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Production & Manufacturing

EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Production & Manufacturing > Process & Production > News

Latest Production & Manufacturing News by Sector

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Fine & Speciality Chemicals

Bayer plans to focus entirely on Life Science businesses
Bayer intends in the future to focus entirely on the Life Science businesses – HealthCare and CropScience – and float MaterialScience on the stock market as a separate company. In this way Bayer is positioning itself as a world-leading company in the field of human, animal and plant health.
Production & Manufacturing > Fine & Speciality Chemicals > News
CordenPharma agrees to purchase Peptisyntha from Solvay
By PBR Staff Writer
International Chemical Investors Group (ICIG) and the Solvay Group have embarked on an agreement, whereby ICIG will purchase Belgium-based Peptisyntha SA, a custom manufacturer of peptides for pharmaceutical use.
Production & Manufacturing > Fine & Speciality Chemicals > News

Process & Production

FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News

OTC

Valeant to divest iNova Pharmaceuticals for $930m
By PBR Staff Writer
Valeant Pharmaceuticals International has agreed to divest its iNova Pharmaceuticals business for around $930m.
Production & Manufacturing > OTC > News
Fresenius Kabi agrees to acquire Akorn for $4.3bn
By PBR Staff Writer
German healthcare firm Fresenius Kabi has agreed to acquire US prescription and over-the-counter (OTC) pharmaceutical products manufacturer Akorn for around $4.3bn.
Production & Manufacturing > OTC > News

Manufacturing

Eli Lilly completes $90m expansion of biotechnology center in San Diego
Eli Lilly and Company has completed the $90m expansion of its biotechnology center in San Diego, California, US.
Production & Manufacturing > Manufacturing > News
Bristol-Myers Squibb to divest Irish manufacturing facility to SK Biotek
Bristol-Myers Squibb has agreed to divest its small molecule active pharmaceutical ingredient manufacturing facility in Swords, Ireland, to South Korea based SK Biotek, a subsidiary of SK Holdings.
Production & Manufacturing > Manufacturing > News