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Breaking News on Global Pharmaceutical Technology & Manufacturing

‘Game changer’: latest GDP rules spell full traceability for APIs

26-Mar-2015 - Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.

FDA plans new approach to manufacturer inspections in India

24-Mar-2015 - Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.

Lethal injection drug shortage brings return of firing squad in Utah

24-Mar-2015 - Utah will allow execution by firing squad as European pharmaceutical companies refuse to provide drugs for lethal injection.

CRISPR tech raises urgent ethical questions, say original DNA pioneers

24-Mar-2015 - Gene-editing technology CRISPR-Cas9 must not be used to alter human DNA until the risks have been researched and the ethical issues considered, say scientists.

Good news for Sandoz? GSK confident UK will accept Bexsero price proposal

24-Mar-2015 - Speculation GSK's meningitis B vaccine Bexsero will soon be available on the UK National Health Serivice will be welcomed by campaigners, protein supplier Sandoz and its parent company, Novartis.

US diabetics pay most for drugs, but world’s poorest bear the biggest economic burden

23-Mar-2015 - Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month in a study assessing the diseases’ economic impact.

WHO calls for proactive strategies to combat falsified, substandard medicines

23-Mar-2015 - The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.

Judge rejects Amgen’s attempt to block first US biosimilar launch

20-Mar-2015 - A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).

Novel orphan drug boom in 2015, predict experts

19-Mar-2015 - The pharma industry reached a high water mark in 2014 with a record number of new molecular entities approved by the US Food and Drug Administration, especially orphan drugs.

FDA defends guidance timekeeping but admits one document took 15 years

19-Mar-2015 - The FDA has defended the speed at which it finalises draft guidance on drugs in response to criticism from Republican senators.

From Facebook to regulators’ ears… ADRs gathered from online comments

18-Mar-2015 - Computer scientists have found a way to “translate” social media comments about drugs into adverse drug reaction (ADR) reports.

US DEA drug ingredient quota review failings increasing shortages says GAO

16-Mar-2015 - The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.

People on the Move

Ex-Total exec joins Sanofi committee

16-Mar-2015 -

Endotoxin and microbial testing to become portable

16-Mar-2015 - Bacterial testing is moving from the lab to the manufacturing floor, says an expert at CRO Charles River.

FDA wins Ranbaxy ANDA approval suit as judge raises ‘grave concerns’ over FDA actions

13-Mar-2015 - Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing concerns.

Distributing donated drugs a major challenge says UK neglected diseases group

13-Mar-2015 - More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them to the remote communities is still a challenge according to a consortium led by the Liverpool School of Tropical Medicine (LSTM).

Speciality Compounding banned after contaminated shots cause blood infections

12-Mar-2015 - Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria. 

Novacyl’s acetyl salicylic acid plant in Thailand hit with FDA warning letter

11-Mar-2015 - For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.

Label to warn of aggressive alcohol interaction for Pfizer’s Chantix

11-Mar-2015 - Patients who mix Chantix with alcohol can become aggressive or suffer memory loss says the US FDA, which has ordered Pfizer to update the smoking cessation drug’s side-effects label.

J&J pleads guilty, pays $25m over manufacturing adulterated infants’, children’s OTC medicines

10-Mar-2015 - J&J unit McNeil-PPC has admitted breaking US law by selling contaminated liquid medications, including Infants’ Tylenol and Children’s Motrin, deemed adulterated under the federal Food, Drug and Cosmetic Act (FDCA).

EU safety logo set to tighten net on dodgy food supplement sales

10-Mar-2015 - The Danish and Austrian authorities have warned against toxic food supplements ahead of an EU-wide safety logo set to crack down on illegal retailers posing as online pharmacies.

US FDA expects more resources to fund biosimilar reviews and plant inspections

10-Mar-2015 - Biosimilars will mean more facility inspections and reviews according to the US FDA, which is confident its funding will be increased accordingly.

Drug shortages? There’s an FDA app for that

10-Mar-2015 - The US FDA has turned to smartphone technology to fight drug shortages with an app aimed at doctors, pharmacists and patients.

Slew of recalls, Form 483 shake Hospira

09-Mar-2015 - Quality troubles for Hospira continue as the company announced on Friday recalls of two injections, in addition to the recall of two infusion pumps, as well as a Form 483 for an Indian manufacturing site.

Spotlight

Message is clear: Europe is in trouble in terms of pharma growth, experts say
Dispatches from DCAT

Message is clear: Europe is in trouble in terms of pharma growth, experts say

The European pharma market isn’t likely to deliver much growth over the next five years as generic...

Distributing donated drugs a major challenge says UK neglected diseases group

Distributing donated drugs a major challenge says UK neglected diseases group

More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them...

'Black Mamba' or 'OMG': which fake sex pill has the best name?
QUIZ

'Black Mamba' or 'OMG': which (fake) sexual enhancement pill has the best name?

The FDA has tested hundreds of creatively named bogus supplements and found they contain hidden APIs. Take...

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