With briefing documents and history on its side, the biologic license application for NPS Pharmaceuticals Inc.'s Natpara emerged with success from a meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) as expected, scoring eight votes in favor of approval and five against – but a handful of panelists said their ballots might have gone either way. Read More
Oxygen Biotherapeutics Inc. has decided to stop a phase IIb trial of Oxycyte for traumatic brain injury after difficulty recruiting patients made it clear the company wouldn't be able to complete the program as soon as it had hoped. Read More
LONDON – The discovery of two genes which, when mutated, cause a type of muscular dystrophy is leading researchers closer to the cause of this condition and, ultimately, to ways in which it might be treated. Read More
Shares of Receptos Inc. (NASDAQ:RCPT) spiked 20 percent last week, hitting a 52-week high of $61.13 on Thursday, after the abstract was posted for Saturday's late-breaker podium presentation at MS Boston 2014 of the complete dataset from the phase II portion of the company's phase II/III RADIANCE trial of RPC1063 in relapsing multiple sclerosis (RMS). Read More
Heidelberg, Germany-based Affimed Therapeutics AG graduated to the public ranks by pricing its initial public offering (IPO) of 8 million common shares at $7 each. Although the price was lower than its original $11 to $13 range, the company did dial up the number of shares it offered. Read More
RIO DE JANEIRO – Product development partnerships (PDP) have become increasingly popular in Brazil, even as regulators work to establish clear rules and boundaries. The country has reported an increase of PDPs in the past few years, forcing regulators to deal with a number of issues including rules for technology transfers and finding a successful model for the public and private sectors to work together. Read More
Beigene Co. Ltd., of Beijing, said it achieved a $9 million milestone payment relating to its collaboration with Merck Serono, the biopharmaceutical division of Merck KGaA, of Darmstadt, Germany, for BGB-290, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor candidate currently in phase 1 development. Read More
Ironwood Pharmaceuticals Inc., of Cambridge, Mass., appointed Thomas Graney chief financial officer and senior vice president of finance and corporate strategy, and Lisa Adler senior vice president of corporate communications. Read More
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said researchers presented data from an integrated analysis of survival from two open-label, phase II studies of asfotase alfa in pediatric patients (ages ≤ 5 years at enrollment) with hypophosphatasia (HPP) compared with data from a retrospective natural history study of untreated historical control patients matched for age and disease severity. Read More
Shire plc, of Dublin, said the FDA is granting priority review of its supplemental new drug application for Vyvanse (lisdexamfetamine dimesylate) capsules as a treatment for adults with binge eating disorder. The company expects the agency to decide whether to approve the new indication in February 2015. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said data from the pivotal phase III fracture outcomes study for odanacatib, an investigational once-weekly cathepsin K inhibitor, in postmenopausal women with osteoporosis met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and nonvertebral fractures compared with placebo. Read More
Scholar Rock Inc., of Cambridge, Mass., reported its $20 million series A financing, which will be used to advance its niche modulators into clinical drug development. Arch Venture Partners, a new investor, led the round with the participation of founding investors, Polaris Partners and Timothy Springer. Read More
Scientists at the University of Toronto have analyzed DNA binding domains for transcription factors from more than 130 species, and used their data to develop a more general library of transcription factor binding preferences that can be used to understand and map transcriptional networks. Read More
Eager investors drove shares of Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) to a 52-week high of $13.09 Monday after the company reported phase II data on AVP-923 to treat agitation in patients with Alzheimer's disease (AD). Shares closed the day at $12.49 for a gain of $5.75, or 85.3 percent, on volume of more than 87 million – 40 times the company's daily average. Read More
In a first for both the country and the company, the Drug Controller General of India approved Epirus Biopharmaceuticals Inc.' infliximab biosimilar. Read More
SHANGHAI – Beike Biotechnology Co. Ltd., a pioneer in China's stem cell industry, has entered a partnership with Altor Bioscience Corp. in a two-part licensing and equity deal. On the front end, Altor will see its coffers increase by $9 million, in a deal worth potentially $200 million in milestones and sales royalties. Read More
LONDON – After surviving one phase III failure, the plug has finally been pulled on tecemotide when it became clear that the cancer vaccine was going to fail a phase II lung cancer study in Japan. Read More
HONG KONG – The world's largest health care-dedicated investment firm, Orbimed, has secured a $325 million pan-Asia fund to invest in health care markets in the region, particularly in China and India. Read More
RIO DE JANEIRO – Difficult and often uncertain intellectual property protections may be a key barrier to the development of a stronger biotech sector in Brazil, but new efforts from government, industry and academia may be slowly smoothing the way, according to multiple discussions at last week's BIO Latin America conference. Read More
A mixed but positive FDA advisory panel vote combined with the looming Oct. 24 PDUFA date cast into questions whether NPS Pharmaceuticals Inc.'s recombinant human parathyroid hormone (PTH) for hypoparathyroidism, Natpara, will be approved without delay. Read More
Gilead Sciences Inc. has signed licensing deals with seven Indian generic drugmakers to manufacture its flagship chronic hepatitis C virus (HCV) medicine, Sovaldi (sofosbuvir), and an investigational ledipasvir/sofosbuvir combination for distribution in 91 developing countries. The deal will expand access to the medicines for as many an 100 million people living with HCV by steeply discounting the medicines' price tag. Read More
