Parexel’s expanded Managed Access Program helps biopharmaceutical companies provide compassionate access to patients as the industry faces an increasing public demand for treatment options.
Almac Group has launched a GDP-compliant web-based platform, TempEZ, to provide customers with a single database to store temperature data from the manufacturing stage to patient administration.
Ferring is the third company in a week which will use Enteris BioPharma’s Peptelligence engineering platform for small molecules to develop oral formulations.
The GMP certification of a Dutch cannabis production facility is a “major step” in bringing medicinal marijuana to the level of evidence based medicines, says Bedrocan.
Vetter will close one facility and migrate staff to the now open €100m expansion center for aseptic packaging of injectables at its headquarters in Ravensburg, Germany.
With no production sites of its own, we question whether Johnson & Johnson’s manufacturing network is likely to incorporate Actelion’s substantial product portfolio.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
Wuxi Biologics has confirmed its intention to go public in an IPO application that reveals the contracter has seen revenue double and profits increase three-fold since 2014.
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.
ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.
Quintiles, Parexel and Icon are likely to report declining bookings growth in their upcoming financials, says a Jefferies’ analyst, but mid-sized CROs should fare much better.
Schulman IRB is integrating its WebPortal platform with Veeva’s eTMF solution to offer real-time IRB status updates and approval documentation to clients.
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.
Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.
ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
EAG Laboratories has added dermal absorption studies to its GLP-compliant testing services suite, as part of the company’s plan to continue expanding its capabilities.
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.
The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.
Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.
Evotec AG and MaRS Innovation have launched Fibrocor Therapeutics LP – a new company which will focus on developing first-in-class therapeutics targeting fibrotic diseases.
A pool of contractors will compete for task orders as part of the NIAID's preclinical drug development services contract to develop therapeutics for a range of global infectious diseases.
Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
