The Daily Reviewer | multiple sclerosis

Acorda MS drug approval sparks buyout buzz

Jan 25, 2010 5:07am

Late Friday afternoon regulators at the FDA approved Acorda's multiple sclerosis drug Ampyra based on data demonstrating that patients taking dalfampridine were able to walk faster than a control group. And this is the first time the FDA has approved a therapy for improving walking speeds. "Trouble with walking is one of...

FDA approves Acorda's new MS drug

Jan 22, 2010 12:49pm

The FDA announced Friday afternoon that it has approved Ampyra (dalfampridine) extended-release tablets to improve walking in patients with multiple sclerosis. In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with a placebo. This is the first drug approved for this use. "Trouble with walking is one...

Blockbuster data: Studies back efficacy of late-stage MS pills

Jan 21, 2010 6:31am

A trio of new studies has underscored both the distinct therapeutic advantages as well as the blockbuster market potential of two new oral drugs for multiple sclerosis. But while the studies demonstrated a reduction in the number of relapses and a slowing of disease progression--while beating an established interferon therapy...

Avanir stock boosted by promising Zenvia data

Oct 9, 2009 8:23am

A Phase III trial of Avanir Pharmaceuticals' closely-watched drug Zenvia showed that the drug relieved Pseudobulbar affect (PBA) in a subset of multiple sclerosis patients, sending Avanir's stock up as much as 16 percent. PBA is a neurologic disorder that occurs secondary to neurologic disease or brain injury, causing sudden and...

Novartis on track to seek oral MS drug OK

Sep 30, 2009 4:36am

Novartis took a big stride toward filing for approval on an oral therapy for multiple sclerosis, revealing that a two-year, Phase III trial for FTY720 produced solid evidence of its superiority to a placebo. Better yet, though, some analysts were quick to conclude that the data lays out a clear case...

Opexa shares rocket up on promising MS trial data

Sep 8, 2009 8:23am

Shares of Opexa Therapeutics more than doubled this morning after the developer announced that 83 percent of all patients taking its therapeutic vaccine for multiple sclerosis had remained relapse-free for a year. The mid-stage trial focused on 150 patients with relapsing-remitting MS, an early stage at which the disease flares up and...

Merck KGaA races to regulators with oral MS drug

Jul 23, 2009 6:05am

Racing to beat Novartis to the world's biggest drug markets with a new oral therapy for multiple sclerosis, Merck KGaA has filed for regulatory approval of cladribine in Europe and plans to file in the U.S. later this quarter. The application brings Merck "closer to the possibility of providing an oral short-course treatment to...

Analysts applaud positive MS data for Merck KGaA drug

Apr 30, 2009 7:30am

Analysts were juggling a new set of positive data about the efficacy of Merck KGaA's cladribine--a potential blockbuster which would be the first oral drug for multiple sclerosis, if approved--against safety concerns about a small number of cancer cases reported among the study group. Their verdict: Good overall but worries remain...

Novartis, Merck KGaA spotlight new MS drugs

Apr 27, 2009 6:34am

Novartis and Merck KGaA are leading a group of developers who are advancing a new generation of therapies for multiple sclerosis. The National Multiple Sclerosis Society says it is tracking five new pills and two infusion therapies that could be approved by 2014. Both Novartis and Merck will be in the...

Acorda resubmits MS drug early, shares jump

Apr 23, 2009 1:14pm

Acorda saw its shares rebound Thursday on the news that the company has resubmitted its experimental multiple sclerosis drug fampridine to the FDA ahead of schedule. Last month, the FDA refused to review the drugmaker's application, asking the company to reformat its submission and provide more information on the drug. The...

MS Society teams with Merck KGaA on $19M R&D pact

Mar 18, 2009 7:51am

Merck KGaA is funneling $19 million into a joint research project between one of its subsidiaries--EMD Serono--and the National Multiple Sclerosis Society to fast-track new therapies for MS. The deal starts as a two-year R&D pact with an option to extend it by another three years. Under the deal, EMD Serono will...

Acorda reports positive results on MS drug

Feb 27, 2009 6:08am

Acorda Therapeutics registered positive results from a late-stage trial of a new drug under review for approval to treat multiple sclerosis. Researchers said that slightly more than a third of the patients taking fampridine were able to walk faster over the 14-week course of the study, compared to only 8 percent...

Biogen explores new therapy to repair MS damage

Jan 21, 2009 6:54am

The Wall Street Journal takes a close look at Biogen Idec's preclinical program for a new drug designed to repair the damage wrought by multiple sclerosis. Evidently a first for any developer, the biotech's researchers are exploring the therapeutic value of an antibody that inhibits the Lingo molecule from blocking...

Novartis gains option to license MS drug

Jan 15, 2009 8:20am

Novartis has gained the option to develop and commercialize Peptimmune's multiple sclerosis drug candidate PI-2301, in a deal that could be worth up to $500 million. If Novartis chooses to exercise that option, it will take on clinical development, manufacturing and marketing of PI-2301 and all associated costs. Peptimmune stands to...

Novartis touts new MS data

Dec 15, 2008 8:56am

Novartis is touting new data that demonstrates its experimental pill for multiple sclerosis performed better than Biogen Idec's established injectable Avonex. And Novartis says it is on track to file for an approval in late 2009. Researchers reported fewer relapses for FTY720 compared to Avonex. Report...

Avigen shares plunge on mid-stage trial failure

Oct 21, 2008 7:32am

Shares of Avigen went into a free fall after the developer announced that its mid-stage trial for an experimental therapy for spasticity associated with multiple sclerosis failed to meet its primary endpoint. Patients taking AV650 failed to demonstrate a statistically significant improvement in increased resistance to passive limb movement when...

Biogen Idec data supports oral MS therapy

Sep 19, 2008 7:52am

Biogen Idec says that new data shows that an experimental therapy for MS--BG-12--prevented the worsening of brain lesions. In the trial, the drug reduced the conversion of inflammation spots into permanent damage--a key objective. The company is trying to get the first approval for an oral therapy for MS. Late-stage...

BioMS wins $10M milestone on pivotal trial progress

Aug 14, 2008 8:13am

According to BioMS Medical, an independent monitoring board has recommended that a phase II/III study of dirucotide (MBP8298) in patients with secondary progressive MS should continue to completion. And that milestone is worth a $10 million payment from Eli Lilly, which is partnered on the project. The interim analysis assessed the...

Merck Serono, Bionomics partner on MS programs

Jun 18, 2008 8:45am

Merck Serono has signed up with Bionomics in a quest to develop new therapies for multiple sclerosis. Bionomics gains $2 million upfront, committed research funds and a partner who will pay up to $47 million for each new program they pursue. The collaboration will target the potassium ion channel Kv1.3,...

Biovail focuses on CNS drugs

Jun 13, 2008 9:34am

As the battle for Biovail continues, current CEO William Wells emphasized the company's focus on CNS drug development at Goldman Sachs' annual healthcare conference. Biovail is investing $600 million over the next four years for work on epilepsy, multiple sclerosis, and Parkinson's. Wells said the company will "maintain its drug delivery technology...