Breaking News on Global Pharmaceutical Technology & Manufacturing

FDA warning for Sandoz after data and training issues at Indian plants

25-Nov-2015 - Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.

Seaweed shortage prompts Thermo to suspend sale of two lab agars

25-Nov-2015 - Thermofisher Scientific has stopped selling two agars used in pharmaceutical industry control labs, citing a worldwide shortage of the seaweed used to make them.

EC mulls changes to Orphan Drug rules

24-Nov-2015 - Tweaks to EU orphan drug rules (OD) may be needed to accommodate Ebola treatment development and block industry attempts to delay generic entry says the European Commission.

Pfizer gets OK for $160bn Allergan acquisition

23-Nov-2015 - The boards of Pfizer and Allergan yesterday signed a $160bn merger that will create the world’s biggest pharmaceutical company.

Dispatches from PCT Europe

Future epidemic trials must cut through red tape, says Ebola researcher

19-Nov-2015 - A professor who conducted fast-track trials during last year’s Ebola outbreak says next time such trials must be part of humanitarian response… because there will be a next time.


CEO who ‘only employs beautiful women’ guilty of sex discrimination

18-Nov-2015 - The CEO of Immuno Biotech who said he only employs “beautiful women” and noted a candidate’s lipstick and high heels on her job application has been fined for sex discrimination.

Catalent: Suspension at French plant likely due to human interference

17-Nov-2015 - Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.


Ex-Italian medicines chief heads EMA

16-Nov-2015 -

As Philidor closes, Valeant tries to shake off ties

13-Nov-2015 - Specialty pharmacy Philidor Rx has been forced to fold as its sole customer Valeant distances itself from claims their relationship broke the law.  


MHRA medical assessors tackle challenging evolving drug complexity

12-Nov-2015 - The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?

Recall round-up

Pfizer withdraws 20,000 Xanax, plus Hong Kong OTC recall

11-Nov-2015 - Pfizer has issued a recall of more than 20,000 bottles of Xanax after discovering the strength of the batch may be weaker than labelled.

AZ halts Dr Reddy’s ‘purple pill’ generic; firm responds to FDA Letter

11-Nov-2015 - In the second setback for Dr Reddy’s within a week, the District Court of Delaware has granted a temporary restraining order preventing the company from selling esomeprazole, the generic version of AstraZeneca’s Nexium.


Isys CEO resigns; job news at Merck and BI

09-Nov-2015 -

Three Dr Reddy’s sites hit with Warning Letters in India

09-Nov-2015 - Dr Reddy’s shares have slumped 14% after the company received an FDA Warning Letter over manufacturing conditions at three Indian sites.

Accelerated access

UK innovation drive will change licensing, reimbursement and trials

05-Nov-2015 - A UK government report on accelerated access to medicines proposes overhauling conditional licensing and reimbursement pathways to drive drug development.

Indiana aspirin maker hit with Warning due to tablet inconsistencies

04-Nov-2015 - Inconsistent tablet colour and issues with compressing procedures have landed Indiana OTC maker American Family Pharmacy (AFP) with a US FDA warning letter.

Pfizer: No safety snags at China plant despite ‘missing document’ 483

03-Nov-2015 - Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.

News in brief

FDA warning letter for two Sandoz plants in India

03-Nov-2015 - The FDA last week issued a warning letter to Novartis following inspections of two Sandoz plants in India in 2014.

Europe plans IP waiver for pharma manufacturing

02-Nov-2015 - The European Commission plans to introduce a waiver to supplementary protection certificates (SPCs) to stimulate pharma manufacturing in Europe.

Sanofi says injectable recall could cost company $110m

02-Nov-2015 - Sanofi’s mass recall of faulty auto-injectors will cost the French company about €100m ($110m), its CFO says.

News focus

Women less likely to be prescribed post-heart attack drugs, researchers find

29-Oct-2015 - Younger women are less likely than younger men to be prescribed or fill their medication after a heart attack, new research shows.  

Russia's clinical trial approvals 'on the increase'

26-Oct-2015 - The number of clinical trials given the green light in Russia has increased 13% in the third quarter of the year, which could be thanks in part to a reduction in red tape.

News in brief

MHRA seizes $1.5m worth of unlicensed ED drugs

22-Oct-2015 - Around 500,000 doses of unlicensed erectile dysfunction (ED) drugs have been seized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

CPhI Worldwide 2015

After the M&A bubble bursts: the four types of pharma firm to survive

21-Oct-2015 - An advisor to the pharma industry on M&A says the current boom in pharma valuations will not last, and R&D cost pressures will reshape firms of the future.

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