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Headlines > January 2017

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Novartis unit Lek to expand Slovenian antibiotics plant

31-Jan-2017 - Sandoz subsidiary Lek will expand production capacity at its antibiotics facility in Prevalje, Slovenia.

Shredded records and unofficial spreadsheets land Italian plant with FDA warning

31-Jan-2017 - Data integrity issues have landed Italian drugmaker FACTA Farmaceutici with a US FDA warning letter.

Novartis oncology drug bolsters revenue with another EU approval

31-Jan-2017 - The European Commission has approved oral formulation of Novartis' seizure treatment Everolimus under the trade name Votubia.

Italy bans antibiotic APIs made by Antibioticos do Brasil

31-Jan-2017 - Italy has banned APIs made by Antibioticos do Brasil LTDA (ABL) at its facility in Bairro Itapavussu, Sao Paulo over sterility concerns.

Ferring licenses Enteris Peptelligence to turn injectable into oral drug

30-Jan-2017 - Ferring is the third company in a week which will use Enteris BioPharma’s Peptelligence engineering platform for small molecules to develop oral formulations.

Beximco forms manufacturing JV with Malaysia's BioCare

30-Jan-2017 - Beximco Pharmaceuticals Limited has partnered with BioCare Manufacturing Sdn Bhd to make generic drugs for the Malaysian market.

Lundbeck banks on shark antibody delivery tech to cross blood-brain barrier

27-Jan-2017 - Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.

Biocon wins $68m Malaysian contract for biosimilar insulin and pen supply

26-Jan-2017 - Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.

GMP-status 'a major step' for medical marijuana recognition, Bedrocan

26-Jan-2017 - The GMP certification of a Dutch cannabis production facility is a “major step” in bringing medicinal marijuana to the level of evidence based medicines, says Bedrocan.

Comment

J&J buying Actelion for $30bn, but should CMOs be concerned?

26-Jan-2017 - With no production sites of its own, we question whether Johnson & Johnson’s manufacturing network is likely to incorporate Actelion’s substantial product portfolio.

FDA hits UK state-owned CDMO with warning over leukemia drug production

25-Jan-2017 - Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.

Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience

Sanofi and Nordic Bioscience deals ‘validate’ oral delivery tech, Enteris

25-Jan-2017 - Enteris Biopharma has secured two deals in as many days to use its excipient-based platform to enhance delivery of preclinical peptide candidates.

A 'small sale for MannKind' as it offloads Californian HQ and production site

25-Jan-2017 - MannKind Corporation has agreed to sell its headquarters and manufacturing site in Valencia, California to Rexford Industrial Realty for $17.3m.

Belgian CDMO to launch generic of vaginal contraceptive device NuvaRing

24-Jan-2017 - Mithra Pharmaceuticals SA will seek US and EU approval for a rival to the NuvaRing contraceptive device in Q2, manufacturing the ring through its independent CDMO platform.

Azelis lands nitroalkanes distribution deal with Angus Chemical

24-Jan-2017 - Angus Chemical Company has hired Azelis to distribute its nitroalkanes to pharmaceutical and biotech companies in Europe.

ADMA to buy US Biotest plant and fix problems that derailed RI-002

24-Jan-2017 - ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.

Sun declines to comment on New Jersey plant sale speculation

24-Jan-2017 - Sun Pharmaceutical Industries has declined to comment on reports it is to sell its US manufacturing business Ohm Laboratories.

Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

23-Jan-2017 - Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

GCP 'Renovation' paper outlines revisions to ICH E8 and E6

23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

Serialisation, automation and data integration: Zenith talks manufacturing in 2017

19-Jan-2017 - The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.

News in brief

Cipla targets South African asthma market with breath activated inhaler

19-Jan-2017 - Cipla has launched a breath activated inhaler in South Africa.

SUKL finds GDP problems at B.Braun warehouse in Czech Republic

19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.

Improving solubility: MilliporeSigma opens dedicated meglumine site

19-Jan-2017 - MilliporeSigma has opened a facility in Spain dedicated to the manufacture of the solubility-enhancing excipient meglumine.

Q&A with CEO and CMO

Medical marijuana chewing gum to treat IBS in Dutch trial

18-Jan-2017 - AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS). 

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