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Production & Manufacturing

FDA and EMA accept Bristol-Myers’ filing for expanded Opdivo indications The US Food and Drug Administration (FDA) and the European Medicines Agency have accepted to review Bristol-Myers Squibb’s market applications seeking approval to expand the use of Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). 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

LSK BioPharma announces successful outcome from End-of-Phase 2 meeting with FDA for apatinib
LSK BioPharma (LSKB) announced the successful completion and positive outcome of an End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA) for apatinib, an investigational drug for treatment of solid tumors.
Production & Manufacturing > Process & Production > News
Merck's Ebola Zaire vaccine gets accelerated review designations in US and Europe
By PBR Staff Writer
Merck’s experimental Ebola Zaire vaccine, V920, has received accelerated review status in the US and European Union.
Production & Manufacturing > Process & Production > News

OTC

Espada acquires GlyDerm line of skin care products from Lautus Pharmaceuticals
Espada Dermatology has acquired the GlyDerm line of skin care products from Lautus Pharmaceuticals.
Production & Manufacturing > OTC > News
Moberg Pharma completes acquisition of US OTC brands from Prestige Brands
On 30 June, Moberg Pharma announced the acquisition of three Over-The-Counter brands in the U.S. from Prestige Brands. The acquisition has now been completed. The purchase price amounted to $40 million.
Production & Manufacturing > OTC > News

Manufacturing

Oxford BioMedica secures UK MHRA approval to manufacture drugs at new facilities
By PBR Staff Writer
Oxford BioMedica has secured approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for investigational medicinal products at its new facilities.
Production & Manufacturing > Manufacturing > News
GSK to invest £275m in three UK manufacturing sites
By PBR Staff Writer
GlaxoSmithKline (GSK) has unveiled plans to invest £275m in its UK manufacturing network, and said that it views the country as an attractive location for investment despite last month's vote to leave the European Union.
Production & Manufacturing > Manufacturing > News