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APIs (active pharmaceutical ingredients)

News headlines

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.

Apax's proposed Azelis takeover backed by unions

25-Feb-2015 - Apax Partners says workers' unions have backed its plan to buy a controlling stake in chemical distributor Azelis from fellow private equity firm 3i.

Shire steps further into rare diseases with $70m acquisition

25-Feb-2015 - Shire has acquired privately-held Meritage for an upfront fee of $70m and additional contingent payments based on the achievement of development and regulatory milestones. 

Assembly line could cut cost of HIV drug API production say German researchers

24-Feb-2015 - The HIV drug API efaverinz could be made faster and more cheaply using continuous manufacturing according to the German team behind a new ‘assembly line’ production method.

Facility already supplying Granules' JV partner Ajinomoto Omnichem with validation batches

Granules predicts US and EMA approval for new API plant in two years

23-Feb-2015 - An API and intermediates plant set up by Granules India and Ajinomoto Omnichem is a step closer to opening after an offical inauguration ceremony last week. 

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.

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.

Sanofi: deals like Lead Pharma accord not a replacement for in-house R&D

18-Feb-2015 - Sanofi has partnered with Dutch biotechnology spin-out Lead Pharma to discover autoimmune drugs that target ROR gamma t hormone receptors.

Fresenius Kabi sells cancer compounding biz to NewCo Pharma

17-Feb-2015 - Fresenius Kabi has sold its cancer drug pharmacy network CFL GmbH to NewCo Pharma GmbH five years after spending €42m to buy compounding capacity in Germany.

More US FDA draft guidance for compounders

16-Feb-2015 - The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.

PE-backed Laurus Labs sets up US drug ingredients business

16-Feb-2015 - Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.

survey

Ever wanted to buy catalysts on your iPhone? Now you can thanks to Johnson Matthey

16-Feb-2015 - Quick question for chemists: Have you ever wanted to research chemical reactions and buy catalysts on your mobile phone? 

Enteris plans to beat established API CMOs on lead times

16-Feb-2015 - Enteris Biopharma says it can compete with established API CMOs by offering shorter lead times and greater flexibility.

Suboxone sales down as opioid addiction drug market intensifies

12-Feb-2015 - Opioid addiction drug Suboxone lost market share in 2014 according to newly independent Indivior, whose management says it is not intimidated by increased competition.

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.

AMRI looks to close API facility in Wales as part of network realignment

12-Feb-2015 - AMRI has announced plans to close an API development and manufacturing plant in Wales, UK, after efforts to establish it as a conduit between the US and Europe were deemed unsuccessful.

Ex-Unigene execs who run Enteris add API contracting service to delivery tech licensing business

12-Feb-2015 - Enteris BioPharma has broadened its business beyond drug delivery tech licensing and launched a contract API manufacturing service.

News in brief

London calling: Gilead to expand operations in UK capital

11-Feb-2015 - Gilead Sciences has committed S20m (€18m) to expand its presence in the UK and will double its workforce in the country.

BMS follows Merck as glut of HCV drugs leads to loss of fast-track status

11-Feb-2015 - The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.

Penn is mightily pleased with safety record

10-Feb-2015 - Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.

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