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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

EMA proposal concerns: “Public health trumps commercial confidentiality”

23-May-2017 - Proposed amendments to the European Medicines Agency’s (EMA) access to documents policy have been criticised by medicines watchdogs, including not-for-profit Health Action International and Prescrire.

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.

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.

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.

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.

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.

Pfizer ‘disappointed’ with US FDA outcome at ex-Hospira plant

04-May-2017 - Pfizer says it is committed to addressing ongoing problems across Hospira's manufacturing network.

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.

Dr Reddy's: No production halt at Bachupally plant hit with Form 483

02-May-2017 - The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).

UK industry group wants next Government to invest in drug production

27-Apr-2017 - Industry group the ABPI has called on the next UK Government to support local drug production, increase National Health Service (NHS) funding and put life sciences at the heart of its post-Brexit plan.

Management’s management of quality still a problem say MHRA inspectors

26-Apr-2017 - The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.

update

US FDA warns Lonza about Walkersville site

25-Apr-2017 - The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

Saudi Arabia serialization rules prompt Recipharm investment; US plant open

25-Apr-2017 - Drug track and trace rules introduced in Saudi Arabia prompted a €300,000 ($326,078) investment in processing technology and software according to Sweden-based contractor Recipharm.

WHO pressures Big Pharma to donate more drugs for tropical diseases

24-Apr-2017 - The World Health Organisation (WHO) has urged pharma companies to help combat neglected tropical diseases (NTDs) via increased drug donations.

US FDA issues Sun with Form 483 after Dadra plant inspection

24-Apr-2017 - The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

24-Apr-2017 - Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

UK MHRA announces pre-election quiet period

21-Apr-2017 - Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.

EMA and FDA agree how drug firms should include Q8, Q9 and Q10 QbD concepts in applications

20-Apr-2017 - The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.

Aurobindo Pharma gets Form 483 from US FDA after Bachupally inspection

19-Apr-2017 - The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.

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