Breaking News on Biopharmaceutical Development & Manufacturing

Top Headlines

News in brief

Mailroom and legal staff at Sandoz and Amgen are in for a busy six months after the US FDA agreed to review a biosimilar version of the anti-infective, Neupogen.

The biopharma services market keeps expanding and “growth prospects look fabulous,” says Thermo Fisher, reporting better than expected sales across its Life Sciences business.

Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.

Sartorius Stedim Biotech has attributed strong sales and order growth in the second quarter 2014 to recent acquisitions and demand for single-use products.

Biologic manufacturer PlantForm and PharmaPraxis have established a joint venture to develop, manufacture and commercialize biosimilar versions of six key biopharma treatments.

Global Industry News

UK Gov should seek licenses for off-patent drugs in new indications says MP from in-PharmaTechnologist.com

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.

Feature

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests from in-PharmaTechnologist.com

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.

Is your drug name ok? Run a role-play, says FDA from in-PharmaTechnologist.com

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.

Ipca halts API shipments to US following 483 at Indian plant from in-PharmaTechnologist.com

Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

Italy to look at drug pricing during EU presidency from in-PharmaTechnologist.com

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.

Strategic partnerships driving consolidation of CDMO industry, says report from Outsourcing-Pharma.com

Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.

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...