Breaking News on Contract Research, Manufacturing & Clinical Trials

AMRI says Burlington issues resolved, pending final FDA inspection

09-Feb-2012 - AMRI says the US FDA has no concerns about its sterile fill-finish facility in Burlington, Massachusetts and that the challenge now is to win back customers.

GSK brings work in-house in bid to boost efficiency and cut costs

09-Feb-2012 - GSK is bringing outsourced work back in-house and placing manufacturing at existing sites in a bid to boost efficiency.

AMRI posts Q4 loss but expects contracting revs to grow in 2012

08-Feb-2012 - AMRI posted a Q4 loss on lower sales but predicts that contracting revenues and margins will increase in 2012 thanks to cost cutting measures and new contracts

United Drug in €30m packaging services deal as rise continues

08-Feb-2012 - United Drug has inked a four-year, €30m packaging services deal as it continues to grow the division, particularly in the US.

Jubilant posts unhappy Q3 earnings despite record sales

07-Feb-2012 - Foreign currency effects left Indian contractor Jubilant Life Sciences with a third quarter loss despite record sales.

New approvals and contracts at CMOs

06-Feb-2012 - Outsourcing-pharma.com presents a round up the latest developments in the contract manufacturing sector – with news from Cambrex, Florida Biologix, SCM Pharma, Recipharm and OctoPlus.

CMO news roundup – Foster, Excella, Catalent and RohnerChem

02-Feb-2012 - A round-up of news in the contract manufacturing space, with developments at Foster Delivery Sciences, Excella, Catalent and RohnerChem.

Ipsen to take writedown after Lonza warning letter hits supply

02-Feb-2012 - Ipsen may take a writedown up to €180m after FDA action against its API CMO, Lonza, created supply uncertainties.

Encap lands long-term manufacturing contract

01-Feb-2012 - Encap Drug Delivery has won a contract manufacturing deal for a European licensed liquid-filled capsule product after the owner parted from its current CMO.

CMO Cytovance adds 1,000L bioreactor for trial supplies

01-Feb-2012 - Cytovance Biologics has added a 1,000L bioreactor at its Oklahoma site to support scale-up as clients move through clinical trials.

Dishman considers future of Chinese API plant

31-Jan-2012 - Ingredient maker Dishman Pharmaceuticals has confirmed that it may offload its Chinese API (active pharmaceutical ingredients) factory.

News in brief

Lpath suspends dosing after FDA warns of CMO failings

30-Jan-2012 - Lpath has suspending dosing in its iSONEP clinical trials after learning the CMO handling fill and finish has cGMP failings.

Contract manufacturing round-up

26-Jan-2012 - Outsourcing-Pharma presents a round-up of the latest headlines within the world of contract manufacturing. Catalent and Patheon have each launched oral dosage partnership news, whilst Frontage and AMPAC have received regulatory go-aheads.

News in brief

DHL gains license for packing & labelling medical devices

26-Jan-2012 - DHL has obtained a license for packaging, labelling and storing medical devices at its logistics site in Tokyo, Japan.

An experienced CMO is key to successful biologics development says Cobra Biologics

25-Jan-2012 - Detailed market knowledge and an experienced CMO are still critical to successfully developing a biopharmaceutical or biosimilar according to Cobra Biologics.

EU CMO market to top $20bn as big pharma ups outsourcing

25-Jan-2012 - A patent loss-fuelled surge in big pharma outsourcing will push the European CMO market through the $20bn barrier by 2018, analysis claims.

Plummeting profits prompt Lonza to fire CEO

25-Jan-2012 - Lonza has fired its CEO after a halving of net income prompted the board to find another leader for “the challenging years ahead”.

News in brief

Pii to double sterile capacity in Maryland site expansion

19-Jan-2012 - Pharmaceutics International, Inc (Pii) is to double its sterile GMP production capacity by building a 24,000 sq ft facility.

US DoD awards CMO Paragon Bioservices $15m vaccine deal

18-Jan-2012 - CMO Paragon Bioservices has won a $15m DoD contract to develop a large-scale mammalian process for a trivalent filovirus vaccine.

Carbogen Amcis buys French CMO Creapharm Parenterals

17-Jan-2012 - Swiss API maker Carbogen Amcis has bought French contract manufacturer Creapharm Parenterals to boost capabilities in early-phase high potency drug development.

Doxil supplies going further but J&J CMO uncertainty remains

17-Jan-2012 - J&J has enough Doxil to meet the needs of patients on its waiting list but warned CMO Ben Venue is unlikely to resume supply until late 2012.

Contract manufacturing news round-up

16-Jan-2012 - Outsourcing-Pharma presents a round-up of the latest contract manufacturing headlines in the industry, including news from Nanohale, Fleming and Trophogen.

Indian CRAMS sector to fuel export growth, CARE says

12-Jan-2012 - Outsourcing to Indian CRAMS and bulk drug businesses will drive the country’s export growth, a credit rating agency said.

Amarin wants fourth omega-3 API supplier for AM101

11-Jan-2012 - Amarin plans to add a fourth API maker to its supply chain as it prepares for a potential launch of its triglyceride lowering therapy, AMR101, in the US in 2012.

News in brief

Catalent to build biologics plant at former GE Healthcare facility

11-Jan-2012 - US contractor Catalent Pharma Solutions’ new biologics plant will be a facility formerly owned by GE Healthcare.