The FDA said its voluntary pilot project that introduced industry to an automated form for field alert report (FAR) submissions has been successful, and the agency is making a new version of the automated form – FDA 3331a – publicly available on its website. Read More

Mersana Therapeutics Inc., of Cambridge, Mass., set terms for its IPO, aiming to raise $75 million through the sale of 5 million shares at a price range between $14 and $16. J.P. Morgan, Cowen & Co. and Leerink Partners are the joint bookrunners on the deal. Read More

Resq Pharma Inc., of Chicago, said the FDA has granted orphan drug designation for Lipidrescue therapy for the indication of local anesthetic systemic toxicity. Read More

Galera Therapeutics Inc., of Malvern, Pa., said it completed enrollment in its phase IIb study testing GC-4419, a dismutase mimetic, in reducing the incidence and duration of oral mucositis (OM) in head and neck cancer patients receiving chemoradiation therapy. Read More

As medicines have become more potent and patient groups have become more targeted, the need has arisen for cGMP (current good manufacturing practices) processes that are suitable for producing drugs at volumes of kilograms, which is far less than is produced in one manufacturing run by classical batch manufacturing systems. Read More

HONG KONG – South Korean startup Orum Therapeutics Inc. has a shot at effectively blocking RAS gene function with an innovative technology co-developed with Ajou University in South Korea and last week raised $8 million in a series A round to advance work in oncology indications. Read More

PERTH, Australia – Industry stakeholders in Australia welcomed the Senate passage of the drug and device reforms contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 last week. Read More

HONG KONG – China has seen a huge spike in patent applications, many of which are for pharmaceutical products. However, regulatory agencies such as the CFDA have yet to adapt to the changing patent landscape and to cope with the rapid surge. Read More

SAN DIEGO – The Biotechnology Innovation Organization's (BIO) International Convention, which runs June 19-22, returns to the thriving southern California biotechnology hub of San Diego just three years since it last hosted the giant event in 2014. The meeting allows a chance for industry leaders to take stock of progress that has been made to date. Overall, it appears that the report card is good. The biopharmaceutical sector, despite some major challenges in the intervening years, is continuing to generate support from investors, and that is reflected by the 10 percent growth in the BioWorld Biopharmaceutical Index in that period, and the almost $140 billion collectively raised by public and private companies to fuel their product development activities. Read More

LONDON – The equivocal result in the snap U.K. general election has amplified uncertainty but left the life sciences sector more hopeful of a Brexit that preserves its interests in trade, regulation and access to skills. Read More

DUBLIN – The heads of the European Union's member states are due to agree on the ground rules for the contest to decide on a new location for the London-based EMA during a European Council meeting in Brussels this coming Thursday. The beauty pageant involving more than a dozen European cities will then begin in earnest, with a winner expected to be named in October. Read More

Checkmate Pharmaceuticals Inc. might be the only immuno-oncology (I-O) company that's not attending the BIO International Convention in San Diego. Instead, the Cambridge, Mass.-based firm will spend the week plotting the next moves to advance its only asset, CMP-001, after completing a $27 million series B preferred financing led by new investor F-Prime Capital Partners. Read More

BOSTON – The human brain, Jürgen Knoblich told the audience at the 2017 annual meeting of the International Society for Stem Cell Research (ISSCR), consists of "86 billion neurons that have to be born at the right time, move to the right positions and wire up in the right way." Read More