Breaking News on Pharmaceutical Technology

DSM invests in microchip compliance packaging

DSM has invested in The Compliers Group (TCG), a company developing pharmaceutical packaging containing microchips to monitor a patient's compliance.

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 Premier Pneumatics, GE Healthcare and WaterSep.

Marketing deal for Prosonix’s SonoLab

Syrris has become the primary marketer for Prosonix’s new SonoLab laboratory scale sonocrystallisation and sonoprocessing equipment.

Sagent acquires rights to multi-chamber syringe

Sagent Pharmaceuticals has acquired the rights to a patented, multi-chamber, sequential dose syringe from Infusive Technologies.

PEPFAR drops Ranbaxy from recommended list

Ranbaxy’s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFAR’s list of approved products until ongoing GMP problems at two of the firm’s Indian manufacturing plants are resolved.

Handheld device for validating raw materials

Ahura Scientific has launched an updated version of its TruScan handheld instrument, which allows for raw materials to be quickly verified.

Alpharma licenses transdermal delivery patch

Alpharma has licensed an investigational transdermal bupivacaine patch from Durect for an initial $20m, with further payments based on reaching developmental milestones.

Dragon files new drug packaging film with SFDA

Chinese packaging specialist Dragon International is seeking SFDA marketing approval for a new composite film product for the suppository drug market.

Teva Kowa JV to target Japanese generics market

Teva and Kowa have set their sights on Japan’s $4.6bn (€3.1bn) generics market with their development and manufacturing joint venture Teva-Kowa Pharma.

EU cash for plant cell biosynthesis

The production of pharmaceutical products in plant cells has been given a boost, after the European Union ploughed $8.8m into a research programme.

Health Canada adds to Ranbaxy’s woes

A domino effect appears to have been started by the FDA blocking Ranbaxy imports, with other regulatory bodies paying close attention to the generics giant.

Pfizer’s API unit to use Prosonix' Prosonitron

Prosonix, a specialist developer of ultrasonic industrial processing solutions, says that global drug giant Pfizer is to begin using its Prosonitron reactor and sonocrystallisation technology at its manufacturing facility in Ireland.

Manufacturing facility news in brief

in-PharmaTechnologist.com’s periodic round-up of developments in the pharmaceutical manufacturing space includes news on MannKind, Nycomed, ABS and Tris.

Pharma manufacturing: People on the move

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

FDA guidance on GE animal drug production

The US Food and Drug Administration (FDA) has issued draft guidance for the use of genetically engineered (GE) animals to produce drugs.

Zentiva board accepts Sanofi’s revised €1.8bn offer

Sanofi-Aventis’ €1.8bn ($2.6bn) offer for Czech generics firm Zentiva has been unanimously accepted by the latter firm’s board after four months of wrangling that has seen the bid increase by 9.5 per cent.

Sandoz’ SA plant gets WHO NoC letter

The WHO has issued Sandoz with a Notice of Concern (NoC) after an inspection of the firm’s Kempton Park facility in South Africa identified 41 deviations from GMP standards.

EnWave’s new dehydration method shows promise

EnWave says that its freezeREV dehydration technology can reduce the moisture content of single vial vaccines to between 3 and 3.5 per cent, bettering the mark achieved by its bioREV platform.

Reaxa and RohnerChem partner on EnCat scale-up

UK-based Reaxa and Switzerland’s RohnerChem have teamed up to develop the former’s EnCat catalyst technology for industrial applications in the API and drug manufacturing sector.

Skills shortage predicted in Massachusetts

Massachusetts needs to do more to produce workers for its life sciences industry if it is to avoid a skills shortage in years to come, according to research.

DSM and LibraGen enter transaminase deal

Dutch chemicals giant DSM and France’s LibraGen are targeting the chemical and pharmaceutical industries with their new chiral amine production accord, which aims to develop a range of new catalytic enzymes.

Joint API inspection service to cut costs

Germany-based Diapharm has launched a service allowing pharmaceutical manufacturers to perform joint third-party audits of active pharmaceutical ingredients (APIs).

Aseptic outsources “revolutionary” vial filler

CMO NextPharma has signed a deal to make Aseptic Technologies “revolutionary” ‘closed-vial’ filling system available as part of its offering to clients.

Exclusive interview with IPEC China chairman Nevin Cheng

IPEC China’s chairman sets out next steps

IPEC China must become a “harmonisation bridge between China and other countries,” according to Colorcon’s Nevin Cheng who was recently elected chairman of the new organisation.

Neose sells PEG tech for $43m

BioGeneriX and Novo Nordisk have signed deals to acquire most of Neose Technologies’ intellectual property for a combined total of $43m.

Capsugel targets toxics sector with vibration-free hood

Oral dose filling specialist Capsugel hopes that its new Xcelohood containment system will improve industrial weighing operations during the preparation of high-potency drugs.

DSM and Caliber team up to develop drug delivery balloon

DSM Biomedical and Caliber Therapeutics aim to expand their presence in the balloon catheter market with a project to develop new drug delivery devices for vascular diseases, including atherosclerosis.

Formatech’s solution for improved solubility

Formatech hopes its new formulation method, which solubilises compounds in micelles consisting of fatty acids or alcohols, will improve both the safety and bioavailability of pharmaceutical products.

hGH to drive novel drug delivery market

A surge in research into novel drug delivery systems will occur as companies seek to differentiate their products in response to pressure from biosimilars, according to a publication from Frost & Sullivan.

FDA blocks imports from two Ranbaxy plants

The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing “extensive deviations from US cGMP requirements” at the firm’s manufacturing plants in Dewas and Paonta Sahib, India.

Small step for MannKind resurrects inhaled insulin

MannKind’s inhaled insulin treatment, Technosphere, has met its study goal in the first of three Phase III trials, leading to Pfizer transferring its remaining Exubera patients to the treatment.

FDA fast-tracks ocular drug delivery tech

The US Food and Drug Administration (FDA) has granted fast track designation to Neurotech’s treatment for two ocular diseases.

Manufacturing facilities: News in brief

in-PharmaTechnologist.com's latest round-up of developments in pharmaceutical manufacturing features news of the world’s “biggest pharmaceutical allergen production unit”, Lentigen’s relocation and a cytotoxic robot.

Artelis and Selexis’ project achieves record MAb yield

Artelis president Jose Castilo believes that the record MAb yield from CHO cells grown in its iCELLis bioreactor shows the platform could shift the paradigm for the "production of recombinant proteins.”

Millipore plans to close four facilities

Millipore is planning on closing four facilities, generating annual savings of up to $15m, as it attempts to cut costs by streamlining its operations.

Nanoparticle made for delivering combination therapies

A nanoparticle capable of carrying a soluble and insoluble drug has been created for the delivery of combination therapies, according to research published in Nature.

New EC GMP regulations for radiopharma

Revised good manufacturing practice (GMP) requirements for the production of radiopharmaceuticals have been published by the European Commission (EC).

Alcan Packaging may break-up after year on the shelf

Speculation is rife that Australia’s Amcor is one of several companies to have tabled bids for Rio Tinto’s $4.4bn (€3.1bn) Alcan Packaging division that serves the pharmaceutical, food and tobacco industries.

Fresenius’ APP expands Grand Island capacity

APP Pharmaceuticals has bought additional facilities at a site in Grand Island, New York seizing the opportunity created by Astellas Manufacturing’s decision to shift production of its dermatitis drug Protopic to Japan.

MonoSol film technology gets US protection

US drug delivery specialist MonoSol Rx says it has received USPTO patent rights to processes used in the manufacture of PharmFilm, its proprietary thin film drug delivery technology.

Residual solvents guidelines cause ANDA “uncertainty”

Companies have failed to provide the information needed under the USP’s new chapter regarding residual solvents, causing them to incorrectly file ANDAs, according to the Office of Generic Drugs (OGD).

Le Fur flies as GSK exec made Sanofi CEO

GlaxoSmithKline’s head of North American operations, Chris Viehbacher, is to takeover as chief operating officer (CEO) at Sanofi-Aventis after he missed out on the top spot at GSK last year.

CFC-free compliance a "blessing in disguise"

As the December 31 deadline for the removal of CFC albuterol inhalers in the US approaches, a new report by Kalorama Information forecasts big changes in the global $36bn (€26bn) a year respiratory products market.

CSL begins this year’s Alfuria shipments

CSL Biotherapies, part of Australia’s CSL group, has begun shipping the first of six million doses of its thimerosal-free vaccine Afluria to the US CDC ahead of this year’s flu season.

Merger beefs up German CMO Haupt Pharma

Haupt Pharma has completed its merger with fellow German companies Amareg and Wülfing Pharma to create a major new force in the European contract development and manufacturing sector, with around 1,500 staff and an annual turnover of €180m.

Gene delivery helped by deadly worm

Gene therapy could be advanced by a worm more commonly associated with causing a deadly parasitic disease, according to researchers presenting at the British Pharmaceutical Conference (BPC).

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 Genevac, Lock and AdvantaPure.

Sandoz boosts Canadian production capacity

Sandoz Canada, a unit of Novartis’ generics arm, has opened a second manufacturing plant at its site in Boucherville, Quebec, boosting local production capacity 66 per cent.

US OK for Akorn’s first lyophilised product

The FDA has granted sNDA approval for Akorn’s IC-Green injection dye, which is the first lyophilised product manufacturered at the firm’s Decatur facility to gain such status.

Abraxis and ProMetic target US biopharma market

Abraxis has licensed rights to use ProMetic’s protein technology in the development of four new biopharmaceuticals that it hopes will generate around $600m (€422.5m) in US sales.

FDA lists drugs with potential safety issues

A list of drugs currently being evaluated for potential safety issues by the US Food and Drug Administration (FDA) has been posted on its website.

FDA publishes final rule on cGMP amendments

The US Food and Drug Administration (FDA) has published its latest amendments to current good manufacturing practice (cGMP) regulations.

Alembic seeks to mix it with US and European players

Indian pharmaceutical firm Alembic is seeking to expand its presence in the lucrative US and European drug markets through an expanded partnering programme.

Drugmakers within EC's REACH, says SAFC

Despite a decade-long build up, drugmakers are yet to wake up to the “no data, no market” mantra of the EC’s REACH legislation, according to SAFC’s marketing director Amanda Halford.

“Volatile” Asian markets drive Aceto’s Q4 growth

US fine and industrial chemicals specialist Aceto says that its expansion on the global stage, particularly in Europe and Asia, is starting to pay financial dividends.

Pharma manufacturing: People on the move

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

Loramyc’s excipient shows BioAlliance the whey

Drug delivery specialist BioAlliance Pharma says that its decision to focus on the oncology and infectious disease markets helped it reduce its half-year 2008 losses.

SAFC Pharma to get even bigger in high-potency APIs

US fine chemical company Sigma-Aldrich said this morning that subsidiary SAFC Pharma has kicked off a $30m expansion plan for its active high-potency pharmaceutical ingredient (API) manufacturing facility in Madison, Wisconsin.

Cost of drug licensing on the wane, says Lehman Bros

Growth in licensing deals between large drugmakers companies and their smaller, research-based counterparts continued apace in 2007, but the average total value of each deal has started to fall.

Antibiotic alternative could make protein production cheaper

UK and Swedish researchers have developed a system that eliminates the need for antibiotics and resistance genes in the engineering of biopharmaceutical products, making the process both safer and less costly.

Pharma manufacturing news in brief

in-PharmaTechnologist.com's periodic round-up of developments and deals in the pharmaceutical manufacturing space, includes news on 3M and Ligacon, Dishman, Stiefel and Barrier and Forbes.

Bioxel signs up new generic docetaxel customers

Canada’s Bioxel Pharma believes that the six new generic docetaxel supply deals it has signed, represents a real leap forward in its business plan

Shionogi seeks US sales boost with $1.4bn Sciele bid

Japan’s Shionogi is paying $1.4bn (€959m) for US drugmaker Sciele Pharma as part of a plan to strengthen its sales position in the country’s $286bn a year drug market.

Chromatide signs HPLC deal

UK-based polymer technology specialist Chromatide and Akzo Nobel's Separation Products (SP) unit are teaming to develop a HPLC media for purification applications in the drug manufacturing industry.

bioMerieux launches new clean room testing range

bioMerieux hopes that its new specially-packaged growth media products will help it “clean up” in the pharmaceutical industry’s lucrative sterility testing market

Marksans sets sights on EU generics sector

Contract services firm Marksans Pharmaceutical says that the RPS 1bn (€15.4m) acquisition of UK generics group Relonchem will expand its distribution network and build its presence in the European market.

UCB refocuses and cuts workforce 17%

UCB is moving forward with efforts to focus on CNS disorders and immunology and plans to cut around 2,000 jobs as part of its SHAPE restructuring program.