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Breaking News on Contract Research, Manufacturing & Clinical Trials

News in brief

US FDA to review new drug application using Catalent softgel drug delivery tech

05-Aug-2015 - The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel...

AMRI acquisitions driving up contract revenue in Q2

05-Aug-2015 - With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio , two Aptuit facilities and a UK aseptic facility pay off.

Update

Baxter CMO business to decline 10% after loss of ‘major customer’

04-Aug-2015 - Baxter’s contract manufacturing business is expected to take a nearly 10% hit as one of its "major customers" has elected to self-manufacture products previously made by the CMO (contract manufacturing...

TxCell: we’ll continue to use CMO even after we get back our GMP

04-Aug-2015 - French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.

Xcelience invests in CMO Powdersize

03-Aug-2015 - CDMO (contract development and manufacturing organization) Xcelience has made a structured cash investment in Pennsylvania-based Powdersize, which specializes in milling, micronization and powder size classification.  

AMRI's business risk profile 'weak,' says S&P

27-Jul-2015 - A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO...

Roche expanding capacity 40% across network, but will still use CMOs

24-Jul-2015 - Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.

Patheon sells chemicals sites to focus on pharma ahead of IPO

24-Jul-2015 - Patheon has sold a production plant in Italy to LIVIA and agreed to a management buyout at a site in Austria as it prepares to go public.

Capsugel expanding Encap plant on rising HPAPI demand

23-Jul-2015 - Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).

News in brief

Chicago CMO opens potent small molecule site

23-Jul-2015 - Contract manufacturing organisation Regis Technologies has added an HPAPI (highly potent active pharmaceutical ingredient) service.

Compound sentence? Two 'outsourcing facilities' hit with US FDA warning letters

22-Jul-2015 - Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.

Lonza: global hedge helped offset currency exposure but Visp still a risk

22-Jul-2015 - Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.

West scaling up AZ plant on demand for Smartdose wearable injector

21-Jul-2015 - Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.

Gadea's steroid intermediates biz means AMRI not reliant on Asian suppliers say execs

20-Jul-2015 - AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.

Green GMP criteria would help responsible API firms compete with polluters says DSM Sinochem

20-Jul-2015 - API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental...

Perfusion and chromatography beat ALS cell therapy production challenges, says Goodwin

17-Jul-2015 - Goodwin Biotechnology says making trial supplies of Q Therapeutics’ amyotrophic lateral sclerosis (ALS) cell therapy meant overcoming considerable technical hurdles.

Eisai to transfer RTP manufacturing campus to Biogen, plans 35 layoffs

17-Jul-2015 - Eisai has agreed to transfer ownership of its Research Triangle Park (RTP) manufacturing campus to Biogen, which will continue to manufacture oral solid-dose products and parenteral products at the sites...

Peregrine flying high as CMO biz preps to open new mAb facility

16-Jul-2015 - Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialise its breast cancer candidate.

Nordea mulling holdings in drugmakers that source APIs from water polluters

16-Jul-2015 - Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.

Proteon extends vonapanitase manufacturing deal with Lonza

16-Jul-2015 - Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.

WuXi to create $200m investment fund following initial success

15-Jul-2015 - The almost-private China-based CDMO (contract development and manufacturing organization) WuXi is looking to reap larger rewards from investing in US and China pharma and biotech firms.

Aptuit expands to bring on later-stage capabilities following client demand

14-Jul-2015 - CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial...

CiMaas selects PharmaCell as CMO for early efforts with cell therapies

14-Jul-2015 - CiMaas BV, a company developing cellular immunotherapies to treat cancer, has selected CMO (contract manufacturing organization) PharmaCell, to help in the clinical development and manufacturing of CiMaas’ ATMPs (Advanced Therapy...

Environmental group welcomes DSM-Sinochem and GSK efforts to halt spread of antibiotic resistance

13-Jul-2015 - Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.

Catalent hit with FDA Form 483 at North Carolina plant

13-Jul-2015 - Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483  with six observations.

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