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Breaking News on Global Pharmaceutical Technology & Manufacturing

EMA re-confirms drug suspensions due to faulty trial data from GVK Biosciences

25-May-2015 - Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences in Hyderabad, India. 

US scientists vow to answer CRISPR’s sticky moral questions

22-May-2015 - Top science academics have launched an initiative to consider emerging human gene-editing tools such as CRISPR-Cas9.

US Senator dubs Sovaldi price ‘abuse of power’ and calls to defy patent

21-May-2015 - US Senator Bernie Sanders has called on the Secretary of Veteran Affairs to invoke a law which would break Gilead’s patent on Hepatitis C drug Sovaldi and allow cheaper generics.

Industry calls for global alignment of qualification and validation guidelines

21-May-2015 - EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.

EMA: show clinical justification for combination drugs

20-May-2015 - The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).

Two sterile compounders hit by FDA warning letters for violating cGMP

20-May-2015 - The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.

PEOPLE ON THE MOVE

Top lawyer moves to Amgen

19-May-2015 -

News in brief

US FDA investigates AZ, J&J and B-I's type 2 diabetes drugs after adverse events

18-May-2015 - Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.

EMA drug reviews must be independent of pharma influence as an example to others, says AMF

18-May-2015 - The EMA's assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)

People on the Move

CEO pay row at Sanofi AGM

11-May-2015 -

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office of the Inspector General (OIG).

PEOPLE ON THE MOVE

Favourite for Novo Nordisk CEO suddenly quits

30-Apr-2015 -

FDA’s Woodcock calls to cut clinical costs via new efficiencies

30-Apr-2015 - As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there are “ways to greatly improve clinical trial efficiency,” and cut costs through the use of master protocols and real-world data.

EBG BIOSIMILARS 2015

Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.

MHLW says PIC/S membership means high quality drugs will get to patients faster

29-Apr-2015 - Japan’s membership of the PIC/S international inspection and manufacturing scheme bodes well for patients in Japan and elsewhere according to the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency (MHLW)

WHO: Pharmas should give cash not drugs to aid Nepal earthquake relief efforts

28-Apr-2015 - Drug companies that want to support aid efforts in Nepal should donate cash rather than medicines according to the World Health Organisation (WHO).

Allergan and Hospira recalls

28-Apr-2015 - Hospira has recalled one lot of the anaesthetic Bupivacaine after a customer discovered orange and black particles floating and embedded in a glass vial.

News from CPhI Japan

Sakigake: New Japanese drug laws will foster global innovation says MHLW

28-Apr-2015 - ‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.

News from CPhI Japan

Generic firms still face brand loyalty challenge in Japan say experts

27-Apr-2015 - Generic drug use in Japan has started to increase but 'brand loyalty' is still a considerable challenge according to industry experts.

People on the Move

UN appoints new Ebola head

27-Apr-2015 - And microbiology awards to research scientists and Médecins Sans Frontières.

Special from BPI Europe 2015

Eliminating fear culture can save operational costs and jobs, says Pfizer

23-Apr-2015 - Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.

Concerns over data manipulation lands Chinese API maker with US FDA Warning

22-Apr-2015 - The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.

EDQM seeks industry input on water for injection monograph revision

20-Apr-2015 - The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.

Concerns climate change will see tick-borne diseases spread to the UK are legitimate, says PHE

15-Apr-2015 - Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.

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