The US Patent and Trademark Office has granted a notice of allowance for ‘shelf life’ timer technology used to protect time-sensitive biologic materials in transit.
Novartis will sell its stake in a consumer healthcare joint venture to partner GSK and plans to invest the $13bn into its core pharmaceutical businesses.
Syngene International has signed a multiyear agreement with GSK through which the companies will focus on accelerating the discovery of new drug candidates using the CRO’s discovery services platforms.
Ubiquitous M&A activity in the pharmaceutical industry raises several concerns – with many scholars arguing that 70 to 80% of acquisitions end up destroying value.
Watson for Clinical Trial Matching has shown an 80% increase in clinical trial enrollment at Mayo Clinic, which is expanding its partnership with IBM to further develop the cognitive computing platform.
The race to buy Pfizer’s OTC business – including Advil painkillers and Centrum vitamins – may have collapsed after both GlaxoSmithKline and Reckitt Benckiser officially walked away from the auction within days of each other.
Envigo is increasing its surgical footprint ten-fold to create a West Coast Center of Excellence for surgery and supply myocardial infarction research models regionally.
Parexel’s new medical writing solutions offering will provide communications services throughout the drug development and commercialization process to help sponsors meet higher documentation quality standards, says VP.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
Grand River Aseptic Manufacturing has purchased a new lot of land to expand its manufacturing capabilities as growth in the market drives demand, says CEO.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
‘Splinter-like’ nanostructures have been developed by researchers in the US to deliver biomolecules straight into patient cells for immune-oncology and gene therapies.
Thermo Fisher Scientific has announced plans to build a supply chain facility, which it says will increase capacity for cold and ambient clinical trial materials in Europe.
An online portal designed to connect sponsors with trial sites and contract research organizations has been launched by the Victorian state government in Australia.
Thermo Fisher Scientific says its proposal to move manufacturing and R&D operations from Ashford, Kent to existing sites in Mexico, China and Denmark was a “very difficult decision.”
More efficient clinical trials may reduce global CRO revenue, potentially slowing adoption of new technology, says Otsuka director – noting that the industry doesn’t often take operational risks, but it must.
Worldwide Clinical Trials has acquired the Continuum Clinical’s Late Stage research practice following a dramatic increase in demand for real-world evidence, says CRO.
The Danish drugmaker says it will take responsibility for commercial manufacturing after acquiring Parkinson’s disease candidate foliglurax in a deal worth up to €905m ($1.1bn).
BiondVax is working closely with a CRO to advance its universal flu vaccine candidate, which will be manufactured in-house and in collaboration with a CMO to support tech-transfer pending a successful trial.
Covance has formed a global immunology and immunotoxicology (I&I) unit, which will be dedicated to the “innovative and complex” approaches required by biologics, says CRO.
CDMO Ardena has purchased active pharmaceutical ingredient and nanomedicine maker ChemConnection, as part of an acquisition strategy focused on development services.
PCI Pharma Services has validated its former Millmount site to help Ireland’s ‘thriving pharma community’ comply with Europe’s Falsified Medicines Directive.
Parexel has announced an alliance with CHA Medical Group to augment clinical development in South Korea, where demand for early phase trials has grown significantly, says VP.
Diurnal has named Worldwide Clinical Trials as its preferred clinical services provider ahead of its planned Phase III study which is expected to begin later this year.
Bristol-Myers Squibb is conducting a pilot program through which it will use GRYT Health’s mobile app to collect real-world data – with the goal of improving clinical trial design and patient wellbeing.
The non-clinical contract research organization (CRO) Citoxlab Group has acquired Solvo Biotechnology, a CRO specializing in drug transporters studies and the assessment of drug-drug interactions (DDI).
A lack of generic competition for Pfizer’s contraceptive Depo-Provera has influenced Amphastar’s decision to prioritise its pre-filled syringe version, says executive.
Trans-Hit Bio and Q&T Research have entered into an exclusive strategic partnership, which will provide biopharma customers with access to human biospecimens, for which there is “a great demand,” says exec.
Zelluna Immunotherapy has partnered with the CDMO MasSTherCell to develop its T-cell receptor (TCR) adoptive cell therapy platform with clinical trials expected to begin in 2019.
The industry is set up to accelerate the availability of new patient options in a “new era of medicine”– though robust intellectual property protection is critical to continued innovation.
A new method to predict the physical stability of drug candidates is attracting interest from pharmaceutical companies who could use the technology to de-risk early development.
The R&D playbook is evolving as the industry looks to break down the silos between clinical and commercial operations – bringing commercial voices to the earliest phases of asset development.
