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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

Indian firm, 26 others cited for failing to pay GDUFA fees

01-Oct-2014 - Indian generic manufacturer Marck Biosciences has received a warning letter from the US FDA for failing to pay its annual facility fees for the past two years, which for foreign fixed-dose formulation facilities in 2014 was $235,152 .

Impax settles lawsuit related to manufacturing issues for $8m

30-Sep-2014 - Hampered by manufacturing issues, Impax Laboratories has decided to settle a lawsuit over allegations related to the issues in order “to eliminate the uncertainty, distraction, burden and expense of further litigation,” the company said in a SEC filing .

FDA says no to anti-addiction rule on Ritalin, painkillers

29-Sep-2014 - The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.

India accuses American Enterprise Institute researchers of "smear campaign"

29-Sep-2014 - The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”

People on the Move

GSK appoints RBS chairman, AstraZeneca knight joins R&D charity

29-Sep-2014 - The Chairman who steered the Royal Bank of Scotland Group (RBS) after its financial crisis losses will join GSK’s Board as a Non-Executive Director and...

'Worst addiction epidemic in US history' sparks call for Hamburg's resignation

25-Sep-2014 - An anti-addiction group has called for a change in leadership at the US FDA following the approval of Zohydro and other high-dose opioid analgesics.

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

24-Sep-2014 - The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.

GS1 offers guide for adhering to new US supply chain security law

24-Sep-2014 - As the US Drug Supply Chain Security Act (DSCSA) traceability requirements become mandatory in 2015, standards group GS1 is offering a 137-page guideline to help manufacturers follow the new stipulations.

Production on hold at GSK vaccine plant after poliovirus enters water supply

23-Sep-2014 - GlaxoSmithKline will not restart production at a vaccine plant in Belgium until an independent investigation determines how liquid contaminated with polio virus was released into the local sewage system.

Pharmacies banned from compounding for docs without prescription

23-Sep-2014 - The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.

Say ‘cheese’: database collects pill photos

22-Sep-2014 - The US National Institutes of Health (NIH) is collecting photos of pills and tablet in a database for use in apps to improve public safety.

Diluent mix-up not vaccine most probable cause of Syrian deaths says WHO

18-Sep-2014 - Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.

Dispatches from ChemOutsourcing

ICH elemental impurities guideline expected to be finalized at end of September

18-Sep-2014 - After much discussion and some confusion , the ICH’s (International Conference on Harmonization) Q3D guideline , which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.

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...

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