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Headlines > August 2017

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EMA plans biomarker and drug-matched guidelines

17-Aug-2017 - The European Medicines Agency (EMA) is working on guidelines to help drug firms to develop companion diagnostics in parallel with medicines.

ScinoPharm showcases water treatment tech at Baxdela API plant

17-Aug-2017 - ScinoPharm has emphasised its compliance with waste water treatment rules, weeks after being contracted to supply API for Melinta Therapeutics’ antibiotic Baxdela.

GSK opens API facility in Scotland

16-Aug-2017 - GlaxoSmithKline has officially opened its aluminium salts facility in Montrose, Scotland.

EMA bids to clarify API starting material info pharmas should provide

16-Aug-2017 - The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.

Aerie Pharma to use DSM polymers to develop eye drug delivery tech

16-Aug-2017 - Aerie Pharmaceuticals Inc will use a DSM polymer technology to develop an implant to deliver AR-13154, its wet AMD drug candidate.

BASF outlines plans for $50m Mumbai R&D campus

16-Aug-2017 - BASF has confirmed the innovation campus it is setting up in India will employ 300 people and cater for multiple markets across Asia and elsewhere.

Warehouse serialization: TraceLink acquires ROC IT Solutions

14-Aug-2017 - Track and trace-focused TraceLink has acquired ROC IT Solutions, extending its scanning capabilities to the warehouse.

Corning collaborates for Merck & Co and Pfizer-tested vials

14-Aug-2017 - Corning has penned separate collaboration agreements with Italy-based Stevanato Group and Germany-headquartered Gerresheimer to supply glass packaging for injectable drugs. 

Wuxi AppTec says expanded STA will get drugs to market faster

14-Aug-2017 - Wuxi AppTec says merged development services and API business will provide customers with more integrated service. 

EMA acts its age: drug development push for older populations

14-Aug-2017 - The European Medicines Agency is encouraging drug makers to formulate and package medicines with the continent’s ageing population in mind.

SK Capital will pay $110m for Perrigo's drug ingredients business

14-Aug-2017 - SK Capital has said it will buy Perrigo Company Plc’s drug ingredients business for $110m (€85m) in cash.

Germany refuses to renew GMP cert for Dr Reddy's Bachupally FTO 2 plant

10-Aug-2017 - German regulators have not renewed the GMP certificate for Dr Reddy’s manufacturing plant in Bachupally, Hyderabad.

Avara agrees to buy ex-Hospira plant in Italy from Pfizer

10-Aug-2017 - Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.

Pfizer pulls lorazepam pills in Japan due to faulty engraving

10-Aug-2017 - Pfizer has recalled a batch of the antidepressant Wypax (lorazepam) in Japan after discovering faults with the engraving on some of the pills.

US FDA warns against PharmaTech LLC-made meds over B.cepacia risk

10-Aug-2017 - The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.

Vernalis stopped cold: US FDA rejects cough medicine NDA

10-Aug-2017 - The US FDA has rejected Vernalis’ new drug application for its investigative cough and cold treatment CCP-08, which is the second time the firm has failed to win approval for...

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Pfizer chooses Sanford, North Carolina site for $100m gene therapy plant

09-Aug-2017 - Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.

Class I drug recalls soared in Q2 according to new research

09-Aug-2017 - More drugs were recalled in the US in the three months to the end of June than in any period since Q4 2014 according to analysis by Stericycle ExpertSolutions.

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Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

08-Aug-2017 - Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK....

Valeant’s site for sore eyes: US FDA again issues CRL

08-Aug-2017 - The US FDA has rejected Valeant Pharmaceuticals International’s eye drop candidate following a site inspection at its subsidiary’s facility in Tampa, Florida, US.

Japan tells Pfizer, Bayer, Daichi and others to expand drug warnings

08-Aug-2017 - The MHLW has ordered Pfizer, Bayer, Daichi Sankyo and firms selling generic warfarin and azithromycin in Japan to expand their products’ adverse event warnings.

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Teva confirms API plant will be among 15 sites shut in cost cutting plan

07-Aug-2017 - Teva Pharmaceutical Industries Ltd has confirmed its API plant in Netanya, Israel will close as part of the cost reduction programme announced last week. 

US FDA finds faults at Biocon plant slammed by French regulators in July

07-Aug-2017 - The US FDA has issued Biocon with a Form 483 detailing problems inspectors identified at a plant in Bangalore, India.

Cambrex sees Q2 revs and earnings rise, confirms interest in takeovers

07-Aug-2017 - Cambrex Corporation says higher demand for APIs for controlled substances and branded drugs drove Q2 growth and confirms it is on the lookout for acquisitions. 

Lonza buys Micro-Macinazione to bolster micronization biz

07-Aug-2017 - Lonza Group AG has acquired API processing firm Micro-Macinazione SA from private equity investor Cross Equity SA.  

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