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Breaking News on Global Pharmaceutical Technology & Manufacturing

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 its post-Brexit plan.

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.

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.

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 MHRA limit communication to essential information.

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.

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.

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.

Japanese drug production grew in 2015 according to new MHLW data

12-Apr-2017 - Domestic pharmaceutical production increased in Japan in 2015 according to data released by the MHLW.

US FDA criticizes quality systems at Mylan NV's Nashik plant

12-Apr-2017 - The US FDA has criticized quality systems at Mylan’s HIV drug plant in Nashik in Maharashtra, India. 

EMA sets up inbox for pharma whistle-blowers and adopts investigation policy

11-Apr-2017 - The EMA has set up an email inbox for drug company employees who report improper manufacturing and trial activities.

US FDA hands Neuland Laboratories Form 483 after plant inspection

10-Apr-2017 - The US FDA has found fault at Neuland Laboratories Limited manufacturing facility in Bonthapally, India.

News in brief

Fresenius Kabi in talks to buy Akorn

10-Apr-2017 - Akorn Inc is in takeover talks with German injectable drug specialist Fresenius SE & Co. KGaA.

News in brief

Synergy launches anthro-poo-morphic emojiis for constipation patients

10-Apr-2017 - Synergy Pharmaceuticals Inc has launched a set of smartphone emojis – the Poop troop – to help chronic constipation sufferers express the physical and emotional impact of their disease in text messages.

News in brief

US FDA OKs Cadila Healthcare topicals plant

10-Apr-2017 - Cadila Healthcare Limited says its topical drug manufacturing plant has passed an inspection by the US Food and Drug Administration (FDA).

US FDA hits Indoco with warning due to leaky glaucoma drug

05-Apr-2017 - Leakage problems for of an ophthalmic drug has landed contract manufacturer Indoco Remedies with a US FDA warning letter at its plant in Goa.

China proposes changes to drug trial and API importation laws

03-Apr-2017 - Chinese regulators have proposed changes to rules covering clinical trials, API importation and drug approval in a bid to improve access to medicines.

update - US FDA declines to comment on potential investigation

EMA says CRO monitoring activity not location based

30-Mar-2017 - The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.

US FDA wants evidence Opto-Pharm's Tuas plant remediation effort has worked

30-Mar-2017 - The US FDA has criticised Opto-Pharm Pte for selling unlicensed "drugs" and not bringing its Singapore manufacturing plant up to code.

Wockhardt says US FDA has approved Fresenius Kabi-made generic Zosyn

28-Mar-2017 - Wockhardt claims the US has approved its version of the combination antibiotic Zosyn (piperacillin and tazobactam).

Half of CMOs unprepared for serialisation requirements, says Tracelink

28-Mar-2017 - As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.

EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

27-Mar-2017 - Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.

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