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BioMarin’s Palynziq gets FDA approval to treat adults with phenylketonuria The US Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) Injection for the treatment of adults with phenylketonuria (PKU), a serious genetic disease. Regulatory Affairs > News
EC approves Sandoz' Zessly to treat gastroenterological, rheumatological and dermatological diseases Sandoz has secured approval from the European Commission for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
News Malvern Panalytical unveils Zetasizer Pro and Ultra systems Malvern Panalytical has launched its new Zetasizer Pro and Ultra systems, designed to help in decision-making within crucial analytical workflows associated to product development and quality control.
Production & Manufacturing > Process & Production > News BioMarin’s Palynziq gets FDA approval to treat adults with phenylketonuria By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) Injection for the treatment of adults with phenylketonuria (PKU), a serious genetic disease.
Regulatory Affairs > News
FDA declines to approve Cosmo’s NDA for Methylene Blue MMX The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Cosmo Pharmaceuticals, saying that it cannot approve the latter’s Methylene Blue MMX as a visualization aid to increase detection of lesions in the colon.
Regulatory Affairs > News Epigen to license LPA1 receptor small molecule program to Novo Nordisk Epigen Biosciences has entered into a collaboration agreement with Novo Nordisk, under which Novo Nordisk has licensed the LPA1 receptor antagonist EPGN696 for development in diabetic and chronic kidney disease and other chronic diseases associated with metabolic syndrome.
Drug Research > Drug Discovery & Development > News Cara out-licenses Korsuva injection ex-US rights to Vifor Fresenius for $520m By PBR Staff Writer
Cara Therapeutics has granted licensing worldwide rights with the exception of the US, Japan and South Korea to commercialize its Korsuva (CR845/difelikefalin) injection to Vifor Fresenius Medical Care Renal Pharma (VFMCRP).
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Malvern Panalytical unveils Zetasizer Pro and Ultra systems
Malvern Panalytical has launched its new Zetasizer Pro and Ultra systems, designed to help in decision-making within crucial analytical workflows associated to product development and quality control.
Production & Manufacturing > Process & Production > News
Takeda to sell Techpool to Chinese JV partners
Takeda Pharmaceutical has agreed to divest its its majority shareholding of 51.34% in Guangdong Techpool Bio-Pharma (Techpool), a China-based firm focused on urinary protein biopharmaceuticals and production of biopharmaceuticals in critical care, to its joint venture (JV) partners for $280m.
Production & Manufacturing > Manufacturing > News

Drug Research

Malvern Panalytical unveils Zetasizer Pro and Ultra systems
Malvern Panalytical has launched its new Zetasizer Pro and Ultra systems, designed to help in decision-making within crucial analytical workflows associated to product development and quality control.
Production & Manufacturing > Process & Production > News
Epigen to license LPA1 receptor small molecule program to Novo Nordisk
Epigen Biosciences has entered into a collaboration agreement with Novo Nordisk, under which Novo Nordisk has licensed the LPA1 receptor antagonist EPGN696 for development in diabetic and chronic kidney disease and other chronic diseases associated with metabolic syndrome.
Drug Research > Drug Discovery & Development > News

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

Midatech begins dosing in first human trial of cancer drug Q-Octreotide
Midatech has commenced initial dosing in the first in-human study of its sustained release product Q-Octreotide (MTD201) for the treatment of carcinoid cancer and acromegaly.
Contract Research & Services > Clinical Trials > News
Janssen's Erleada shown to reduce PSA progression by 94% in nmCRPC patients
By PBR Staff Writer
Janssen Pharmaceutical's androgen receptor inhibitor Erleada (apalutamide) succeeded in a phase 3 trial by significantly cutting down the risk of prostate specific antigen (PSA) progression in patients having non-metastatic castration-resistant prostate cancer (nmCRPC).
Contract Research & Services > Clinical Trials > News

Automation

Horizon Discovery out-licenses cell line engineering technology to US firm
Horizon Discovery Group has entered into a non-exclusive out-licensing agreement with an undisclosed US-based immuno-oncology company (the Partner) for its technologies to support the development and manufacture of a biomanufacturing cell line for commercial use.
Automation > IT & Software > News
GE to provide biomanufacturing platform for Clover’s Chinese facility
By PBR Staff Writer
GE Healthcare will provide its biomanufacturing platform for Clover Biopharmaceuticals’ new production facility in China.
Automation > IT & Software > News

Regulatory Affairs

EC approves Sandoz' Zessly to treat gastroenterological, rheumatological and dermatological diseases
Sandoz has secured approval from the European Commission for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
News
BioMarin’s Palynziq gets FDA approval to treat adults with phenylketonuria
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) Injection for the treatment of adults with phenylketonuria (PKU), a serious genetic disease.
Regulatory Affairs > News



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