The FDA granted orphan designation to Hansa Medical's IdeS, which is being developed as a treatment for patients with Guillain-Barré syndrome. The company anticipates results later this year from two ongoing studies in highly sensitized patients who do not respond to available desensitization methods.
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Osmotica Pharmaceutical received approval from the FDA for its once-daily Osmolex ER, or amantadine, extended-release tablets as a treatment for patients with Parkinson's disease and drug-induced extrapyramidal reactions in adults.
Pragma Pharmaceuticals is expected to launch Decadron, or dexamethasone, tablets this year. The drug is used to treat inflammation in disorders of organ systems, including dermatological, gastrointestinal, neoplastic, renal and respiratory diseases; allergies; and endocrine, hematologic, neurologic, ophthalmic and rheumatic disorders.
Janssen reported at the 2018 American Academy of Dermatology that patients with moderate to severe plaque psoriasis who were treated with Tremfya, or guselkumab, achieved 90% improvement in their condition at week 28 and maintained that through to week 72 if treatment was continued. Results were from the VOYAGE 2 study, which also demonstrated that 87.6% of the 173 patients who stopped receiving the drug achieved a Psoriasis Area and Severity Index 90 response within six months of restarting retreatment.
FDA Commissioner Scott Gottlieb said the agency is taking steps to prevent the potential misuse and abuse of gabapentinoids, which could result in serious adverse events. The agency was alarmed by reports of off-label prescribing of gabapentinoids to treat pain, and as an alternative to opioids.
An upsized follow-on funding brought in $300 million for Amicus Therapeutics. Amicus' new-drug application for migalastat, indicated for patients 16 years of age or older with Fabry's disease who have amenable mutations, received priority review status by the FDA.
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Health Canada has approved Roche and Genentech's Ocrevus, or ocrelizumab, as a treatment for adult patients with early-stage primary progressive multiple sclerosis and signs of inflammatory activity. The decision was backed by results of the ORATORIO study, in which the patients who were treated with Ocrevus had a 25% lower risk of disability progression sustained for at least 24 weeks versus placebo use.
The FDA, European Medicines Agency and Japan Pharmaceutical and Medical Devices Agency are reviewing Pfizer's new drug application for lorlatinib, an anaplastic lymphoma kinase tyrosine kinase inhibitor for patients with ALK-positive metastatic non-small cell lung cancer who were previously treated with another ALK TKI. The experimental drug blocks tumor mutations that cause drug resistance and crosses the blood-brain barrier, according to Pfizer.
Food Standards Australia New Zealand released a consultation paper encouraging views on how it will regulate food products derived from biotechnology. "The review is being conducted to ensure that a broad range of issues has been considered before any decision is made to consider varying the Code," said FSANZ CEO Mark Booth.
The PT Jakarta Tank Terminal's total tank capacity for ethanol, biodiesel and gas will be expanded to more than 350,000 cbm, including an additional eight tanks with a capacity of 100.000 cbm. The expansion will enable compliance with Indonesia's Biofuel Blending Mandate regulations.
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