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T-cell lymphomas treatment trial update announced by Innate Pharma
Enrolment of new patients in the TELLOMAK trial, which has been evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas, has been suspended.
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US Food and Drug Administration (FDA)
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FDA approves Ayvakit, the first targeted gastrointestinal stromal tumour treatment
The FDA has approved Ayvakit for the treatment of GISTs with platelet-derived growth factor receptor alpha mutations, following 84 percent response rate in clinical trials.
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Establishing a new pharmaceutical track and trace system in Dubai
Health authorities in Dubai have announced that they will introduce a new track and trace system to the emirate by mid-2020. This article investigates how this will help to improve the safety and quality of medicinal products.
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FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
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Acute myeloid leukemia treatment receives FDA Orphan Drug Designation
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
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FDA announces new centre to improve compounded drug quality
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
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FDA issues warning letter which highlights the importance of a quality unit
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
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FDA announces US recall of mirtazapine tablets due to mislabelled strength
Aurobindo Pharma USA, Inc. has issued a voluntary nationwide recall of certain mirtazapine tablets as bottles labelled as 7.5mg may contain 15mg tablets.
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Lynparza approved by FDA to treat germline BRCA-mutated metastatic pancreatic cancer
The FDA has approved Lynparza as a first-line treatment after it reduced the risk of disease progression or death by 47 percent in patients.
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EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
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First interoperable, automated insulin dosing controller authorised by FDA
The FDA has authorised the first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customise their diabetes management.
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New Drug Application submitted for first-ever Progeria treatment
A New Drug Application has been submitted to the FDA for lonafarnib, the first-ever treatment for Progeria and Progeroid Laminopathies.
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Intellectual property, divestments, fragmentation and the future: M&A in life sciences
Mergers and acquisitions in any market can define the landscape for its players. In this article, Emma Danks of Taylor Wessing reflects on recent M&A activity in the biopharmaceutical industry, highlighting influencing trends and what this might mean for the future.
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New steps taken to lower US prescription drug prices
The FDA has announced that a notice of proposed rulemaking has been issued that would allow for the importation of certain prescription drugs from Canada which could lead to lower prescription drug prices.
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Lumasiran drug achieves primary and secondary endpoints in Phase III study
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
