The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.
Takeda is in talks to sell Shire’s experimental inflammatory bowel disease pipeline in an effort to meet European regulators approval for the acquisition.
The EMA has expanded the list of excipients that drug firms must declare on product labels in a bid to address safety concerns about undeclared components.
Fareva Group has set up an aerosol manufacturing facility at its site in Richmond, Virginia as part of a $40m (€37m) investment in its drug, OTC medicine and beauty care business.
Grünenthal has selected Patheon as its preferred development partner for its anti-abuse formulation platform INTAC, based on Hot Melt Extrusion (HME) technology.
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
As Big Pharma and biotech companies continue to outsource more of their work, one of the leaders in the preclinical and discovery space – Charles River Laboratories – is seeing more strategic relationships with both large and small clients, CEO James...
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.
The implementation of track and trace will drive the outsourcing of drug packaging and UDG Healthcare is well-placed to benefit, according to a UK broking firm.
Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.
Consolidation in the pharma industry is driving the second-hand processing equipment market but despite attempts to regulate the industry, a glut of online vendors means illegal drugmakers can buy such systems.
Supply chain security consortium Rx-360 has shifted its focus to China where it is forming a working group to further ensure compliance in a country that has had some difficulties with spurious drugs in the past.
For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
The US Food and Drug Administration (FDA) is founding a $3.3m (€2.4m) regulatory science centre jointly with the University of California San Francisco (UCSF) and Stanford University.
Manufacturing powerhouse Roche is doubling down on its small molecule manufacturing with investments of $134.6m in two facilities in Basel, Switzerland.
Novaliq has raised funds to further development of its bioavailability boosting delivery technology and take its candidate dry eye drug into Phase I trials.
Lasco, Medimpax and GSK are among those to receive manufacturing and supply deals under the J$3.3bn ($37m) worth of contracts issued by the Jamaican Government.
PRA has expanded its operations in the Netherlands and the UK in a bid to meet what it says is soaring client demand for late phase and product registration services.
The European CMO sector is set to double in the next six years and will hit revenues of up to $20.75bn, according to Frost & Sullivan’s Aiswariya Chidambaram.
Ashland says it will ramp up production of the tablet disintegrant and dissolution aid polyvinylpyrrolidone (PVPP) to meet growing drug industry demand.
Baxter International has expanded freeze-drying capacity at its biomanufacturing facility in Halle, Germany citing growing pharmaceutical industry demand for cytotoxic contract manufacturing.
UK-based contract manufacturing organisation (CMO) SCM Pharma has struck a deal with urology experts Speciality European Pharma (SEP) to help bring SEP's oncology product, Plenaxis, to the European market.
Genzyme will build a second manufacturing plant in Geel, Belgium to ensure it has the capacity to meet demand for its Pompe disease drugs Myozyme and Lumizyme.
Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.
The USP is building a database of counterfeit essential medicines to support international drug procurement organisations, such as WHO, and the timely sharing of information between national regulators.
Adoption of electronic submission by regulators around the world is good news for drugmakers’ efforts to access emerging markets says industry expert Kate Wilber.
The role of the pharma industry in supporting the COE anti-counterfeiting treaty, which aims to criminalise activities, “cannot be underestimated”, according to a directorate member.
The Consortium for the Advancement of Patient Safety (CAPS) says research shows that USP plans to restrict printing on pharmaceutical vial ferrules and caps are “ambiguous and vague.”
in-PharmaTechnologist presents exclusive interactive maps of pharma manufacturing facilities in India, detailing the number of bulk drug and formulation facilities in each region of the country.
Amcor Flexibles has expanded its drug packaging capacity with the installation of a new blown-film production line at its facility in Mundelein, Illinois, US.
Xceleron will provide services to GSK and its collaborators, such as academics and biotechs, under a novel deal that emphasises the big pharma’s attempts to change its drug development model.
US firm Compass Pharma Services is now offering ISO class 8 certified packaging services in a bid to capture a share of the expanding high-potency drug sector.
