The Challenge of Change - Managing Excipients Control
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Genzyme has rejected Sanofi-Aventis' $18.5bn (€14.5bn) takeover bid, describing it as offering no improvement in price on the previous proposal and failing “to establish a basis for engagement.”
Laboratory study shows succinyl-chitosan extended-release (XR) excipient could outperform commercially-available delivery technologies, says Spenser Pharmaceuticals.
Syringe maker Unilife said it was hit by falling revenues, costs of US relocation and workforce expansion in Q4, but that significant business progress was made in fiscal 2010.
SK Chemicals hopes Xcellerex’ manufacturing technology will boost vaccine production business.
Cell culture, LAIV vaccines and recombinant DNA technology should be supported by the US government as part of a long-term overhaul of pandemic response capabilities, according to PCAST.
Proposed changes to compulsory licensing and foreign ownership oversight in India sparked discussion last week. To explore the topic, in-PharmaTechnologist presents interactive charts detailing market changes in the country over the past 15 years.
Lonza buys viral-based biologics maker Vivante GMP Solutions to broaden custom manufacturing offering.
ZRG Partners says there was a “fight for talent” in hiring, firing and vacancies in Q2, with the outsourcing and pharmaceutical sectors battling for employees within regulatory, quality and clinical roles.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Discovery Labs, NewAge Industries and Jennerex.
Sanofi Aventis has gone public with its $18.5bn (€14.5bn) takeover bid for US biotech Genzyme, putting more pressure on firm’s “unwilling” board
The Flexibles packaging unit acquired in Alcan Packaging deal boost sales, but integration costs hit fiscal 2010 net profit at Australia’s Amcor.
Electronic batch recording (EBR) capabilities have been added to version 2.1 of FactoryTalk Pharma Suite by Rockwell Automation.
Transdermal delivery of a broader range of therapeutics could be possible using microdevice fabrication technology Vyteris inked a deal to access.
A fully-equipped disposable manufacturing facility has been added to CMC Biologic’s Seattle, WA site, as the first stage of a major expansion plan.
Mtech Bioprocess is to double scale-up square footage and staff to support Maryland, US biotechs’ non-GMP production work.
India is considering strengthening compulsory licensing provisions, which allow third parties to produce patented products, in response to concerns about overseas takeovers and drug prices.
Indian pharmaceutical firm Cipla is to buy Meditab Specialties to boost active pharmaceutical ingredient (API) and intermediate production capacity.
Cell penetration and pharmacodynamics boosting “stapled peptide” tech wins Aileron Therapeutics potential billion dollar protein drug development deal with Roche.
Stirling Pharma’s state-of-the-art Canadian plant will open its doors in late September, and first to come off the production line will be the drug, acetaminophen.
A review of US capabilities has concluded that the time to produce a pandemic vaccine could be halved through adoption of short-term policies.
Proposed changes to USP chapters 232 and 233 on trace impurities would increase drug industry use of automated analysis, creating “huge number” of potential new customers says Thermo Fisher Scientific.
Delivery technology-focused CRO NexMed says it has strengthened its IP position with a new patent award for its NexACT technology from Israeli authorities.
The FDA has approved Alexion Pharmaceuticals’ Rhode Island, US plant for commercial supply of Soliris (eculizumab), giving the biopharm a second source.
Stabilitech is increasing the temperature range tolerance and ambient storage lifespan of two vaccines for the US military.
The US HHS is allocating $2bn (€1.6bn) to overhaul pandemic and bioterrorism capabilities through improvements to regulatory, developmental and manufacturing processes.
Chemir Analytical Services launches custom synthesis service for organic molecules for drug R&D, aimed at small pharma companies with rush or emergency projects.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including J&J strengthening manufacturing and appointments at Alexza and Inspire.
Mettler Toledo’s new in-line granulation monitoring tech may make in-process particle characterisation less of a grind.
SAFC and Novozymes Biopharma have agreed to extend their partnership by ten years for the exclusive distribution of LONG R3 growth factor, used for industrial cell culture applications.
Midatech and MonoSol Rx have filed a provisional US patent application covering a nanoparticle film drug delivery system for administering biologics.
Allied Vision Technologies (AVT) says new imaging machine offers “100 per cent inspection” capability to help drugmakers meet quality rules.
Improving safety and efficacy coupled with drug industry desire for “stronger” patents will drive growth of the biologics sector over the next five years, according to new research.
Imclone has closed the manufacturing facility in Branchburg, New Jersey where it produces the cancer drug Erbitux, according to reports in the US media.
CardioGenics predicts yield boosting “biologics beads” will change the antibody extraction landscape after signing distribution deal with Merck Chimie.
Producing conjugate vaccines in recombinant E coli is potentially simpler and more cost-effective than alternatives, say researchers, but the method suffers from low yields.
Aesica will build a “high containment” manufacturing plant to expand its high potency drug formulation capabilities in line with growing demand.
AstraZeneca workers in the UK have voted to strike next month unless the company drops proposed changes to its final salary pension scheme.
API maker Granules India’s Q1 profit hit by “challenging environment,” bad debts write-off and foreign exchange rates, but revenue climbs.
Bioprocess purification chromatography tech wins BAC new deal after Swiss protein maker Octapharma licenses it for commercial-scale manufacture.
Patheon is partnering with TraceLink to increase manufacturing efficiencies through closer integration and collaboration with clients.
Scolr Pharma reduces losses despite drop in revenue by cutting spending on product R&D and operations.
Australia-based Sigma has agreed to sell its pharmaceutical division to Aspen for A$900m (US$802m).
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Ranbaxy’s CEO stepping down and appointments at Avid, the USP and Novavax.
The EMA and FDA are seeking pharma manufacturers to participate in a joint GMP (good manufacturing practice) inspection pilot programme.
Gujarat Foils says India’s position as global pharmaceutical manufacturing hub will be a key driver for the aluminium foils sector.
The US army is funding development of a delivery system for administering pain and infection control drugs to treat battle-related injuries.
Furiex posts Q2 loss as increased R&D spending and higher admin costs offset revenue gains, but firm is confident development model can boost partners’ pipelines.
BARDA is providing the WHO with $6.4m (€5.0m) to cooperatively develop influenza vaccine production capacity in under-resourced nations.
Elan puts plans to sell EDT delivery division on hold because market is not “conducive to an appropriate valuation.”
US drugmaker Merck & Co has announced plans to reacquire a Pennsylvania manufacturing plant to guarantee supply of key active pharmaceutical ingredient (API).
China-based Weifang Shengtai Pharmaceutical is to supply Kelun Pharmaceutical with 10,000 tons of injection grade dextrose monohydrate.
Medicago is to build a 90,000 sq ft cGMP vaccine facility in RTP, North Carolina, US using a $21m (€16.1m) grant from the US Department of Defense.
Label manufacturer ATL has licensed anti-counterfeiting technologies from Document Security Systems (DSS) to meet growing demand from pharma clients.
Lower overseas demand from key customers hurt fine chemicals maker Synthetech in first quarter fiscal 2011, continuing the decline seen in the previous financial year
Endo Pharmaceuticals will pay $168m (€127.7m) for drug delivery tech and formulations firm Penwest Pharmaceuticals in bid to expand pain portfolio.
Researchers in the US have received a grant to fund a three-year, collaborative research project looking at lipid bilayer encapsulated liposomes.
Respiratory formulations specialist Vectura has licensed two dry-formulation technologies to GSK, further strengthening its position in the $25bn (€19bn) asthma and COPD market.
A Johnson & Johnson (J&J) unit has licensed a gastric retentive drug delivery technology from Depomed for use in a combination therapy.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Watson Pharmaceuticals, Shire, Lupin and AmerisourceBergen.
Cel-Sci’s recently opened “Cold fill” facility has passed its first manufacturing test by completing filling of a batch of the candidate head and neck cancer drug Multikine for a late-stage trial.
Penwest Pharmaceuticals raises guidance citing Opana ER royalties, deals and patent settlements as Q2 highlights; but warns that job cuts likely under cost cutting plan.
Ampac Fine Chemicals posted a 28 per cent jump in revenues in the third quarter but this was offset by manufacturing inefficiencies and validation costs.
In the first of a series of special in-pharmatechnologist podcasts Kate Wilber, Image Solutions’ (ISI) director of regulatory Services, Europe discusses the emerging trends in BPO and talks about how it can benefit drugmakers.
A bill to strengthen drug safety requirements and FDA powers has been introduced into the US congress.
High tech packaging sales and revenue from acquired delivery businesses drive West Pharmaceutical Services growth in second quarter, but US firm cuts guidance.
Lotus Pharmaceuticals has completed production of the active pharmaceutical ingredient (API) and tablets of R-Bambuterol for use in clinical trials.
Pfenex has won a US federal contract to use its expression technology for the rapid, cost-effective production of “unprecedented” amounts of anthrax vaccine.
Calls for US government to break Genzyme’s Fabrazyme patents accompany more speculation that French drugmaker Sanofi Aventis is in takeover talks.
Bilcare to buy Ineos’ rigid polymer films business for €100m ($132m) to improve access to pharmaceutical packaging customers worldwide.
Greater recognition of toxicity risks of HPAPIs and continued growth of oncology sector are driving drug industry demand for safe manufacturing capacity says US fine molecules firm SAFC Pharma.
FDA draft guidance published this week recommends manufacturers of drug delivery patches adopt QbD to minimise the amount of excess residual drug.
Recently-acquired Italian R&D facility helps Aptuit win new contract after local neuroscience-focused developer Siena Biotech names the CMO as “supplier of choice.”
Cancer Research UK has established a £18m ($28.4m) biopharm manufacturing unit to produce complex experimental drugs, such as monoclonal antibodies.
Heinkel expands pharmaceutical filtering and drying systems business with acquisition of Italian equipment maker Comber.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Roche, Caraco, CMP Therapeutics and Unilife.
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