Industry News

- Read more about BioXcel’s BXCL101, Receives Orphan Drug Designation from the U.S. FDA
BioXcel, a privately held biopharmaceutical company based in Connecticut, announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Type 2 (NF2), an orphan disease with significant unmet medical need. BXCL101 is the first and only systemic therapy being developed to eliminate existing lesions and prevent the formation of new lesions by targeting the molecular mechanism of NF2 pathophysiology.
- Read more about Akari Therapeutic’s Coversin receive Orphan Drug Designation from the U.S. FDA
Akari Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted to Akari an Orphan Drug Designation for recombinant protein inhibitor of complement factor 5 for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Coversin, Akari’s lead clinical product, which falls within the Orphan Drug Designation, is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC).

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- Read more about Snail venom contains 'ultra-fast-acting' insulins
New research has found that venom extracted from a species of marine cone snail could hold the key to developing 'ultra-fast-acting' insulins, leading to more efficient therapies for diabetes management.
- Read more about New Research could lead to novel HIV vaccine
A new study from scientists at The Scripps Research Institute (TSRI) shows that "holes" in HIV's defensive sugar shield could be important in designing an HIV vaccine.
- Read more about Sanofi & Google joint for Diabetes Management
Sanofi and Verily Life Sciences LLC, (formerly Google Life Sciences), an Alphabet company, today announced the launch of Onduo, a joint venture created through Sanofi and Verily’s diabetes-focused collaboration. The joint venture is based in Kendall Square in Cambridge. Onduo’s mission is to help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management.
- Read more about USFDA & EC grant Orphan Drug Designation to Boehringer Ingelheim’s Nintedanib
Boehringer Ingelheim announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).
- Read more about Novartis launch Niji System & Total IgE test
Novartis introduces a novel in office point of care diagnostic tool - the Niji System and Total IgE Test. This first test delivers quantitative total IgE (Immunoglobulin E) levels in about 12 minutes using only one to two droplets of finger stick blood, allowing for quick in-office diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.
- Read more about Adverse effect of Afatinib can reduce with dosage monitoring, says Clinical Trial
Results from a new post-hoc analysis of two large phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Giotrif (afatinib) in patients with advanced non-small cell lung cancer (NSCLC) were published in Annals of Oncology. The analysis suggests specific dose reductions, as described in SmPC / prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.
- Read more about Biogen to present new research from MS patients at ECTRIMS congress
Biogen announced that the new research collected from more than 16,000 multiple sclerosis (MS) patients across Europe, in the largest study to capture the widespread impact of the disease, along with updated clinical findings from the company's broad portfolio of MS therapies will be presented at the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London, 14-17 September 2016.
- Read more about Raptor Pharma presents positive results from Quinsair study at ERS congress
Raptor Pharmaceutical Corp., a biopharmaceutical company developing and commercializing transformative treatments for rare diseases, presented results from a network meta-analysis comparing inhaled antibiotics for cystic fibrosis (CF) patients with lung infections involving Pseudomonas aeruginosa. The study showed that Quinsair, a levofloxacin inhalation solution, had efficacy comparable to three other inhalable antibiotics also approved for use in Europe. These data were presented at the European Respiratory Society (ERS) International Congress 2016 in London.

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