The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).
Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.
Vector-based vaccine tech firm Vaccitech has secured £20m ($27.1m) in venture capital with investors Google Ventures, Sequoia China, Neptune Ventures and Oxford Sciences Innovation.
Research looks to microneedle patch to combat antimicrobial resistance
A skin patch designed to deliver antibiotics directly into the bloodstream could prevent the development of antimicrobial resistance in gut bacteria, say scientists in Ireland.
Arrowhead Pharmaceuticals says it is looking to move six candidates into the clinic within the next year thanks to its newly unveiled RNAi delivery platform.
Emergent BioSolutions says it is looking to expand auto-injector manufacturing capacity due to growing demand for its nerve agent antidote product Trobigard.
Novo Nordisk’s once-weekly diabetes treatment Ozempic has been given the US FDA green light, and the firm said it expects approval in Europe and Japan early 2018.
Almac will “eventually” move into sterile injectables says executive Brian Eastwood, adding the market has good potential for growth in the contract manufacturing space.
The US Food and Drug Administration has approved ViiV Healthcare’s two-drug treatment for HIV-1 maintenance, the first time the drugs have been combined into a single pill.
Scientists have developed opioid pain relievers that do not slow or stop breathing – the cause of opiate overdose – they say could reduce the risk of accidental death.
Corium says it is in talks with commercialisation partners for its transdermal Alzheimer’s disease candisate Corplex Donepezil ahead of a potential 2019 launch.
Otsuka Pharmaceutical’s pill embedded with a sensor that digitally verifies if patients have taken their medication has received US approval for mental illness indications.
Evoke Pharma has selected Patheon to commercially manufacture its nasal delivery formulation of metoclopramide Gimoti ahead of a planned US FDA submission next year.
Takeda has partnered with Portal Instruments to develop a needle-free drug delivery device for biologic medicines, starting with the former’s Entyvio (vedolizumab).
Teva has lowered its 2017 guidance on the back of higher-than-expected generic price erosion and lower-than-expected Copaxone sales due to competition.
Generic injectables are a solution to rising healthcare costs says Fresenius, which is expanding its US manufacturing network to benefit from the long-term growth prospects.
Daiichi Sankyo Company has signed an option agreement to develop Glycotope’s antibody drug conjugate (ADC) to target various cancers including ovarian, lung and breast tumours.
Novartis has announced plans to buy radiopharmaceutical firm Advanced Accelerator Applications (AAA), which will add neuroendocrine tumour treatment Lutathera to its portfolio.
InMed Pharmaceuticals is developing a gel-based cannabinoid drug for eye diseases such as glaucoma, which it says could be cheaper and more accessible than cannabinoid-based products on the market.
The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.
Antimalarial drug resistance in Southeast Asia is threatening the control and elimination of malaria, and drug makers can help, says a tropical medicine expert.
Titan has teamed with Opiant to investigate skin implant technology in the administration of opioid antagonists over extended periods, to combat opioid relapse and overdose in outpatients.
Rare disease therapies need to be administered in a way that suit the patient according to Shire CEO Flemming Ørnskov, who says smart, flexible delivery devices are core to the firm's product development strategy.
3-D microparticles which degrade at differing rates in the body could allow multiple doses of drugs or vaccines to be administered in a single injection, say MIT researchers.
Bristol-Myers Squibb will also make up to $160m in milestone payments for each candidate developed using Halozyme Therapeutics’ large-volume biologics delivery platform.
Oramed is eying up commercial partnerships for its oral insulin candidate following a positive meeting with the US FDA to discuss an appropriate approval pathway.
AstraZeneca has said it will wait to see how Brexit negotiations progress before deciding whether to make mid-to-large scale manufacturing investments in the UK.
Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.
Lonza will feed demand for its drug quality testing and formulation capabilities through an expansion at its Drug Product Services site in Basel, Switzerland.
