SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Apps pathetic: Drug industry mobile techs underperforming

30-Oct-2014 - Hardly anybody downloads Big Pharma apps according to a new report that suggests drugmakers seeking greater mHealth engagement should ditch the product-focused model and seek expert help.

Auf Wiedersehen PET? India to ban plastic bottles for liquid drugs

29-Oct-2014 - India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.

Sanofi's US-based CEO Viehbacher resigns after board votes to remove him

29-Oct-2014 - So it appears the future of Sanofi’s CEO Christopher Viehbacher was on the agenda after all.

EDQM sets new policy for testing of bacterial endotoxins

29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.

Neuro experts call for drug name shake-up; manufacturers more cautious

28-Oct-2014 - Psychiatric drugs should be renamed according to their chemical make-up, not the symptoms they treat, according to leading neuropsychopharmacologists.

People on the Move

People on the Move

27-Oct-2014 - Former employees of Procter & Gamble, Merck & Co. and Bristol Myers Squibb have all found new homes in the pharma industry in this week's People column.

Lawyers question legality of US FDA final guidance on delaying, denying inspections

27-Oct-2014 - What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance , “critically vague and legally questionable in several ways.”

EMA launches rolling review process for Ebola vaccine makers

23-Oct-2014 - Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.    

EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

22-Oct-2014 - DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

Global TB drug development efforts underfunded says WHO

22-Oct-2014 - Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.

NIH: without budget cuts, we’d have Ebola vaccine

22-Oct-2014 - The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over the last decade.

Correction

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

FDA to combine all of its quality ops under a new ‘super’ office

21-Oct-2014 - By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.

People on the Move

Job changes: Sanofi, AstraZeneca, Novo Nordisk

20-Oct-2014 - Sanofi has hired an ex-AstraZeneca president as its General Manager for the UK and Ireland.Tarja Stenvall was previously Country President for AstraZeneca Belgium and Luxembourg,...

Canada issues licenses for critical drugs hit by Apotex/IPCA import alert

20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.

AbbVie leaves $50bn Shire deal for dead following US tax rule changes

16-Oct-2014 - AbbVie’s proposed £31bn ($50bn) takeover of Shire is very likely “dead” after the US biopharma's board changed its recommendation and advised shareholders not to back the bid.

News from cphi

Big Pharmas and API suppliers eyeing Brazilian Government deals says EMS

16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.

Exclusive interview

Global regulators demanding needless drug quality levels, says Indian Gov

15-Oct-2014 - Overzealous and unnecessary quality demands by some regulatory agencies are driving up the cost of medicines, according to the Indian Government.

Free trade and strong IP held back Ebola vaccine development says NGO

15-Oct-2014 - The lack of an Ebola vaccine decades after the virus was discovered is due in part to IP protections in trade deals like TTIP that discourage innovation according to NGO, Health Action International (HAI).

News from EDQM 50th anniversary conference

Drug complexity will change how Big Pharma uses Ph. Eur. says Pfizer expert

13-Oct-2014 - Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook. 

Dispatches from EDQM conference

EDQM set to fight fakes and forge closer ties with EMA

07-Oct-2014 - Counterfeit drugs and collaboration will be key topics for the EDQM say delegates at the organisation's 50th anniversary conference on Monday.

Generics competition: change patent law over FAST Act, says expert

06-Oct-2014 - As US Congress considers the FAST (Fair Access for Safe and Timely Generics) bill to tackle “smokescreens” preventing competition, an expert tells in-Pharmatechnologist.com the problems behind marketing exclusivity run deeper and could be solved with changes to patent law.

New EMA trial transparency policy may mean higher legal costs for CROs say campaigners

06-Oct-2014 - The European Medicines Agency (EMA) on Jan. 1 will begin publishing clinical trial reports, which underpin the decision-making on medicines. 

Pre CPhI Special

Complex regs and unknown markets top API shippers' logistics headaches

02-Oct-2014 - The world is getting larger, at least it is in terms of the pharmaceutical industry, according to execs who cite security concerns when shipping to new markets as the top logistics worry.

Spotlight

Share API audits or see quality slump, says Hovione

Share API audits or see quality slump, says Hovione

The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert...

Personalised meds to deliver bigger market for oral film technologies says expert
dispatches from technopharm

Personalised meds to deliver bigger market for oral film technologies says expert

Flexible inkjet printing and personalized medicine will grow the market for orodispersible delivery technologies according to experts...

Complex regs and unknown markets top API shippers' logistics headaches
Pre CPhI Special

Complex regs and unknown markets top API shippers' logistics headaches

The world is getting larger, at least it is in terms of the pharmaceutical industry, according to...

How green was my Valium? Not very, despite industry claims
Pre CPhI Special

How green was my Valium? Not very, despite industry claims

Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to...

WHO welcomes industry response to Ebola crisis but calls for new drugs

WHO welcomes industry response to Ebola crisis but calls for new drugs

The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid...

Say ‘cheese’: database collects pill photos

Say ‘cheese’: database collects pill photos

The US National Institutes of Health (NIH) is collecting photos of pills and tablet in a database...

Key Industry Events

 

Access all events listing

Our events, Events from partners...