QA/QC

Sun Pharma facility placed on FDA import alert

13-Dec-2022 By Ben Hargreaves

The company’s Gujarat facility has been listed under import alert, after an inspection earlier this year found it was not cGMP compliant.

Lilly deploys AI-powered tech to expedite drug approval process

18-May-2022 By Jenni Spinner

The pharmaceutical company is partnering with Yseop to install the software company’s Augmented Analyst, designed to elevate and accelerate data analysis.

Veeva launches Vault CTMS with Bristol Myers Squibb

17-May-2022 By Jenni Spinner

The pharmaceutical company reportedly opted to implement the cloud software provider's clinical trial management system to help streamline its processes.

FDA outlines benefit-risk approach to drug or biologic product quality assessment

10-May-2022 By Jane Byrne

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

CPhI North America 2022

Pharma growth, partnerships focus of 2022 CPhI North America

04-May-2022 By Jenni Spinner

A leader from the organizer of the pharmaceutical event discusses what’s in store for the upcoming conference, and for the drug development industry itself.

MyMeds&Me acquisition paves path for pharmacovigilance expansion

14-Apr-2022 By Jenni Spinner

The company’s recent purchase by Drug Safety and Pharmacovigilance Services Solutions reportedly will fuel expansion of its Reportum PV platform technology.

Big pharma experts join forces to drive automation of data workflow

05-Apr-2022 By Nick Taylor

Leaders from some of the industry’s most notable companies are working together to streamline and automate IDMP workflow and come up with various standards.

Tech Innovations: March 2022

17-Mar-2022 By Jenni Spinner

The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.

The right tech can fill gap between lab scientist and data: ACD/Labs

16-Mar-2022 By Jenni Spinner

An expert from the R&D tech provider discusses how automation, integration, and other tools can help with effective access and analysis of lab information.

People on the Move: March 2022

03-Mar-2022 By Jenni Spinner

This month’s announcements include hiring, expansion, and acquisition news from companies like DFE Pharma, ClinOne, Novartis, LEGO, Benchling, and more.

scope 2022

Data history visibility keeps clinical studies on track: Almac

01-Mar-2022 By Jenni Spinner

Experts from the clinical tech firm talk data challenges and how monitoring technology can enable sites and sponsors to better manage audit trail reviews.

rare disease day 2022

Lilly planning $700m genetic medicine development center

24-Feb-2022 By Jenni Spinner

The pharmaceutical company’s Lilly Institute for Genetic Medicine reportedly will focus on developing RNA-based therapeutics in a ‘state-of-the-art’ facility.

SCOPE 2022

Risk-based quality management ‘perfect’ for DCTs: CluePoints

26-Jan-2022 By Jenni Spinner

A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on tools suited to decentralized trial design and management.

More than ever expected of today’s data managers: IQVIA

13-Jan-2022 By Jenni Spinner

With the amount of available data increasing and technology evolving, says a company leader, the job of data manager is more demanding than ever before.

Managing QC lab data is important part of research equation: Veeva

13-Jan-2022 By Jenni Spinner

A leader from the company discusses challenges in control labs and shares how a new solution aims to clear some key obstacles to greater effectiveness.

2021 year-end wrapup

Pandemic leads to challenges, opportunities in drug development: ACD/Labs

16-Dec-2021 By Jenni Spinner

A leader from the R&D tech provider discusses the obstacles faced by drug development professionals in recent months, and ways they rose to the occasion.

2021 year-end wrapup

Risk-based approach driving manufacturing improvements: Cognizant

16-Dec-2021 By Jenni Spinner

A leader from the information technology specialist explains how evolved thinking and digital transformation are leading to benefits across the industry.

AstraZeneca opens new advanced therapeutics R&D facility in Cambridge

23-Nov-2021 By Jane Byrne

AstraZeneca has built a new R&D facility - The Discovery Centre (DISC) - in Cambridge in the UK.

Pharmaceutical packaging firm adds QC laboratory in Ireland

10-Nov-2021 By Jenni Spinner

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

Azzur opens new on-demand cleanroom facility in California

03-Jun-2021 By Jenni Spinner

The company’s Azzur Cleanrooms on Demand division has established another facility in Vista, a city in the San Diego Area, for life-sciences operations.

On-demand capabilities help drug developers in a pinch

18-Feb-2021 By Jenni Spinner

With demand for fast-tracking therapies, vaccines and other products increasing, companies like Azzur Group offer the ability to add capabilities quickly.

FDA halts domestic inspections, calls for industry to ‘own’ quality

19-Mar-2020 By Ben Hargreaves

The US FDA announces that it will no longer be able to carry out domestic facility inspections due to the risk posed by COVID-19.

US FDA details problems that led to Biocon’s Form 483

13-Mar-2020 By Ben Hargreaves

The published Form 483 details five points of concern raised by inspectors to the company’s API facility in India.

‘You get what you pay for’ on API quality

19-Feb-2020 By Ben Hargreaves

As C2 Pharma works to expand its API portfolio, its CEO states that there is ‘no short game’ on API quality.

Lupin denies quality is a company-wide issue despite run ins with FDA

18-Feb-2020 By Nick Taylor

Lupin refutes suggestion that history of manufacturing quality failings highlighted by the US FDA reflect a company-wide issue.

In-vitro models reduce ‘risk and cost’ for topically-delivered generics

05-Feb-2020 By Vassia Barba

Developers of generic drugs administered with topical drug delivery methods benefit from MedPharm’s in-vitro models to safely demonstrate bioequivalence.

Partnership aims to identify over 8,000 antibiotic-resistant pathogens

30-Jan-2020 By Vassia Barba

Noscendo builds on its diagnostic platform to enable identification of antibiotic resistant microorganisms, in partnership with German hospital.

LomÉ Initiative Signing

Fake drugs: Unharmonized legislation threatens the lives of African patients

27-Jan-2020 By Vassia Barba

Although control measures are applied, falsified medicines are present in the supply chain in Niger, with solutions requiring cross-country collaboration, says the country’s Ministry of Health.

LOMÉ INITIATIVE SIGNING

Demanding quality: WHO on securing a vulnerable supply chain

23-Jan-2020 By Vassia Barba

As African countries look to secure their supply chains, head of the WHO’s team on fighting falsified and substandard medicine speaks about how to ‘demand quality’.

WHO on local manufacturing to tackle fake drugs in Africa

22-Jan-2020 By Vassia Barba

With efforts to tackle fake drugs in Africa increasing, the WHO's director-general speaks on the need to shorten the supply chain with local manufacturing.

LomÉ Initiative Signing

African governments agree to criminalize falsified drugs trafficking

20-Jan-2020 By Vassia Barba

Heads of state of seven African countries met in Lomé, Togo, to sign the Lomé Initiative, a political declaration to tackle fake medicine distribution on the continent.

Sterling expects further HPAPI demand, looks for buy-out opportunities

15-Jan-2020 By Vassia Barba

Sterling continues expansion and lines up further acquisitions, as the HPAPI market continues to see increasing demand, a company executive says.

NDMA investigation leads to cases discovered in diabetes treatment

09-Dec-2019 By Ben Hargreaves

After NDMA contamination is found by Singaporean authorities, both the FDA and EMA state they are working on the testing of metformin treatments.

Mylan aims to address FDA warning letter in next 6 months

09-Dec-2019 By Nick Taylor

Mylan sets sights on addressing US FDA warning letter in the ‘next quarter or a couple of quarters.’

Kyowa Kirin creates quality unit with direct line to CEO

05-Dec-2019 By Nick Taylor

Kyowa Kirin reorganizes to create quality division that reports directly to CEO Masashi Miyamoto.

Europe sets up backup site for reference standards

18-Nov-2019 By Ben Hargreaves

EQDM opens a second site for European Pharmacopoeia reference standards, used in the quality control of medicines across 120 countries.

FDA hits Zydus Cadila plant with another warning letter

11-Nov-2019 By Nick Taylor

US FDA serves Zydus Cadila’s sterile injectables plant with a warning letter for the second time in four years.

NEWS IN BRIEF

Mylan recalls anxiety medication due to ‘foreign material’

28-Oct-2019 By Ben Hargreaves

A voluntary recall of one lot of alprazolam tablets was announced by Mylan, after the potential presence of contaminant was discovered.

FDA hits Glenmark with warning letter over GMP failings

22-Oct-2019 By Nick Taylor

The US FDA hits Glenmark’s manufacturing plant with a warning letter over quality problems first identified in 2010.

US FDA recommends Lupin ‘assess its global manufacturing operations’

07-Oct-2019 By Ben Hargreaves

After an investigation last year, the FDA cites problems across multiple sites within the Lupin manufacturing network, raising questions about ‘management oversight and control’.

The five potential sources of nitrosamine contamination

02-Oct-2019 By Ben Hargreaves

With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.

Provepharm builds plant to cover its own APIs supply needs

30-Sep-2019 By Vassia Barba

Provepharm expands its facilities in order to manufacture its own active pharmaceutical ingredients, which will be used for molecule revitalization.

Torrent expands recall of losartan products, again

23-Sep-2019 By Ben Hargreaves

Torrent announces that it will recall batches of losartan tablets for the sixth time, after the detection of NMBA exceeding acceptable daily intake levels in latest recall.

Darmerica recalls API lots due to label mix-up

19-Sep-2019 By Vassia Barba

Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.

UPDATED

FDA delivers warning to Chinese company after no response to Form 483

10-Sep-2019 By Ben Hargreaves

US FDA sends a warning letter to Yino, after the company failed to provide a response to issues raised in a Form 483 regarding relabeling of API.

Shilpa Medicare facility suffers 3 power cuts in 15 minutes, receives Form 483

02-Sep-2019 By Ben Hargreaves

The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.

Analysis finds bulk of warnings delivered to Indian and Chinese drugmakers

30-Aug-2019 By Ben Hargreaves

The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.

FDA makes example out of Chinese OTC manufacturer

23-Aug-2019 By Ben Hargreaves

The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.

Natco Pharma API facility receives Form 483

12-Aug-2019 By Vassia Barba

US FDA issues another Form 483 with six observations to Natco Pharma, noting procedural discrepancies.

Jubilant recalls lot of potentially ineffective contraceptives

06-Aug-2019 By Vassia Barba

Jubilant voluntarily recalls one lot of contraceptive tablets due to out-of-specification dissolution results, potentially decreasing efficacy.