The Challenge of Change - Managing Excipients Control
Colorcon
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AstraZeneca will cut 8,000 more jobs by 2014 with R&D and supply chain operations being the main focus of the cutbacks.
Full-year income at the Lonza was hit by falling demand for life science ingredients and custom manufacturing services and only modest gains for its bioscience unit.
The global market for RFID products and services in the pharma industry will be worth $884m (€631m) in 2015, according to a report, but apprehensions about initial costs and return-on-investment need to be overcome.
Crospon has spun out its transdermal controlled release patch into a distinct company, two years after it licensed the system from HP, using funding from a pharma firm to further its development.
Enzon stockholders have approved the sale of its pharmaceutical business, which has four marketed products and a manufacturing facility, to sigma-tau for an initial $300m (€214m).
Schott says its new Russian packaging plant will help meet demand of growing local pharmaceutical market.
Environmental certification of production facilities should be introduced to GMP legislation and sustainability risk assessments linked to marketing authorisations, according to a MPA report.
Copley Scientific claims new dissolution testing apparatus is first commercially available device specifically designed for inhaled drug formulations.
Merck KGaA has begun work on a new inorganic salts plant in Darmstadt, Germany, citing growing demand as the main motivation for the €30m ($42m) investment.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Vasella stepping down as CEO of Novartis and appointments at Shionogi Pharma and Antares Pharma.
The Formulation Innovation Network has been set up in the North of England as a means of enhancing innovation for all formulation-orientated businesses.
LTS Lohmann Therapie-Systeme (LTS) signs up as manufacturer of drugs that use IntelGenx’s VersaFilm delivery technology.
The SPMC of Sri Lanka is seeking a $10m (€7.1m) loan to buy high-speed tablet and capsule filling machines and ensure it can meet the island’s demand for safe medicines.
Detection of Mycoplasma contamination in biologics manufacture can be cut from up to 35 days to four hours using Millipore’s MilliPROBE, according to the company.
Nipro Medical has recalled all batches of its GlucoPro insulin syringes in the US after discovering that the needles could detach during use.
Nanotechnology safety legislation designed to address potential health and safety risks posed by the technology has been introduced to the US Senate.
Work on “freezer farm” phase of Progenitor Cell Therapy’s (PCTs) new manufacturing facility in Allendale, New Jersey is complete.
Indian CRO Ankur Drugs and Pharma is a step closer to stating production of Romaco’s Siebler StripTabs now the German firm developed a fully integrated manufacturing line.
SurModics has opened a 90,000 sq ft cGMP manufacturing and development facility in Birmingham, Alabama, US to support its partnerships and shorten time to market.
Dr Reddy’s Laboratories is combining some of its products with Aegis Therapeutics’ Intravail drug delivery technology after the companies entered into a partnership.
Emergency relief groups in Haiti can expect to receive continued support from the drug industry, according to the International Federation of Pharmaceutical Manufacturers (IFPMA).
AMRI’s plant in Rensselaer, New York gained SafeBridge potent compound certification this week after an effort that spokesperson Andrea Schulz said istestament to the firm's "willingness to go the extra mile”.
Indian drugmaker Lupin can start seeking US approval for new drugs made at its API plant in Mandideep, Bhopal after resolving the cGMP deficiencies that earned the facility a US FDA warning last year.
Pharmaceutical packaging machinery manufacturer Sepha has reported a 33 per cent increase in sales for 2009, underpinned by strong growth in Asia and South America.
Ocelus’ has received £500,000 from Finance Wales and the Welsh Assembly Government to fund the development of its Microplant Delivery System.
Blow-moulded packaging companies Pretium Packaging and Novapak Corporation have been taken over by New-York-based buyout firm Castle Harlan Inc in a deal worth $200m.
Access Pharmaceuticals’ insulin diabetes treatment has shown promise in preclinical trials, achieving over 80 per cent oral bioavailability, leading the company to target proof-of-concept studies in humans.
Ranbaxy Laboratories has strengthened its vaccine and biologics manufacturing capabilities by acquiring India-based Biovel Lifesciences.
Johnson & Johnson (J&J) has expanded its US OTC drug recall after revealing that many more products than first thought may be contaminated by the wood dye, 2,4,6-tribromoanisole (TBA).
The EFPIA’s European Vaccine Manufacturers (EVM) group has denied allegations that its members were involved in hyping up the threat of the H1N1 pandemic to boost vaccine sales.
The subsidy package used to attract Amylin to Ohio was probably too large and inflated by the biotech’s claim it was considering other locations, according to a report which calls for an end to the “economic war among states”.
New Jersey, US-based contractors Catalent Pharma Solutions and Compass Pharma Services expanded their respective blister pack offerings last week, both citing growing drug industry demand.
Strategic Ventures Fund (SVF) has divested its stake in API producer Shilpa Medicare after four years invested in the company, during which time it has doubled its manufacturing capacity.
Global vaccine revenues will be $52bn (€36.2bn) in 2016, more than double the total for 2009, driven by new products and indication expansions of established therapies, according to a report.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Cel-Sci strengthening its manufacturing team and three promotions at Adolor.
Lonza will shut down its API plant in Riverside, Pennsylvania, US by the end of the year as part of a plan to cut costs and shift small-molecule production to Asia.
Avir Green Hills AG has begun Phase II trials of deltaFLU, its intranasal, seasonal influenza vaccine, which it believes is easier to administer and more effective than traditional treatments.
SyberWorks is collaborating with the Validation and Compliance Institute (VCI) to provide FDA compliance training, including a programme covering cGMP production.
Cel-Sci has completed validation of critical utilities and production equipment at its GMP facility which uses cold 4ºC aseptic filling to improve the shelf-life and potency and biologics.
Pall says its acquisition of MicroReactor Technologies (MRT) broadens its offering in the $1bn (€689m) a year global biopharmaceutical process development market.
Genzyme has reported a small dip in preliminary fourth quarter and full year revenues, driven by declining sales of Cerezyme and Fabrazyme which have been affected by manufacturing problems.
Novavax has completed cGMP scale up of its RSV-F vaccine candidate, with the material being used in preclinical studies, and amended the terms of the H1N1 collaboration with Xcellerex.
Millipore wants to help biopharmas address “virus safety challenges” and believes its new Viresolve Pro+ filtration system may provide the solution.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Genzyme strengthening its quality team and appointments at ISPE and Biogen Idec.
German healthcare packaging group Gerresheimer says operations at its new Brazilian plant will begin in the near future.
Continuing production of medically necessary products (MNPs) in the event of a pandemic will be made easier by developing a contingency plan, according to the FDA which has issued guidance on the subject.
US FDA has missed its review deadline for MannKind’s inhaled insulin candidate Afrezza after failing to complete inspection of third-party contract supplier.
A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.
Production has begun at the US API plant German chemicals firm Evonik Industries recently bought from drugmaker Eli Lilly.
Vaccines could be produced in less than 10 weeks from first isolation of the RNA sequence by using insect cell derived influenza VLPs, according to research which has implications for H1N1 and H5N1.
GSK says it will start making its BPH drug Avodart (dutasteride) at its facility in Poznan, Poland when it completes a PLN70m (€17m) capacity upgrade in January next year.
The Hong Kong pharma sector should aim to adopt current World Health Organisation (WHO) GMP standards for drug manufacture within two years, according to a new report.
Daiichi-Sankyo subsidiary Luitpold Pharmaceuticals has acquired PharmaForce, giving it a 40,000 sq ft cGMP compliant sterile manufacturing facility and a 20,000 sq ft API production plant.
The Medicines and Healthcare products Regulatory Agency (MHRA) is planning to strengthen penalties against counterfeiters, making it a specific criminal offence with a maximum sentence of 12 years.
Pfizer will soon sell more generic pharmaceuticals in the US after its agreement with Indian non-branded drugmaker Strides Arcolab.
US preclinical CRO MPI Research has formed an alliance with Oregon-based needle-free delivery specialist Bioject Medical Technologies.
InNexus Biotechnology believes 2010 is the year for biotechs to differentiate and has begun this process by using its Transmab delivery technology in a product for treating psoriasis.
The US PTO has granted CyDex new patent for the production of ultra high-purity modified cyclodextrin.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including the retirement of Biogen Idec’s CEO and appointments at Dishman and Noven.
Cost savings and more consistency in the quality of pills could be realised if near-infrared spectroscopy (NIR) is used to predict dissolution rates of matrix tablets in the body, according to researchers.
Ranbaxy Laboratories has sold its Chinese JV, Ranbaxy Guangzhou China Limited (RGCL), as part of a new approach to the country’s rapidly expanding drug market.
The US Department of Justice (DOJ) has given partial approval for Amcor’s takeover of Alcan after announcing it would now limit its review to Alcan’s Medical Flexible operations.
Zydus Cadila has become the first Indian pharma company to begin multi-centre clinical trials of a H1N1 vaccine after it received approval from the Drug Controller General of India (DCGI).
Genzyme is outsourcing fill and finish manufacturing of several major drugs to Hospira in response to in-house difficulties at its Allston Landing facility in Boston, Massachusetts, US.
Ownership of FrieslandCampina Domo’s pharmaceutical lactose business will be transferred to DMV-Fonterra Excipients, the 50/50 JV set up by Domo owner Royal FrieslandCampina and partner Fonterra.
Novartis intends to acquire the remaining 75 per cent of Alcon for $39.3bn (€27.3bn), adding to the shares it bought in April 2008 and giving the big pharma control of the ophthalmic specialist.
Rexam will close its pill and tablet bottle making facility in New Hampshire, US by the end of the year to further align global plastics operations according to new CEO Graham Chipchase
Marksans Pharma will sell or lease its API manufacturing plants in Pune, India in a bid to raise $125m (€87m) and focus
McNeil Consumer Healthcare has recalled all lots of its Tylenol Arthritis Pain caplet 100 count bottles in the US due to reports of nausea and stomach pain.
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