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Breaking News on Global Pharmaceutical Technology & Manufacturing

FDA looks to incentivize abuse-deterrent opioid development with final guidance

02-Apr-2015 - Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.

Hamburg exits US FDA calling on increased international co-operation

01-Apr-2015 - Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.

Peer-review cheating ring discredits another 43 papers

01-Apr-2015 - Publisher BioMed Central has withdrawn 43 papers from its scientific journals after discovering a conspiracy to rig peer review runs deeper than previously thought. 

UK politician pledge would ban 89% of animal research, say scientists

31-Mar-2015 - British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 - Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

Lilly says Indy Religious Freedom law is discriminatory and may hamper cancer and AD drug development

30-Mar-2015 - Indiana’s new “religious freedom” law is discriminatory and will make it harder to attract the staff needed to develop drugs for cancer and Alzheimer's disease according to Eli Lilly.

PETA joins preclinical CROs at SOT to promote animal testing alternatives

27-Mar-2015 - Testing the toxicity of drug candidates in animals is archaic and unreliable according to PETA, which joined preclinical CROs at SOT to put forward alternatives.

Aarti says US FDA has not detailed GMP problems that earned it an import ban

27-Mar-2015 - Aarti Drugs says the US FDA has not provided details of observations that earned its E-22 facility in Tarapur, India an import ban.

US FDA rejects Amgen bid to force biosims firms to share info before review

27-Mar-2015 - Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.

‘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.

Spotlight

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...

Novasep to make API for Celladon's heart attack gene therapy
update

Novasep joins Lonza as Mydicar API producer in deal with Celladon

Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

Lethal injection drug shortage brings return of firing squad in Utah

Lethal injection drug shortage brings return of firing squad in Utah

Utah will allow execution by firing squad as European pharmaceutical companies refuse to provide drugs for lethal...

Growing elderly population to drive drug excipients sector, study

Growth with aid of Grey: Elderly folks to drive excipients sector, study

Demand for pensioner friendly pills will be an important growth driver for the drug excipients sector according...

WHO calls for proactive strategies to combat falsified, substandard medicines

WHO calls for proactive strategies to combat falsified, substandard medicines

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

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

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

Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month...