Ritter Pharmaceuticals Inc., of Los Angeles, said phase IIa microbiome data published in the Proceedings of the National Academy of Science showed that lead candidate RP-G28, a short-chain galactooligosaccharide (GOS), significantly modulated the gut microbiome composition of lactose-intolerant individuals. Significant changes in the diversity of the microbiota occurred in treated subjects upon reintroduction of dairy into the diet, and key bacterial taxa changes included increases in lactose-fermenting Bifidobacterium, Lactobacillus and Faecalibacterium, with those changes correlating with a symptomatic improvement in tolerance to lactose. Read More
Clovis Oncology Inc., of Boulder, Colo., priced an underwritten public offering of 5 million shares of its common stock at $41 each. The size of the offering was upsized from $175 million to $205 million. In addition, the underwriters have a 30-day option to purchase up to an additional 750,000 shares of common stock on the same terms and conditions. The company intends to use the net proceeds for general corporate purposes, including the commercial planning and sales and marketing expenses associated with the launch of Rubraca (rucaparib) in the U.S and also in Europe, if approved by the EMA. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., said that the National Institute for Health and Care Excellence (NICE) Highly Specialised Technologies Evaluation Committee has issued a positive final evaluation determination for reimbursed patient access to Galafold (migalastat). NICE has recommended the commissioning of the drug for use within the National Health Service in England as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. The company expects to launch Galafold in England, Wales and Northern Ireland early this year. Read More
A handful of generic company takeovers and several buyouts by Dublin-based biopharmas highlighted the mergers and acquisitions landscape in 2016, in which BioWorld recorded 144 deals representing a $143 billion value. Read More
Scott Wasserman, Amgen Inc.'s vice president of global development, told BioWorld Today that a new, 5,000-patient observational study will "cast a more focused light on the unmet need" in knocking down levels of low-density lipoprotein cholesterol (LDL-C), as researchers will take "multiple snapshots" over a three-year period. "It's meant to help the medical community get a pulse on how we're doing in terms of treating these high-risk patients," he said. Read More
As technology has advanced – and overlapped – in the life sciences and information technology spaces, it has created a nexus in which areas such as math, physics, computing, chemistry and biology intersect. And that intersection is the focus of Digitalis Ventures, which launched a new $100 million fund aimed at investing in health solutions. Read More
Rana Therapeutics Inc. made a bold move by acquiring the messenger RNA (mRNA) replacement therapy (MRT) platform developed by units of Shire plc, which took an undisclosed equity stake in Rana and is set to receive undisclosed milestones and royalties on products developed with the technology. Read More
DUBLIN – Nerre Therapeutics Ltd. raised £23 million (US$28.2 million) in a series B round to take forward a portfolio of clinical stage neurokinin (NK) receptor antagonists in both women's health and respiratory indications. Read More
Neon Therapeutics Inc., a company developing neoantigen-based therapeutic cancer vaccines and T cell therapies, completed a $70 million series B financing that it said will help it advance its lead candidate, NEO-PV-01, through an ongoing phase Ib clinical trial. Read More
