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EMA proposes changes to Ph I guidelines after fatal BIA 10-2474 trial

21-Jul-2016 - European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.

Update: Sandoz remains committed to launching 5 biosims by 2020

US FDA rejects Sandoz’s Neulasta biosimilar

19-Jul-2016 - The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.

Report: Congress needs to update human research regulations

19-Jul-2016 - Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.

Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech

19-Jul-2016 - A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.

FDA adds 4 API manufacturers to 'Red List'

19-Jul-2016 - Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”

China's complex API regs fuelling US meth problem says congressional committee

19-Jul-2016 - Legal loopholes and poor enforcement let criminals in China divert APIs for illegal drug production according to a US congressional committee which says the country is fast becoming the major global supplier of crystal meth precursors.

News in brief

CDSCO imposes 45 day limit on provision of supplemental data

19-Jul-2016 - Drug manufacturers seeking approval in India now have 45 days to provide the CDSCO with any supplementary information or the application will be rejected.

Ziopharm investigating death in Ph I trial of brain cancer gene therapy

18-Jul-2016 - Ziopharm Oncology has started investigating a death that occured during a Ph I trial of its candidate brain cancer gene therapy, Ad-RTS-hIL-12.

update

Juno trial restart positive, but CAR-T sector still on a learning curve says TxCell

15-Jul-2016 - The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.

FDA issues draft guidances on next gen sequencing

14-Jul-2016 - The FDA has issued two new guidances as part of the President’s Precision Medicine Initiative.

DIA 2016

FDA, EMA leaders address barriers, 'big projects,' and Brexit

13-Jul-2016 - 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.

EMA reviewing several drugs made by Pii in light of MHRA inspection

13-Jul-2016 - The EMA has started assessing some drugs made by Pharmaceutics International Inc (Pii). 

Facing death in the fight against counterfeit medications

11-Jul-2016 - In their pursuit to apply criminology theory to counterfeit medications, Nigerian leaders faced death, says researcher – but the country's efforts have ultimately been successful.

KaloBios CEO on its post-Shkreli 'restart'

11-Jul-2016 - After announcing a new pricing model that promises transparency, affordably, and reasonable return, KaloBios has emerged from bankruptcy – but transparency moving forward will be a shared burden.

Exclusive interview

Regulatory changes 'defining' serialization processes: key considerations and opportunities

11-Jul-2016 - With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.

Sequence and Adents team to help pharmas follow track & trace rules

07-Jul-2016 - Compliance consultant Sequence Inc. has partnered with software firm Adents to develop a track & trace solution for pharmaceutical products.

EDQM says 18% of inspected API sites were non-compliant in 2015

05-Jul-2016 - Almost one in five active pharmaceutical ingredient (API) facilities inspected by the European Directorate for Quality of Medicines and Healthcare (EDQM) last year failed to meet quality standards.

Moonshot and independence… A week in the life of the US FDA

30-Jun-2016 - An oncology centre to support the Moonshot Initiative, conflict-of-interest guidance and calls to become independent. Welcome to in-Pharmatechnologist’s US FDA round-up.

“There are units that are doing first-in-human studies that frankly have no business doing them”

DIA: Calls for set standards in Phase I studies following Bial trial tragedy

29-Jun-2016 - Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.

US FDA slams two Chinese API makers for quality systems and data issues

29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

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