenue miss; plus Verana, Sanofi, VIB, Coda, Blueprint

Myriad misses Street as CEO Capone departs Myriad Genetics Inc. (NASDAQ:MYGN) fell $8.27 (28%) to $21.02 after reporting fiscal 2Q20 EPS and revenues that missed consensus estimates and announcing the departure of President and CEO...
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