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.
The company’s Tempod 1000 USB device captures and stores clinical site temperature data automatically for simplified capture and reporting.
Takeda is in talks to sell Shire’s experimental inflammatory bowel disease pipeline in an effort to meet European regulators approval for the acquisition.
Novotech has partnered with the Asian Eye Institute to accelerate clinical research conducted at the Philippines-based ophthalmology institute.
News in brief
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.
Biotech Week Boston
Successfully transferring manufacturing tech to a second facility or CMO relies on site readiness and sponsor oversight, says Janssen.
Cipla Ltd has formed a joint venture with Ahran Tejarat Company to manufacture and sell drugs in Iran.
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.
Dispatches from DCAT Week
China and India are causing a “tsunami” in the drug substance market – yet significant hurdles may bring fine chemical outsourcing back to the West.
Security is the top priority for the database intended to stop fake drugs entering European supply chains according to EFPIA.
With a new manufacturing deal in place, Crossject is on course to launch the first product based on its needle-free injector system next year.
Grünenthal has selected Patheon as its preferred development partner for its anti-abuse formulation platform INTAC, based on Hot Melt Extrusion (HME) technology.
The cost of outsourcing is far more than simply the price per kilogram of an API says Hovione, which is expanding a plant in New Jersey.
A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation.
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...
News from CPhI Japan
‘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.
Manufacturing powerhouse Roche is doubling down on its small molecule manufacturing with investments of $134.6m in two facilities in Basel, Switzerland.
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.
The UK MHRA has ordered the recall of 16 drug products made by Wockhardt in light of manufacturing deficiencies at its plant in Waluj, India.
Novaliq has raised funds to further development of its bioavailability boosting delivery technology and take its candidate dry eye drug into Phase I trials.
Swedish CDMO Recipharm has been cleared by French regulators to fill biotech drug products at its site in Tours.
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.
Company authorisations issued to drugmakers in Denmark will not feature expiry dates under new measures designed to reduce regulators admin.
Specialist aerosol CDMO Exemplar Pharma has been issued with a 483 by the US FDA for inadequate process control procedures.
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.
Acuros is seeking development partnerships with Big Pharma over its recently launched water-powered drug delivery pump.
Ashland says it will ramp up production of the tablet disintegrant and dissolution aid polyvinylpyrrolidone (PVPP) to meet growing drug industry demand.
Baxter ramps up Halle plant lyophilisation capacity, again
Baxter International has expanded freeze-drying capacity at its biomanufacturing facility in Halle, Germany citing growing pharmaceutical industry demand for cytotoxic contract manufacturing.
SCM Pharma teams with SEP in cancer product manufacturing deal
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.
USP launches database to tackle poor-quality drugs
The US Pharmacopeia (USP) has launched a free, public database of its drug testing to improve surveillance of poor-quality medicines.
Genzyme to build new Belgium manufacturing plant
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.
Monographs, heavy metals and globalisation on USP agenda
Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.
USP building database of fake & substandard meds
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.
Proposed USP limits on vial labelling “ambiguous and vague”, says CAPS
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.”
Map of India’s bulk drug and formulation facilities
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 adds blown-film capacity at US plant
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.
Coldpack hopes Pharma Pouch gets a warm reception
Insulated packaging specialist Coldpack says its new Pharmaceutical Pouch product can help ensure drugs are kept at the correct temperature during transportation.
Abbott beats Nycomed and UCB in battle for Solvay’s drug unit
Abbott Laboratories will buy Solvay’s pharmaceutical unit for €4.8bn ($7bn) according to reports released earlier today.
Novartis buys HySolv technology from BTG
Swiss drug major Novartis will UK specialty pharma firm BTG up to $10m (€7m) for its HySolv drug delivery technology.
Xceleron providing services to GSK & collaborators
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.