All news articles for February 2013

Always Money for Good Ideas says Drug Delivery Pioneer

28-Feb-2013 - Good ideas in drug delivery will continue to attract investment though the increasing cost of clinical trials does pose a difficulty according to MIT Professor Robert Langer.

FDA Cites API Manufacturer for Stability, Purification Violations

28-Feb-2013 - The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.

BIO, PhRMA Blast FDA Draft Guidance on E-Subs for Trial Site Data

28-Feb-2013 - Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time...

South Africa & Lonza Venture Hits Delay on API Facility Construction

27-Feb-2013 - A South African and Lonza joint project says issues in funding, competitiveness and green technologies have delayed construction of its API plant.

Cash Injection to 'Glide' the way for Solid Dose Injectors

27-Feb-2013 - Glide Pharma says it is working to bring its Solid Dose Injector (SDI) to market in the next 2-3 years.

Raman Spectroscopic Device in Fight Against Counterfeit Drugs

27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.

Albemarle Expands Manufacturing Capacity in Pennsylvania

27-Feb-2013 - Albemarle is adding new capacity at its manufacturing facility in Pennsylvania with a $30 million expansion.

Drug Shortages, Lost Business Chief among Concerns on EU API Import Deadline

26-Feb-2013 - US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.

Oral Dose Competition Intensifies as Qualicaps Expands Manufacturing

26-Feb-2013 - Following a bout of investments, the oral dose solution market has been described as “competitive” and “dynamic” by two of the major players.

SHL: Auto Injectors Drive Further Expansion at Taiwan Plant

25-Feb-2013 - SHL says the prevalence of injectable drugs will drive auto injectors as it ramps up its Taiwanese production plant.

Pantarhei Sells Stake in Oral Contraceptive JV

25-Feb-2013 - Pantarhei Bioscience has sold in Estetra, its oral contraceptive development JV, to partner Uteron Pharma and will use the proceeds to fund further development.

GOED: Pharma is important for omega-3 but growing slowly

25-Feb-2013 - Pharmaceutical omega-3 products are important but will grow more slowly than some expect because of the long timeframe for drug approval, says the chief of the Global Organisation for EPA...

West: Proprietary Products Propped by Packaging and Manufacturing

25-Feb-2013 - West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.

FDA: Risk-based Immunogenicity Testing will Boost Protein Development

25-Feb-2013 - The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.

People on the Move: Jobs in Pharma

25-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

BASF says Bend Accord Targets Different Chemistries than Dow deal

25-Feb-2013 - Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.

Cost Increases Likely for API Distributors in Europe Under New GDP Proposals

21-Feb-2013 - European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.

Capsugel Launches New Oral Formulation Business Unit

21-Feb-2013 - Capsugel says it will focus on lipid-based formulations as it launches a new Dosage Form Solutions Business Unit.

Collaboration With Britest Already Paying Off Says Aesica

21-Feb-2013 - UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment.

Dispatches from Informex

Updated IPEC Guide Steers Excipient Manufacturers Away From Unnecessary Tests

21-Feb-2013 - Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.

Dispatches from Informex

Intermediate CMOs Shift Attention to Nucleoside Development

20-Feb-2013 - CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.

DSM says generics-focused partnering will drive pharma growth

20-Feb-2013 - Royal DSM expects its pharma unit to perform better in 2013 driven by a generics and end-of-lifecycle drug-focused partnership strategy.

ATMI: Single Use Bioreactors on the Up, but US Tails Europe

20-Feb-2013 - New innovations in single-use bioprocessing systems are being picked up quicker in Europe than in the US, according to ATMI.

IMCD Buys Indian Distributor Indchem for Pharma business

20-Feb-2013 - Chemical distributor IMCD Group says acquisition of Mumbai-based Indchem will build its presence in the Indian pharmaceutical sxcipient sector.

Unichem Sell Indian Formulation Plant to Mylan

19-Feb-2013 - Mylan Laboratories has purchased a new finished formulations facility in an Indian Special Economic Zone from Unichem Laboratories.

Biocatalysis Becoming Big Business for CMOs

19-Feb-2013 - Biocatalysis is emerging as a hot topic for CMOs in 2013 with AMRI, Almac and DSM all citing drug industry demand as the driver for recent collaborations.

Dow Signs Up Cambrex for Bioavailability Partnership

19-Feb-2013 - Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.

IPEC Welcomes 'Long Awaited' EC Excipient Risk Assessment Plan

19-Feb-2013 - ‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.

update

Aesica and EmulTech Claim Micro-Encapsulation can Revive Formulation Projects

18-Feb-2013 - Aesica and EmulTech claim a new sterile formulation technology could help drugmakers resurrect abandoned projects and extend the lifespan of marketed medicines.

AMRI to Focus on Large Scale Manufacturing

18-Feb-2013 - AMRI has predicted continuing revenue growth in its contract manufacturing with its API pipeline and once-troubled Burlington site leading the way.

People on the Move: Jobs in Pharma

18-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

Hospira’s Manufacturing Woes Continue with US Device Plant 483

14-Feb-2013 - Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.

Protalix Looks to Capitalize on Plant-Based Manufacturing Technology

14-Feb-2013 - Protalix Biotherapeutics is attempting to use its US FDA-approved Gaucher's disease treatment as a proof of concept and springboard for its plant-based cell manufacturing technology.

Merck: ‘In-House API Production Remains Important Strategy’

14-Feb-2013 - Merck says it will keep in-house API production capacity as it continues to evaluate its manufacturing strategy.

AMRI Deal a Catalyst for Pharma Growth says Codexis

14-Feb-2013 - AMRI has teamed up with biocatalysis firm Codexis to develop cheaper, faster and greener ways of manufacturing APIs.

EpiVax says Novozymes Collaboration has $3bn Potential

13-Feb-2013 - EpiVax says combining its immune 'off switch’ drugs with Novozymes’ half-life boosting Albufuse platform could deliver a $3bn (€2.2bn) section of the autoimmune disease market.

Boost for Ireland as Sanofi Invests in Lantus Production

13-Feb-2013 - Genzyme says it will produce the insulin drug Lantus for Sanofi following a second investment in its Irish facility.

FDA Reveals More Info on API File Submissions

13-Feb-2013 - Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).

BMS Manufactures for Now as Reckitt Benckiser Enters Latin America

13-Feb-2013 - Bristol-Myers Squibb (B-MS) will continue to make the OTCs it licensed to Reckitt Benckiser for the time being but will hand over manufacturing if the UK drugmaker buys them outright.

Beximco starts shipping Formulations to Europe

12-Feb-2013 - Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.

Antibiotic to Resist Resistance as Pergamum Ink Development Deal

12-Feb-2013 - Pergamum says its partnership with Cadila will lead to a new type of antibiotic which will overcome the problem of resistance.

PSL says demand for HPAPI containment growing

12-Feb-2013 - Powder Systems Limited (PSL) says the low OEL achieved by its redesigned containment technologies meet demands of HPAPI focused drug industry.

Johnson Matthey to optimise API biz; Fine Chem forecasts roundup

11-Feb-2013 - in-Pharmatechnologist.com presents a roundup of news in the fine chemicals sector, beginning with Johnson Matthey which has started a review of its active pharmaceutical ingredient (API) business after competition in...

Update

Teva to Sell Californian Plant as Part of Cost-Cutting Initiative

11-Feb-2013 - Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.

News in brief

Sun Takeover Bid Burns Out as Taro Grows

11-Feb-2013 - Sun Pharmaceutical Industries has abandoned its long running efforts to buy Israel’s Taro, explaining the move is in the best interest of shareholders.

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences

11-Feb-2013 - The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.

People on the move: Jobs in Pharma

08-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

Novo Nordisk Says Warning Letter for Backup Plant Won’t Cause Insulin Shortages

07-Feb-2013 - In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company...

CDSCO oversight plan for APIs shipped to EU published by Pharmexcil

07-Feb-2013 - An Indian export group has published what it claims are draft CDSCO guidelines setting out what API makers must do to comply with EU import rules that come into effect...