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Headlines > October 2013

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Lonza says Pharma business and restructuring efforts are on track

31-Oct-2013 - Lonza says its pharmaceutical business ‘performed as expected’ in the third quarter and that its restructuring efforts – which have seen it cut nearly 800 jobs– are on track to...

Capsugel and Bend: 'Marriage made in heaven' as first tech transferred

31-Oct-2013 - The acquisition of Bend Research by Capsugel may be “a marriage made in heaven” for customers, the firms say, as the first drug delivery tech is transferred.

update

Novasep to keep supplying Amarin with Vascepa API

30-Oct-2013 - Novasep has confirmed it will keep supplying Amarin with omega-3 API as the US FDA withdraws special status afforded to Vascepa trial.

update

Granules calls for greater Indian regulatory efficiency; EU API demand drove Q2 gains

30-Oct-2013 - API, drug intermediates and formulations firm Granules India ended the second quarter of fiscal 2013 with higher revenue and profit thanks to gains made by all three of its units.

Teva CEO resigns days after denying departure rumors

30-Oct-2013 - Teva CEO Jeremy Levin has resigned just days after he denied rumours he would leave and called the speculation "an invention."

Dispatches from CPhI

Novasep granted US FDA approval at two EU API facilities

29-Oct-2013 - French CMO Novasep has received the thumbs up from US regulators at two of its European API manufacturing facilities.

China plant dosage error leads to insulin recall for Novo Nordisk

29-Oct-2013 - Novo Nordisk has recalled 30 batches of a prefilled insulin product following a dosage error at a manufacturing facility in China.

GSK partners with Brazilian chem experts to make drugmaking greener

29-Oct-2013 - GSK has teamed up with Brazilian researchers to develop ‘sustainable chemistry’ processes it will use to make drug manufacturing greener.

Teva CEO Jeremy Levin's resignation rumours 'an invention' - People

29-Oct-2013 - Welcome to in-Pharmatechnologist's People (not!) on the Move, with Teva's CEO denying he is contemplating resigning following reports he had fallen out with the Board over recent job cuts.

UPDATE - Dispatches from CPhI

Capsugel's purchase of Bend will strengthen partnership, says Dow

28-Oct-2013 - Dow says the acquisition of partner Bend Research is “good news” and will strengthen its developments in solving solubility and bioavailability issues in drug formulation.

dispatches from CPhI

Risk-based supply chain management means more audits for excipient firms

28-Oct-2013 - Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.

News in brief

GSK reopens OTC plant after gas leak causes a stink

28-Oct-2013 - Drug giant GlaxoSmithKline says operations have restarted at an OTC plant forced to close last week following a methane leak.

DISPATCHES FROM CPhI

Catalent launches softgel products at CPhI: one vegetarian, one anti-abuse

23-Oct-2013 - Catalent has announced two new softgel solutions as it adds greater versatility to its Advanced Technologies Business Unit.

Amarin supplier continues production of Omega-3s following US FDA panel decision

23-Oct-2013 - Omega-3 supplier BASF will continue to produce the API for Amarin, as well as its competitor GlaxoSmithKline, despite an FDA panel saying that Amarin’s drug should not be approved for...

Mylan Labs, Natco Pharma look to expand injectable manufacturing, CEOs say

23-Oct-2013 - Indian manufacturing heavyweight Mylan Laboratories is looking to build off its major acquisition of Agila with a number of smaller acquisitions, while Natco is about to receive a cash infusion...

Almac and Novozymes team to offer pharmacokinetic improvements

22-Oct-2013 - Linking peptide and small molecule drugs to albumin will improve pharmacokinetics, says Almac as it partners its manufacturing capabilities with Novozymes’ half-life extension platform.

Teva subsidiary opens $100m manufacturing facility in Croatia

22-Oct-2013 - Teva subsidiary Pliva has opened a new $100m (€73m) oral dosage manufacturing facility in Zagreb, Croatia to increase its export of tablets and capsules to the US and EU.

Azelis to bring PVP excipients from China to the West

22-Oct-2013 - Azelis says its partnership with JH Nanhang (JHNH) will feed a large demand for polyvinylpyrolidones (PVP) excipients and bring the China-made ingredients to new markets.

UPDATE - CPhI Day 3

Frankfurt becomes Phrankfurt as drug industry gathers in Germany

21-Oct-2013 - Drugmakers, fine chemicals firms, delivery technology manufacturers and processing system developers from around the world meet in Frankfurt, Germany.

People - Mylan to maximise opportunities with new EU President

21-Oct-2013 - News from Mylan in Europe and Johnson & Johnson tops this week's in-Pharmatechnologist.com's People on the Move.

Comment

Unregistered vs fake - How terminology sparked a media war in Ghana

21-Oct-2013 - In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers...

Swiss intercept 400kg of counterfeit Xanax en route to Egypt

21-Oct-2013 - Airport customs in Zurich, Switzerland announced Friday that they intercepted more than a million counterfeit drugs labelled as Pfizer’s Xanax.

Protein Sciences' efforts to expand approval for Flublok slowed by Shutdown

17-Oct-2013 - The US Government Shutdown has delayed the regulatory review of a new egg-free influenza vaccine production process developed by Protein Sciences.

update

US and French regulators OK restart of LentiVector delivered eye drug trials

17-Oct-2013 - US and French regulators have given Oxford BioMedica the go ahead to restart studies of three eye drugs it is developing with Sanofi after an impurity found in trial materials...

Cirrus studies formulation effects on MDI performance for US FDA

17-Oct-2013 - Cirrus Pharmaceuticals has received a grant to investigate the effect of excipient concentration and API molecule size on metered dose inhaler (MDI) formulations.

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