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Headlines > January 2013

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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.

Pfizer wants manufacturing 'efficiencies' in 2013

30-Jan-2013 - Pfizer's CEO has raised the possibility of more cost cutting in manufacturing operations in 2013 to offset the impact of patent loss for key products.

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Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs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.

Synthon Unveils ADC Facility as Data Show Promise for First Candidate

24-Jan-2013 - Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials...

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.

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