FDA Deputy Commissioner, Joshua Sharfstein will be acting Commissioner until Margaret Hamburg's nomination is approved

Reuters

Biosimilars bill introduced in US Senate

New York Times

Cobra Biomanufacturing sees improved H2 in 2008, as losses for year almost double

Cobra

Consortium wins manufacturing technology grant

A consortium of US and UK companies has been awarded an $11m phase 2 contract by the US Defense Threat Reduction Agency (DTRA) - Joint Science and Technology Office, Transformational Medical Technologies Initiative (TMTI), to develop technology for accelerated monoclonal antibody and vaccine manufacturing. The consortium combines Xcellerex’s microbial process development and single-use manufacturing technologies with Dowpharma’s Pfenex expression technology, deltaDOT’s analytical technology and BioPharm Services' systems integration, data management/process economics, and simulated event modeling technology. The consortium won a phase 1 grant in July 2007 (FINE Newsletter, 19 July 2007).
Boston Globe

Pharma industry calls for FDA food-drug split

Associated Press

Cobra Biomanufacturing reaches agreement with customer over contract variation

Cobra

Chemtura files for bankruptcy protection

Reuters

DSM to establish JVs in China

DSM has taken a 10% stake in North China Pharmaceutical Group Corporation Ltd and the two companies are establishing three joint ventures: one for vitamin C and two for anti-infective APIs and intermediates. DSM will hold a 51% share in the two anti-infectives joint ventures.
DSM

Almac has "topped-off" it new headquaters site in Pennsylvania

Almac

Wacker expects fine chemicals growth in 2009

Wacker's fine chemicals business saw sales fall 13% in 2008, despite higher sales of its biotech products. The company put this down to consolidation and reducing the number of catalogue products it makes. The company expects overall business to fall in 2009, but believes the fine chemicals unit will see growth.
Wacker Chemie

Onyx Scientific, Cyprotex Discovery and Glytech will jointly offer drug metabolite identification and synthesis services

Onyx

Novasep to build HPAI facility

Novasep will develop an R&D-phase pilot facility for highly potent active ingredients (HPAIs) as part of a consortium funded by the French government to develop innovative cancer therapies.
Business Wire

Obama announces FDA picks

President Obama has finally announced his picks to head the FDA. The President has nominated Margaret Hamburg as FDA Commissioner and Joshua Sharfstein as deputy commissioner. Hamburg will face a congressional approval committee.
Forbes

Cobra Biomanufacturing customer in discussions to terminate contract

Share Cast

Rudolf Hanko is to take over as CEO of Siegfried from 1 May

BioSpace

BASF to sell-off business unites to get EU approval of Ciba acquisition

Reuters

Roche finally gets Genentech - for $46.8bn

New York Times

Obama settles on FDA choices

Wall Street Journal

Dow and Rohm & Haas settle merger disagreement

Fox

Ampac Fine Chemicals has inaugurated its kilogram scale cGMP batch/continuous processing development facility

Contract Pharma

Lonza speeds biologics development timeline

Lonza has developed a cell line construction process that reduces the time taken from DNA sequence to cGMP material to 14 months. The customer-tailored cell line construction process uses rapid methods for generating clonal cell lines and chemically defined, non-animal origin components.
Bio Valley

Dow back in talks with Rohm & Haas

Bloomberg

UKTI seeks companies for ChemSpec Europe

UK Trade and Investment is seeking up to 14 companies for a stand share at ChemSpec Europe in Barcelona. The companies must be of UK origin and offer UK origin products and services within the fine and speciality chemical industry.
For more information contact UKTI

Merck to acquire Schering Plough for $41.1bn

New York Times

DSM and Roquette are to commercialise a bio-based succinic acid production process

MSNBC

Penn Pharmaceuticals has launched a £12m, 5-year expansion programme at its Tredegar, Wales, site

Outsourcing Pharma

US Senators propose clamp down on unsafe drug imports

A bi-partisan group of US Senators has introduced a Bill that will limit imports of drugs into the US. The Bill - The Pharmaceutical Market Access and Drug Safety Act - will only allow drugs - and drug ingredients - to be imported from FDA-inspected plants.
Domain B

Lonza to manufacture TcL Pharma antibody

TcL Pharma has chosen Lonza to manufacture its lead monoclonal antibody. Lonza will provide strain development using its XS Microbial Expression Technologies through to cGMP manufacture of Phase I clinical material.
Manufacturing Chemist

RFCL-Mallinkrodt Baker deal off

RFCL has called off plans to acquire Mallinckrodt Baker. The two companies failed to agree a common valuatio, analysts expected the deal to be worth $325-350m.
Economic Times

Dow considers selling assets to fund Rohm & Haas deal

ICIS

Novacta and CML partner for chiral processes

Novacta Biosystems and Cambridge Major Laboratories will collaborate to develop new manufacturing routes to chiral pharmaceutical intermediates. Novacta will develop biocatalytic approaches to target chiral intermediates which Cambridge Major will scale-up at its facility in the Netherlands.
In-Pharma Technologist

India to be top five pharma hub

The Indian Government is planning to make the country one of the top five global pharmaceutical innovation hubs within four years. It aims to invest $1bn as part of its Vision 2020 - half of which will be public funds half from industry.
Pharma Times

Lonza leases 2200m2 space in Hopkinton, MA

Metro West Daily News

Ranbaxy lab falsifies data

US News

Fine Organics plans 5% sales growth

Financial Times

Lonza to manufacture Opsona antibody

Lonza will provide process development and cGMP manufacturing services for preclinical and Phase 1 studies of Opsona Therapeutics monoclonal antibody OPN- 305, using its GS Gene Expression System.
Morning Star