Breaking News on Pharmaceutical Technology

GSK jumps on the 'reverse genetics' bandwagon

GlaxoSmithKline (GSK) has licensed MedImmune's 'reverse genetics' technology for use in its non-live human influenza vaccines production programme.

Inside India: special series

Pall nurturing its Indian presence

Pall Life Sciences gave Outsourcing-Pharma.com an update on its budding operations in India, one of the most promising markets for the firm, where the pharmaceutical industry is growing at a rate of nearly 9 per cent annually.

Pfizer looks to new delivery systems to boost Exubera

Pfizer has started development on two next generation inhalers with the aim of replacing the underperforming Exubera inhaled insulin device.

Nobilon nabs adjuvant for new flu jabs

Organon subsidiary Nobilon has got its hands on a promising new adjuvant that it plans to use to enhance it pandemic and seasonal flu vaccines.

SAFC in latest biomanufacturing capacity expansion

Contract manufacturer SAFC is investing $29m (€21m) to expand its Jerusalem, Israel manufacturing capacity for high-potency biologics.

Novo Nordisk relocates data management from Singapore to India

Novo Nordisk is in the process of relocating its clinical data management centre to India after closing down the operation in Singapore, where it had been previously run for many years.

New asthma treatment gets US go-ahead

An extended release formulation of an asthma treatment recently recommended by the National Asthma Education and Prevention Program has been launched on the US market.

Gerresheimer gets pat on the back for packaging concept

German packaging company Gerresheimer has received recognition for its packaging expertise again after winning the German Packaging Award the second year in a row.

Eli Lilly settles 4-year lawsuit with Emisphere

Eli Lilly has agreed to fork out $18m (€12.8m) to settle an ongoing lawsuit with one of its former biotech research partners and in doing so has avoided a court battle earmarked for next year.

Merck failure not our fault, says Crucell

Dutch firm Crucell is hastily trying to reassure investors that its popular cell line technology, PER.C6, was not to blame for the failure of Merck's hotly touted HIV vaccine last week.

Pharmaceutical manufacturing: people on the move

Stiefel Laboratories, BASF, Uluru, BiPar Sciences and NanoBio have all had people on the move in the world of pharmaceutical manufacturing.

Two pharma get US anthrax biodefense contracts

Emergent BioSolutions and Elusys Therapeutics have been granted US contracts each for the development of anthrax therapeutics.

Protherics catches Korean partner for new drug delivery tech

UK firm Protherics has inked a deal with a Korean partner allowing the company to make use of its temperature sensitive sustained release drug delivery system.

Allergies not a patch on DBV

DBV Technologies is advancing into the realm of allergy treatment and vaccine delivery using its Viaskin technology, which has already proved successful as an allergy diagnostic.

Gardasil beware, Cervarix hot on your heels

GlaxoSmithKline (GSK) has been granted EU approval of its adjuvanted cervical cancer vaccine Cervarix, and is confident that the jab can challenge the likes of Merck's high-profile Gardasil.

Up to 25,000 patients affected by Viracept contaminant, reapproval on the cards

European regulators have recommended that Roche's marketing authorisation for HIV drug Viracept (nelfinavir) be reinstated, following serious good manufacturing practice (GMP) deviations that caused toxic contamination of drug batches distributed to up to 25,000 patients.

Inside India: special series

Indian manufacturers need to lose generic mindset

Indian drug manufacturers need to rid themselves of their generic mindset in order to evolve and remain competitive for the future.

Wyatt lights up protein aggregation

Wyatt Technologies has launched a new instrument that automates protein aggregation measurement for use in all areas of the pharmaceutical industry from drug development to quality control (QC).

Biogen bags two discovery partnerships

Biogen Idec has bagged two new partnerships in the past week which will see it involved in the search for new drugs for central nervous system (CNS) and inflammatory ailments.

Epinephrine CFC inhalers on the way out

The US Food and Drug Administration (FDA) has proposed plans to phase out chlorofluorocarbons (CFCs) in metered dose inhalers that contain epinephrine, but the decision could spell the end for some asthma treatments.

Weekly Comment

Viracept contaminant could be widespread, FDA says

Following the recent news that pharma heavyweight Pfizer has also been struck by contamination of its HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com spoke to the US Food and Drug Administration (FDA) to find out how far reaching the consequences of this latest contamination case could be.

Novartis piling up approvals

Novartis has announced its latest batch of thumbs up from EU regulators, potentially adding a few more products to its 'approved' list for this year.

Bespak for sale?

UK-based Bespak, one of the two contract manufacturers of Pfizer's inhaled insulin Exubera, confirmed on Friday it has been approached by a potential buyer.

Inside India: special series

Innovation 'key' to India's pharma future

The key to the future of India's pharmaceutical industry will depend on its ability to scale back its over-reliance on low-cost manufacturing and to foster innovation, with drug discovery and biosimilars presenting particular opportunities.

DSM takes on purification tech

Netherlands-based DSM has invested an undisclosed sum in Danish purification technology company Upfront Chromatography to boost its protein separation business.

SolVin to increase PVDC production

SolVin is to expand its polyvinylidene chloride (PVDC) latex manufacturing site in Tavaux, France, in a bid to meet growing demand for the packaging material.

Chairman to step down as Whatman's profits plunge

UK-based separations expert Whatman has seen operating profits for the first six months of 2007 plummet nearly 30 per cent on the back of a 'weak order book' and an inability to fulfil orders.

3D scaffold elevates drug screening results

UK researchers have developed a plastic cell scaffold that enables cells to be grown in realistic 3D structures and promises to enable better cell based drug screening results.

China in latest drug safety offensive

Chinese drug manufacturers could be given a 24-hour deadline by regulators to pull unsafe pharmaceuticals off the market or face a fine, a Chinese newspaper reported.

SkyePharma posts six-month results

SkyePharma is looking towards a positive future despite a pre-tax operating loss of £14.1m (€20.3m), announced in the UK company's unaudited six-month results.

Catalent reshuffles business, reports operating loss

Catalent Pharma Solutions, the firm born from the spin out of Cardinal Health's contract manufacturing business, is reorganising its production facilities with an expansion of its UK site and the divestiture of some of its French operations.

Kiddy Tamiflu for the EU

Roche has just had the child-size, lower strength version of its blockbuster flu treatment Tamiflu (oseltamivir) approved by EU authorities, though possibly just a little too late for this year's flu season.

Lonza adds new expression media to portfolio

Swiss supplier and services provider Lonza has added another product to its catalogue of cell culture media, the most recent addition to the offering of its new bioscience unit.

ARx opens new facility

Pennsylvania-based ARx has officially opened a new pharmaceutical manufacturing facility as it races to meet demand for its drug delivery components and keep up with the times.

Pharma manufacturing products: news in brief

System Planning Corporation, Precision Stability Storage, ISPE, Ossid and NJM/CLI have all recently launched products used in the pharmaceutical manufacturing industry.

Pharmaceutical manufacturing: people on the move

Cadence Pharmaceuticals, Mylan Laboratories, Cardiokine, The NeoStrata Company and Anika Therapeutics have all had people on the move in the world of pharmaceutical manufacturing.

Parexel beefs up European GMP expert team

Parexel Consulting is strengthening its good manufacturing practice (GMP) expert team in Europe to help its clients cope with complex EU regulations.

ProMetic purification tech gets selected

ProMetic's purification technology has been implemented in a large-scale biomanufacturing process with an undisclosed client for a product that will be used in clinical trials.

Groupe Novasep bound for the Bahamas

French processing and synthesis specialist Groupe Novasep is heading to the sun with the acquisition of Bahamas-based ingredients and intermediates firm PharmaChem Technologies.

Belgian jobs fall to J&J axe

Almost 700 jobs are to be lost at Belgian firm Janssen Pharmaceutica, as the Johnson and Johnson subsidiary falls victim to a restructuring drive at its parent company.

Lipidic tech for cough products

Two US pharmaceutical companies have joined forces to develop new prescription adult cough products using an oral drug delivery technology.

Massive counterfeit drug ring cracked

The biggest counterfeit drugs conspiracy ever to be encountered in the UK was crushed this week, as gang members were found guilty of conspiracy by a UK court following a lengthy investigation by the authorities.

Sanofi plans to shake up 'stagnant' industry

Sanofi-Aventis hopes it can buck a pharma industry trend of declining numbers of new drugs with potentially 31 new drug submissions over the next 3 years.

Genentech's Avastin to be reviewed for breast cancer

Genentech announced last week that a US regulatory advisory panel will soon review its blockbuster Avastin (bevacizumab) for use in breast cancer patients.

ZaCh Systems acquires fine chemicals unit

ZaCh Systems has acquired PPG Industries' fine chemicals business for approximately $65m (€46.9m), which includes a pharmaceutical fine chemicals facility in Texas.

Biologic coatings go supercritical

UK researchers are developing 'green' methods of coating delicate biopharmaceutical drugs that reduce the risk of damaging the drugs while replacing the harsh solvents normally used in the process.

Low dose bird flu shot promises pandemic protection

A new H5N1 pandemic flu vaccine developed by Sanofi Pasteur could make all the difference in pandemic stockpiling, the new super low dose shot stimulating high immune response in trial subjects.

Newspaper report on full outsourcing strategy incorrect, says AZ

AstraZeneca said that fully outsourcing supply and manufacturing activities is not part of its strategy, in contrast to what a UK media report implied yesterday.

FDA gives guidance on biologics-producing spore-forming microbes

The US Food and Drug Administration (FDA) has released new recommendations for manufacturers of biologics using spore-forming microorganisms.

Sontra and Echo hook up for transdermal techs

Sontra Medical has announced its intention to merge with Echo Therapeutics in a bid to create a company with a powerful transdermal drug delivery offering, and steadying Sontra's rickety financial position.

Sontra and Echo hook up for transdermal techs

Sontra Medical has announced its intention to merge with Echo Therapeutics in a bid to create a company with a powerful transdermal drug delivery offering, and steadying Sontra's rickety financial position.

Soma 250mg dose gets approval

Swedish speciality pharma company Meda AB has announced its new low dose of Soma (carisoprodol) has been approved by the US Food and Drugs Administration (FDA).

All change at BioProgress

UK tabletting specialist BioProgress made a series of announcements last week, not only landing itself a commercial partner and patent protection for its novel tablet coating technology, but also rebranding itself under a new name, Meldex International.

Bayer, Novartis settle Betaseron battle

Novartis and Bayer Schering Pharma have finally settled their disputes over multiple sclerosis (MS) drug Betaseron (interferon beta-1b), with an agreement outlined in March now complete.

SAFC expands EU capacity, eyes more acquisitions

SAFC is investing $10m (€7.2m) to increase manufacturing capacity at its Ireland facility and to expand its Swiss plant, as well as eyeing two acquisitions in Europe, the company said last week.

Wyeth backs Flamel drug delivery tech

Wyeth has signed a license agreement with French firm Flamel Technologies to apply the company's second innovative drug delivery technology to one of its protein therapeutics.

New funding drive for 'Eurostars'

The European Commission has named research-performing small and medium-sized enterprises (SMEs) as 'the entrepreneurial stars of Europe', and hopes to raise €800m of extra funds for them.

bioMerieux buys standards innovator BTF

Industrial microbiology expert bioMerieux has acquired Australian firm BTF, strengthening its quality control (QC) and manufacturing quality assurance (QA) offerings to the pharmaceutical industry.

Vivalis' EBx cell lines show more promise for MAbs

Vivalis is set to stamp out the Chinese Hamster Ovary (CHO) cell line competition as the French company announces initial results in a second study on monoclonal antibody production using its avian-derived cell line.

Amgen and Ortho Biotech breathe collective sigh of relief after FDA panel vote

Amgen and Ortho Biotech are breathing a sigh of relief after a regulatory committee recommended not to change the label on their blockbuster anaemia drugs when used in the kidney failure setting.

SAFC makes first foray into China

SAFC is making its first foray into the Chinese market with the building of a new manufacturing facility in Shanghai, the firm announced during a press conference yesterday.

Aspartame safe, study says

A new report looking at the safety of aspartame has concluded there is "no credible evidence" the sweetener is unsafe.

Pharma manufacturing products: news in brief

JDSU, Applied Biosystems, Hitachi High Technologies America, Infor and Brenton Engineering have all recently launched products used in the pharmaceutical manufacturing industry.

GSK tops up US flu vaccine supplies

More flu shots are on their way over to the US, with GlaxoSmithKline (GSK) today announcing that its contribution to the flu vaccine stash has started making its trip over from Europe.

Another plant bites the dust

Yet another production site has fallen to the unrelenting axe of big pharma's consolidation drive as Pfizer announces that its only UK manufacturing plant is to be closed down.

Pharmaceutical manufacturing: people on the move

Crucell, Endo Pharmaceuticals, Wyeth Pharmaceuticals and SupplyScape have all had people on the move in the world of pharmaceutical manufacturing.

Micro-needles show they could be the better option

A team of UK researchers have established micro-needles are a safer and less painful method for injections than the traditional hypodermic syringe.

Biogen dips toe in Indian waters

US-based biotech firm Biogen Idec has decided to enter the booming Indian market and establish its presence in the country.

Contract manufacturing news in brief

Hyaluron Contract Manufacturing, Tepnel and Eden Biodesign have all recently announced new contract manufacturing news.

Cellectricon delivers genome-wide RNAi screening system

Swedish cell-based screening expert Cellectricon has placed the world's first high throughput (HT) genome-wide RNAi screening system at a beta-test site for evaluation.

ABN and VGX score biodefense contracts

Two US-based pharma companies have been granted biodefense contracts from the US Government for $3.6m between them.

Innocoll and TGR collaborate to develop wound healer

Innocoll Technologies has announced collaboration with Australian-based TGR BioSciences to combine Innocoll's drug delivery technology with TGR's bioactive wound healing protein.

Crospon to make drug delivery smarter

Irish start-up Crospon has licensed a 'smart' drug delivery skin patch technology from HP Labs that uses inkjet printing technology to deliver drugs under the skin.

Biotest scoops up ailing Nabi's biologics unit

German firm Biotest has bought up Nabi Biopharmaceuticals biologics division in a multi-million Euro deal, less than three months after the unit was created following Nabi restructuring efforts.

Evotec hives off chemical development biz

German firm Evotec has sold off its chemical and pharmaceutical development (CPD) business along with the associated facilities in the UK.

FDA probe ghost stops haunting MDS Pharma

It seems that the ghost of the US Food and Drug Administration (FDA) probe has stopped haunting MDS Pharma as the firm posted encouraging financial results in the third quarter.

SkyePharma's Flutiform progresses through red tape

SkyePharma is moving forward with its asthma treatment Flutiform following talks with the US Food and Drug Administration (FDA) on an agreed approach for additional clinical data that had been requested.

Serious adverse drug events on the increase

The safety of America's drugs are being called into question following a damning report that claims serious adverse drug events have more than doubled in an eight year period.

BDSI takes on full ownership of BEMA drug delivery tech

BioDelivery Sciences International (BDSI) has acquired the US rights to the BEMA oral adhesive disc drug delivery technology for $3m, with a further $4m to be paid at a later date.

Pfizer blighted by Viracept scare

It appears that pharma heavyweight Pfizer has not emerged unscathed from the contamination chaos that has affected EU supplies of HIV drug Viracept (nelfinavir), with the company this week warning that its version of the treatment is also tainted with the same toxic compound.

Colorcon takes on Chr. Hansen's excipient and coating division

Denmark-based Chr. Hansen has sold its excipients and coating division to US company Colorcon for an undisclosed sum to concentrate on its food business.

FluMist finally on track

Manufacturing problems hindering production of MedImmune's intranasal flu vaccine FluMist have finally been resolved at the company's Liverpool, UK facility, with doses on track to be available for this year's flu season.

Merck, Crucell strengthen vaccine partnership

Dutch firm Crucell has strengthened its relationship with Merck & Co, granting the pharma heavyweight exclusive use of its popular PER.C6 technology in two disease areas.

Patheon continues to show the strain of Puerto Rico

Patheon's third quarter results continue to show the strain of the company's underperforming Puerto Rican operation.

Aurobindo gets API facility approval

Indian company Aurobindo Pharma has received UK approval on its active pharmaceutical ingredient (API) facility in Kazipally.

Hep C hope hovers on the horizon

Hope may be on the horizon in the quest for a preventative hepatitis C virus (HCV) vaccine after scientists said they have been able to identify and characterise the antibody responses to the virus.

J&J contract fuels Draxis growth

Johnson & Johnson (J&J) has awarded Canadian contract manufacturer Draxis a new supply contract large enough to warrant the construction of a new facility and an expansion of its workforce by one fifth.

Biomira, Antisoma in lung cancer drug race

Biomira and Antisoma have both released clinical data showing their respective drugs, a vaccine vs. a standard molecule, improve anticancer responses and survival for patients with non-small cell lung cancer (NSCLC).

China persists with pharma reforms

China has confirmed the target areas of planned sweeping pharmaceutical industry reforms and also handed down the latest in a string of sentences to corrupt former drug officials.

Anasys enables point and click local thermal analysis

Anasys Instruments has launched the world's first easy-to-use local thermal analyser which promises to help pharmaceutical companies' quality control (QC) of drug coatings and formulations.

LFB to take over MAbgene

French pharmaceutical firm LFB has announced its plans to incrementally acquire fellow biotech company MAbgene through the development of a new entity for a total of €6m.

Pharma manufacturing products: news in brief

Mixquip, Microfluidics, Freeman Technology, Syrris, and UT-Hart Scientific have all recently launched products used in the pharmaceutical manufacturing industry.

PURE gets cGMP manufacturing approval

PURE Bioscience has received the two thumbs up for its manufacturing facility of a new molecular entity which is being explored as an antibacterial, antiviral and antifungal pharmaceutical.

Stada acquires Forum Bioscience Group

German pharmaceutical company Stada Arzneimittel has acquired British pharmaceutical Group Forum Bioscience Holdings for €55.6m.

Medarex, Centocor extend antibody deal

US biotech Medarex has announced it has extended its licensing deal with Centocor, giving the firm continued access to its antibody production technology.

Pharmaceutical manufacturing: people on the move

Novo Nordisk, Ensemble Discovery, Nitec Pharma and Benda Pharmaceutical have all had people on the move in the world of Pharmaceutical manufacturing.

Eden's bio garden grows

Britain's Eden Biodesign has been selected by Cancer Research UK as the beneficiary of two new biomanufacturing contracts as its biomanufacturing business continues to grow.

ADHD transdermal patches withdrawn

Shire and Noven Pharmaceuticals have announced the voluntary withdrawal of a limited amount of Attention Deficit Hyperactivity Disorder (ADHD) transdermal patches following reports of a mechanical problem when applying the patch.

Biopharma sector: people on the move

Novo Nordisk, Rheosciences, ImClone, Omrix Biopharmaceuticals, Biogen Idec and Human Genome Sciences, have all had people on the move in the biotech world.

CytoGenix expands DNA manufacturing

US biopharmaceutical company CytoGenix has announced breaking ground on a new $3.8m facility to expand the company's manufacturing capability of synthetic DNA.

Acambis gets smallpox vaccine approval

Acambis has had its smallpox vaccine approved by the US, coming one step closer to closing another supply contract for the US Strategic National Stockpile.

Abbott and AstraZeneca combine cholesterol drugs

Abbott and AstraZeneca are the latest pharmaceutical companies to take on the $21.6bn (€15.8bn) cholesterol market with a combination drug.

J&J 'concerned' as Sandoz gets biosimilar EU approval

J&J has expressed its concern over patient safety as Novartis' subsidiary Sandoz has received the green light from the European Commission to launch the first epoetin alfa biosimilar on the EU market.

South African Enaleni to reopen plant

The end of the tunnel seems to be getting closer for South African manufacturer Enaleni as the firm confirmed it will resume production in its recently closed Durban facility in the next ten days.

Dow extracts the stress from bioprocessing

US researchers have shown certain organic solvents can be used to selectively extract therapeutic proteins from host bacteria, avoiding the need for cell lysis and increasing product purity by a factor of five.

Granulation tech foaming good

Bristol-Myers Squibb (BMS) has signed a license contract to use Dow Wolff Cellulosics' Foam Granulation Technology (FGT) to manufacture tablets.

Six-month prostate cancer drug soon to be launched

A six-month formulation of a prostate cancer drug will soon be launched in 23 European countries following its successful approval procedure.

Boehringer Ingelheim recalls clobutinol products

Boehringer Ingelheim is voluntarily recalling all worldwide products containing clobutinol hydrochloride, which has been on the market for 46 years, following a report questioning the drug's safety.

Pseudoephedrine drugs still OTC

Reformulations of pseudoephedrine- and ephedrine-containing drugs in the UK look unlikely following the announcement of less extreme restrictions on the sale of the pharmaceuticals.