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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.

Chongquing Succeway made APIs in undeclared plant and faked records says ANSM

24-Jul-2017 - French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.

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.

Rousselot is first gelatin firm to join IPEC Europe

17-Jul-2017 - Gelatin firm Rousselot BV has joined IPEC Europe describing the move as an opportunity to contribute to the development of regulatory standards for pharmaceutical excipients.

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.

Another regulatory hit for Ocular, US FDA rejects eye drug

13-Jul-2017 - The US FDA has rejected Ocular Therapeutix’s eye pain treatment Dextenza for a second time, again citing concerns about how the drug is made and tested.

Label lapse: Brazil suspends ulcer drug

12-Jul-2017 - The Brazilian National Health Surveillance Agency (ANVISA) has suspended a batch of Omeprazole due to labelling defects.

GE Healthcare and Oritain launch testing service to combat serum fraud

12-Jul-2017 - Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.

Mallinckrodt pays $35m to settle alleged oxy reporting and production breaches

12-Jul-2017 - The US has told Mallinckrodt LLC to pay $35m (€30m) to settle allegations it broke record keeping rules at its oxycodone plant in New York and failed to notify the DEA of suspicious orders.

Concerns raised about Italy and Greece as backdoors into the FMD protected meds markets

11-Jul-2017 - A directive granting Belgium, Greece and Italy a six-year reprieve in serialisation adoption has raised concerns delayed implementation could be an opportunity for drug counterfeiters. 

update - includes statement from Gilead

Gilead HIV drug API sourcing suit reopened by US Appeal Court

11-Jul-2017 - Gilead Sciences Inc. faces renewed allegations it bought an API used in three of its HIV drugs from an unapproved Chinese supplier after a US Court of Appeals ruling.

US FDA warns Vista Pharmaceuticals about Telangana plant

11-Jul-2017 - Vista Pharmaceuticals Limited’s plant in Nalgonda, Telangana is in a state of disrepair according to the US Food and Drug Administration (FDA).

Vaccine booster for France, big pharma prepared

10-Jul-2017 - The French government has announced it will make more vaccines mandatory from 2018 onwards.

Elite halts trials of reformulated SequestOx after BE data falls short

10-Jul-2017 - Elite Pharmaceuticals has halted trials of its reformulated opioid painkiller SequestOx (naltrexone and oxycodone hydrochloride) after disappointing bioequivalence data from a study testing the drug in combination with a high fat meal.

Mylan's EU biosimilar ambition hit by GMP issues at Biocon plant

10-Jul-2017 - Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.

EC says Merck and Sigma-Aldrich broke M&A procedures and could face $170m fine

06-Jul-2017 - German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission

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