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23-Dec-2011

News in brief

Happy holidays from in-Pharmatechnologist.com

In-Pharmatechnologist.com would like to wish all our readers a happy holiday

22-Dec-2011

FDA researching gluten in drugs to help celiac disease patients

The US FDA is seeking information to help it protect celiac disease patients from pharma ingredients derived from wheat, barley, or rye.

Pall to buy ForteBio to build biopharma biz

Pall will buy US instrument maker ForteBio next year in a continuation of efforts to build its biomanufacturing technology offering.

Amgen and Watson team on biosimilars but agree to spare Amgen's drugs

Amgen has partnered with non-branded drugmaker Watson to develop biosimilar cancer drugs in a deal that goes some way towards protecting its own portfolio from generic competition.

Parexel discusses transdermal drug delivery techs

Electroporation is the wave of the future for transdermal drug delivery, according to Parexel’s Ravi Harapanhalli.

21-Dec-2011

API Christmas everybody! - Top 10 API related developments in 2011

It’s been a busy year for API (active pharmaceutical ingredient) manufacturers with new facilities, cost pressures and regulatory developments all hitting the headlines. And it seems recent developments in HPAPIs (high potency APIs) have caused a stir with news of the industry taking up the top 4 places of our end-of-year run-down. Here are the most read API stories from in-PharmaTechnologist in 2011…

Ranbaxy inks consent decree & prepares for $500m penalty

Ranbaxy has signed a consent decree with the US FDA and set aside $500m for penalty payments to settle its longstanding dispute.

News in brief

Eli Lilly collaborating with Arecor on stable protein formulations

Eli Lilly is collaborating with Arecor to develop stable aqueous or higher concentration formulations of protein and peptide drugs.

US scientists develop 'light up' delivery monitoring tech

Intracellular drug delivery testing could become quicker thanks to probes that "light up" when a medicine is delivered to a tumour.

20-Dec-2011

DSM signs MoU with AIBN on biologics commercialisation

DSM Biologics will work with the Australian Institute for Bioengineering and Nanotechnology (AIBN) on the commercialisation of development-stage biologics projects.

China’s intermediates and API sector set growth, say researchers

China will keep its position as a leading API and intermediates supplier thanks to recovering global demand and the growth of the generic sector say market analysts.

News in brief

Eli Lilly expands collaboration to advance drug delivery tech

Eli Lilly has expanded its drug delivery partnership with Starpharma to include further in vivo studies and clinical testing.

SE Asia likely source of fake anti-malarials in Africa; study

Counterfeit anti-malarials containing the Viagra API were probably manufactured in Southeast Asia, researchers found.

19-Dec-2011

News in brief

BASF hikes ethanolamine prices for second time in 2011

BASF has raised its prices for three ethanolamines (EOA), key intermediates in the production of a wide range of active pharmaceutical ingredients (API).

Drug-loaded lollipops could boost oral thrush compliance

Drug-loaded lollipops are the ideal dosage form to boost compliance in children with oral thrush, Indian researchers found.

People on the move; jobs in Pharma

in-PharmaTechnologist presents its weekly round-up of the latest appointments within the pharmaceutical industry, including news from Vertex, Pfizer and Prolong.

Final rule adds manufacturing delay reporting requirements

Manufacturers of certain critical drugs must report production interruptions to the FDA under a new interim final rule.

GE wont say if turnkey bioplant partnership will cut prices for emerging nations

GE Healthcare wont say if its new turnkey biologics plant development service will offer Governments in emerging nations discounted rates.

15-Dec-2011

Speed coating tech sales soaring, says Seppic

Seppic has seen a boom in demand for its new natural origin coating agents for pharmaceuticals, which can speed up production time by 50 per cent at lab stage.

News in brief

Trojan-horse nanoparticles used to deliver steroids to retina

Researchers have developed a Trojan-horse-style delivery system that transports steroids to the retina for the treatment of age-related macular degeneration and retinitis pigmentosa.

Drug quality treaty needed to raise standards, academics say

A treaty on medicine quality is needed to fix the major public health problem of substandard drugs, according to academics.

AMPAC posts Q4 loss as process improvement drags on profits

AMPAC posted a fourth quarter loss as process improvement difficulties offset rising demand for CNS and oncology ingredients.

14-Dec-2011

Archimedes licenses Targit delivery tech to Pharmalink

UK-headquartered Archimedes Pharma has licensed its Targit drug delivery tech to Sweden’s Pharmalink AB for its candidate renal failure treatment, Nefecon.

GE and M+W team on plant and tech biologics production solution

GE Healthcare and M+W Group aim to capture a share of the rapidly expanding global biologics market with a new plant and manufacturing tech partnership.

EMA calls for Vistide recall over Ben Venue contamination fears

The EMA has recommended recalling a batch of Gilead’s Vistide manufactured by Ben Venue over particle contamination concerns.

13-Dec-2011

ADC Bio wins development grant for new ADC production tech

ADC Biotechnology (ADC Bio) has secured a development grant for a new antibody drug conjugate (ADC) manufacturing technology that, it says, can make drug production cheaper.

Joint FDA-EMA inspection programme to launch in January 2012

The FDA and the EMA will begin sharing facility inspection data in their respective territories from January to make better use of resources and reduce drugmakers’ inspection burdens.

UPDATE

Chairman's departure not due to investor pressure says Hospira

Hospira says Chairman Christopher Begley’s impending retirement is unrelated to quality problems at manufacturing plant or recent investor criticism.

One-stop gene therapy could wipe out hemophilia, say UCL researchers

Scientists believe they have developed one-stop gene therapy that could almost eradicate haemophilia.

12-Dec-2011

Vertellus opens new cyanopyridine plant in China

Chemicals firm Vertellus Specialties has begun manufacturing operations at a new facility in China, citing growth of the country’s cyanopyridines market as the key driver for the investment.

Drug delivery news roundup

in-PharmaTechnologist presents its round-up of the latest drug delivery developments, including multi-component particles, metering valve technology and crystalline salts.

News in brief

AZ buys Chinese generics manufacturer

UK drug maker AstraZeneca has bought Chinese non-branded drugmaker Guangdong BeiKang Pharma.

People on the move: jobs in pharma

Outsourcing-Pharma presents its weekly round-up of the latest movers and shakers in the pharmaceutical industry, including news from Inviragen, Auxilium, and Icon Biosciences.

08-Dec-2011

UPDATE

Drug delivery researchers must focus on carrier shape, says new study

Drug delivery developers need more focus on the shape of the carrier, rather than the size and surface chemistry, according to a new study.

Mettler Toledo says new tech will speed up API fermentation

Mettler Toledo says its new dissolved oxygen (DO) measuring optical sensors can speed up the API production process and reduce maintenance costs.

IMCD buys pharma supplier Organotec in Italy

Netherlands-based IMCD has bought Italian fine chemicals supplier Organotec Srl to expand its pharma actives across Europe.

07-Dec-2011

PhRMA backs FDA plans for biosimilar fees discussion

US drug industry group PhRMA has backed FDA plans to discuss fees for biosimilars with pharmaceutical manufacturers.

Merck & Co to set up Asian R&D hub in China

US drugmaker Merck & Co has chosen Beijing, China as the site of its Asia R&D headquarters.

Gel that releases drugs in vivo could replace implants, say researchers

An injectable gel that releases drugs when triggered by an AA battery powered electric field could replace implants, say researchers.

Bosch lauds new extrusion and calendaring line’s API solubility benefits

Bosch Packaging Technology says melt extrusion is the answer to drug manufacturers’ active pharmaceutical ingredient (API) solubility questions.

06-Dec-2011

UPDATE

Stevanato expands its ready-to-fill glass vial capabilities

Stevanato Group has pulled forward the expansion of its EZ-Fill facility in Italy by one year in a bid to dominate a bigger portion of the “rapidly expanding” ready-to-fill vials market.

People on the move: jobs in pharma

in-PharmaTechnologist presents its weekly round-up of the latest changes within the pharmaceutical job sector, including news from Takeda, Immune Design, and Pharmacyclics.

News in brief

Ampio buys ODT tech for to accelerate ED drug development

US developer Ampio Pharmaceuticals says new orally disintegrating tablet (ODT) tech will boost market acceptance of its premature ejaculation rug.

Samsung and Quintiles' biosimilars JV teams with Biogen Idec

Samsung will set up a $300m biosimilars development JV with Massachusetts, US-based Biogen Idec, building on the partnership it forged with CRO Quintiles earlier this year.

05-Dec-2011

Patents, legal battles and R&D dominate drug delivery headlines

Legal battles, patent acquisitions and R&D dominate in-pharmatechnologist.com’s round up of developments in drug delivery this week with news from MonoSol, Acacia and a US University team working on GSK’s Relenza.

Ethiopian quality control lab gains ISO testing accreditation

The Ethiopian national quality control laboratory has gained ISO accreditation to improve access to safe medicines.

News in brief

Actavis buys packaging firm to cut lead times & freight costs

Actavis has bought Netherlands-based PharmaPack to cut its tablet packaging lead times and freight costs.

FDA releases draft co-crystal guidance to support NDAs

The US FDA has published draft guidance to help companies submit marketing applications for API-excipient co-crystals.

01-Dec-2011

US firm offering modular plant leases as alternative to CMOs

Biologics Modular is leasing its mobile production facilities to help clients make FDA regulated drugs without fixed plants.

ATMI launches large-volume bioreactor with GMP compliance in mind

Large volume production is a must for the cell therapy sector according to ATMI, which claims the latest addition to its single-use bioreactor range can help manufacturers overcome the GMP hurdles that hinder commercial scale-up.

Vivimed expands EU, LatAm API capabilities in £35m deal

India-based Vivimed Labs is buying Uquifa for £35m ($55m) to add API capabilities in Europe and Latin America.

People on the move: pharma jobs

in-PharmaTechnologist presents its round-up of the latest career moves within the world of pharmaceuticals, including news from AstraZeneca, Apricus, and BioTime.

Sepha sees growing demand for cost saving testing tech

The drug industry's need to improve product quality while reducing production costs is driving global demand for testing technologies according to Sepha.

News in brief

Ranbaxy forms pact with Teva to launch generic Lipitor in US

Ranbaxy has introduced generic Lipitor in the US after partnering with Teva and gaining FDA approval for manufacture at its US plant.

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