Breaking News on Global Pharmaceutical Technology & Manufacturing


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.


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.


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.

Spanish regulators suspend Inmunotek's manufacturing license and order recall

13-Apr-2016 - Inmunotek has been ordered to recall vaccines made at a facility in Madrid after Spanish regulators identified a number of GMP deficiencies.

US 'foots the bill' for global biopharma innovation, says ITIF

12-Apr-2016 - The US ranks first in terms of how its domestic policies contribute to global biopharmaceutical innovation, according to a recent analysis.

Allergan moves on with Heptares collaboration

11-Apr-2016 - After announcing it won’t acquire Pfizer last week, Allergan has announced a partnership with Heptares to advance medications for neurological disorders.

Sun's so-long wave to Tipperary: Indian firm to close Ranbaxy plant this year

07-Apr-2016 - Sun Pharmaceuticals has confirmed it will close a Ranbaxy Laboratories facility in Ireland by the end of the year.

Mouse model to aid Zika vaccine testing

06-Apr-2016 - Researchers have established a new mouse model for testing vaccines and therapeutics to fight the Zika virus.

News in brief

Pfizzles out: Pfizer pulls out of Allergan merger citing US tax clampdown

06-Apr-2016 - Pfizer Inc will remain a US firm after calling off a proposed $160bn merger with Ireland’s Allergan Plc.

Supply chain fraud continues to plague companies, poll says

05-Apr-2016 - For the third year in a row, about 30% of Deloitte poll respondents say their companies experienced supply chain fraud, waste, or abuse in the previous year. 

Rusan Pharma plant still breaks GMP rules says UK MHRA

04-Apr-2016 - Quality systems at a plant run by Rusan Pharma still break GMP rules according to a MHRA statement of non-compliance published this week.

Cadila Healthcare confirms WHO notice of concern in BSE filing

30-Mar-2016 - Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.

AI solution redacts 'hundreds of studies per day,' Synchrogenix President

30-Mar-2016 - A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.

BioClinica expands eHealth leadership team

30-Mar-2016 - BioClinica is expanding its eHealth Solutions to support futher growth with the announcement two global executive-level additions.

India: PET OK in packaging, but phthalate excipient use should be minimized

30-Mar-2016 - There is no evidence PET (polyethylene terephthalate) packaging poses a threat to health but use of phthalate excipients should be minimized according to an Indian Government committee.

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