Noven Pharmaceuticals Inc., of Miami, said it entered an agreement with Shionogi & Co. Ltd., of Osaka, Japan, to co-promote Brisdelle (paroxetine) capsules, 7.5 mg. Read More
SAN FRANCISCO – As Wall Street calmed in the wake of Alnylam Pharmaceuticals Inc.’s double shot of news – a $700 million expansion of the pact with Sanofi SA’s Genzyme unit, and the $175 million buyout of RNAi peer Sirna Therapeutics Inc. – investor eyes turned to the prospects of ALN-TTR-sc, the subcutaneous therapy targeting transthyretin (TTR), in Phase II trials for familial amyloid cardiomyopathy (FAC). Read More
Teva Pharmaceuticals Industries Ltd., of Jerusalem, said data that demonstrates significant differences in biological and immunological effects between Copaxone (glatiramer acetate, GA) and a purported generic glatiramer acetate (GA), marketed in India, (Glatiramer, Natco Pharma Ltd., Hyderabad, India), with potential clinical ramifications were published in PLOS ONE. Read More
Argen-X BV, of Breda, the Netherlands, reported it has advanced its CD-70 targeting ARGX-110 into the safety and efficacy expansion part of its Phase Ib study to further investigate its safety in CD70-positive cancer patients, and to evaluate efficacy in order to select the indications to be studied in Phase II clinical development. Read More
Mimetas BV, of Leiden, the Netherlands, and Galapagos NV, of Mechelen, Belgium, are collaborating on the development of organ-on-a-chip-based human disease models for new drug development. Read More
SAN FRANCISCO – Jacqualyn Fouse, Celgene Corp.’s executive vice president and chief financial officer, drew polite laughter in the overcapacity breakout session following the company’s presentation at the 32nd Annual J.P. Morgan (JPM) Healthcare Conference when she said “we might want to save a few things for our earnings call” on Jan. 30. Read More
SAN FRANCISCO – The regenerative medicine sector is on the move thanks to positive clinical data readouts, strong investor interest during 2013 and big pharma now starting to get involved in the space. This momentum will only grow going forward. That was the message coming out of the Alliance for Regenerative Medicine’s (ARM) state of the industry briefing Monday at the Biotech Showcase meeting. Read More
Attracted to Moderna Therapeutics’ messenger RNA (mRNA) technology platform, Alexion Pharmaceuticals Inc. purchased 10 product options to develop and commercialize rare disease treatments. The Cheshire, Conn.-based company paid $100 million up front for the options, in addition to making a $25 million preferred equity investment in Moderna. Read More
SAN FRANCISCO – Amid the flurry of deals and financings news to hit on the first day of the J.P. Morgan Healthcare Conference, Jazz Pharmaceuticals plc disclosed the latest acquisition to its growing pipeline, with the licensing of a Phase III-ready narcolepsy drug, and its goal of topping the $1 billion revenue mark in 2014. Read More
Apogenix GmbH is meeting officials from three of Europe’s leading national drug regulators in the coming weeks to evaluate whether they will support a bid to obtain conditional marketing approval for its glioblastoma drug APG101, following a fresh biomarker analysis, which shows that the therapy offers likely responders a 10-month survival benefit. Read More
DUBLIN – Shares in Alkermes plc (NASDAQ:ALKS) edged up 2.8 percent Monday on news that the Dublin-based specialty pharma firm netted $248.4 million in a new share offering directed at two Invesco Perpetual funds managed by UK investment management firm Invesco Ltd. The company issued about 5.92 million new shares, priced at $42.25 each, a slight discount to the Friday’s closing share price of $43.05. Read More
The FDA unveiled long-awaited draft guidance Monday on the use of social media to promote prescription drugs, but it’s not the final word on the subject. Read More
TVM Life Science Ventures VII, of Montreal, made a third investment, this time in the special purpose company GLWL Research Inc., also of Montreal, which was created to develop GLWL-01 to treat Type II diabetes. Read More
Dendreon Corp., of Seattle, expects net product revenue for the fourth quarter of 2013 will reach about $74.8 million, up 10.1 percent on a sequential basis. Read More
