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Headlines > April 2017

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H&T Presspart buys rights to Hovione inhaler tech

27-Apr-2017 - H&T Presspart has bought the rights to manufacture and commercialise a capsule-based dry powder inhaler (DPI) from Hovione.

Catalent to increase spray-drying capacity for APIs at Pharmatek

27-Apr-2017 - Catalent Pharma Solutions has said it will increase spray drying capacity at a plant owned by recent acquisition Pharmatek Laboratories.

UK industry group wants next Government to invest in drug production

27-Apr-2017 - Industry group the ABPI has called on the next UK Government to support local drug production, increase National Health Service (NHS) funding and put life sciences at the heart of...

Acasti strengthens IP position for krill-derived rival to GSK's Lovaza

27-Apr-2017 - Acasti Pharma Inc. has been granted two additional composition and use patents for its investigational, hypertriglyceridemia drug candidate CaPre. 

MPP to make hep C drug affordable for low and middle income countries

26-Apr-2017 - Pharco Pharmaceuticals has granted a license to make, sell and export the hepatitis C drug ravidasvir (RAV) to Medicines Patent Pool (MPP). 

DISPATCHES FROM BPI EUROPE 2017

Messenger RNA a ‘game-changer’ for vaccine industry, Sanofi Pasteur

26-Apr-2017 - Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.

Management’s management of quality still a problem say MHRA inspectors

26-Apr-2017 - The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.

update

US FDA warns Lonza about Walkersville site

25-Apr-2017 - The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

LabCorp to relocate and expand UK CMC business

25-Apr-2017 - LabCorp will relocate its UK CMC services unit to a larger site and has said it is confident the Government will maintain its commitment to the drug industry after Brexit.

Saudi Arabia serialization rules prompt Recipharm investment; US plant open

25-Apr-2017 - Drug track and trace rules introduced in Saudi Arabia prompted a €300,000 ($326,078) investment in processing technology and software according to Sweden-based contractor Recipharm.

DSM Sinochem to up capacity at Delft antibiotic intermediates plant

24-Apr-2017 - DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

WHO pressures Big Pharma to donate more drugs for tropical diseases

24-Apr-2017 - The World Health Organisation (WHO) has urged pharma companies to help combat neglected tropical diseases (NTDs) via increased drug donations.

US FDA issues Sun with Form 483 after Dadra plant inspection

24-Apr-2017 - The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

24-Apr-2017 - Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

UK MHRA announces pre-election quiet period

21-Apr-2017 - Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the...

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

20-Apr-2017 - Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

EMA and FDA agree how drug firms should include Q8, Q9 and Q10 QbD concepts in applications

20-Apr-2017 - The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.

Partnering key to deliver next-gen drug delivery tech, say industry experts

19-Apr-2017 - Partnering and collaborating to advance drug delivery innovation  is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.

Aurobindo Pharma gets Form 483 from US FDA after Bachupally inspection

19-Apr-2017 - The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

19-Apr-2017 - Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

US ban for levonorgestrel supplier Qinhuangdao Zizhu raises WHO concerns

19-Apr-2017 - Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.

update

Teva confirms US FDA warning letter for Hangzhou, China API plant

18-Apr-2017 - Teva Pharmaceutical Industries says the US FDA has raised concerns about its API plant in Hangzhou, China.

DHL looks to strengthen presence in South American market

18-Apr-2017 - Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes. 

UK firms should look to global opportunities to offset Brexit woes, says biotech CEO

18-Apr-2017 - UK life science companies must become global to help offset staffing and funding problems potentially caused by Brexit, says Arecor CEO Sarah Howell.

Pork firm Smithfield sets up organ supply unit for regenerative meds sector

13-Apr-2017 - Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.

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