Esperite N.V., of Amsterdam, The Netherlands, which is focused on regenerative and precision medicine, said a 21st tranche of €300,000 has been issued as a private placement consisting of 30 convertible notes with a principal amount of €10,000 each, with 485,611 share subscription warrants attached. The financing was made under an agreement of up to €13 million that was signed with the European Select Growth Opportunities Fund in March last year. Read More
The FDA launched its new pilot program Wednesday to give participating drug and biologic companies additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs. Read More
Hesperos Inc., of Orlando, Fla., received a phase I SBIR grant from the National Institute on Aging to help create a new multi-organ "human-on-a-chip" model that can realistically mimic the biology of Alzheimer's disease and the effects of potential new therapies. Read More
You could say Invenra Inc. has been working toward bispecific antibodies for years. Founded in 2011, the University of Wisconsin-Madison spin-off launched with the aim of making antibody drug discovery more efficient, eventually developing a platform based on ultra-high-throughput technology capable of synthesizing hundreds of thousands of full-length antibodies using cell-free expression, with a screening platform that allows researchers to pinpoint those with the most promising biological activity. Read More
Australian researchers have identified for the first time in decades a previously unknown immune system microstructure, which they have demonstrated to be responsible for immunological memory. Read More
Back on track with topsalysin in prostate cancer (PC) after a patient died in the phase IIb trial, Sophiris Bio Inc. is taking aim at a pivotal push to verify encouraging data that have turned up so far. CEO Randall Woods told BioWorld that "most people didn't believe the drug was related to the death of the patient, but unlike in the legal system, where you're innocent until proven guilty, in this case you're guilty until you can prove otherwise." Read More
Pfizer Inc. is asking the FDA to become the speech police to protect the U.S.'s emerging biosimilar market from innovators' verbal assaults. Pfizer petitioned the agency to issue guidance spelling out what's inappropriate or would be considered misleading for the sponsors of reference biologics to say about biosimilars and interchangeables. Read More
Emergent Biosolutions Inc. positioned its pick-up of Adapt Pharma Ltd. as an opportunity to diversify and expand the company's presence in medical countermeasures and threats to public health by adding Adapt's flagship product, Narcan (naloxone HCI), developed by Lightlake Therapeutics Inc. and still the only nasal form of naloxone approved by the FDA for emergency treatment of known or suspected opioid overdose. (See BioWorld Today, Nov. 20, 2015.) Read More
