Imprimis Pharmaceuticals says it is evaluating pursuing New Drug Application (NDA) status for some of its product reformulations through the US FDA 505(b)(2) development pathway.
Heptares Therapeutics has entered into a drug discovery and licensing agreement with Daiichi Sankyo – providing further validation of the company’s structure-based drug design approach, says CEO.
Last week, President Donald Trump announced Scott Gottlieb as his nomination for the new US FDA commissioner – a candidate that ACRO says, “understands the complexities of drug development.”
Cytel Inc. has established a dedicated quantitative pharmacology and pharmacometrics team to meet an increasing demand for model-informed drug development from biopharma clients.
The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.
SRI International will advance compounds with the potential to treat persons exposed to biological, radiation, nuclear, and chemical agents – in a deal worth up to $90m.
Charles River Laboratories has extended its integrated respiratory program with Chiesi Farmaceutici, through which it identifies and tests candidates for preclinical development.
The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.
NovAliX has signed an insourcing agreement with UCB Biopharma, a model that the CRO says “energizes scientific organization” and offers "significant" cost advantages.
Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.
Certara has developed a new licensing approach, which provides smaller organizations access to its physiologically-based pharmacokinetic (PBPK) modeling and simulation platform.
SGS has signed a partnership agreement under which it will operate a dedicated clinical pharmacology unit for conducting Ph I inpatient clinical trials in Budapest, Hungary.
Former J&J controlled substance API unit Noramco is to rejig its business to cater for branded and generic drug firms and companies looking for formulation tech solutions.
Wacker Biosolutions says an excipient shown to increase the bioavailability of a food supplement by a factor of 40 could have implications in the API space.
Lab staff at an API plant run by Chongqing Pharma Research Institute Co., Ltd. deleted out of spec test results according to the US Food and Drug Administration (FDA).
Pharmaron has acquired a majority stake in Shin Nippon Biomedical Laboratories Clinical Pharmacology Center, continuing its strategy of becoming a full service R&D service provider.
GSK has asked Angus Council for advice as it prepares to submit a planning application for an API plant it intends to build at its site in Montrose, Scotland.
Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank.
Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.
Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.
Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.
API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
Quotient Clinical has acquired SeaView Research – with another US acquisition to be announced next week, as the company looks to expand its US footprint.
Rentschler Biotechnologie has announced a strategic alliance with Leukocare through which the CDMO hopes to emphasize drug formulation as a “key success factor” in drug development.
ChemDiv is providing Janssen Research & Development with access to its small molecule discovery platform resources as part of a hit identification collaboration.
Mezzion has hired Pol Pharma and Halo Pharma and accused former CMO Dr Reddy’s of hiding manufacturing problems that cost its erectile dysfunction candidate, udenafil, US approval.
Ferring is the third company in a week which will use Enteris BioPharma’s Peptelligence engineering platform for small molecules to develop oral formulations.
Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience
Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.
The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.
President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
