Breaking News on Global Pharmaceutical Technology & Manufacturing

US politicians plan fast-track vouchers to reward Ebola R&D

26-Nov-2014 - Bipartisan bills introduced in the US House of Representatives and the Senate would give manufacturers of Ebola therapies vouchers to speed up review of a drug of their choice.

Diversity in pharma: why ‘risk minimisation’ has it all wrong

25-Nov-2014 - The lack of women on pharma boards is well-known, so why are companies still slow to balance the genders? A recruiter tells us the problem is “demand, not supply” and why quotas aren't a simple fix.

EMA adopts guidelines on phthalate excipients, cross-contamination in manufacturing

25-Nov-2014 - The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.

Ousted: rule-breaking Lundbeck CEO and Novartis scientist get the boot

25-Nov-2014 - Two pharma giants are today looking for new employees after pushing out the CEO of Lundbeck and a Novartis researcher for rule-breaking.

US, Chinese regulators forge closer ties as FDA looks to triple staff

24-Nov-2014 - As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

$15k and API info: FDA releases guide to registering drug compounders

24-Nov-2014 - The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.

People on the Move

Does Sanofi have a replacement CEO in its sights?

24-Nov-2014 - Plus the latest drug industry hirings, firings and awards in this week's column.

Dispatches from the FT Global Healthcare and Biotech Conference

EMA: New pathways and Ebola vaccines can help expedite approvals

20-Nov-2014 - The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.

UK Hospitals to play part in Gov efforts to speed clinical trial process

20-Nov-2014 - UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is key for Big Pharma and patients.

MHRA says quality system deficiencies are most common issue from inspections

20-Nov-2014 - Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections .

US FDA calls out two companies over fake Ebola treatments

20-Nov-2014 - The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by the agency.

People on the Move

Going places: pharma's movers and shakers

19-Nov-2014 - The Association of the British Pharmaceutical and novel drugmakers feature in this week's People on the Move column.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 - The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.

Dispatches from the Financial Times Global Pharmaceutical and Biotechnology Conference

Pipelines not tax cutting should prompt smaller pharma mergers says AstraZeneca exec

18-Nov-2014 - 2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.

Expert cautions: DSCSA deadlines may cause drug shortages

18-Nov-2014 - Drug shortages could be an issue in the near future as some wholesale distributors and drug suppliers may not be able to meet a key Jan. 1 deadline from the Drug Supply Chain and Security Act (DSCSA), an expert says.

FDA commish in China in search of more facility inspector visas

18-Nov-2014 - US FDA commissioner Margaret Hamburg is traveling to China this week and at least part of her trip will be devoted to securing visas for new drug manufacturing site inspectors.

Big Pharma has improved access to meds since 2012 but marketing practices still a concern says AMF

17-Nov-2014 - Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.

EU Ombudsman raises issues with some of EMA’s redactions of AbbVie data

13-Nov-2014 - The EMA said Wednesday it will formally respond to a letter sent by EU ombudsman Emily O'Reilly to the agency in which she took particular issue with some redacted information from AbbVie’s CSRs (clinical study reports).

China sets new requirements for hospitals running clinical trials

10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. 

Dispatches from AAPS 2014

BARDA: Ebola is “a bioterrorism threat”

06-Nov-2014 - BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”

Dispatches from AAPS

Pfizer Director: Need for regulatory commitments clarity in NDAs, and US FDA concurs

05-Nov-2014 - A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.

People on the Move

Sanofi offers to poach AZ CEO

04-Nov-2014 - IN PICTURES: Plus who's on the move at biotechs and the UK's National Health Service. 

dispatches from AAPS

Why Apple and Google hold the key to avoiding Pharmageddon

03-Nov-2014 - In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies which fail to innovate risk being left behind.

AAPS 2014: Avoiding pharmageddon and pharma innovation discussed in San Diego

03-Nov-2014 -   [View the story "Cali-pharm-ia: Live from AAPS 2014" on Storify]

GSK, Sanofi see setbacks in flu vaccine production for US market

03-Nov-2014 - Two major influenza vaccine producers have run into manufacturing issues that have delayed and reduced the number of doses that will be provided for the US.


DPI delivered peptide could prevent deaths during childbirth, says GSK
Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed...

Why Apple and Google hold the key to avoiding Pharmageddon
dispatches from AAPS

Why Apple and Google hold the key to avoiding Pharmageddon

In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies...

India cuts stability data reqs for API firms seeking docs to ship to EU

India cuts stability data reqs for API firms seeking docs to ship to EU

India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to...

Life on Mars? Ground control to remotely deliver drugs in space

Life on Mars? Ground control to remotely deliver drugs in space

Animal astronauts on the International Space Station will test an implant which allows doctors back on earth...

Why there's no sign of Pfizer among top pharma employers

Why there's no sign of Pfizer among top pharma employers

A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but...

EDQM sets new policy for testing of bacterial endotoxins

EDQM sets new policy for testing of bacterial endotoxins

The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set...

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