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Novartis ordered to halt drug production in Japan for 15 days

27-Feb-2015 - Novartis’s Japanese unit has been ordered to temporarily halt production of drugs by Japan’s health Ministry as punishment for delayed reporting of side effects.

California bill would require Big Pharma to unveil how drugs are priced

26-Feb-2015 - A new California bill introduced earlier this week would, for the first time, require pharma companies to unveil a number of unique operational costs as a way to better understand drug pricing.

Sagent shifts production in-house after US FDA concerns about CMO Emcure

25-Feb-2015 - Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.

Transcelerate teams to take on investigator selection bias

24-Feb-2015 - A register of clinical investigators can help eliminate bias according to Big Pharma Group Transcelerate, which has teamed with DrugDev to develop such a database.

FTC requires Novartis to divest two potential cancer drugs to Array as part of GSK deal

24-Feb-2015 - In order to close Novartis’ $16bn purchase of GlaxoSmithKline’s portfolio of cancer treatments , the FTC (Federal Trade Commission) is requiring Novartis to divest all assets related to its potential BRAF and MEK inhibitor drugs to settle anticompetitive charge.

EMA calls for industry involvement in applying new ISO standards to drugs

23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.

Celltrion: Remsima could save UK, Italy and France $336m in five years

20-Feb-2015 - Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK. 

Rebooting HAL part of Indian plans to boost API capacity and cut relaince on China

19-Feb-2015 - The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.

IPEC raises concerns over FDA guidance related to inactive ingredients

19-Feb-2015 - The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.

SGS rolls out latest Ph.Eur. amino acid impurities testing method at German lab

18-Feb-2015 - SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.

update

Switzerland rejects allegations it offers drug fakers easy route to the EU

12-Feb-2015 - The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.

EMA defends Humira redactions, says only commercial info was blacked out

10-Feb-2015 - The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’

Merck's loss of HCV Breakthrough status shows FDA's pragmatism, says analyst

10-Feb-2015 - Stripping Merck & Co.'s hep C pill of breakthrough status shows the US FDA is monitoring market developments in real-time warns one industry analyst. 

Dispatches from BIO CEO 2015

Experts say industry interactions with US FDA improving

10-Feb-2015 - Though it’s difficult to quantify, industry experts told investors at the BIO CEO conference in New York on Monday that the US FDA-industry interactions are improving though there’s still some inconsistency between FDA leadership, division directors and reviewers.

Pfizer 'comfortable' with Hospira's manufacturing network after quality review

09-Feb-2015 - Pfizer visited three troubled facilities in Hospira’s manufacturing network before entering a $17bn definitive merger agreement, the company says.

UPDATE-2

US FDA Commissioner Margaret Hamburg to retire after six years

05-Feb-2015 - Margaret Hamburg will retire from her role as Commissioner of the US FDA after nearly six years.

Drug excipients industry meets in Nice

05-Feb-2015 -   [View the story "Nice work if you can get it: Excipient firms on the Côte d'Azur" on Storify]

UPDATE: Merck says switching cell lines would impact safety and quality

Anti-abortion group won't judge parents who choose Merck & Co's MMR vaccine

04-Feb-2015 - The anti-abortion group that blames Merck & Co for the recent US measles outbreak says it would not judge parents who have children vaccinated with MMR II for the good of society.

Think you’re on track for 2018 EU serialisation? No you’re not

04-Feb-2015 - Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.

Two Indian manufacturers cited by FDA for data integrity issues

04-Feb-2015 - Bangalore, India-based Apotex and Verna, India-based Micro Labs both received warning letters last month from the US FDA detailing data integrity questions linked to their quality systems.

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