Alkermes plc’s plan, unveiled this summer, to “retool” its opioid drug R&D got its first vote of confidence from the FDA, which is letting the company forgo the customary end-of-Phase-II meeting and move directly into Phase III trials with Alks 5461 for refractory major depressive disorder (MDD). Read More
Although the Supreme Court is just getting into the swing of its fall term, drugmakers seeking relief from escalating damage awards and shareholder lawsuits have already lost a few battles. Read More
Lpath Inc. moved quickly to digest the disappointment that partner Pfizer Inc. plans to divest “a number of” its ophthalmology R&D assets, including its exclusive option for a global license to develop and commercialize Lpath’s wet age-related macular degeneration (AMD) candidate Isonep. Scott Pancoast, Lpath’s president and CEO, said the path forward for Isonep is a choice between regaining rights to the compound, currently in a four-arm Phase II study, or having them reassigned to a third-party bidder – either of which offers potential upside. Read More
SAN FRANCISCO – New platforms for crowdfunding of biotech are cropping up as a potential solution to the eternal funding gap for new companies. Representatives from traditional venture investing and the newer crowdfunding paradigm discussed the problems and potential of bringing more and smaller investors into biotech at the early stages at the BIO Investor Forum in San Francisco. Read More
LONDON – Pharming Group NV has taken the opportunity to raise €12 million (US$16.2 million) in a private placement after institutional investors started to buy its shares in the market. Read More
The 2013 Nobel Prize in Chemistry was awarded to Martin Karplus, Michael Levitt and Arieh Warshel, “for the development of multiscale models for complex chemical systems.” Read More
• Catalyst Biosciences Inc., of South San Francisco, and Isu Abxis, a Korean biologics manufacturing and development company, formed a collaboration to develop Catalyst’s next-generation Factor IX development candidate, FIX-NG (CB 2679d), for the prevention and treatment of bleeding in hemophilia B patients. Read More
• Morphotek Inc., of Exton, Pa., a subsidiary of Eisai Inc., said the Children’s Oncology Group (COG) has opened enrollment in a Phase I trial with MORAb-004 in pediatric patients with relapsed/refractory solid tumors. The open-label study will assess the safety, tolerability and pharmacokinetics of MORAb-004 administered in weekly intravenous infusions. Read More
• Bayer Healthcare, of Whippany, N.J., said the FDA approved Adempas (riociguat) tablets to treat adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and to treat adults with pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class and delay clinical worsening. Read More
• Pfizer Inc., of New York, reported top-line results from two Phase III trials of tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated to treat adults with moderate-to-severe chronic plaque psoriasis: OPT Compare (A3921080) and OPT Retreatment (A3921111). Read More
