The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.
Debate rages over the significance of safety data from a trial of Oramed’s oral insulin pill, but the firm is still confident in its delivery technology.
A new study published in the Institute of Physics Science reveals that Chinese researchers have developed gold nanoparticles that may help deliver cancer treatments to specifically targeted cells.
The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.
An increased trend in dealmaking for targeted drug delivery last year will continue to drive partnerships in 2014, according to a pharmaceutical partnering expert.
Clarus Therapeutics has submitted to the FDA a testosterone replacement it claims overcomes the toxicity problems that have plagued other oral drugs like methyltestosterone.
Actavis has announced plans to sell its stake in its Chinese subsidiary just days after telling investors the country is 'too risky' for new investments.
Complex generics will represent over 50% of Teva’s generic market by 2017, the firm says, but investments in delivery technology will have positive implications across the full business.
Alnylam has both acquired Merck & Co. subsidiary Sirna therapeutics and extended an alliance with Genzyme in order to advance its small interfering RNA (siRNA) delivery programme.
A drug delivery technology that ‘shuttles’ molecules across the blood-brain-barrier could have major implications in developing drugs for disorders such as Alzheimer's and Parkinson’s disease, Roche says.
AstraZeneca says the small molecule cyclin-dependent kinase 9 (CDK9) inhibitor programme acquired from Probiodrug has the potential to target cancer cells.
The US Food and Drug Administration (FDA) is working towards a method to validate the effectiveness and safety of medicated chewing gums such as nicotine gum.
Injectable device manufacturer Unilife has announced a contract with a pharmaceutical multinational for the use of its Ocu-ject eye syringe, marking its fifth major contract in four months.
Aprecia Pharmaceuticals has set out to try and raise money to support the commercial launch of the first drug product that uses its ZipDose delivery tech.
Apotek Produktion & Laboratorier AB (APL) says manufacturing knowledge and drug delivery tech knowhow gained by its compounding business is a boon for its CMO unit.
Unilife has signed a $40m long-term supply agreement with Hikma and says it is committed to becoming the world’s largest and most successful injectable drug delivery systems supplier.
Particle Sciences has been tasked with creating a nasal formulation of the steroid hormone progesterone that can be used to treat patients who have suffered traumatic brain injury.
Eli Lilly is investing over $700m (€518m) at a number of its insulin producing sites globally saying it is a response to the “growing diabetes epidemic.”
There are multiple ways to make amorphous dispersions in order to enhance bioavailability but spray dry dispersion (SDD) is often the most applicable, Bend Research says.
Understanding how a drug will interact with food is vital even if predicting it accurately during development can be a challenge according to speakers at AAPS yesterday.
The acquisition of Bend Research by Capsugel may be “a marriage made in heaven” for customers, the firms say, as the first drug delivery tech is transferred.
Dow says the acquisition of partner Bend Research is “good news” and will strengthen its developments in solving solubility and bioavailability issues in drug formulation.
Indian manufacturing heavyweight Mylan Laboratories is looking to build off its major acquisition of Agila with a number of smaller acquisitions, while Natco is about to receive a cash infusion for manufacturing expansions.
Linking peptide and small molecule drugs to albumin will improve pharmacokinetics, says Almac as it partners its manufacturing capabilities with Novozymes’ half-life extension platform.
US and French regulators have given Oxford BioMedica the go ahead to restart studies of three eye drugs it is developing with Sanofi after an impurity found in trial materials was identified as a harmless culture media derivative.
Cirrus Pharmaceuticals has received a grant to investigate the effect of excipient concentration and API molecule size on metered dose inhaler (MDI) formulations.
Roche will build an antibody-drug conjugate production facility to support production of its approved drug Kadcyla and others in its development pipeline.
An intravaginal ring filled with an anti-retroviral drug being developed by Northwestern University could be used to deliver drugs for a number of indications, says the Professor behind the research.
Enteris has secured its first partnership to develop metabolic peptides for Nordic Bioscience using an oral delivery platform it says offers unparalleled bioavailability.
