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EMA revises guidance on developing flu vaccines

The new modular guideline is intended to update in a consolidated document the existing guidance

The European Medicines Agency (EMA) has released a second module of a new guideline on influenza vaccines  for a six-month public consultation, which covers the non-clinical and clinical requirements for the development of new flu vaccines. 

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News in brief

A newly discovered virus which infects intestinal bacteria might be a cause of obesity, but could increasing interest in bacteriophages drive new personalised medicines and alternatives to antibiotics?

We explore the US and Israeli biologics makers joining the NASDAQ this week ahead of clinical development plans.

Scientists from USP (US Pharmacopoeia), Apotex and an advisory board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.

Hospira says it expects to be among the first to launch an EPO biosimilar in the US following FDA submission later this year.

Pfizer has agreed to pay $635m (€474m) to Baxter International for its vaccine business, including two marketed products and a facility in Austria.

Global Industry News

Hospira's Rocky Mount 'returns to health' as reinspection cites no observations from in-PharmaTechnologist.com

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 from in-PharmaTechnologist.com

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

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.

Chinese firm imported misbranded API into US, says FDA warning letter from in-PharmaTechnologist.com

Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Impax preparing response to FDA Form 483 with 10 observations from in-PharmaTechnologist.com

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.

I’m sticking with you: McKesson and CVS JV solid for 3 more years from Outsourcing-Pharma.com

McKesson Corporation, a healthcare services and information technology company, today announced a three-year extension to its pharmaceutical distribution agreement with CVS Caremark.

Spotlight

US venture capital investors continue to back biotech

US venture capital investors continue to back biotech

Biopharma firms continued to attract US venture capital investment in Q1 according to new analysis by PricewaterhouseCoopers...

EMA revises what it classifies as advanced-therapy treatments

EMA revises what it classifies as advanced-therapy treatments

The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products...

BioOutsource targets biosimilars testing growth with new US lab

BioOutsource targets biosimilars testing growth with new US lab

US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which...

Rentschler expands manufacturing capacity with stainless steel

Rentschler expands manufacturing capacity again, this time with stainless steel

The Laupheim, Germany-based CMO (contract manufacturing organization) Rentschler Biotechnologie has invested €24m ($33m) to build a twin...

EU green lights first insulin biosimilar from Lilly, BI

EU green lights first insulin biosimilar from Lilly, BI

The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting...