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New App for Pharmaceutical Biotech Industry Executives
NSF International has launched a new app designed for pharmaceutical biotech industry executives. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 28, 2017 Category: Pharmaceuticals Source Type: news

FPS to Exhibit at EXPO PACK 2017
FPS is pleased to announce it will be exhibiting at the EXPO PACK 2017 trade fair, which takes place 13-15 June in Guadalajara, Mexico. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 28, 2017 Category: Pharmaceuticals Source Type: news

Pierre Fabre to buy Igenica Biotherapeutics ’ assets for treating cancer patients
French private pharmaceutical group Pierre Fabre has signed a new definitive purchase agreement to acquire several assets from US biotechnology company Igenica Biotherapeutics. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

SITraN researchers report positive results of new MND drug
New research conducted by scientists from the Sheffield Institute for Translational Neuroscience (SITraN), part of the University of Sheffield, into a new drug candidate that can possibly delay the onset of Motor Neurone Disease (MND) has shown early … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: SciVision Biotech, Symic Biomedical, Palladio Biosciences
Taiwanese company SciVision Biotech intends to raise up to $30m in gross proceeds through a public offering of overseas secured convertible corporate bonds. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

FPS Provides High-Containment Integrated System for Pharmaceutical Applications in India
FPS has announced delivery of a high-containment Integrated system for an Oncology plant in Bangalore, India. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

Continuous Flow Sterilization of Simple Biowaste Streams
PRI Bio's AutoFlow is designed for applications in biologics, virology, vaccine, genetically modified organism (GMO), and contract manufacturing organization (CMO) pilot plant research labs through large-scale manufacturing facilities. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

World Courier - Process
This PCM panel could play a role in curing cancer. Preconditioned in offices worldwide, it is one of thousands that can be used at a moment's notice for the safe transport of clinical trial drugs. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

Protein Misfolding and Aggregation Examinations using Calorimetric Methods
Under specific physiological conditions, unfolded proteins fold into thermodynamically favourable native structures to gain function. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 25, 2017 Category: Pharmaceuticals Source Type: news

Unisys unveils PharmaTrack software to manage global pharmaceutical supply chain
Global information technology company Unisys has launched a new software to provide enhanced visibility and management of the entire pharmaceutical supply chain worldwide. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 24, 2017 Category: Pharmaceuticals Source Type: news

FDA approves Sun Pharma ’s tildrakizumab for moderate-to-severe plaque psoriasis
Indian company Sun Pharmaceutical Industries has received the US Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for tildrakizumab to treat patients with moderate-to-severe plaque psoriasis. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 24, 2017 Category: Pharmaceuticals Source Type: news

Bioverativ to purchase True North Therapeutics for $400m
Global biotechnology company Bioverativ has entered a definitive agreement to acquire US-based company True North Therapeutics for $400m. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 24, 2017 Category: Pharmaceuticals Source Type: news

Upcoming Quality Assurance and Regulatory Adherence Courses by NSF
NSF International has released a list of upcoming courses for June and July. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 24, 2017 Category: Pharmaceuticals Source Type: news

What is a Biosimilar and How Does it Differ Compared to Drug Development?
Prior to 23 March 2010, there was no regulatory pathway for biosimilar development in the US. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 24, 2017 Category: Pharmaceuticals Source Type: news

UK CMA accuses Merck of breaking competition law with discount scheme
The UK Competition and Markets Authority (CMA) has accused US pharmaceutical company Merck Sharp& Dohme (MSD) of operating an anti-competitive discount scheme for its medicine Remicade. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 23, 2017 Category: Pharmaceuticals Source Type: news

Ardelyx ’s first-in-class NHE3 blocker Tenapanor boasts positive phase III data
On May 12, Ardelyx, a US-based clinical-stage company focused on the development of treatments for cardio-renal and gastrointestinal (GI) diseases, announced positive top-line results from the T3MPO-1 Phase III study for the use of tenapanor to treat … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 23, 2017 Category: Pharmaceuticals Source Type: news

FDA approves Sanofi and Regeneron ’s Kevzara for adult rheumatoid arthritis
Sanofi and Regeneron Pharmaceuticals ’ drug Kevzara (sarilumab) has received the US Food and Drug Administration (FDA) approval to treat adult patients affected with moderately to severely active rheumatoid arthritis (RA). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 23, 2017 Category: Pharmaceuticals Source Type: news

Selexis and OSE Immunotherapeutics to support OSE-127 (Effi-7) development
Swiss-based Selexis has signed a commercial licence agreement to provide French biotechnology firm OSE Immunotherapeutics with access to high-performance research cell banks (RCBs) from its SUREtechnology Platform. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 23, 2017 Category: Pharmaceuticals Source Type: news

BLUE Software Celebrates 20th Anniversary
To celebrate its 20th anniversary, BLUE Software has announced it will introduce new software as a service (SaaS) products BLUE Essentials, BLUE Premier, and BLUE Enterprise to its label and artwork management (LAM) technology. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 23, 2017 Category: Pharmaceuticals Source Type: news

AstraZeneca signs deal to sell commercial rights for Seloken in Europe
AstraZeneca has entered an agreement to provide the commercial rights for Seloken/Seloken ZOK (metoprolol tartrate and metoprolol succinate respectively) and associated Logimax fixed-dose combination (metoprolol succinate and felodipine) treatments i … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 22, 2017 Category: Pharmaceuticals Source Type: news

AC Immune and Essex to develop biological treatment for neurodegenerative diseases
AC Immune and Essex Bio-Technology have signed a research collaboration agreement to conduct a pre-clinical study and clinical codevelopment of a novel biological therapeutic to treat neurodegenerative diseases and neuroinflammation. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 22, 2017 Category: Pharmaceuticals Source Type: news

Singapore eDevelopment subsidiary starts advanced research on Linebacker
Singapore eDevelopment subsidiary Global BioLife has started advanced research on a new universal therapeutic drug platform called Linebacker to tackle multiple conditions such as Alzheimer's, diabetes, and cancer.   (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 22, 2017 Category: Pharmaceuticals Source Type: news

Rules for Investigating Good Manufacturing Practice (GMP) Deviations in Sterile Processing
When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to det … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 22, 2017 Category: Pharmaceuticals Source Type: news

Medicon Valley Inhalation Consortium (MVIC)-Full Service CRO and Inhalation Product Development Specialists
Medicon Valley Inhalation Consortium (MVIC) offers a comprehensive range of first-class services for the entire value chain of inhalation products, from drug discovery to late-stage development. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 22, 2017 Category: Pharmaceuticals Source Type: news

Cancer Research UK funded scientists to test Zika virus on brain tumours
Scientists funded by Cancer Research UK will investigate the effectiveness of the Zika virus in destroying brain tumour cells, which could lead to new treatments for cancer. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 21, 2017 Category: Pharmaceuticals Source Type: news

Merck ’s Isentress receives CHMP positive opinion to treat HIV-1 infection
Merck ’s Isentress (raltegravir) 600mg film-coated tablets have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the treatment of HIV-1 infection in adults and paedi… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 21, 2017 Category: Pharmaceuticals Source Type: news

Sanofi ’s insulin lispro receives CHMP positive opinion to treat diabetes
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Sanofi's insulin lispro. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 21, 2017 Category: Pharmaceuticals Source Type: news

Bluerock: Canada ’s stem cell contender on the journey from petri dish to clinical trial
Toronto-based regenerative medicine biotech BlueRock Therapeutics was launched in December with a massive $225m series A financing. So what stem cell-based therapies is the company working on? (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 21, 2017 Category: Pharmaceuticals Source Type: news

Prudential Cleanroom Services Completes Surveillance Audits
Prudential Cleanroom Services has announced that it has completed its surveillance audits for ISO 9001:2008 through T Ü V S Ü D America. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 19, 2017 Category: Pharmaceuticals Source Type: news

Ez biopac
ILC Dover's EZ BIOPAC single-use containment and transfer system can help you improve productivity and profitability. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 19, 2017 Category: Pharmaceuticals Source Type: news

European Molecular Biology Laboratory Site, Barcelona
European Molecular Biology Laboratory (EMBL) is developing a new facility within the Barcelona Biomedical Research Park (PRBB) campus in Spain. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

Sobi receives SFDA approval for Orfadin capsules
Specialist healthcare company Swedish Orphan Biovitrum (Sobi) has received approval from the Saudi Food and Drug Administration (SFDA) for Orfadin (nitisinone) capsules in strengths of 2mg, 5mg, 10mg and 20mg. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

NPPA issues notice to pharmaceutical firms for non-compliance of pricing provisions
Indian drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued notices to several pharmaceutical companies that have marketed combination drugs without complying Drug Price Control Order (DPCO) 2013. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

M & As this week: Lonza Group, Shandong Buchang Pharmaceutical
Swiss biopharmaceutical company Lonza Group has completed the acquisition of HansaBioMed Life Sciences OU, an Estonian pharmaceutical company. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Shanghai Fosun Pharmaceutical Group, Shandong Buchang Pharmaceutical, 4SC
Shanghai Fosun Pharmaceutical Group intends to raise approximately HK$2.32bn ($298.3m) through a private placement of 80.6 million shares. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

NSF International to Attend 2nd PDA Europe Annual Meeting, Germany
NSF International's pharma biotech team has announced it will be present at the 2nd PDA Europe Annual Meeting in Berlin. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

Pharmatest Launches Novel Humanised Mouse Model of Tumor Growth in Bone
Pharmatest Services has announced it has collaborated with Taconic Biosciences to develop a novel humanised mouse model of tumour growth in bone that can be used for testing immunotherapies. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

Solving Complex Pharmaceuticals Dosing Tasks
For dosing and filling in the pharmaceutical industry, you usually think of water-like, non-viscous products such as solutions for injecting. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

Thermo Fisher Services Granted Access to ATUM's Gene Design Platform
Formerly known as DNA2.0, ATUM has announced it has signed a patent licensing agreement granting Thermo Fisher Scientific access to its novel gene design platform. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 18, 2017 Category: Pharmaceuticals Source Type: news

ST Asia signs licensing agreement with PharmaMar for anti-cancer compound lurbinectedin
Singapore-based biopharmaceutical company Specialised Therapeutics Asia (ST Asia) will commercialise a new anti-cancer compound known as lurbinectedin (PM1183) throughout South East Asia, following a second major licensing deal with Spanish pharmaceu … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

X-Chem and Vertex form multi-target genetic disease collaboration
US-based firms X-Chem and Vertex Pharmaceuticals have signed a collaboration agreement to discover new drug leads against targets involved in multiple speciality diseases. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Micro-machines: nanotech offers new possibilities for disease detection and drug delivery
For the first time, miniscule molecular machines designed for early disease detection and targeted drug delivery have been shown to work in living cells. Elly Earls meets the researchers behind the breakthrough to find out more. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Bayer receives FDA priority review for copanlisib to treat follicular lymphoma
German drug manufacturer Bayer has received priority review designation for the new drug application (NDA) for copanlisib from the US Food and Drug Administration (FDA). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Applications in Pharmaceutical Manufacturing
The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Pharma Technology Focus – Issue 59
In this issue: Challenging the link between innovation and US drug pricing, the impact of Brexit on life sciences companies, a new study on the effects of cognitive-enhancing drugs, using crowdfunding to unlock cancer therapies, and more. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Stand-Up Pouches by Bernhardt
Holding between 1l and 5l, Bernhardt's Stand-Up Pouches feature a smart design that provides a very high resistance to stop tests. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

NSF Pharma Biotech Human Error Reduction Program
NSF Health Sciences is passionate about protecting the health of people worldwide and helping you prepare for the future, which means continuous improvement (error reduction). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Professional Laboratory Measurement Unit Awtherm
ROTRONIC's AwTherm is a high-end and professional laboratory measurement unit for temperature-stabilised water activity in the food, cosmetics, pharmaceutical, and other industries. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 17, 2017 Category: Pharmaceuticals Source Type: news

Boehringer opens biopharmaceutical manufacturing facility in China
Germany ’s Boehringer Ingelheim has officially opened its commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park in Shanghai, China. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 16, 2017 Category: Pharmaceuticals Source Type: news

Vifor Pharma and Akebia to sell Vadadustat to Fresenius Medical Care
Vifor Pharma Group and Akebia Therapeutics have entered an exclusive licence agreement to sell Vadadustat to Fresenius Medical Care dialysis clinics located in the US after securing approval from the US Food and Drug Administration (FDA). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 16, 2017 Category: Pharmaceuticals Source Type: news