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Regulatory & Safety: Top Headlines

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

RFRA Indianapolis Protests - 2015 - picture credit Justin Eagan

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.

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News in brief

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.

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...