Fire at Aurobindo API plant injures three, operations unaffected

30-Nov-2011 - Aurobindo Pharma says a fire that broke out at its manufacturing plant in India injuring three employees did not disrupt production operations.

Ideal Cures claims film coating tech is twice as quick as others

30-Nov-2011 - Ideal Cures says its new Instacoat E Series film can cut tablet coating times in half and save manufacturers money.

Virus catching filter helps Novo stop batch tests on live animals

30-Nov-2011 - Novo Nordisk has stopped using living animals in batch quality tests after developing a virus filtration tool for factor VII production.

USPTO rejects MonoSol claims in delivery film patent fight with BDSI

29-Nov-2011 - The USPTO has rejected MonoSol RX’s claims that production methods for a cancer pain patch developed by BioDelivery Sciences (BDSI) infringe on manufacturing techniques it uses to make its own...

China-focused USP committee to develop excipient standards

29-Nov-2011 - USP is creating a China-focused East Asia expert committee to develop quality standards for excipients.

Drug delivery research round-up

28-Nov-2011 - in-PharmaTechnologist presents its round-up of the latest drug delivery research developments in the pharmaceutical world, including tumour targeting peptides and lipid nanoparticle drug-delivery technology.

SOHM acquires Novatrend Medicament's product line in latest Indian forray

28-Nov-2011 - Generic drugs manufacturer SOHM is continuing its expansion into the Indian market with the acquisition of Novatrend Medicament’s product line.

FDA anti-adulteration efforts hindered by industry; GAO

28-Nov-2011 - Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.

EC seeks industry feedback to shape serialisation policy

24-Nov-2011 - The EC is seeking industry comments before implementing the serialisation aspect of the falsified medicines directive.

Biocon close to finalising partnership for development of oral insulin

24-Nov-2011 - Biocon is close to signing an agreement with a partner willing to inject cash into its experimental insulin pill, said its MD.

People on the move: jobs in pharma

24-Nov-2011 - in-PharmaTechnologist presents its weekly line-up of the latest appointments in the pharmaceutical industry, including news from Genesis, Acino and Pharmalink AB.

News in brief

Pfizer gains 1st ISO 50001 energy accreditation at Ireland plant

24-Nov-2011 - A Pfizer Ireland plant has become the first in its network to achieve ISO accreditation for cutting CO2 emissions and energy use.

pSivida signs tech evaluation agreement for injectable implant

23-Nov-2011 - pSivida has inked a technology evaluation agreement with an unnamed global pharma over its Durasert drug delivery technology.

GSK urges FDA to consider absorption of nanomaterials in new guidance

23-Nov-2011 - GlaxoSmithKline (GSK) has urged the US FDA consider the absorption of nanomaterials in the gastrointestinal (GI) tract within its proposal for new regulations on nanotechnology.

EMA recalling oncology drugs manufactured by Ben Venue

23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.

News in brief

Shire submits regulatory filings for Massachusetts Vpriv plant

23-Nov-2011 - Shire has submitted EMA and FDA regulatory filings to add ‘substantial manufacturing capacity’ for Vpriv (velaglucerase alfa).

FDA sends Mylan Puerto Rico plant a GMP warning letter

23-Nov-2011 - The US FDA has sent Mylan a warning letter after inspectors found GMP testing failings at its Puerto Rico facility.

Schott strikes deal with Xinkang for joint venture in China

22-Nov-2011 - German technology giant Schott has signed an agreement with a Chinese firm to provide the fast-growing pharmaceutical market with a range of high-end glass packaging products.

FDA nanomaterial draft guidance means pointless extra regulation, say experts

22-Nov-2011 - FDA draft guidance defines nanoparticles too broadly and could result in APIs being categorised as nanomaterials, industry said.

News in brief

Biocon introduces insulin pen to Indian market

22-Nov-2011 - Biocon has begun selling a reusable insulin pen, based on Haselmeier technology, to patients in India.

Novavax leasing cGMP plant to meet expected vaccine demand

22-Nov-2011 - Novavax is leasing a cGMP plant in Maryland under ‘very favourable terms’ to meet anticipated demand for its VLP vaccines.

Gold nanoparticles can cut blood supply to tumours, say researchers

21-Nov-2011 - Gold nanoparticles can target endothelial cells to cut the supply of oxygen to most types of tumour, according to a new study.

Shortages to worsen after Ben Venue suspends manufacture

21-Nov-2011 - Ben Venue Laboratories has voluntarily suspended manufacture at the Ohio plant linked to drug shortages.

News in brief

IntraPac hiring 63 in NJ to IN packaging plant relocation

21-Nov-2011 - IntraPac is creating 63 jobs by relocating operations from New Jersey to an 80,000 sq ft packaging plant in Indiana.

News in brief

AptarGroup buys Oval Medical stake in injectable expansion

17-Nov-2011 - AptarGroup has bought a 20 per cent stake in Oval Medical to enter the injectable drug delivery device business.

Ashland predicts ISP buy will accelerate pharma unit growth

17-Nov-2011 - Ashland expects integration of ISP and demand for pharma ingredients to drive “accelerated growth” in the next few years.

Aanjaneya’s profit soars as post-IPO expansion continues

17-Nov-2011 - Net profit at Indian API and formulation business Aanjaneya Lifecare jumped as it enacted post-IPO expansion plans to ‘dominate’ its markets.

India to end ‘anti-competitive’ bulk drug price control policy

17-Nov-2011 - India plans to end price control of bulk drugs as the practice ‘is inherently anti-competitive’ and gives China an advantage.

IPEC India fees will be ‘fair’ for excipient makers, says IPEC Federation

16-Nov-2011 - IPEC India membership dues will be fair for excipient manufacturers, users and distributors in the country according to the IPEC Federation.

ProMetic sales recover on affinity absorbent demand

16-Nov-2011 - ProMetic grew third quarter sales on demand for affinity absorbents and expects the recovery to continue.

News in brief

Boehringer investing $65m in early development API plant

16-Nov-2011 - Boehringer Ingelheim is investing $65m (€48m) in a US API manufacturing facility to meet its early development needs.

USP forges closer ties with Chilean drug standards group

15-Nov-2011 - The USP has forged closer bonds with the Chilean Pharmacopoeia Foundation (CPF) in the latest of a series of agreements with regional drug quality groups.

News in brief

Merck inks Bend deal to access spray-dried dispersion tech

15-Nov-2011 - Merck & Co has gained access to spray-dried dispersion technology through an agreement with Bend Research.

Trust in drug source may blind wholesalers to counterfeits

15-Nov-2011 - Wholesalers’ trust in the quality of products from some countries could decrease vigilance and allow counterfeits to reach pharmacies, research found.

Pall sets up Singapore processing COE

14-Nov-2011 - Processing technology maker Pall has opened a new centre of excellence in Singapore in a bid to capture a share of the country’s growing biomanufacturing sector.

Bristol-Myers Squibb inks tech transfer with Brazilian MoH for HIV meds

14-Nov-2011 - Bristol-Myers Squibb has penned a technology transfer agreement with the Brazilian government in what it says is a bid to increase access to HIV drug Reyataz (atazanavir sulfate) in the...

News in brief

EDQM has busy month of CEP suspensions

14-Nov-2011 - The EDQM has suspended five CEPs in a little over a month, bringing the total to nine so far this year.

IPEC India could launch in 2012

14-Nov-2011 - Indian excipient manufacturers could have a new trade body in early 2012 according to an international industry organisation asked to set up an association in the country.

Mylan to buy Pfizer's respiratory delivery platform

10-Nov-2011 - Pfizer will sell Mylan its dry-powder inhaler delivery system in an agreement set to pit the generics firm against UK drug major GlaxoSmithKline (GSK).

Neuroderm hopeful for its Phase II Parkinson's medication patch

10-Nov-2011 - Neuroderm has seen “promising” results in its Phase II clinical trial of a new drug delivery patch to increase the efficacy of Parkinson’s medication.

News in brief

AGC to open intermediate & API plant in Japan

10-Nov-2011 - AGC is to open an API and intermediate production plant in Japan to meet increased demand from the aging population.

Bosch packaging to open second production plant in China

09-Nov-2011 - Bosch Packaging has started work on a second production facility in Chengdu, China to increase manufacturing capacity.

News in brief

Pharma CSR reporting up 39% in 2011 according to KPMG

09-Nov-2011 - Pharma sector corporate social responsibility (CSR) reporting has increased dramatically in recent years according to a new report that argues such activity enhances financial value.

K-V prompts FDA investigation into compounding pharmacies

09-Nov-2011 - The FDA is investigating compounding pharmacies’ Makena after K-V Pharmaceutical said they differ from approved forms.

Globalised supply chain drives EMA to rethink batch release

09-Nov-2011 - The EMA plans to update guidance on certification and batch release in response to globalisation of the pharma supply chain.

Chinese FDA should hire CMC staff to boost QbD; Pfizer exec

08-Nov-2011 - The Chinese FDA should hire more CMC reviewers to encourage QbD applications, a Pfizer executive said.

News in brief

Canada’s pharmaceutical intellectual property laws need re-vamp to encourage R&D, says analysts

08-Nov-2011 - Canada’s pharmaceutical intellectual property laws need a shake-up to encourage innovation in drug development, according to an article in CMAJ.

FDA sends Genentech 483 after finding failings at Avastin plant

08-Nov-2011 - The US FDA has sent Genentech a GMP 483 after inspectors found failings in the capping process for Avastin.

Greater FDA inspection role increased drug recalls in Q3, study

07-Nov-2011 - Greater FDA oversight of US manufacturing plants increased the number of drug recalls in Q3 in a trend that is likely to continue according to a new report.

People on the move: pharma jobs

07-Nov-2011 - in-PharmaTechnologist presents its round up of the latest comings and going within the pharmaceutical industry, including news from SPBT, Viamet and Virobay.

News in brief

Drug delivery tech drives 3Q sales growth at Cambrex

07-Nov-2011 - Demand for drug delivery technologies helped Cambrex post double-digit sales growth but guidance fell below expectations.

EMA to clarify acceptability of multi-product plants in guidance

07-Nov-2011 - The EMA is to clarify when a product should be manufactured in a dedicated facility to avoid risk of cross contamination.

FDA updates ICH Q&A to clarify design space requirements

07-Nov-2011 - The US FDA has updated its ICH Q8, Q9 and Q10 question and answer document to clarify design space requirements.

update

Novozymes rolls out new HA product

03-Nov-2011 - Novozymes Biopharma says its new hyaluronic acid has sustainability, safety and production benefits for the pharmaceutical manufacturing sector.

ViiV teams with Russian manufacturer

03-Nov-2011 - ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.

Obama pushes FDA and drugmakers to solve shortages

02-Nov-2011 - US President Barack Obama has leaned on the US FDA to ramp up its early warning system for drug shortages and asked manufacturers to do more.

People on the move: pharma jobs

02-Nov-2011 - in-PharmaTechnologist presents its round-up of the latest appointments in the pharmaceutical industry, including news from BIO, Natrix, Amarantus and 3M.

Evonik to buy SurModics’ drug delivery assets and cGMP plant

02-Nov-2011 - SurModics is selling its drug delivery assets and cGMP manufacturing facility to Evonik for $30m (€22m) in cash.