Breaking News on Global Pharmaceutical Technology & Manufacturing

Hospira's Rocky Mount 'returns to health' as reinspection cites no observations

31-Jul-2014 - Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.

UK says hidden drugs shortage ‘getting worse’ as generics supply slows

31-Jul-2014 - The UK All-Party Pharmacy Group (APPG) has warned Britain is suffering from a shortage of branded and generic drugs.

Impax preparing response to FDA Form 483 with 10 observations

30-Jul-2014 - Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.

Who are pharma's movers and shakers?

28-Jul-2014 - The latest changes at Bayer, biopharma, and the winner of Professional Woman of the Year in this week's column.

First come, first served? FDA may allow reservation of drug names

28-Jul-2014 - The US Food and Drug Administration (FDA) is inviting public comment on plans to allow drug companies to reserve proprietary names for medicines as early as the end of Phase II trials.

UK Gov should seek licenses for off-patent drugs in new indications says MP

24-Jul-2014 - The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.

Is your drug name ok? Run a role-play, says FDA

24-Jul-2014 - Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.

Italy to look at drug pricing during EU presidency

24-Jul-2014 - Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Generics: change in pill shape makes patients 66% more likely to quit

23-Jul-2014 - Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

Feature

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

22-Jul-2014 - Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.

PhRMA supports Customs drug destruction, responds to critics of law

21-Jul-2014 - PhRMA (Pharmaceutical Research and Manufacturers of America) has warned that illegal medicines rejected at the US border will continue to be resubmitted for importation unless a proposed law allows their destruction.

People on the Move

Role changes for AbbVie and Shire CEOs after merger

21-Jul-2014 - It has been a hectic few days for the chief executives of AbbVie and Shire since their companies agreed a £32bn ($53bn) merger on Friday.

US FDA looks to increase cooperation with Latin American counterparts

21-Jul-2014 - The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014 - Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

India's CDSCO to pay people who report fake drugs

17-Jul-2014 - The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.

Dispute over FDA bid to destroy personally imported drugs

17-Jul-2014 - Pharma groups and patients have objected to US Food and Drug Administration (FDA) plans to destroy prescription medicines personally imported into the US by patients.

Italian API manufacturer hit with FDA warning letter over data control

16-Jul-2014 - Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.

Mylan buys Abbott’s generics business for $5.3bn

15-Jul-2014 - Abbott has sold its generics business to Mylan in a deal worth approximately $5.3bn (€3.9bn).

News in brief

India’s Cipla to invest £100m in UK R&D

10-Jul-2014 - Mumbai-based drugmaker Cipla has announced it will invest “up to £100m” ($171m) in drug development in the UK.

David and Goliath can coexist says group accusing US Pharma of anti-Indian tactics

10-Jul-2014 - The Indian industry group that accused US Big Pharma of anti-Indian tactics last week has said there is room for both generics firms and innovators. 

Waters to open laboratory with Chinese Pharmacopoeia

10-Jul-2014 - Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

GRAS always greener? FDA considers overhauling OTC monograph system

09-Jul-2014 - The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances. 

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

09-Jul-2014 - Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Ease regulations to cure drug industry antibiotic resistance, says RPS

08-Jul-2014 - The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College, London, who told in-Pharmatechnologist.com the key to encouraging antibiotics manufacture is lightening companies’ regulatory burden.

Spotlight

G-CON: Pfizer investment an endorsement of 'podular' manufacturing

Pfizer investment an endorsement of 'podular' manufacturing, says G-CON

G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards...

US FDA enforcement evolving in India will drive compliance costs

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and...

Ease regulations to cure drug industry antibiotic resistance, says RPS

Ease regulations to cure drug industry antibiotic resistance, says RPS

The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College,...

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix has modified its much-debated painkiller Zohydro with abuse-deterrent formulations.

Afrezza approval: Validation for Mannkind's drug and delivery tech

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry...

Key Industry Events

 

Access all events listing

Our events, Events from partners...