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News Breaks
March 25, 2013
07:53 EDTSNY, TEVA, BIIB, NVSRuling on Sanofi MS drug may have implications for Teva, Biogen, Reuters says
Sanofi's (SNY) new multiple sclerosis pill Aubagio won an EU approval recommendation, but the European Medicines Agency refused to give it a "new active substance" designation because it is too similar to an older drug, meaning generic copies could be launched in Europe in as little as three years, reported Reuters, citing a Bernstein analyst. The analyst added that such generics could "wreak havoc" on the rest of the European MS market and could impact drugs from Teva (TEVA), Biogen Idec (BIIB) and Novartis (NVS). Reference Link
News For SNY;TEVA;BIIB;NVS From The Last 14 Days
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September 30, 2014
16:39 EDTSNY, NVSCMS 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 EDTNVS, SNYSachs 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 29, 2014
08:07 EDTNVSPhase 2 trial of binimetinib in NRAS melanoma shows promising clinical activity
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07:26 EDTBIIBInforma Business Information to hold a conference
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07:19 EDTTEVAUBS to hold a field trip
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05:26 EDTTEVAProtalix appoints Moshe Manor as CEO
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September 26, 2014
07:30 EDTNVSNovartis drug Signifor LAR recommended by CHMP for EU approval
The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion for Signifor long acting release, or LAR, formulation to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. If approved in the EU, this next-generation SSA could fill a current unmet need, providing a new therapeutic option for the approximately 45% of acromegaly patients whose growth hormone, or GH, or insulin-like growth factor-1, or IGF-1, levels remain inadequately controlled despite treatment with currently available SSAs.
September 25, 2014
05:28 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies
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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
16:07 EDTNVSAnacor announces commercial launch of KERYDIN topical solution in U.S.
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07:21 EDTSNY, BIIBEBD Group to hold a conference
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September 17, 2014
11:01 EDTTEVAActavis drops after NY AG seeks to block Alzheimer drug switch
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08:05 EDTTEVAEagle Pharm says Teva requests motion to dismiss Bendamustine lawsuit
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06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTNVSEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.

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