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Headlines > May 2016

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Monsanto bid may mean Bayer will cut pharma R&D spending, says analyst

31-May-2016 - The proposed $62bn merger with agrochemical firm Monsanto would jeopardise Bayer’s pharmaceutical business, according to a BMI Research analyst.

Europe OKs Samsung Bioepis’ Remicade biosimilar Flixabi

31-May-2016 - The European Commission (EC) has approved Samsung Bioepis’ Remicade (infliximab) biosimilar.

Granules 483-hit API plant receives all clear from US FDA

31-May-2016 - A Granules API plant in Hyderabad which received a Form 483 with three observations has been given the all clear by the US FDA.

Oasmia reviewing proposals from firms interested in API solubility enchancement tech

31-May-2016 - Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.

US FDA warns CordenPharma about Italian antibiotic API and cancer injectables plant

30-May-2016 - The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.

Inflectra-maker Celltrion to expand biosimilar capacity by 170,000L

27-May-2016 - Celltrion will invest $275m at its biosimilar production site in Korea to ramp up capacity from 140,000L to 310,000L by 2021.

Safety board clears TxCell to restart Ovasave study that was halted last year

27-May-2016 - TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.

Biocon granted permission for $158m expansion at Indian biomanufacturing site

27-May-2016 - Indian drugmaker Biocon has been given the go-ahead to expand a biopharmaceutical manufacturing facility in Bangalore.

Xellia starts work on testing lab at Hungary API plant citing growing demand

26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.

Novo Nordisk and Sanofi diabetes combo drugs receive US recommendation

26-May-2016 - The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.

CGT to test scaffold tech for commercial-scale T-cell production

25-May-2016 - The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.

Drugs tracked in Ongar: Selcia opens radiolabelled API plant

25-May-2016 - Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.

Mock sheets and lack of stability data: US FDA hits two API makers with warnings

25-May-2016 - The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.

Croatia's Halmed finds GMP deficiencies at Dhanuka Labs' antibiotic API plant

25-May-2016 - An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.

Catalent launches new kit labeling system to reduce 'risk of human error'

24-May-2016 - Catalent Pharma Solutions has released a new clinical supply labeling tool in response to a "work-around" which could put patients' safety at risk.

Combination therapies key to curing cancer, says Pfizer

24-May-2016 - Combination therapies and collaboration will be key in curing cancer, according to Pfizer which has seen 'astounding progress' in its immuno-oncology partnership with Merck KGaA.

Recipharm will serialize customers' drugs for free until US and EU rules come into force

24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.

update

Biotrial criticised over fatal Phase I study by France's social affairs inspectorate

23-May-2016 - French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.

Albumedix tech key to Chinese efforts to develop once-a-week diabetes drug

23-May-2016 - Recombinant albumin supplier Albumedix will help Hebei Changshan Biochem Pharma develop a once-a-week diabetes treatment.

Olon SpA to buy Infa Group

23-May-2016 - Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.

IMA: Angina drug API firm JP Laboratories cannot keep Daund plant up to code

23-May-2016 - Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).

Italian regulator slams simvastatin-maker Krebs for GMP deviations

23-May-2016 - APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.

Ajinomoto Althea gets US patent for fast, industrial-scale antibody crystallization method

19-May-2016 - Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.

New technique creates 'nearly pure drug' for injection

19-May-2016 - Researchers have developed an “easy-to-adopt” process for removing excess additives from injectable drugs.

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