Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.
Centogene and Denali entered a strategic collaboration to identify and recruit patients with a gene mutation to be enrolled in a Parkinson’s disease study.
A Swedish company’s combination gel and pump delivery system, Lecigon, has received regulatory approval for the treatment of patients with advanced Parkinson’s disease.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased transparency.
The outsourced pharmaceutical services industry is getting out of its comfort zone, leveraging resources and partnership and focusing on how to make improvements – as demand continues to increase, says CRO.
The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.
Nanoform specialises in producing APIs in a nanoparticle size range, which the company claims can significantly improve bioavailability and potentially change the fate of an asset in the clinic.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
The companies announced a partnership to integrate 4G’s technology with Clarkston’s clinical supply chain services in an aim to enrich clinical trial strategy and operations.
Following a review of its Ulverston site, GSK announced at the end of last week it would shed positions related to the manufacture of active ingredients for sterile injections.
Dr. Reddy’s Laboratories antibiotic manufacturing site in Bristol, Tennessee, has been sold to Neopharma, along with all issued and outstanding membership interests and related assets.
The new season has brought a change in line-up for some companies with new hires and retirements, but for some it meant changing the rules to keep key players.
Metrion has bolstered its drug discovery leadership team, CluePoints has upped its RBM services, and Concept Life Sciences has added to its analytical services division, among other moves this month in the outsourced pharmaceutical services industry.
TriNetX is releasing a series of new tools that will enable more people to conduct health research on their own, with access to rich datasets and analytics, says VP.
Premier Research is expanding its presence in the Asia-Pacific region to include South Korea, Singapore, and Taiwan – with greater health care spending and patient access to new drugs driving demand.
Comprehend, a clinical intelligence software company, has packaged its clinical trial risk detection and management service offerings to accommodate the needs of mid-sized CROs.
The pharmaceutical supply services provider Experic has marked its official launch with plans to construct its headquarters at a newly leased Class A research, manufacturing, and packaging facility.
Ahead of the CPhI Worldwide in Madrid next week, Nemaura announced that it would be showcasing its newly developed 48-hour diclofenac transdermal patch and would be linking up with an unnamed global pharma company to develop three new products.
Specialized capsules and encapsulation techniques can streamline early phase clinical studies – and help researchers meet drug program timelines, says CDMO.
Altasciences’ acquisition of a preclinical testing business marks the “next major milestone” in the CRO’s goal to provide an integrated offering from lead candidate selection to proof of concept.
Quanticate is using CluePoints’ software to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service.
The China-headquartered CDMO PharmaBlock has purchased a GMP compliant manufacturing facility and is investing in new technology and capacity to support clients long term, says chairman.
CMO-focused marketing and PR agency, ramarketing, has signed a lease on offices in the rapidly growing pharma and biotech hub of Cambridge, Massachusetts.
Insmed has become the first company to receive approval through the limited population pathway for antibacterial and antifungal drugs set up by the US FDA in 2016.
The middle-market private equity firm Nautic Partners has acquired Mikart, an Atlanta, GA-headquartered contract development and manufacturing organization (CDMO).
The identity and access management firm Exostar has acquired UK-headquartered Pirean Limited to provide the pharma industry with simplicity, speed, and security, says VP.
LabKey and Linguamatics have designed an integrated NLP data management solution to help accelerate clinical data abstraction and curation of unstructured notes and reports for clinical research.
Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.
MSD has warned regulators to expect a shortage of its Parkinson’s medicine, Sinemet, due to production constraints at a contract manufacturer’s facility.
The issue of pricing is a familiar discussion for the pharma industry and Ruchin Kansal, of Virtusa, believes that there is the potential for a win-win situation.
