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.
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.
Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.
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.
Titan Pharmaceuticals has put plans for a trial of its candidate Parkinson’s disease implant ropinirole after the US FDA asked for additional information.
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.
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.
Rentschler Biotechnologie has added an antibody stabilising platform to its manufacturing services through a strategic alliance with formulation tech firm Leukocare.
Ferring is the third company in a week which will use Enteris BioPharma’s Peptelligence engineering platform for small molecules to develop oral formulations.
Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.
Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience
Mithra Pharmaceuticals SA will seek US and EU approval for a rival to the NuvaRing contraceptive device in Q2, manufacturing the ring through its independent CDMO platform.
Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen.
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
Aurobindo Pharma Limited has agreed to buy Portugal-based Generis Farmaceutica SA for €135m in a deal that includes a tablet and capsule plant in Amadora.
The Gates Foundation has invested $140m in Intarcia Therapeutics Inc to develop the biotech’s needle-free delivery pump for use with an HIV prophylactic therapy.
Baxter International has agreed to pay Claris Lifesciences $625m (€598m) for three manufacturing facilities and a portfolio of 11 approved injectable drugs.
Lonza has agreed to buy US capsule manufacturer Capsugel for $5.5bn (€5.2bn) in cash in an acquisition the Swiss firm says will expand its drug delivery business and enable savings of CHF100m a year by 2019.
The US FDA has criticized Pocono Coated Products' (PCP) efforts to bring its transdermal patch plant in Cherryville, North Carolina into compliance with cGMP standards.
Aptar Pharma is nearing completion of its US-based manufacturing site, as it continues to expand globally to keep pace with growth in the injectable drug delivery industry.
As part of its collaboration with the National Institutes of Health (NIH) in the DNA vaccine clinical trial for the Zika virus, PharmaJet is providing its Stratis Needle-Free device and training to the NIH.
Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
AstraZeneca has partnered with Bicycle Therapeutics in a potential $1bn deal to develop a new class of small molecules which have antibody-like properties.
Arrowhead Pharmaceuticals Inc. has also laid off its Chief scientific officer David Lewis - as part of the 34 staff cull - after several trials using delivery vehicle Ex1 were stopped by the firm.
The US FDA has cleared Aduro Biotech to recruit for trials of its listeria-based immunotherapies after the firm modified protocols to reduce the risk of subjects developing listeriosis.
Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.
Despite requiring more API, the price of inhaled insulin Afrezza has dropped below that of injected rapid-acting rivals says MannKind's CEO, reporting a resilient Q3.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
Bespak says the availability of the autoinjector version of UCB’s Cimzia on the UK National Health Service (NHS) is a validation of its delivery technology.
