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US ban for Changzhou Jintan Qianyao raises questions about customers says expert

24-May-2017 - The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

24-May-2017 - The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.

Looking to the long-term: Serialisation regulations here to stay, Tracelink

23-May-2017 - Pharma and CMOs must start addressing their serialization needs ahead of 2019’s EU Falsified Medicines Directive, says Tracelink which is bringing its supply chain event NEXUS to Barcelona next month.

DSM Sinochem wins patent infringement ruling against Sinopharm Weiqida

23-May-2017 - The High Court of Delhi, India, has granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement of DSM Sinochem Pharmaceuticals’ enzyme-based antibiotic production IP.

US FDA warns liquid drug firms to test for Burkholderia cepacia

23-May-2017 - Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.

EMA committee says AB Science’s Masitinib should not be approved in light of GCP failings

22-May-2017 - AB Science’s candidate cancer drug Masitinib (masitinib) should not be approved according to an EMA committee, which cited concerns about data and failings identified in a 2015 trial.

US triples indications for Kalydeco without needing new clinical data

22-May-2017 - The US FDA has approved Vertex’s cystic fibrosis drug Kalydeco (ivacaftor) to treat a further 23 genetic mutations based solely on in vitro data.

CEFIC: members will only sell GHB intermediate to legitimate industry users

18-May-2017 - Cefic has agreed to make sure its members only sell the intermediate gamma butyrolactone (GBL) to legitimate users to stop it being abused or used in “date rape” drug GHB.

France's ANSM raises GMP concerns at Brazilian aseptic plant

17-May-2017 - Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.

Russia clears Saneca Pharma to supply dosage forms made at Slovakian site

16-May-2017 - Russian Regulators have issued Saneca Pharma with a cGMP certificate after inspecting its facility in Hlohovec, Slovakia.

Frontida site receives US FDA all-clear for former Sun Pharma site

16-May-2017 - The US Food and Drug Administration (FDA) has given the go ahead to Frontida BioPharm’s Pennsylvania, US-based site, eight months after distributing a Warning Letter for the facility.

AB Science suspends French masitinib trials after ANSM finds deviations

15-May-2017 - AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.

Trump needs to back bioscience to boost US drug making say experts

11-May-2017 - President Donald Trump should foster biotech investment if he wants more US-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.

Italian regulators find problems at Kores' API plant in Roha

10-May-2017 - Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.

Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns

10-May-2017 - The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.

US FDA sends Biocon Bangalore plant 483 with 8 observations

10-May-2017 - Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.

Vikshara says plant banned by US FDA has stopped making APIs

10-May-2017 - The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.

update - WHO outlines biosimilarity requirements and inspection plan

WHO plans biosimilar prequalification scheme to increase access to cancer meds

04-May-2017 - The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.

EC warns UK pharma to review drug authorisations ahead of Brexit

03-May-2017 - The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.

US FDA warns Indian API maker for faking certificates of analysis

03-May-2017 - Falsified certificates of analysis (COA) and misbranding violations have landed Indian API maker Sal Pharma a US FDA warning letter.

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