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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

Swissmedic ramps up ad hoc inspections in 2015

28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.

Brexit: Indian firms worried but Big Pharma and EMA remain positive for now

Worried and bewildered: Brexit sparks uncertainty for Indian pharma in Europe

28-Jun-2016 - Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.

DIA 2016

'Now is the time to include Japan' says Parexel

24-Jun-2016 - Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.

UK Biopharma looks to remain strong as Brexit leads to uncharted waters

24-Jun-2016 - The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.

BIO 2016

Commissioner Califf commits to tackling staffing issues at US FDA

23-Jun-2016 - Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.

India to rewrite 75-year old drug laws with an eye on business, biologics and devices

23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.

update

Three drug wholesalers have failed GDP checks according to Czech regulator

22-Jun-2016 - Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.

Opko extended-release kidney disease drug approved after Catalent 483 delay

22-Jun-2016 - The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

Scancell stops dosing in long-term trial of cancer vaccine SCIB1

21-Jun-2016 - Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.

Comparing ClinicalTrials.gov and FDA review for accuracy and completeness

20-Jun-2016 - Clinical trial sponsors are required by law to report results to ClinicalTrials.gov; however it’s not clear if these posts are complete and accurate.

News in brief

Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection

20-Jun-2016 - 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.

News in brief

CDSCO working on new Drug and Cosmetics Act; calls for input

16-Jun-2016 - Indian regulator CDSCO is developing a new Drug and Cosmetics Act that is more in keeping with the modern pharmaceutical industry.

Austin Biotechnology hit with US FDA warning at Taipei facility

15-Jun-2016 - 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.

update

Prosecutors examining fatal BIA-10-2474 trial start manslaughter investigation

14-Jun-2016 - French authorities have started a manslaughter investigation in connection with a Ph I trial  conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised.

CDSCO renews API firms' 'written confirmations' days after industry raises trade concerns

13-Jun-2016 - CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.

updated

MHRA says Akums' cannot prove progesterone made at Hardiwar plant is sterile

13-Jun-2016 - The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.

BIO 2016

Califf: New FDA guidance to ensure all drug info is available to patients

13-Jun-2016 - Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.

Dispatches from BIO 2016

Who defines value? Quintiles talks changing reimbursement landscape

09-Jun-2016 - With the emergence of the empowered patient, the reimbursement landscape is shifting and stakeholders must navigate who really holds the power – and how this changes the definition of value.

DISPATCHES FROM BIO 2016

US FDA Commissioner Califf calls on industry to tackle supply chain quality issues

09-Jun-2016 - 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.

update

TTIP negotiators mull end of duplicate US, EMA facility inspections

08-Jun-2016 - Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.

Teva confirms it halted production at Hungary injectables plant in January

08-Jun-2016 - Teva has confirmed it stopped making all but two sterile injectable drugs at its plant in Godollo, Hungary in January after a US FDA inspection.

EMA portal will make EU more attractive for drug research says EUCROF

07-Jun-2016 - The EU will be a more attractive place to test drugs when the EMA clinical trial portal goes live in 2018 according to industry group EUCROF.

EMA working on Ph I concept paper after death in Biotrial BIA 10 2074 study

06-Jun-2016 - A revised concept paper on first-in-human trials will be ready next month according to the EMA which is reviewing the French Phase I trial in which one volunteer died in January.

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