Wednesday, 30 April 2008

Goodwin Biotechnology has completed expansion of its biologics custom manufacturing facility

Goodwin biotechnology

FDA asks for cash

The director of the US FDA’s Center for Drug Evaluation and Research, Janet Woodcock, has told the House Energy and Commerce subcommittee on oversight and investigations that the FDA would need $225m - 20 times more than its current foreign inspection budget - in additional funding to inspect the 3300 foreign drug-making plants as frequently as it reviews plants in the US.
Los Angeles Times

Dr Reddy's buys US facility

Continuing the moves of Indian companies acquiring western manufacturing facilities, Dr Reddy's has acquired the Shreveport, Louisiana, custom manufacturing plant from BASF. GV Prasad, Dr Reddy's Vice Chairman and CEO, said the purchase was "an infrastructure play to support our North American generics business".
Money Control

SOCMA criticises call for US-REACH

Jim DeLisi, president of Fanwood Chemical, representing SOCMA told a US Senate Environment and Public Works Committee hearing that "an American REACH would not only hamper innovation but would reverse progress made over many years by federal regulators and the chemical industry to appropriately manage risk”. The committee chair, Senator Barbara Boxer has called for US chemical producers to be responsible for proving their products are safe before entering the market.

ProBioGen has begun a biologics manufacturing technology integration deal with Boehringer Ingelheim


Tuesday, 29 April 2008

Angel's Estonian deal

Angel Biotechnology will provide biomanufacturing services for EPhaG AS. Angel will support the production of four products over the next three years, for which it will get royalty payments for five years on the sale of the first three products. EPhaG will make a £1m investment in Angel.

DSM expects its Pharmaceutical Products business to recover from a weak first quarter

In-Pharma Technologist

Sunday, 27 April 2008

FDA calls on pharma to oversee quality

Janet Woodcock, director of the US FDA’s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee that the increasing number of ingredients sourced from overseas makes it almost impossible for the agency to ensure the safety of all drugs sold in the US. Woodcock said responsibility also lay with the pharma companies ensuring their ingredients reached quality standards.

Friday, 25 April 2008

Archimica sells plant, completes turnaround

Archimica has sold its Puerto Rico 5-fluorouracil plant to Teva. The sale completes the company's turnaround to multi-purpose facilities for manufacturing intermediates and APIs.

Wednesday, 23 April 2008

Record quarter for SAFC

SAFC saw record quarterly sales of $157.5m in Q1 2008 a growth of 18.2%. The company reported continued strong demand from pharmaceutical customers in the US and improved demand from biotech customers worldwide. Booked orders are at an all time high for SAFC.
PR Newswire

Jubilant sees 38% sales increase in year to end March 08

Business Wire

Tuesday, 22 April 2008

FDA weak on foreign inspections

The US Government Accountability Office has criticised the FDA for not conducting enough inspections of manufacturing facilities outside the country. in 2007 the FDA inspected 30 inspections this year it plans to conduct 50. However there are 3200 foreign drug firms listed by the FDA.
Associated Press

Pfizer to cut more manufacturing

Pfizer will close or sell 13 more manufacturing facilities as it cuts its number of production plants to 44 by the end of 2009. CFO Frank D'Amelio, was implementing an outsourcing programme.
In-Pharma Technologist

Evonik confirms bidders

Evonik ceo Werner Mueller has confirmed the four parties interested in acquiring the 25% stake the company is selling. They are Blackstone Group, Kohlberg Kravis Roberts, Bain Capital and CVC Capital Partners. Binding offers are expected by June.
Previously on FINE

Albemarle sees 4% drop in Q1 fine chemicals sales

Houston Chronicle

Indian companies shopping for CMOs

Indian life sciences companies are seeking acquisitions in the US and Europe in the chemistry and custom synthesis space.
Financial Express

Friday, 18 April 2008

Origin labels for drugs proposed

Democrats on the US House Energy and Commerce Committee have proposed county of origin labels for drugs. The labels would have to identify the source of the active ingredient and its place of manufacture.
Associated Press

Wednesday, 16 April 2008

DSM Biologics will optimise Upfront Chromatography’s fully disposable chromatography system for its biopharmaceutical production

Business Wire

Senators: FDA underfunded

Following a US Senate Appropriations Committee hearing, Senators from both parties said the FDA needed more funding than proposed by President George Bush.
New York Times

Analysts suggest Clariant and Ciba are takeover targets


AZ to outsource all manufacturing

AstraZeneca chief executive David Brennan said the company plans to outsource all API manufacturing within a decade. AZ has piloted the outsourcing of API for Seroquel and is will extend outsourcing to low-cost third-party manufacturers, especially in India and China.
Financial Times

Tuesday, 15 April 2008

FDA to open China office in May

The US FDA is to open three offices in China by October, the first beginning operations next month. Agency Commissioner Andrew von Eschenbach said it eventually hopes to open offices in India, Europe, the Middle East and South America.
Wall Street Journal

Monday, 14 April 2008

Sumitomo will be the exclusive sales agent for Chiral Quest's chiral products in Japan and selected worldwide accounts

Earth Times

Laureate Pharma to manufacture Alopexx Pharmaceuticals’ mAb F598 antibody

Laureate Pharma

Codexis files for IPO

Codexis hope to raise around $100m in an IPO underwritten by Credit Suisse Securities, Goldman Sachs, Piper Jaffray, RBC Capital Markets and Thomas Weisel Partners. Codexis did not reveal the offer price or number of shares to be sold in its submission to the SEC. Last year Codexis had sales of $25.3m but made an overall loss of $39m. Since it was founded as a spin out from Maxygen, Codexis has accumulated a deficit of $94.2m.

Saturday, 12 April 2008

Almac facility under threat from waste plant

Belfast Today

Evonik plans chemicals acquisitions

Klaus Engel head of Evonik's chemicals division said the company is ready to make acquisitions again. The Degussa division has a budget of about €2.5bn for expansion in China, South America and Europe over the next three years.

Thursday, 10 April 2008

Actavis buys in China

Actavis has purchased a 90% of Zhejiang Chiral Medicine Chemicals. The purchase of the Hangzhou-based API manufacturer is designed to help reduce costs.
In-Pharma technologist

Tuesday, 8 April 2008

Laureate Pharma to manufacture Cytheris’ Interleukin-7 (IL-7), a fully glycosylated recombinant human protein

Laureate Pharma

Overhaul coming for FDA

Congressional Quarterly reports that John Dingell, who heads the House Energy and Commerce Committee, is planning a fundamental overhaul plan that is likely to form the model for a Democratic or Republican White House following the US elections later this year. Dingell plans more full time inspectors in the developing world, adding country of origin labeling and levying new user fees on manufacturers to finance spot checks at overseas drug plants and at US points of entry.

Calls for FDA to label products with origin of ingredients

Wall Street Journal

Monday, 7 April 2008

India faces pharma manufacturing threat from China

Business Standard

FDA to hire

The FDA plans to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance its postmarket drug-safety activities.
FDA News

Saturday, 5 April 2008

Jubilant buys Draxis

Jubilant Organosys is to purchase Draxis Health for $225m. Jubilant said the deal gives it "an entry into the attractive, regulated, high growth and high margin radiopharmaceutical business".

Friday, 4 April 2008

Atrium Innovations will sell its active ingredients and specialty chemicals division AXA Private Equity for $155m


Archimica is expanding capacity for cryogenic production of boronic acids in Germany and France


Carbogen adds high potency in India

Carbogen Amcis' Indian subsidiary will open a high potency facility on the Bavla site of its parent company, Dishman Pharmaceuticals & Chemicals Ltd. The 4300m3 facility, which is expected to be operational by Q1 2009, will include four segregated high potency cells with reactor sizes ranging from 630L to 1600L and a number of contained development laboratories.
Carbogen Amcis

Thursday, 3 April 2008

Schering-Plough to cut manufacturing

Playing its part in the wave of cut backs in the pharma sector, Schering-Plough plans to reduce its head count by 10% and its number of manufacturing plants.
Wall Street Journal

Evonik bidders named

Insiders say that Blackstone Group, Kohlberg Kravis Roberts, Bain Capital and CVC are the preferred bidders for a stake in Evonik. They are each believed to have bid €2bn.

Lonza to expand nicotinate capacity

Lonza will expand its manufacturing capacity for nicotinates by 40% over the next three years to meet demand. The first phase of the SFr50m investment is due on-stream in 2010 with full operation in 2011.

Wednesday, 2 April 2008

PharmAthene has completed its acquisition of Avecia’s biodefense vaccines business


Evonik field down to four

RAG has ruled out an IPO for part of its Evonik business for the time being. It plans to sell a 25% stake this year, with a further 50% stake sold between 2010 and 2012. Reports suggest there are four potential buyers for the current stake, one of which is Blackstone Group.
The Guardian

Tuesday, 1 April 2008

Alpharma has completed the sale of its API business to 3i for $395m


Dowpharma sells UK assets

Dowpharma has sold its small molecules facilities in Mirfield and Cambridge, both in the UK, to Dr Reddy's. Although the actual transaction cost was not revealed, G V Prasad, vice-chairman and ceo of Dr Reddy's, said the cost was slightly above the business's $25m revenue. The acquisition will include the relevant business, customer contracts, associated products, process technology, intellectual property, trademarks as well as the transfer of the facilities. Dr Reddy’s will also have a non-exclusive license to Dow’s Pfenex Expression Technology for biocatalysis development.
Money Control