update

BASF unveils R&D realignment plan, citing drug excipients as important

29-Mar-2012 - BASF has announced plans to restructure its R&D operations, citing solubility enhancing excipients as an opportunity for growth.

Teva to sell Quebec plant and transfer 150 staff to US CMO

29-Mar-2012 - Teva is to sell its Quebec, Canada manufacturing facility and transfer 150 employees to US CMO Halo Pharmaceuticals.

Longer punishments are poor fake drug deterrents; academic

29-Mar-2012 - An academic has questioned the wisdom of longer maximum penalties for counterfeiters at a House meeting to discuss sentencing.

FDA hits two Mexican firms with GMP warning letters

28-Mar-2012 - The FDA has hit two Mexican companies with GMP warning letters six months after inspectors visited the country.

India finds 1,420 substandard drug samples in first half of ‘11

28-Mar-2012 - In the first six months of fiscal 2011 tests of drug samples found 1,420 substandard pharmaceuticals in India.

Novasep to invest in purification-based manufacturing; opens China plant

27-Mar-2012 - Novasep says it may invest in active pharmaceutical ingredients (API) bioproduction and purification technology citing growing industry demand.

Ideal Cures wins first US patent for solvent-free coating tech

27-Mar-2012 - Ideal Cures has been granted a US patent for an immediate release film coating tech that - it claims - could rid the Pharma production sector of solvents.

More than 80% of Nigerian anti-malarials fail USP tests; study

27-Mar-2012 - More than four-fifths of anti-malarials sampled in Nigeria failed to meet USP specifications for one of the APIs, researchers found.

Pharma needs to rethink supply chains in an era of patent expiry and global outsourcing

26-Mar-2012 - Planning supply chains early is an important part of maintaining margins but is often overlooked by Pharmas too focused on developing the next product in an era of patent expiry...

FDA keeps estimate of online facility registration time burden

26-Mar-2012 - The US FDA is keeping its estimate of the burden imposed by electronic facility registration despite some industry opposition.

White House calls on FDA to consider overall effect of regs

26-Mar-2012 - The US FDA must consider the cumulative impact of regulations on small firms to prevent its actions from suppressing growth, the White House said. 

GSK confirms £500m investment after UK introduces tax 'patent box'

22-Mar-2012 - GSK has made good on its promise to invest in the UK, confirming plans to spend £500m ($789m) on new manufacturing capacity in the country just a day after the...

Drug shortage fixes can ready US for disasters; IOM

22-Mar-2012 - Experience handling the wave of drug shortages in the US can improve disaster response plans, the IOM wrote.

Health Canada working night and day to fix Sandoz shaped hole in supply chain

22-Mar-2012 - Health Canada officials are working “around the clock” to approve 23 new drug applications in one month to combat national meds shortages caused by troubles at Sandoz.

News in brief

IPEC Americas wants input on FDA inactive ingredient database

22-Mar-2012 - IPEC Americas wants member input for US Food and Drug Administration (FDA) inactive ingredient database (IID) subcommittee.

Indian dominance of CEP suspension list reflects inspection policy says EDQM

21-Mar-2012 - Indian API manufacturers may dominate the list of companies that have had CEPs suspended this year, but that may say more about inspection policies than it does about standards outside...

Selecting formulation early cuts time to market, says Formac

21-Mar-2012 - Formac Pharmaceuticals and WR Grace say their silica platform can improve the formulation selection process for poorly soluble APIs (active pharmaceutical ingredients).

Latest developments in biomanufacturing tech

21-Mar-2012 - March has already been a busy month for the biomanufacturing technology sector and here is in-Pharmatechnologist.com’s round-up of some of the developments so far.

Teva eyes delivery devices to gain edge in biosimilar sector

21-Mar-2012 - Teva will try to use different delivery devices for biosimilars to gain an edge over innovator products, its North American CEO said.

Sigma Aldrich shortens China supply chains with Wuxi plant

20-Mar-2012 - Sigma Aldrich says new packaging facility in China will shorten supply chains and help it build in an increasingly important regional market.

'Generic API manufacturers: look at drugs from launch', urges a new report

20-Mar-2012 - Generic API (active pharmaceutical ingredient) makers should consider the off-patent potential of a drug as soon as it is launched, according to a new study by PharmaIntellect.

FDA to publish final rule on cGMP labelling controls today

20-Mar-2012 - The US FDA will today publish a final rule to change cGMP labelling controls, 15 years after proposing the revision.

FDA clampdown driving Indian compliance investment; ICRA

20-Mar-2012 - Indian drugmakers will increase investment in GMP compliance to avoid becoming the next company hit by the FDA, a credit rating agency said.

EMA wants Caelyx and Ceplene production moved away from Ben Venue Labs

19-Mar-2012 - More bad news for troubled CMO Ben Venue Laboratories after European regulators recommend that production of two more drugs – Caelyx and Ceplene – is relocated to other facilities.

Trade union brands Sanofi's UK plant closure "appalling"

19-Mar-2012 - The UK’s biggest trade union Unite has lashed out at Sanofi branding its plan to close a plant in Newcastle, England, as “unacceptable”.

FDA 483 details 400 complaints that led to APP warning letter

19-Mar-2012 - The FDA has published a 483 detailing some of the 400 customer complaints that led to it sending a warning letter to APP Pharmaceuticals.

BASF selects Asia-Pacific excipients distributor

15-Mar-2012 - German chemicals giant BASF has contracted Connell Brothers as its drug excipients distributor in Australia and New Zealand.

DEA to increase manufacturers’ controlled substance fees 30%

15-Mar-2012 - The US DEA is increasing manufacturers’ annual controlled substance fees by 30 per cent from next month.

Apotex suing US gov over FDA’s “devastating” import alert

15-Mar-2012 - Apotex is suing the US government over an import alert it claims was unjust and had a “devastating impact” on business.

Affinium licenses SDD tech from Bend after early-phase success

14-Mar-2012 - Bend Research has licensed its spray-dried dispersion technology to Affinium, adding to similar deals with Eli Lilly and Merck & Co.

AstraZeneca goes Dutch on discovery with split contracts for BioFocus and Argenta

14-Mar-2012 - UK drug major AstraZeneca has contracted BioFocus and Argenta to provide it with discovery services just weeks cutting its internal R&D capacity. 

News in brief

UK MHRA wants Pharma feedback for manufacturing regulation review

14-Mar-2012 - The UK MHRA wants Pharmas to share their thoughts on the regulations governing the industry – including those on manufacturing and safety – under the UK Government’s ‘Red Tape Challenge.’

Ranbaxy stakes claim on African drugs production market with new Moroccan plant

14-Mar-2012 - Generics and API maker Ranbaxy has opened a plant in Casablanca, Morocco in a bid to strengthen its foothold in the “increasingly important” North African drugs market.

FDA warns Warner Chilcott for 5 years of Puerto Rico failings

14-Mar-2012 - The US FDA has sent Warner Chilcott a warning letter outlining five years of manufacturing failings at its Puerto Rico plant.

Merck Millipore partners with CCRM on C$500K bioproduction project

13-Mar-2012 - Canada’s Centre for Commericalisation of Regenerative Medicines (CCRM) has partnered with Merck Millipore to develop optimized methodologies for bioreactor-based stem cell cultivation.

Acuros in talks with Big Pharma over water-powered delivery pump

13-Mar-2012 - Acuros is seeking development partnerships with Big Pharma over its recently launched water-powered drug delivery pump.

News in brief

GSK to launch manufacturing skills apprenticeships

13-Mar-2012 - GSK will launch an apprenticeship programme later this year to train young people in a range of industry disciplines, including manufacturing, R&D and supply chain management.

FDA asks Gulf to hire 3rd party to fix data integrity failings

13-Mar-2012 - The US FDA wants UAE-based Gulf Pharmaceutical Industries to hire a third-party auditor to fix data integrity failings outlined in a warning letter.

update

BDSI delays Onsolis “relaunch” to enable reformulation

12-Mar-2012 - BioDelivery Sciences International (BDSI) has postponed the ‘relaunch’ of its pain drug Onsolis to give it more time to modify the formulation.

News in brief

CDER published upcoming 2012 guidance docs

12-Mar-2012 - The US FDA’s Center for Drug Evaluation and Research (CDER) has published the list of guidance documents it aims to issue this year.

Paediatric safety fears targeted in EMA excipient update

12-Mar-2012 - The EMA plans to update its excipient guidelines to cover safety concerns surrounding use in children and pregnant women.

TGA to audit CSL after ethylene glycol contamination recall

12-Mar-2012 - The TGA will audit manufacturing processes at CSL Biotherapies after a fractured tank led to ethylene glycol contamination.

News in brief

Pall’s Biopharma sales up in Q2

08-Mar-2012 - Filtration and processing tech firm Pall Life Sciences’ biopharmaceutical business made the biggest contribution to its revenues revenues in fiscal Q2.

GE to buy Xcellerex in latest biomanufacturing-focused investment

08-Mar-2012 - GE Healthcare has announced plans to buy US production tech firm Xcellerex, continuing its efforts to build its biomanufacturing offering.

UPDATE

GSK and AstraZeneca fund NMR studies in a bid to improve manufacturing QC

08-Mar-2012 - GlaxoSmithKline (GSK) and Astrazeneca have each funded new nuclear magnetic resonance (NMR) research at the University of Warwick, UK which could improve the QC process for drugsmakers.

Sanofi and Fresenius asked to take writedowns under Greek debt plan

08-Mar-2012 - The Greek government has asked several drugmakers to accept losses on bonds originally issued to cover unpaid bills.

update

WHO joins joint EMA, FDA and TGA inspection programme

07-Mar-2012 - The joint US FDA and EMA active pharmaceutical ingredient (API) manufacturing facility inspection programme has signed up the World Health Organisation as a member. 

Medicago and Mitsubishi team on VLP vaccine production

07-Mar-2012 - Medicago has finalised a research collaboration agreement with Mitsubishi Tanabe Pharma Corporation for the development of new VLP vaccines.

FDA proposes banning DBP & DEHP excipients over tox fears

06-Mar-2012 - The US FDA is asking manufacturers to reformulate products containing DBP and DEHP excipients to cut the risk of toxicity.

BPTF reiterates backing for GDUFA

06-Mar-2012 - The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceutical Task Force (BPFT) has reiterated its support for the generic drug user fees act (GDUFA) debated last month .

EMA outlines herbal starting material quality requirements

06-Mar-2012 - The EMA wants manufacturers using herbal starting materials to assess the substances’ initial and post-processing contaminant profile.

Danadams issues wake-up call to Ghanaian government: “Make more drugs locally”

05-Mar-2012 - Danadams' CEO Yaw Adu Gyamfi will tomorrow meet with the Ghanaian Government urging them to establish a drugs fund which will see more meds manufacturing in the country.

EU regulators should copy US FDA over combination product guidelines, says expert

05-Mar-2012 - Regulation over combination products must be simplified to get products to market quicker, said Marielle Fournier, director of Voisin Life Sciences Consulting.

FDA guidance on API-excipient co-crystals unnecessary; Amgen

05-Mar-2012 - Amgen has called FDA draft guidance on API-excipient co-crystals unnecessary in its written response to the Agency.

Harmonisation would help excipient makers tell Chinese Pharmacopoeia Committee

01-Mar-2012 - The drug excipient industry wants the Chinese Pharmacopoeia Committee (CPC) to harmonise monographs with international compendia says IPEC Americas.

FDA raises sprinkled drug bead size after big pharma criticism

01-Mar-2012 - The FDA has raised its limit on the bead size for drugs delivered by sprinkling after big pharma firms criticised its draft guidance.

UN cracks down on internet drugs fraudsters

01-Mar-2012 - The UN has urged Governments to crack down on the growing number of fake drugs being sold online.