Tilray announced that the U.S. Drug Enforcement Administration as granted approval to import a cannabinoid study drug into the United States from Canada for a clinical trial at the University of California San Diego Center for Medicinal Cannabis Research examining its safety, tolerability and efficacy for Essential Tremor. Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol and tetrahydrocannabinol. Dr. Fatta Nahab, a board-certified neurologist and director of the Functional Imaging of Neurodegenerative Disorders Lab at the UC San Diego Health’s Movement Disorder Center, will serve as the principal investigator for the study. It is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation. Essential Tremor is a neurological movement disorder characterized by involuntary and rhythmic shaking. ET has extremely high prevalence rates; 0.4% of the general population suffer from ET, and that figure rises to 4.6%-6.3% among those 65 and older. Essential Tremor can have a significant impact on a patient’s quality of life, causing embarrassment, social withdrawal, disability, and loss of occupation. Many patients do not experience relief with the current drugs on the market or find the side-effects of these drugs to be unbearable.
Tuesday, September 18, 2018
AstraZeneca says FASENRA shows consistent safety, efficacy in trial
AstraZeneca announced results from the Phase III extension BORA trial evaluating the long-term safety and efficacy of FASENRA as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials. In the BORA trial, FASENRA given for an additional 56 weeks showed a safety and tolerability profile similar to that observed in the placebo-controlled SIROCCO and CALIMA trials, with no increase in the frequencies of overall or serious adverse events. The improvements in efficacy measures observed with FASENRA in the SIROCCO or CALIMA trials were maintained over the second year of treatment. Patients who were treated with placebo in the SIROCCO and CALIMA trials and subsequently transitioned to FASENRA in the BORA trial experienced improvements in efficacy outcomes consistent with those observed for FASENRA-treated patients in the previous trials. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus. 74% of patients with a baseline blood eosinophil count of 300 cells per muL or greater who received FASENRA every eight weeks continuously from SIROCCO or CALIMA and into BORA, were exacerbation-free in BORA in their second year of treatment and maintained improvements in lung function and asthma control. 65% and 66%, respectively, of patients with a baseline blood eosinophil count of 300 cells per muL or greater who received FASENRA 30 mg every eight weeks were exacerbation-free their first year of treatment in the one-year, predecessor SIROCCO and CALIMA trials. The BORA data will be presented during a late-breaking oral session at the European Respiratory Society International Congress 2018 in Paris, France. The overall annual asthma exacerbation rate for patients with baseline blood eosinophil counts of 300 cells per muL or greater who received FASENRA every 8 weeks continuously was consistent with the predecessor SIROCCO and CALIMA trials. Overall improvements in lung function, asthma control, asthma-related and general health-related quality of life scores were maintained for patients who received FASENRA continuously and were improved for patients previously receiving placebo in SIROCCO or CALIMA. Near complete eosinophil depletion was maintained in patients who continuously received FASENRA. The most commonly-reported adverse events in BORA were upper respiratory tract infection, worsening asthma, headache, bronchitis and acute sinusitis. The most commonly-reported adverse events in SIROCCO, CALIMA and ZONDA were headache and pharyngitis.
Novo Nordisk announces plans to restructure R&D
Novo Nordisk announced plans to restructure its Research & Development, or R&D, organization to accelerate the expansion and diversification of its pipeline across serious chronic diseases. To enable increased investment in transformational biological and technological innovation within both core and new therapy areas, approximately 400 employees will be laid off from R&D roles in Denmark and China. To support its strategic ambitions, Novo Nordisk will establish four Transformational Research Units in 2018 to pursue novel treatment modalities and platform technologies. The biotech-like units, based in Denmark, the US and the UK, will operate as satellites of Novo Nordisk’s central R&D function and will drive innovation in priority fields such as translational cardio-metabolic research and stem cell research. Furthermore, to drive a faster and more efficient path towards lead molecule selection and development, Novo Nordisk will significantly increase its investment in automation and digital capabilities including machine learning and artificial intelligence. The integration of laboratory infrastructure and IT systems will also be prioritized to increase the efficiency of the R&D organization, the company said. “The restructuring and re-allocation of resources supports Novo Nordisk’s ambition to transform the way it works within R&D in order to identify and develop truly innovative drug candidates. This will be facilitated by the identification and pursuit of new therapeutic approaches based on external collaborations – a priority that Novo Nordisk will accelerate via the establishment of a new Business Development unit in Cambridge, MA, US,” Novo Nordisk added.
Evolus selloff yesterday not based on fundamentals, says Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen sees no fundamental reason for the 12% pullback yesterday in shares of Evolus (EOLS). The stock weakness was partly attributed to the “upbeat and well-attended” investor day held by competitor Allergan (AGN) last Friday, Chen tells investors in a research note. The analyst points out that shares of Revance (RVNC), which also competes with Allergan in the botulinum toxin space, dropped yesterday as well. Chen believes Allergan’s investor day renewed concerns that the company is and will remain the leading botulinum toxin/aesthetics player in the space. However, this is nothing new and is already priced into Evolus’ valuation, Chen contends. The analyst continues to expect the company’s launch of DWP-450 in spring 2019 to exceed “modest expectations.” She keeps an Overweight rating on the shares with a $35 price target.
Argenx price target raised to $121 from $114 at Wedbush
Wedbush analyst David Nierengarten raised his price target for Argenx to $121 from $114 as he lowered his discount rate on the program following positive topline efgartigimod data in immune thrombocytopenia that demonstrated clinically meaningful improvements in platelet counts that were both deep and durable compared to placebo. In a research note to investors, the analyst says Argenx plans on moving efgartigimod into a Phase 3 ITP trial it schedules an end of Phase 2 meeting with the FDA and looks forward to full ITP data at the ASH meeting in December. Nierengarten maintains an Outperform rating.
https://thefly.com/landingPageNews.php?id=2791873
Zimmer Biomet has opportunity to show turnaround progress, says Cowen
Cowen analyst Joshua Jennings noted supply constraints have weighed on the financials of Zimmer Biomet, but it looks to be nearing a resolution point. The analyst said management expressed cautious optimism toward Q3, citing supply recovery efforts and new product launches as positive tailwinds. Jennings maintained his Market Perform rating and $130 price target on Zimmer Biomet shares.
https://thefly.com/landingPageNews.php?id=2791885
Durect’s Methydur Sustained Release Capsules receive authorization in Taiwan
DURECT announced that Orient Pharma, its licensee for certain Asian and South Pacific countries, has informed DURECT that it has obtained marketing authorization from the Ministry of Health and Welfare in Taiwan for Methydur Sustained Release Capsules. Methydur Sustained Release Capsules are indicated for the treatment of attention deficit hyperactivity disorder, or ADHD, and will be available in three strengths in Taiwan. Orient Pharma also has stated that it expects to have Methydur Sustained Release Capsules commercially available in Taiwan in 2019, while seeking a partner in China and pursuing regulatory approvals in selected other countries where it has commercialization rights and a commercialization presence.
https://thefly.com/landingPageNews.php?id=2791925
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