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

Hospira's Rocky Mount, NC facility has had a 'rocky' few years

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.

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News in brief

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

A group of researchers at Harvard Medical School has developed a strongly cationic nanoparticle that physically absorbs proteins to form a new type of drug-carrier complex in aqueous solution.  

Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.

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.

Global Industry News

Covance finds early phase work rebound in Q2 as central labs growth continues from Outsourcing-Pharma.com

The season of quarterly reports is in full swing, with CRO Covance seeing its income and revenue rise in Q2 compared with the same quarter last year due to stronger-than expected early phase development and central labs work.

BioClinica, Isis relationship maturing with age from Outsourcing-Pharma.com

BioClinica, a provider of clinical trial management tools, is helping Isis Pharmaceuticals and its antisense drug development program bring on more and larger clinical trials, including 16 trials for 2014.

SGS expands Shanghai lab in response to growing pharma demand from Outsourcing-Pharma.com

Growing pharma demand in China has led SGS Life Sciences to expand its validation testing and lab service offerings at its Shanghai site.

Medidata sees revenue growth in Q2 as new clients spike from Outsourcing-Pharma.com

Cloud-based solutions provider Medidata saw its revenue increase 22% over Q2 last year to $83.2m as the company’s customer base saw steep growth.

As Ebola virus rages, funding is the main constraint for new treatments, scientist says from BioPharma-Reporter.com

The worst Ebola virus outbreak in history continues to spread in West Africa as biopharma companies are hampered by funding issues in trying to bring treatments and vaccines to human trials, a scientist says.

Where are tomorrow’s biosimilar hotspots? from BioPharma-Reporter.com

As the US FDA (Food and Drug Administration)’s biosimilars pathway is tested for the first time following Sandoz’s filgrastim submission last week, an expert predicts imminent biosimilars submissions from Celltrion and Hospira.

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...

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