Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.
APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).
Lannett is confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA.
The US Food and Drug Administration (FDA) has signed an agreement with CluePoints to "further explore" a data-driven approach to quality oversight in clinical trials.
Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
Biotrial looks to run 50 clinical trials per year at its new US-based facility as it says group activities are up – with the exception of Ph I activities in France.
Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.
The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.
Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.
Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.
An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
The US FDA has criticised Chinese manufacturer Concept Products for not fixing cGMP violations observed by inspectors who visited its manufacturing site in Tianjin.
Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
Hemispherx Biopharma has hired Avrio Biopharmaceuticals to make Ampligen while it continues to try and win US approval for rejected candidate chronic fatigue syndrome (CFS) drug candidate.
The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
Micro Labs completes repeat studies and predicts drugs will be back on the market in autumn
Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler Research Centre should be suspended.
The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.
Senior leadership from key regulatory bodies gathered at the DIA 2016 Annual Meeting to discuss challenges they face as global regulators, both domestically and as part of international cooperative initiatives.
The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.
The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.
The US FDA has approved Probuphine, a subdermal buprenorphine treatment for opioid dependence using Titan Pharmaceuticals’ ProNeura drug delivery platform.
The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.
VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.
Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.
AstraZeneca will supply Ironwood Pharmaceuticals with the API and finished dosage form of the gout drug Zurampic under the licensing deal agreed this week.
