Breaking News on Pharmaceutical Technology

Pharmalucence issued with FDA warning letter

The US Food and Drug Administration (FDA) has issued a warning letter to Pharmalucence for alleged deviations from current good manufacturing practices (cGMP).

Stable growth in 2009 will reflect new shape of drug market, say IMS

Next year, drug revenues will grow 5 per cent to $820bn according to IMS Health, as the global downturn, patent expiry and flat-lining growth rates in mature markets all make their presence felt.

PPP funds Indian technology park

The Indian state of Orissa and a biotech company have entered into a public-private partnership (PPP) to construct a $20m technology park.

SAFC showcases HPAPI handling capabilities

SAFC's Mike Harris sets out the firm's role in the expanding high-potency active pharmaceutical ingredient (HPAPI) industry.

News in brief

Wyeth narrow early R&D programme

Wyeth is cutting back on its early stage R&D efforts to focus on oncology, inflammation, vaccines, metabolic diseases, musculoskeletal problems and neuroscience.

Taiwan’s biotech statute continues to attract global players

Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.

Versatile BBB drug delivery tech appears safe

AngioChem has posted findings that its lead candidate using its propriety technology for crossing the blood-brain barrier (BBB) is safe and well tolerated.

Bayer’s SFF gains EMEA approval

Bayer HealthCare’s new sterile filling facility (SFF) has been granted license approval by the European Medicines Agency (EMEA).

Deal for development of insulin-producing cells

The development of insulin-producing cells from human stem cells is to be advanced by a collaborative research agreement involving Novo Nordisk.

News in brief

FDA clears Catalent Belgian syringe plant

Contracting giant Catalent says its pre-filled syringe facility in Brussels, Belgium has received Food and Drug Administration approval for the manufacture of products for the US market.

News in brief

Shasun to shut down Scottish plant

India’s Shasun Pharma Solutions is to close its manufacturing facility in Annan, Scotland explaining that the site is being “underused,” according to media reports.

News in brief

Positive results for topical drug delivery

Nuvo Research has presented positive Phase III results for Pennsaid (diclofenac sodium solution), which uses the company’s transdermal drug delivery technology.

NAFDAC blacklists 22 drug fakers

The NAFDAC has banned 22 firms that it says are involved in the manufacture of fake drugs from ever again selling pharmaceuticals in Nigeria, as part of a countrywide clampdown.

Isochem highlights Vitamin E TPGS capacity

Isochem will have manufactured ten tonnes of the multi-purpose drug excipient vitamin E TPGS by the end of the year, marking the end of what it says has been a successful first 12 months of commercial scale production.

BioTrove and Agilent sign mass spec deal

Agilent and BioTrove have forged a non-exclusive mass spectrometry partnership designed to enhance the screening of candidate drug compounds in early stage development.

Clarifying the benefits of sonocrystallisation

David Hipkiss explains the benefits for pharmaceutical manufacturers of using Prosonix’ sonocrystallisation technology.

US generics brighten Sun’s Q2, setting it on acquisition trail

Sun Pharmaceutical has posted a strong set of results for the second quarter of fiscal 2009, driven by improved performance by both its Indian branded drug and US generics businesses.

Pharma manufacturing: People on the move

in-PharmaTechnologist.com presents its latest round up of personnel moves in pharmaceutical manufacturing, including major restructuring at Novartis.

Elan drops EDT sale plans on market uncertainty

Irish drugmaker Elan has shelved plans to sell its contracting arm EDT in favour of improving the division’s profitability, despite receiving what it describes as “considerable interest” in the unit.

Borgas sets out ‘top 8’ pharma industry issues

The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.

Merck must axe a further 7,200 jobs “to survive,” says CEO

Merck & Co plans to cut 7,200 jobs, joining the growing list of big pharma firms enacting restructuring measures in the face of falling earnings and an uncertain market future.

GAO critical of FDA’s overseas inspections

A report has been published detailing the US Food and Drug Administration’s (FDA) failings in its inspection of overseas manufacturing facilities.

Self-assembling hydrogel for drug delivery

Researchers have developed a self-assembling hydrogel, which they claim is biocompatible, easy to tailor and efficient at releasing drugs.

Sanofi invests in Chinese clinical R&D capacity

French drug giant Sanofi-Aventis has set its sights on developing China as its Asian R&D hub, unveiling plans for a significant expansion of its clinical research unit in Shanghai.

Big pharma Q3 results = big smiles?

Pfizer and Schering-Plough have both exceeded their earnings estimates, although this was largely underpinned by favourable exchange rates and low expectations.

Drug delivery tech receives funding

NovaDel Pharma has secured $2.5m in financing, some of which will be used to further use of its proprietary drug delivery technology.

3M and Vaxlnnate pal up for pandemic patch

3M’s drug delivery division and US biotechnology firm VaxInnate have teamed up to develop transdermal influenza vaccine delivery patch in preparation for the anticipated pandemic.

Ethex recalls its second oversized drug this year

Ethex has withdrawn three lots of its generic drug dextroamphetamine sulphate, which is used to treat ADHD and narcolepsy, after analysis revealed that some oversized tablets had been produced.

Eisai plans to open Indian API plant by 2011

India’s reputation as a base for quality, low-cost drug manufacture has proved irresistible for yet another big pharma company with Japan’s Eisai unveiling plans for a new production and R&D facility.

Bend expands drug delivery services

Bend Research is offering companies some of the drug delivery formulation expertise and technologies it developed during its 23 year collaboration with Pfizer.

Novartis makes acquisition; eyes more

Novartis has acquired Nektar Therapeutics’ pulmonary drug delivery business for $115m, with further takeovers possible in the foreseeable future.

SSB signs deal for virus clearance tech

Sartorius Stedim Biotech (SSB) and Bayer Technology Services (BTS) have signed an exclusive cooperation agreement for the manufacture and marketing of UVivatec products.

US OK for Teva’s fentanyl patch

US FDA approval for Teva’s transdermal fentanyl patch ushers the Israeli generics giant into the potentially lucrative but often problematic chronic pain therapy sector.

First podcast from in-PharmaTechnologist.com

Welcome to in-pharma technologist’s podcast. In the next three minutes Gareth Macdonald will take you through the top industry headlines this week. Product authenticity dominated the news, with US regulators announcing increased penalties for those convicted of selling dangerous counterfeits. In Europe IPEC sets out its new third party assessment scheme.

EU votes in chemical labelling law

The European Parliament has voted in favour of incorporating the United Nations’ (UN) Globally Harmonised System (GHS) for chemical packaging into EU law.

Covidien unveils $100m expansion plans

Covidien hopes that a $100m (€74m) expansion of facilities at its production hub in St Louis, Missouri, US will boost efficiency and cut the time it takes to bring products to market.

Step forward for synthesis of complex peptides

ONI BioPharma has produced an antibiotic using its DPOLT technology, a solid phase synthesis platform for manufacturing bioactive peptides.

Pharma manufacturing: People on the move

in-PharmaTechnologist.com presents its latest round up personnel changes in the pharmaceutical sector.

Group offers "pharma leadership on demand”

A UK company has been launched with the aim of providing high level management expertise to pharmaceutical companies on an “on-demand” basis.

News in brief

Hameln sterile plant gets green light

Hameln Pharma has been granted a manufacturing license for its brand new sterile manufacturing plant, the result of a €35m investment programme which has almost doubled the contract manufacturer’s capacity.

News in brief

InfraServ Knapsack gets bigger in GMP analyses

German contract services firm InfraServ Knapsack has added three new capabilities in its analytical division aimed at servicing Good Manufacturing Practice (GMP) production.

News in brief

New tubes from Pöppelmann

The FAMAC Division of Pöppelmann has launched a new range of plastic tubes for applications in the pharmaceuticals and food industries.

News in brief

CMO Hermes invests in new facilities

Hermes Pharma of Germany is planning to boost its manufacturing capacity for effervescent tablets by 50 per cent with a €35m investment at its facilities in Wolfratshausen and Wolfsberg.

News in brief

SCM adds radiopharma, biologics

UK contract manufacturer Specials Clinical Manufacturing has added to its portfolio of capabilities with two new services – radiopharmaceuticals and biologics.

Merck’s Durham facility on road to completion

Merck & Co has completed start-up activities at its vaccine manufacturing plant in Durham, North Carolina, which is intended to further the company’s ambitions in the sector.

Synthetic glycerine is back (but never really went away)!

The relentless commoditisation of glycerine ingredients prompted Dow Chemicals to all but exit the sector a few years back, but now the company says it is seeing a resurgence for its flagship synthetic glycerine brand.

Gerresheimer’s Q3 buoyed up by drug sector focus

Gerresheimer’s decision to concentrate on the pharmaceutical and life science sectors and sell-off non-core divisions appears to be paying dividends judging by a 14 per cent jump in third quarter operating profit.

Wyeth to cut jobs at Irish subsidiary

Wyeth Medica, an Irish subsidiary of US drugmaker Wyeth, plans to cut 250 jobs at its manufacturing plant in Newbridge, County Kildare, according to media reports.

Univar steps into paracetamol breach

Fine chemical company Univar has constructed a network of suppliers for paracetamol (also known as acetaminophen) to avoid shortages following the closure of the last plant making the ingredient in Europe.

Par cuts workforce 30% and restructures generics division

US drugmaker Par Pharmaceuticals is wielding the axe at its generics division, cutting 190 jobs and refocusing its R&D efforts on the completion of its current roster of product candidates

Counterfeiters can get life in jail under new US Act

US President George W Bush has signed a bill under which counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual.

House probes FDA over Actavis recalls

A new avenue of inquiry has been opened in the investigation into the US Food and Drug Administration’s (FDA) ability and commitment to protect the nation’s citizens from unsafe drugs.

Exclusive interview

Artel's QA/QC services driving expansion

With big pharma and biopharma looking to cut costs and increase efficiency, liquid handling experts Artel have found that their services are in greater need than ever before.

Ferro sells fine chemicals arm to private equity

US company Ferro has said it will sell off its fine chemicals division to private equity firm Arsenal Capital Partners, which will rename the business as Novolyte Technologies, for $66m.

Drug delivery round-up: News in brief

in-PharmaTechnologist.com presents its latest round up of developments in drug delivery, including Philips first foray into drug delivery and a licensing deal for 3M.

Applied Biosystems' rapid Mycoplasma detection kit

The MicroSEQ detection platform, developed by Applied Biosystems, looks set to revolutionise the detection of bacterial Mycoplasma in industrial scale biopharmaceutical manufacturing.

FDA issues guidance in CGT potency tests

Draft guidance for testing the potency of cellular and gene therapy products (CGTs) has been issued by the US Food and Drug Administration (FDA).

Another delay knocks back ePedigree until 2015

The implementation of California’s ePedigree system has been knocked back yet again, with 1 January 2015 now the proposed date.

Cody unveils homogenous method for morphine derivatives

API maker Cody Laboratories is targeting the lucrative analgesic and pain management markets with a new process that improves the efficiency of hydromorphone and hydrocodone manufacture.

US proposes country-of-origin labelling

A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.

News in brief

Moorfields invests in ampoule technology

Moorfields Pharmaceuticals, a contract manufacturer based at the Moorfields Eye Hospital in London, UK, has boosted its ability to provide materials for Phase I clinical trials by installing a Rommelag 3012M for ampoule filling.

News in brief

Smoother coatings from ISP

International Specialty Products has extended its portfolio of polymer coatings with the launch of a new range – Advantia Preferred HS – intended as immediate-release films for oral solid dosage forms.

Dow struggling to restore PEG capacity after hurricanes

Dow Chemical is hoping to push production of its Carbowax Sentry brand of polyethylene glycol ingredients up by a third over 2006/2007 levels by the end of the year, and put the production problems of recent months behind it.

Certification at top of agenda for IPEC Europe

The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.

Arkema launches new PVDF grade Kynar Rx

Industrial polymer firm Arkema hopes that Kynar Rx, a new grade of its widely used Kynar resin technology, will help it corner the market for single-use sterile manufacturing applications in the bioprocessing sector.

GE unveils new AxiChrom columns

GE Healthcare’s range of AxiChrom columns will simplify manufacturing operations, improve reproducibility and allow for faster change over according to company senior product manager, Per Karlberg.

Lead-free catalyst opens up new reaction to pharma

BASF introduced new catalysts designed to replace environmentally-unfriendly alternatives based on lead at the CPhI show in Frankfurt last week.

BioVigilant files rapid detection tech DMFs with FDA

BioVigilant says that two type V DMFs for its IMD-A rapid microbial detection system, which it has filed with the US FDA, can now be referenced by clients hoping to use it in drug manufacture, potentially reducing review times.

Lilly’s KwikPen developed using “human centric” design

The UK launch of Eli Lilly’s pre-filled insulin device Humalog KwikPen offers the country’s 800,000 insulin-dependant diabetics a simplified treatment option, according to company development director Stuart Breslin.

Economic turmoil hits Chesapeake

Packaging firm Chesapeake has become a visible casualty of the current economic climate, with the New York Stock Exchange (NYSE) suspending trading of its shares.

Lilly to acquire ImClone for $6.5bn

Eli Lilly has agreed to acquire ImClone for $6.5bn and in doing so appears to have snatched the biotech away from Bristol-Myers Squibb (BMS), which first tabled a bid back in July.

Drug delivery: News in brief

in-PharmaTechnologist.com’s latest round up of developments in drug delivery includes Critical Pharmaceuticals’ sustained release hGH, Phase III results for AP Pharma and nanodiamonds.

Alcan's buys new Indian plant

Alcan says that its new Indian facility further strengthens its position “in pharmaceutical flexibles through growth in emerging markets,” which contributed about 20 per cent of its revenue last year.

Khandelwal stabilise nanoparticle formulation

Khandelwal Laboratories use of silver nanotechnology as an antimicrobial was nominated for this years innovation awards at CPhI.

Marchesini to open doors at new Siena plant

Ahead of the “open house” at its facility in Monteriggioni, Siena, Italian machining specialist Marchesini spoke with in-PharmaTechnologist.com about the new plant and its role in the firm's offering to the drug industry.

PharmAthene battles for anthrax vaccine bucks

PharmAthene has stated its desire to compete for a government anthrax vaccine manufacturing contract, which could be worth up to $600m.

Sanal salt granted GMP certification

AkzoNobel has been awarded a good manufacturing practice (GMP) certificate for Sanal (sodium chloride) salt manufactured at its plant in Mariager, Denmark.

Pharma manufacturing products: News in brief

in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Malvern, Caen, Finesse and Bausch.

Directors prosecuted under Chemical Weapons Act

Two chemical company directors have been sentenced for not notifying authorities that their company produced a substance controlled under the Chemical Weapons Convention (CWC).

Pfizer narrows research focus again

Pfizer is shifting its research focus to those diseases where its sees the potential for the biggest treatment improvements and profits, while dropping eight disease areas including cholesterol.

Pharma manufacturing: People on the move

in-PharmaTechnologist.com presents its latest round-up of personnel changes in the pharmaceutical manufacturing sector.

Novozymes' HyaCare takes top innovation award

Novozymes Biopolymer’s novel hyaluronic acid (HA) HyaCare has been named winner of this year’s gold innovation award at the CPhI worldwide conference in Frankfurt, Germany.

New software to ease regulatory document burden

Good Products and Adlib Software have teamed up to create a streamlined and compliant regulatory document management system for the pharmaceutical industry.

FEI to light-up Sun Pharma’s research

India’s Sun Pharmaceutical has installed a 3D imaging system from FEI Company to speed up the development of new therapeutics and aid its quality control processes.

Novasep expands chiral chromatography offering

French firm Novasep has significantly boosted its ability to provide customers with enantiomerically pure compounds with the addition of a new chiral chromatography unit.