PhaseBio says biopolymer delivery tech could cut insulin injections

31-Jan-2013 - Diabetes sufferers could be injecting insulin just once a week if a new drug delivery technique is picked up by a big pharma company.

Lonza hints at manufacturing cuts

31-Jan-2013 - Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.

EMA Offers Inside Look at Clinical Trial Inspections

31-Jan-2013 - Clinical trial inspectors are being called on by the European Medicines Agency (EMA) to focus their efforts more on findings that are likely to impact the benefit-risk evaluation of a...

Flublok maker open to sharing egg and virus-free manufactuing tech

31-Jan-2013 - Protein Sciences says it will license the novel manufacturing technology behind recently approved influenza vaccine, Flublok, to other producers.

Scinopharm starts developing own drugs with eye on API customers

30-Jan-2013 - Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

30-Jan-2013 - The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial...

FDA Warns Taiwanese Drug Manufacturer Over GMP Violations

30-Jan-2013 - As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter ...

update

Denmark asks API users to register; EU sets out GMP assessment criteria

29-Jan-2013 - Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).

Granules optimistic after poor Q3: "PFI bottleneck will be unblocked"

29-Jan-2013 - Granules India says it expects to be back on track by 2014 following slow sales growth and depressed profitability margins.

FDA Finalizes cGMP Rule for Drug-Device Combo Makers

29-Jan-2013 - The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its...

update

US asks for exemption from EU API import laws

28-Jan-2013 - The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.

EU to Further Align GMP, Process Validation Standards with ICH, FDA

28-Jan-2013 - The European Medicines Agency (EMA) is looking to integrate guidance from the International Conference on Harmonization (ICH) and US Food and Drug Administration (FDA) into the revisions of two annexes...

Industry Lays Out Timelines for Adding 'Black Symbol' to Drug Packs in EU

28-Jan-2013 - European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of...

People on the move: Jobs in Pharma

28-Jan-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Novartis, Bayer and Tranzyme.

Freeman signs up Canadian distributor

28-Jan-2013 - Freeman Technologies has signed a Canadian distribution deal for its powder flow analysis tech in a bid to win more QbD and PAT-focused Pharma customers.

India's Top Court Takes Control as Trial Regulations in Flux

24-Jan-2013 - Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme...

SFDA asks API makers for GMP certificates ahead of new EU import laws

24-Jan-2013 - Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.

Find esophageal transit failure hard to swallow? Fuisz says new pill design can help

24-Jan-2013 - Fuisz Pharma says a new tablet design will be of interest to pharma formulators who find esophageal transit failures hard to swallow.

update

Asian competition and counterfeits top challenges for African drugmakers says FAPMA

23-Jan-2013 - ‘Unfair competition’ from Asian drugmakers and the prevalence of counterfeits are among the challenges facing African manufacturers according to a new pan-African industry group set on fostering local production.

Cost of dissolution testing for levothyroxine a small price to pay for quality says MHRA

23-Jan-2013 - The cost of proposed new tests designed to ensure levothyroxine tablet quality is a small price to pay for manufacturers to ensure patient safety says the UK MHRA.

Impax remains upbeat after NDA rejection

23-Jan-2013 - Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.

UK Cell Therapy Trial Database to Help Advance Trials to Later Stages

23-Jan-2013 - The UK's cell therapy industry now has a database of all ongoing clinical trials in the country with the aim of expanding research partnerships and pushing more early-stage trials to...

Pan-Africa drug industry group to launch this week

22-Jan-2013 - Regional manufacturers’ associations have set up a pan-African organisation designed to promote local drug production.

update

SFDA yet to publish excipient list as implementation date for GMP nears

22-Jan-2013 - Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.

Asian hub’s ambition attracts Amgen into Asia biomanufacture

22-Jan-2013 - The Singapore Economic Development Board (SEDB) says it wants to nurture industry, academic and institutional alliances to attract further global investment in ‘Asia’s fastest growing bio-cluster.’

EC Updates Guidance to Ensure Supplier Compliance

22-Jan-2013 - The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.

EU Agrees to Joint GMP Audits with Israel, New Zealand

22-Jan-2013 - The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all...

Dedicated facility injects CRM197 into conjugate vaccine market

21-Jan-2013 - Reagent Proteins says its ability to produce scalable amounts of protein CRM197 supports the current demand in production of conjugate vaccines.

Updated

Lonza to Evaluate BaroFold’s Protein Refolding Technology

21-Jan-2013 - Lonza has agreed to evaluate BaroFold’s high-pressure refolding technology for difficult to express microbial products expressed as inclusion bodies.

CDSCO Sets 18 Month Deadline for Efficacy, Safety Testing

21-Jan-2013 - Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the...

breaking news - update

BASF sees synergies between new acquisition Pronova and Equateq

21-Jan-2013 - BASF has had its offer for omega-3 API maker Pronova Biopharma accepted by 97.7 per cent of the Norwiegan firm’s shareholders.

Exclusive - update

Odin likely to accept revised offer for Pronova says BASF

18-Jan-2013 - German chemicals giant BASF expects its revised takeover bid for Norwegian omega-3 API manufacturer Pronova Biopharma ASA to be accepted by resistant shareholders.

update

Mitsui confirms increased Arch Pharmalabs investment; wants to build API biz

17-Jan-2013 - Mitsui & Co has upped its stake in Indian API maker Arch Pharmalabs in an effort to expand its CMO business.

XD cell culture technology: DSM boosted by Amgen license

17-Jan-2013 - DSM hints at high yield and cost-cutting benefits in licensing its cell growth technology to Amgen.

SFDA ups rewards for people who shop illegal drugmakers

17-Jan-2013 - People who report illegal drug production could now earn up to 300,000 Yuan ($48,250) under a revised reward scheme launched by the SFDA.

Some Indian Drug Exporters Skirt New Bar Code Requirements

17-Jan-2013 - Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.

Foreign Generic Drug, API Manufacturers Hit Hardest by GDUFA Fees

17-Jan-2013 - Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the...

EMA: Shared Manufacturing Facilities Must Calculate Contamination Risk

16-Jan-2013 - EU pharmaceutical and active substance manufacturers should determine the threshold for cross-contamination when multiple drugs are produced in shared facilities.

People on the move: Jobs in Pharma

16-Jan-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca and Roche.

Industry Seeks Clarity on EU Regulation Governing Changes to MAs

16-Jan-2013 - The drug industry is seeking more clarity on the descriptions of variations made to marketed drugs under the European Commission’s regulation governing the ways marketing authorizations can be re-classified.

BASF ups offer for omega-3 API maker Pronova

15-Jan-2013 - BASF has increased its cash offer for omega-3 API maker Pronova Biopharma to €684m.

update

Greece is the word: BASF tells Pronova shareholders revised bid is fair value

15-Jan-2013 - BASF says revised offer for omega-3 API maker Pronova Biopharma is fair value given recent Greek Government decision to stop reimbursing two key drugs. 

Aptuit’s global connection whizz API to market

15-Jan-2013 - Aptuit says that collaboration amongst its global facilities was a key factor in bringing Lomitapide to market.

FDA Shifts Focus to Abuse-Deterrent Generic Opioid Development

15-Jan-2013 - The US Food and Drug Administration (FDA) can require opioid generics to have abuse-deterrent properties if the same requirements are applicable to their brand name counterparts, FDA Commissioner Margaret Hamburg...

Bioavailability to drive drug delivery deals in 2013 says analyst

15-Jan-2013 - Demand for improved bioavailability solutions will drive drug delivery dealmaking in 2013 according to a pharmaceutical industry expert.

MHRA asks drugmakers for more data on API suppliers

14-Jan-2013 - The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.

Solstice says new RNAi delivery tech will rekindle Big Pharma interest

14-Jan-2013 - Solstice Biologics says its new “limitless” RNAi technology will win back Big Pharmas previously put off by delivery difficulties.

News in brief

Catalent inhales $20m investment

14-Jan-2013 - Catalent will invest $20m to upgrade its US pressurized Metered Dose Inhaler (pMDI) capabilities as part of a wider expansion of its inhaler business.

US approval for omega-3 suppliers BASF and Chemport key for Amarin in 2013

10-Jan-2013 - Winning US FDA approval for omega-3 API suppliers like BASF and Chemport is a key milestone for Amarin in 2013 according to CEO Joe Zakrzewski.

Public Citizen concerned about impact of 'lax' OHRP oversight on kids in trials

10-Jan-2013 - A US advocacy group says poor HHS oversight of an ongoing type-1 diabetes study could undermine rules designed to protect children in trials.

Novartis says Dendreon plant deal will drive CAR processing

10-Jan-2013 - Novartis says the acquisition of Dendreon’s Provengen plant was an investment in its activated cellular immunotherapy programme.

EMA raises drugmaker fees and plans rejig

09-Jan-2013 - The European Medicines Agency (EMA) plans to ask drugmakers to foot the bill for increased spending in 2013. 

Bosch renames Eisai unit emphasizing inspection capabilities

09-Jan-2013 - Bosch has completed the integration of Japanese acquisition Eisai Machinery, renaming the unit as Bosch Inspection Technology.

Lonza to double ADC capacity to address Visp challenge

08-Jan-2013 - Lonza plans to double ADC capacity at its facility in Visp, Switzerland by 2014 in a move that it says could create new jobs.

WHO should buy more China-made drugs says SFDA

08-Jan-2013 - The World Health Organisation (WHO) should buy more drugs made in China according to the SFDA.

News in brief

Kemwell plant passes US FDA inspection

07-Jan-2013 - An oral solid dose manufacturing plant operated by Kemwell has passed an inspection by the US Food and Drug Administration (FDA).

Questcor buys API maker Biovectra

07-Jan-2013 - API maker BioVectra has been acquired by autoimmune disease focused drugmaker Questcor Pharmaceuticals for C$50m.

Saltigo says climbing costs drove 1,2,4-triazole and chloroformate price hike

07-Jan-2013 - Saltigo says climbing raw materials, energy and shipping costs prompted it to increase the price of key chemical intermediates, 1,2,4-triazole and chloroformate.

Arrowhead Research scientists claim RNA delivery bull’s eye

03-Jan-2013 - Scientists from targeted therapeutics firm Arrowhead Research claim a vesicle bursting polymer can overcome siRNA delivery difficulties.

3M gets Radius Health deal extension

03-Jan-2013 - 3M Drug Delivery will help commercialize a transdermal osteoporosis treatment under an extension to its deal with Radius Health.

News in brief

Indian Pharmacopoeia Commission publishes compliance guide

03-Jan-2013 - The Indian Pharmacopoeia Commission (IPC) says a first of its kind guidance manual will help drugmakers comply with quality requirements and testing procedures.

Rare diseases group celebrates Quincy ME star’s role in Orphan Drug Act

03-Jan-2013 - An advocacy group says actor Jack Klugman's support was key for US law that encouraged pharmaceutical firms to make drugs for rare diseases over the past 30 years.

Mitsubishi to buy dominant HPMC capsule maker Qualicaps as gelatin shortages continue

03-Jan-2013 - Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.