The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.
Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.
The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.
Janssen is already working on continuous manufacturing methods for other drugs says Rutgers University which helped develop the new Prezista production process approved by the US FDA.
Catalent has missed its forecast for bringing a suspended softgel facility back online, but says production of essential drugs has begun at the French plant.
The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.
The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database (IID) is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years.
One-third of clinical-trials results in the US go unreported, according to new figures published in the British Medical Journal underlining how far the drugs industry remains from full transparency.
French regulators have raised concerns about heparin made by Chinese supplier Dongying Tiandong Pharmaceutical and called on the EMA to revoke its GMP certificate.
ScinoPharm Taiwan announced its unaudited financial results for fiscal year 2015, and with it, plans to expand its contract businesses through strategic acquisitions.
Biocon, an Indian biopharmaceuticals company, has received European approvals for its Rosuvastatin Calcium, a generic equivalent of AstraZeneca’s Crestor tablets.
Under the President’s FY 17 proposed budget request, the FDA would receive $2.743bn in budget authority appropriations – and many are frustrated with the lack of funding.
Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.
The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.
Certara’s new consulting firm will rely on modeling and simulation expertise to expedite the drug development process, as China commits to increasing innovation.
Drug manufacturers, regulators, and consumers are increasing pressure on pharma companies to make the Rx-to-OTC switch, as non-prescription medications are cheaper and easier to access.
The US FDA has warned Sun Pharmaceutical Industries about its facility in Halol, India just months after it withdrew approval for an epilepsy drug made at the site.
Data falsification at API facilities is getting harder to spot say regulators who have called for more systems training and international collaboration.
Early and efficient communication is the key to cutting approval times says the US FDA, which published a draft best practices guide for drug firms this week.
Clariant will build a CHF10m ($9.7m) moisture control device plant in Cuddalore, Tamil Nadu to cater for the branded and generic drugmakers operating in India.
Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.
Legislation allowing compounders to register as outsourcing facilities was a key driver in the acquisition of PharMEDium, AmerisourceBergen says as it completes the $2.6bn deal.
Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.
Alexion says it is looking to bring more manufacturing capabilities in-house, despite its CMO partner Lonza recently setting up a dedicated suite at a site in New Hampshire.
Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.
The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.
Drugmakers need more certainty and reliabilty around their supply chain in light of increased regulatory vigilance says Mylan, itself carrying out remediation across several Indian facilities.
A Florida company is recalling 26 sexual enhancement and diet pills after the US FDA discovered some contain undeclared active pharmaceutical ingredients (APIs).
