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News Breaks
March 21, 2014
08:06 EDTSNYGenzymeís Lemtrada approved in Brazil for MS treatment
Genzyme, a Sanofi company, announced that Brazilís national health surveillance agency, ANVISA, has approved Lemtrada for the treatment of patients with relapsing forms of multiple sclerosis. The approval in Brazil follows the recent approvals of Lemtrada in Mexico, Canada, Australia and the European Union. Lemtrada is currently not approved in the U.S. The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a in patients with RRMS who had active disease and were either new to treatment or who had relapsed while on prior therapy. In CARE-MS I, Lemtrada was more effective than interferon beta-1a at reducing annualized relapse rates. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The most common side effects of Lemtrada are infusion associated reactions, infections, lymphopenia and leukopenia. Autoimmune conditions and serious infections can occur in patients receiving Lemtrada.
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September 30, 2014
16:39 EDTSNYCMS discloses drug makers' payments to doctors, WSJ says
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10:53 EDTSNYRegeneron dupilumab opportunity improved with new data, says Piper Jaffray
Piper Jaffray said it is increasingly optimistic about dupilumab's broad potential in allergic diseases following the Phase II data on chronic sinusitis with nasal polyps as well as prior data in atopic dermatitis and asthma. The firm views dupilumab as a potential blockbuster and reiterates its Overweight rating and $382 price target on Regeneron (REGN), which announced the data in partnership with Sanofi (SNY).
07:30 EDTSNYSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
05:16 EDTSNYRegeneron, Sanofi announce positive Phase 2 top-line dupilumab results
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps, or CSwNP, who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
September 24, 2014
17:01 EDTSNYMannKind announces closing of global licensing agreement with Sanofi
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08:10 EDTSNYSanofi unit announces research collaboration
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September 23, 2014
09:00 EDTSNYBofa/Merill special situations team to hold an analyst/industry conference call
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September 22, 2014
07:21 EDTSNYEBD Group to hold a conference
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September 17, 2014
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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