SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

23-Jan-2017 - Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.

GCP 'Renovation' paper outlines revisions to ICH E8 and E6

23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

SUKL finds GDP problems at B.Braun warehouse in Czech Republic

19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.

GAO wants US FDA to show benefits of overseas inspections

18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.

US FDA criticises Sato Yakuhin Kogyo Co efforts to fix data issues

18-Jan-2017 - The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.

Janssen-Cilag switches Haldol supplies to Switzerland after production problems

17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.

Biosimilar interchangeability

FDA calls for switching studies in draft interchangeability guidelines

17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.

India clamps down on OTC antibiotic sales to stem spread of superbugs

16-Jan-2017 - The CDSCO has urged pharmacies to stop selling prescription antibiotics over-the-counter in an effort to slow the spread of antimicrobial resistance.

EFPIA and ABPI urge UK to keep drug regs consistent with EU post Brexit

16-Jan-2017 - Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.

update

Trump vows to bring drug production back to US

12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines. 

PEOPLE ON THE MOVE

Hiring and Firing Jan '17

12-Jan-2017 - Welcome to in-PharmaTechnologist's monthly round up of who's been moving where in the small-molecule manufacturing world. The CEO of BMS is moving internally, Axim Biotechnologies and Pharmalink have new board members, whilst Vium and Dova Pharmaceuticals have new Chief executives. 

US FDA finalises combination drug/device product guidance

12-Jan-2017 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.

Trump names chair of vaccine commission to examine 'scientific integrity'

10-Jan-2017 - President-elect Donald Trump has asked noted vaccine skeptic Robert F. Kennedy Jr. to chair a commission to investigate vaccine safety.

Day 2

JP Morgan Conference: Trumpcare, moonshots and M&A

10-Jan-2017 - If you're not going to San Francisco, in-Pharmatechnologist brings you a smattering of the best tweets from the 35th Annual JP Morgan Healthcare Conference.

Danish regulators ban Europharma DK ApS and suggest firm needs new CEO

09-Jan-2017 - Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.

Data integrity and aseptic issues land Wockhardt with FDA warning

04-Jan-2017 - A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.

Fire at Sun Pharma API factory kills two

04-Jan-2017 - Late last week, a fire at Sun Pharmaceutical Industries Limited’s Ahmednagar factory, which manufactures APIs, sent four employees to the hospital.

Data integrity concerns: EMA reviews drugs tested by Micro Therapeutic Research

22-Dec-2016 - The EMA has started reviewing drugs tested by Micro Therapeutic Research Labs after an inspection by Dutch and Austrian regulators identified potential data integrity problems.

Laboratorio Angulema warned by Spanish regulators about Leganes plant

20-Dec-2016 - Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.

News in brief

US FDA OKs Akorn plant after re-inspection

13-Dec-2016 - The US FDA has given Akorn Pharmaceuticals' facility in Decatur, Illinois a clean bill of health after a re-inspection last week. 

A Roche of la Grippe: India’s Natco and Alvogen launch Tamiflu generic in US

13-Dec-2016 - Natco Pharma and partner Alvogen have launched the “first generic equivalent” of Roche’s Tamiflu (oseltamivir phosphate) in the US.

Catalent joins industry group supply chain initiative

12-Dec-2016 - Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.

WHO commits to source drugs and vaccines from 'green' suppliers

09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.

US drug reimportation 'Trump proposal' risky and inefficient, AmerisourceBergen

08-Dec-2016 - AmerisourceBergan has warned of the dangers of reimportation a day after the Senate rejected Bernie Sanders’ “Trump proposal” to overturn the ban.

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...