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Lilly focuses in-house as manufacturing becomes more complex

27-May-2014 By Dan Stanton

Eli Lilly is maintaining greater in-house control as manufacturing processes become more complex, whilst MSD is leveraging external over-capacity to fulfil its needs, the firms told Outsourcing-Pharma.com during a recent visit to Ireland.

Dispatches from the Biological Production Forum

Valeant puts head in the Cloud to manage over 800 CMOs

13-May-2014 By Dan Stanton

Managing over 800 CMOs could lead to quality and compliance nightmares but Valeant says it has come up with a unique cloud-based strategy. 

Outsourcing up for GMP APIs as Onyx completes manufacturing deal

12-May-2014 By Fiona BARRY

Onyx Scientific, a UK contract development and manufacturing organisation (CDMO) has completed an API (active pharmaceutical ingredient) production deal for Neuronascent, a US company developing neurological therapies.

Aesica to lead £200,000 project to improve manufacturing of API

30-Apr-2014 By Anthony King

Aesica has secured a Technology Strategy Board grant to fund a high-value chemical manufacturing process with the winning process set to improve the sustainability of an active pharmaceutical Ingredient (API).

Merck & Co. contracts Catalent to make sublingual hayfever drugs

23-Apr-2014 By Dan Stanton

MSD has selected Catalent to manufacture two recently approved sublingual pollen extract drugs using its Zydis formulation platform.

Swiss site for API maker Cerbios combines chemical and biological R&D

17-Apr-2014 By Fiona BARRY

Swiss high potency active pharmaceutical ingredient (API) contractor Cerbios has broken ground on a building that will bring together its chemical and biological R&D departments.

Catalent to provide cell lines for at least three Hisun biosimilars in China

16-Apr-2014 By Zachary Brennan

Catalent will provide Hisun Pharmaceuticals with cell lines to help it develop infliximab, adalimumab and alemtuzumab biosimilars for the Chinese market.

Shift to CMO strategic alliances key to UK plant turnaround, says Patheon

14-Apr-2014 By Dan Stanton

Strategic alliances and speciality manufacturing have transformed the fortunes of a Patheon UK facility, the company says.

Neuland opens new facility in India as part of deal with Japanese company

10-Apr-2014 By Zachary Brennan

CMO Neuland Laboratories has opened a new manufacturing facility in Hyderabad, India as part of its collaboration with Tokyo-based API Corporation (APIC).

Pacira selects Patheon to manufacture Exparel citing anticipated sales

10-Apr-2014 By Dan Stanton

Anticipated demand for the drug Exparel has led to a contract win for Patheon, though NDA holder Pacira says it will maintain control of all aspects of the manufacturing process.

Foreign customers look to US FDA as stamp of quality

09-Apr-2014 By Fiona BARRY

Passing US FDA site inspections is vital to attracting international clients, a European API supplier has said.

CMO to put old Pfizer plant in Tennessee to use with Amerigen pact

07-Apr-2014

UPM will produce two generic drugs for Amerigen Pharmaceuticals at a former Pfizer facility under a new 10 year supply contract.

Pernix leaves CMO business behind, sells off last manufacturing facility in Texas

03-Apr-2014 By Zachary Brennan

Pernix Therapeutics will no longer be a CMO as it has signed a definitive agreement to divest its Houston, Texas-based manufacturing operations to Woodfield Pharmaceutical to cut costs.

Cobra's French mAb customers to get R&D tax credit

01-Apr-2014 By Gareth Macdonald

French mAb developers that hire Cobra Biologics stand to benefit from tax breaks after the French Ministry of Higher Education and Research (MESR) named the CMO as a preferred provider.

Lupin: Mexican buy a bridgehead to generics and API growth

01-Apr-2014 By Gareth Macdonald

Lupin has bought Mexican eye drugmaker Grin in a deal that gives it a “bridgehead” to grow its API and generics business in the region.

Quality and IP issues driving sponsors away from Indian CMOs, experts say

01-Apr-2014 By Dan Stanton

Quality and IP issues are driving firms back to the US and Europe for their contract manufacturing according to experts, but Kemwell says there are still opportunities for Indian CMOs.

Cevec's cell line bypasses problems that have held back RSV vaccine

25-Mar-2014 By Gareth Macdonald

An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.

AMRI to acquire CDMO Cedarburg for $41M

25-Mar-2014 By Zachary Brennan

AMRI will acquire Cedarburg Pharmaceuticals for $38.2m (€27.7) in cash, plus $2.8m of assumed liabilities, to expand its API and drug development offerings.

UK cell therapy site to help firms avoid failures in “valley of death”

21-Mar-2014 By Gareth Macdonald

Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.

UK energy cuts good for pharma, API and chem firms says industry group

20-Mar-2014 By Gareth Macdonald

Efforts to cut industrial energy bills in the UK's 2014 Budget have been welcomed by the Chemical Industries Association (CIA), a group whose members include drug and ingredient makers.

Drug firms replaced as Lonza's biggest buyers in 2013

20-Mar-2014 By Gareth Macdonald

Drugmakers were replaced by buyers of cosmetics, hygiene and material protection ingredients as Lonza’s biggest customers in 2013 according to a report released by the Swiss CMO today.

IPO positions Recipharm as mid-tier CMO with plans to grow through takeovers

19-Mar-2014

Recipharm has given investors a sneak peak at its finances ahead of its IPO next month that establishes the firm as a mid-tier CMO with plans to grow through acquisitions.

Managing excipient supply needs risk guidance, not ‘fear’ says expert

19-Mar-2014 By Fiona BARRY

US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.

Hospira edges closer to completion of Orchid API deal in India

18-Mar-2014 By Dan Stanton

The Board of Directors at Indian firm Orchid has approved the sale of its API business to Hospira, bringing the acquisition a step closer to completion.

Aesica predicts more CMO consolidation and hints at acquisitions

17-Mar-2014 By Gareth Macdonald

Aesica has predicted that CMO sector consolidation will continue and hinted that it is considering strategic acquisitions as a part of a bid to generate $1bn revenue.

ClinicalRM, PPD awarded BARDA countermeasure contracts

17-Mar-2014 By Zachary Brennan

CROs Clinical Research Management (ClinicalRM) and PPD were awarded contracts by the Biomedical Advanced Research and Development Authority (BARDA) to develop medical countermeasures.

Patheon and DSM fully complementary for biologics post-merger, says DPx Exec

14-Mar-2014 By Dan Stanton

Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.

CMO future? Consolidation and strategic alliances, says Patheon/DSM Exec

13-Mar-2014 By Dan Stanton

In an exclusive interview, Patheon Executive Mike Lehmann talks DSM integration, further growth and how consolidation amongst CMOs may be driving strategic alliances with pharma.

Patheon and DSM complete $2.65bn merger to form private company 'DPx'

12-Mar-2014 By Dan Stanton

Patheon has merged with Royal DSM's pharmaceutical products business to form DPx in a $2.65bn (€1.9bn) deal that analysts believe has created the world's second biggest CMO.

CDSCO analysis reveals prevalence of substandard drugs in India

11-Mar-2014 By Zachary Brennan

Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO. 

WuXi reveals steep increase in quarterly manufacturing revenues

10-Mar-2014 By Zachary Brennan

WuXi PharmaTech has revealed that demand for its manufacturing services increased significantly last year and forecast that its "open access" approach will help it sustain growth into 2014. 

DSM to honour Australian biologics plant contract post-Patheon merger

07-Mar-2014 By Dan Stanton

Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.

DSM's pharma biz reports slight growth before Patheon merger

26-Feb-2014 By Dan Stanton

DSM has reported modest growth in its pharma business as a shareholders advisory firm comes out in favour of the upcoming merger with Patheon.

UPDATE-2

Ranbaxy voluntarily halts production at its Indian API plants

25-Feb-2014 By Dan Stanton

Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.

Glass causes Ben Venue to recall acetylcysteine solution in US

20-Feb-2014 By Zachary Brennan

Ben Venue Laboratories, a Boehringer Ingelheim subsidiary that was recently closed after a spate of quality problems, issued a US-wide voluntary recall for its Acetylcysteine Solution 10% at the patient level.

Great Excipact-ations: more excipient firms certified as predicted

20-Feb-2014 By Gareth MACDONALD

Four more drug excipient suppliers have been certified under the newly independent Excipact quality scheme.

Scinopharm: launches, China and injectables key in FY2014

17-Feb-2014 By Gareth Macdonald

Sinopharm expects customer drug launches and its recent investment in cancer injectables to drive revenue gains and margin growth in 2014.

AMRI to focus on scale and capabilities of API biz following robust 2013

17-Feb-2014 By Dan Stanton

AMRI says it intends to expand its API business to target both generics and more complex molecules after reporting record full year revenue from contract services.

breaking news - update 1

Recipharm confirms plans to list on OMX

17-Feb-2014 By Gareth Macdonald

Recipharm has confirmed that it is making plans to go public this year, citing a desire to finance “rapid growth” and acqusitions as the motivation.

Catalent to increase workforce by two thirds at Kansas City plant

13-Feb-2014 By Dan Stanton

Catalent says it is adding 230 jobs at a Missouri plant recently earmarked for expansion.

Perrigo: contract manufacturing down as OTC client restarts in-house

10-Feb-2014 By Dan Stanton

Perrigo Company has reported a 40% drop in contract manufacturing revenue year-on-year due to a key client, assumed by analysts to be J&J, returning to OTC in-house production.

Johnson Matthey seeks Schedule II license renewal

06-Feb-2014

Fine chemicals firm Johnson Matthey has asked the US to renew its license to make controlled substance drug APIs at its plant in Devens, Massachusetts

Recipharm says no decision yet on rumoured IPO

06-Feb-2014 By Gareth Macdonald

Recipharm says it has not decided whether to go public and list on the Swedish stock market after reports suggested it is preparing to join the exchange.

Johnson Matthey's controlled API biz sees positive Q3 sales after restructure

04-Feb-2014 By Dan Stanton

Johnson Matthey's decision to restructure its narcotic API business in light of increased UK competition has paid off, the company says.

Catalent looks to go public with $100m IPO

30-Jan-2014 By Dan Stanton

Catalent has filed an initial public offering (IPO) with the SEC to raise $100m though this could reach upwards of $500m, according to one investment firm.

NW Bio prepares for large-scale manufacturing expansion

29-Jan-2014 By Zachary Brennan

Northwest Biotherapeutics has agreed with CMO Cognate Bioservices to begin a large-scale expansion of the manufacturing, storage, handling and distribution of its personalized immune therapies for solid tumor cancers.

Lonza confident manufacturing capacity will be filled, post Teva biosimilar JV

24-Jan-2014 By Dan Stanton

The end of Lonza’s biosimilar joint venture with Teva will not affect manufacturing capacity, the firm says, as it reports a drop in overall revenue for 2013. 

Provenge CMO PharmaCell contracted for 2nd product

24-Jan-2014 By Gareth Macdonald

PharmaCell, the CMO that makes Provenge for Dendreon in Europe, has agreed to buy a facility from TiGenix to add capacity and a manufacturing contract for a second commercial product.

Hopkinton phasedown hits Lonza's 2013 sales

23-Jan-2014

Higher earnings and improved margins did not impress investors in Lonza, which saw its share price tumble today after revealing that sales to the drug sector fell in 2013.

Regis Technologies aces recent FDA inspections

23-Jan-2014 By Zachary Brennan

US FDA audits  are a lot tougher than customer inspections according to CMO Regis, which has just passed two agency assessments with no 483 observations.