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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

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.

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. 

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.

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.

update

Pacira to stop making DepoCyt due to long-term production problems

06-Jul-2017 - Pacira Pharmaceuticals Inc. has said it will stop making the cancer DepoCyt (cytarabine), citing persistent manufacturing problems.

EU AMR action plan ignores pharma pollution, say NGOs

05-Jul-2017 - NGOs have criticised the European Commission’s plan to combat antimicrobial resistance (AMR), saying the policy does not adequately address environment contamination concerns.

US FDA slams Chinese heparin API testing facility with warning

05-Jul-2017 - Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.

‘Unrealistic’ serialization deadline? FDA offers one year grace period

04-Jul-2017 - The US Food and Drug Administration (FDA) has released draft guidelines offering a reprieve for manufacturers which have not integrated product identifier requirements by the November 26 serialisation deadline.

Continuous or batch? A quality question

03-Jul-2017 - Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.

Pharma executives make a move: recent appointments

29-Jun-2017 - Ocugen welcomes ex-Pfizer Daniel Jorgensen, the IGBMA’s Biosimilars Committee gets a new chair and drug development consultants Boyds hires two associate directors in one go.

Brazil tells Bayer to recall 13 lots of Gynera contraceptive

28-Jun-2017 - Anvisa has ordered Bayer to recall 13 lots of the contraceptive Gynera (gestodene + ethinyl estradiol) over concerns about stability data.

Open for comment: US FDA confirms backing for continuous manufacturing and calls for industry input

27-Jun-2017 - The US Food and Drug Administration (FDA) has called for drug industry feedback on continuous manufacturing.

Fagron and Advanced Pharma pull drugs made at Pfizer's Rocky Mount site

27-Jun-2017 - Fagron Sterile Services and Advanced Pharma have recalled lots of injectable drugs made at Pfizer’s Rocky Mount facility in North Carolina.

News in brief

Clinical hold for Seattle Genetics’ frontline myeloid leukaemia drug

26-Jun-2017 - The US Food and Drug Administration (FDA) has put Seattle Genetics’ investigational new drug application for vadastuximab talirine (SGN-CD33A) on clinical hold .

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

23-Jun-2017 - Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

US FDA slams Chinese API maker over data breaches

22-Jun-2017 - Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

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