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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

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.

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.

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.

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 a product this year.  

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.

update

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.

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.

Ocular cuts jobs post FDA rejection

03-Aug-2017 - Ocular Therapeutix has announced it is laying off 19% of its workforce in order to cut operating expenses.

Dr Reddy's saw API revenues slide in FY Q1 2018

02-Aug-2017 - Dr Reddy's says efforts to fix plant problems flagged by US FDA impacted its active pharmaceutical ingredient (API) business in the first quarter of fiscal 2018.

More fake Xeplion withdrawn in Denmark

01-Aug-2017 - A fourth batch of Janssen-Cilag’s schizophrenia drug Xeplion has been withdrawn in Denmark after the identification of counterfeit packs.

Lupin says it fixed issue flagged by US FDA during Aurangabad audit

01-Aug-2017 - Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July. 

Lilly says manufacturing and pricing swayed revenue rise

27-Jul-2017 - Manufacturing efficiencies and positive pricing boosted Eli Lilly’s margins in the second quarter, offsetting lower sales outside the US.

New drugs now: UK provides funds for smaller drug makers

26-Jul-2017 - The UK government has announced £6m ($7.8m) funding for small and medium sized enterprises (SMEs) to speed up access to new medicines.

Site shut, 875 jobs cut: Endo to close US manufacturing facility

24-Jul-2017 - Endo International has announced it will close its manufacturing plant in Huntsville, Alabama and eliminate 875 positions.

The serialisation stragglers: industry concern for complacency

20-Jul-2017 - The US Food and Drug Administration’s (FDA) decision to delay serialisation regulations shows drug companies and contract manufacturers are still unprepared, say industry representatives.

Update - comments from EMA and EFPIA

EU to probe if drug firms' pre-submission meetings sway EMA approval decisions

19-Jul-2017 - Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation 

US FDA reaffirms hold on oral Proellex trials prompting Repros rethink

19-Jul-2017 - The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.

US FDA warns opthalmic supplier Tubilux about Italian plant

19-Jul-2017 - The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.

US FDA to decide on Spark's vision loss gene therapy Luxturna in January

18-Jul-2017 - The US FDA has promised to review Spark Therapeutics’ candidate vision loss gene therapy Luxturna by next January.

Unorderly Brexit will cause UK drug shortages warn industry groups

17-Jul-2017 - UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.

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