Breaking News on Contract Research, Manufacturing & Clinical Trials

Profits and capacity utilisation up at Lonza in H1 thanks to pharma

24-Jul-2014 - 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.

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

USFDA approves Novasep facilities for kinase inhibitor contract

23-Jul-2014 - Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

Pamplona CMO bullish about biopharma prospects after fundraising

22-Jul-2014 - 3P Biopharmaceuticals has raised funds and announced plans to invest in its manufacturing capabilities to meet the needs of international clients.

Sterile injectables M&A could indicate return to in-house production

22-Jul-2014 - Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.

Big Pharma's 'intellectual arrogance' stunts CMO partnerships, says GPCM Chair

22-Jul-2014 - Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.


Baxter Q2: Drop in demand hits CMO biz, despite overall sales growth

21-Jul-2014 - Baxter BioPharma Solutions dropped four percent year-on-year for the second quarter 2014 due to a fall in demand for contract manufacturing services.

Catalent looks to cash in with $872m IPO

18-Jul-2014 - With its expected sale of 42.5m shares for $20.50 each, CDMO (contract development and manufacturing organization) Catalent is looking to become a public company.

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014 - Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

West is East - Indian plant opens to serve Asian-Pacific customers

17-Jul-2014 - West’s new pharmaceutical packaging facility in India will reduce supply lead times for its Asia-Pacific customers, the company says.


Hovione and Merrion team on solubility solutions

16-Jul-2014 - Hovione has teamed up with delivery tech developer Merrion Pharmaceuticals to provide developers of BCS class III and IV drugs with more solubility enhancement options.

Consultant: For CMO selection, its the (molecule) size that counts!

16-Jul-2014 - The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.

Consultant: For CMO selection, its the (molecule) size that counts!

16-Jul-2014 - The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.

News in brief

Aesica adds roller compaction unit in growing German market

10-Jul-2014 - CDMO Aesica Pharmaceuticals is adding additional services to its Zwickau, Germany oral solids capabilities, including a new roller compaction unit for dry granulation production.

CMO quality audits: necessary and beneficial to all, says consultant

10-Jul-2014 - A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.

Russia set for first foreign CMOs as pharma preps for 2020 policy

09-Jul-2014 - Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.

Xellia bags Fresenius Kabi plant and supply contract

08-Jul-2014 - Finished dosage form and API manufacturer Xellia has acquired a US plant from Fresenius Kabi in a deal it says enhances supply chain security.

Kemwell's oral solid dose plant approved following joint European inspection

07-Jul-2014 - An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the...

Hospira finally completes Orchid plant acquisition

07-Jul-2014 - Hospira has paid Orchid Chemicals and Pharmaceuticals $218m (€160m) for an API plant in Aurangabad, India to increase its antibiotics production capacity and cut reliance on external suppliers.

News in brief

Rechipharm contracted to make lidocaine formulation for IUD-related pain

03-Jul-2014 - Recipharm AB will manufacture commercial supplies of a topical formulation of the anaesthetic lidocaine called Shact that is soon to be launched by developer Pharmanest AB.

Bulk ingredient prices skyrocket in US as payers clamp down

03-Jul-2014 - Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.

News in brief

Catalent to open Japanese development lab

02-Jul-2014 - Catalent Pharma Solutions will open a development lab for oral formulation in Japan, citing the popularity of fast dissolve formulations in the country as a key driver.

US FDA to set more specific GMP regulations for outsourcing facilities

02-Jul-2014 - Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for outsourcing facilities and the cGMP requirements for them.

Onyx invests in continuous flow following API demand

01-Jul-2014 - UK API-maker and contract research organisation (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.

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