BioCentury | Apr 24, 2020
Product Development

Sanofi sets MS submission goals for Principia-partnered Btk inhibitor, details Phase II data

Two months after Sanofi announced plans to send its oral multiple sclerosis therapy into Phase III testing, the company unveiled the detailed Phase IIb data from recurring MS patients driving the Btk inhibitor’s clinical advancement....
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 | Nov 1, 2019
Product Development

Novartis, Merck KGaA see opportunity in select pockets of MS patients

As companies continue to pile into the multiple sclerosis market with new therapies, Novartis and Merck KGaA are dissecting the landscape to define populations for their newly launched drugs. While the former is staking out...
BioCentury | Oct 25, 2019
Product Development

Deciding factors in the shifting MS treatment landscape

The efficacy and convenience advantages that established oral medicines as the go-to therapy in multiple sclerosis are the same factors now squeezing them out. Two years post-launch, the success of injectable Ocrevus ocrelizumab from Roche...
BioCentury | Sep 13, 2019
Clinical News

Novartis’ ofatumumab data comparable to Ocrevus in RRMS

Roche’s blockbuster MS therapy Ocrevus ocrelizumab could soon have company in relapsing-remitting multiple sclerosis as Phase III data presented Friday for ofatumumab by Novartis show the two anti-CD20 mAbs could have comparable efficacy. Data from...
BioCentury | Sep 11, 2019
Product Development

Pharmas’ challenge: learning from rare disease units while leaving them alone

How do you build a rare disease portfolio inside a pharma focused on large indications, and do right by both the new and the old? That’s a question faced by pharmas expanding from their traditional...
BioCentury | Aug 30, 2019
Clinical News

Aug. 30 Clinical Quick Takes: Pharnext falls on FDA request for second Phase III study, plus Genentech, Novartis and Seqirus

Pharnext shares sag on regulatory slowdown Shares of Pharnext S.A. (Euronext:ALPHA) lost €4.99 (41%) to €7.16 on Friday after the company said FDA advised it to conduct a second Phase III study of PXT3003 prior...
BioCentury | Aug 21, 2019
Distillery Therapeutics

Targeting CAD or DHODH to inhibit pyrimidine synthesis for glioblastoma

DISEASE CATEGORY: Cancer INDICATION: Brain cancer Blocking pyrimidine synthesis via inhibition of CAD or DHODH, an enzyme downstream CAD, could treat glioblastoma. In patients, high tumor expression of a pyrimidine metabolism gene signature was associated...
BioCentury | Jul 25, 2019
Clinical News

July 25 Clinical Quick Takes: J&J’s ponesimod hits MS endpoint; plus a CRISPR first, Genkyotex and Aeglea

Janssen’s ponesimod tops Aubagio in Phase III The Janssen Pharmaceuticals unit of Johnson & Johnson (NYSE:JNJ) said it plans to submit NDAs to FDA and EMA this year after reporting ponesimod met the primary endpoint...
BioCentury | May 20, 2019
Distillery Therapeutics

Aubagio and other DHODH inhibitors as epilepsy therapies

DISEASE CATEGORY: Neurology INDICATION: Epilepsy Patient sample, cell culture and mouse studies suggest inhibiting DHODH could help treat epilepsy. Metabolic modeling of transcriptome data from the cortex and hippocampus of epilepsy patients and two rat...
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