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Headlines > February 2015

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Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

27-Feb-2015 - The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make...

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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.

Sosei, so good: Heptares' collaborations to continue post takeover

26-Feb-2015 - Sosei's takeover will not impact Heptares's antibody tech collaboration with Morphosys according to the UK membrane protein specialist.

Salix latest purchase by Valeant after Dendreon deal

26-Feb-2015 - Valeant has signed a $14.5bn deal to acquire GI drugmaker Salix days after agreeing to purchase Provenge-maker Dendreon.

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...

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.

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.

People on the Move

Who's on the move in pharma?

25-Feb-2015 -

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.

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...

Syringe reuse not clever: WHO advocates use of "smart" syringes to stop disease spread

23-Feb-2015 - ‘Smart’ syringes that can’t be reused should be the drug and vaccine delivery technology of choice for healthcare programmes according to the WHO, which says needle reuse is spreading deadly...

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.

Drug delivery tech’s shares skyrocket as it helps Novo Nordisk clear Phase II hurdle

23-Feb-2015 - A potential Type 2 diabetes drug from Novo Nordisk has met the primary endpoint of a Phase II trial and shares of Emisphere Technology, which helped to formulate the oral...

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. 

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...

Rebooting HAL part of Indian plans to boost API capacity and cut reliance 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...

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.

Lupin plans to take on GSK’s Advair and Forest Labs’s Aerochamber in the US

18-Feb-2015 - Lupin will co-develop a rival to GSK’s Advair in the US and has licensed rights to an inhaled drug delivery tech competitor for Forest Labs’s Aerochamber.

Targeting stem cell cilia could prevent obesity and yield new cancer and arthritis drugs say researchers

17-Feb-2015 - Having shorter hair stops you becoming fat…at least it does if you are a stem cell say researchers who claim restricting the growth of hair-like cilia found on such cells...

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.

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