US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial
TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.
Archives for June 29, 2015
Juniper to make OxSonics' ultrasound particles to aid cancer drug delivery
Juniper Pharma Services has won a contract to manufacture ‘sono-sensitive particles’ used to aid delivery of cancer drugs into solid tumours for OxSonics.
ICH clarifies Q7 guidance on API GMP manufacturing
In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all...
Sequenom case leaves pharma confused over patent law
US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer.
Eurofins not agnostic about diagnostics as evidenced by Emory investment
Eurofins has outlined plans to buy Emory Genetics Laboratory in the latest in a series of investments in the contract diagnostics sector.
Aeterna Zentaris adds a Phase III trial to CRO Ergomed’s plate
Aeterna Zentaris has selected UK-based Ergomed again for a clinical trial, this time for a confirmatory Phase III study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth...
Teva pays $35m upfront for implantable drug delivery device partnership
Generic juggernaut Teva Pharmaceuticals has partnered with Microchips Biotech to use its implantable drug delivery device to improve outcomes for patients on chronic drug therapies.
'Outperform' Perrigo better off without Mylan, says analyst report
The proposed Perrigo merger with Mylan would be of no benefit to either firm in the “highly competitive” OTC sector, according to financial analysts BMO.
Novasep expanding conjugation capability to help simplify ADC supply chain
Novasep is investing €10m ($11m) in a bio-conjugation plant it says will offer drugmakers a more complete antibody-drug conjugation (ADC) service.