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Breaking News on Global Pharmaceutical Technology & Manufacturing

Catalent launches new kit labeling system to reduce 'risk of human error'

24-May-2016 - Catalent Pharma Solutions has released a new clinical supply labeling tool in response to a "work-around" which could put patients' safety at risk.

Recipharm will serialize customers' drugs for free until US and EU rules come into force

24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.

update

Biotrial criticised over fatal Phase I study by France's social affairs inspectorate

23-May-2016 - French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.

Exclusive interview

Clinical Trials Day: focusing on awareness, the ‘war on talent,’ and an industry-wide commitment

19-May-2016 - Clinical Trials Day celebrates the first randomized clinical trial conducted in May 1747 and the clinical research professionals that work in the industry more than 265 years later.

MPA withdraws Bend's Oregon plant GMP certificate citing deficiencies

17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”

Live from EDQM: Regulators say quality will drive generics availability

13-May-2016 - Working together could save regulators millions and increase availability of medicines for patients, delegates say at the EDQM's International Generic Drug Regulators Programme (IGDRP) in Strasbourg.

News in brief

Packaging defect prompts VistaPharm oxy recall

12-May-2016 - VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.

ANSM says Medreich plan will bring non-compliant Bollaram plant up to code

11-May-2016 - A remediation plan by Medreich Limited is sufficient to bring its Andhra Pradesh antibiotics plant in to compliance with GMP according to French regulator ANSM.

Brexit bad for patients according to ABPI which says UK would lose regulatory influence

10-May-2016 - Brexit would add extra barriers to licensing medicines in the UK according to the Association of the British Pharmaceutical Industry (ABPI).

Concealed compliance info lands ex-Ranbaxy owners $385m costs

10-May-2016 - The former owners of Indian drugmaker Ranbaxy have been ordered to pay Daiichi Sankyo $385m for concealing quality problems across its manufacturing network before selling the business.

News in brief

Drug firms would prioritize EU over smaller UK market post Brexit warns ABPI

09-May-2016 - Drug companies will prioritize the EU over the UK in the event of Brexit according to the ABPI, which says members recognize the benefits of centralised licensing.

Europe delays Merck & Co.'s HCV drug on back of CMO quality issues

09-May-2016 - Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).

update

EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.

Manufacturers concede on price as drug spending increases

02-May-2016 - Specialty medicine innovation is driving growth, yet advances are being offset by price concessions from manufacturers, according to IMS Health.

Biotrinity 2016

Biopharma 'future is better in Europe,' says UK life science minister

27-Apr-2016 - Britain’s minister for life sciences has called on the country’s £60bn pharma sector to rally together in support of remaining in the European Union.

Controlled substances: fewer CMOs, more regulations

26-Apr-2016 - The manufacture of controlled substances has faced increased scrutiny over the years, and as such, fewer CMOs are in the market.

Almac Group launches new serialization solution

26-Apr-2016 - Almac Group has expanded its serialization capabilities to include its US commercial packaging facility in Audubon, PA.

George Freeman: New meds and delivery methods a regulatory challenge

26-Apr-2016 -   [View the story "Live from #Biotrinity2016" on Storify]

WHO says Semler Research manipulated data and warns repeat studies may needed

25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.

Brexit bad for biosimilar developers says new industry group

22-Apr-2016 - Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).

Exco InTouch partners with Regulatory Strategies to meet data regulations

21-Apr-2016 - Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.

US FDA hits another Indian drugmaker over data integrity issues

21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.

update

US National Cancer Institute stops making cell therapy in light of contamination risk

20-Apr-2016 - Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.

US FDA guidance looks to stem ‘major problem’ of data integrity

18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.

update

Trade secret laws adopted by MEPs create legal uncertainty for pharma whistleblowers says HAI

14-Apr-2016 - Trade secret laws adopted by the European Parliament mean employees who raise concerns about drug safety and efficacy face legal uncertainty says HAI.

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