Mixed response to EC plan to extend Directive 2003/94/EC to APIs

30-Aug-2012 - The EC plan to extend drug GMP guidelines to APIs has met with a mixed response from industry groups, drugmakers and API manufacturers with some - like DSM and CEFIC...

Hospira buys Indian API plant to boost antibiotics biz

30-Aug-2012 - Hospira has bought Orchid Chemicals and Pharmaceutical’s active pharmaceutical ingredient (API) facility in Aurangabad, India, to support its expanding antibiotic business.

News in brief

Germed recalls cyclosporine after 'quality deviation'

30-Aug-2012 - Brazilian drugmaker Germed Pharmaceuticals has voluntarily recalled batch of the drug cyclosporine.

Siegfried sees sales and earnings grow in H1

30-Aug-2012 - Siegfried says lower raw materials costs helped its API business grow in the first half of 2012 and set out plans to expand manufacturing operations in China.

CDSCO gives manufacturers three weeks to comply with PSUR reporting rules

30-Aug-2012 - Drugmakers and importers are not complying with safety reporting requirements according to the Indian Drugs Controller General (DCG), which has given the offending firms three weeks to comply.

Vitamin B3 could be antibiotic sidekick when tackling superbugs

29-Aug-2012 - Vitamin B3 may be used to improve the efficacy of antibiotics when treating drug-resistant ‘superbug’ infections such as MRSA, according to new research.

People on the move: jobs in pharma

29-Aug-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest new faces and changing places in the world of pharmaceuticals, including news from AstraZeneca, Cresset and Aurobindo.

News in brief

US FDA revises blood storage and testing rules for manufacturers

29-Aug-2012 - The US FDA has revised storage and testing requirement for human blood intended for transfusion or further manufacturing.

CDSCO wants more medical experts for drug and trial reviews

29-Aug-2012 - The CDSCO wants to expand its pool of reviewers for drug applications, clinical trials and medical devices and is seeking applications from experts.

Bosch launches"future-proof" filling tech

28-Aug-2012 - Bosch packaging has launched two new capsule filling machines which it says are capable of handling all current and future applications.

BE/BA sites must be logged with US FDA under GDUFA

28-Aug-2012 - Bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.

News in brief

Pfizer calls on Mylan to make generics for Japan

28-Aug-2012 - Mylan will manufacture Pfizer’s generic drugs for the Japanese market under a new collaboration.

Delivery tech deals for Depomed, Silence and funding for Micropoint

28-Aug-2012 - New developments in the delivery space with Depomed signing up another Big Pharma licensee, Silence teaming up to test its tech for MiReven and Micropoint securing development funds for its...

FDA to develop GDUFA self-identification database; warns about ANDA backlog fee

27-Aug-2012 - The US FDA plans to establish a new database for manufacturing facilities required to ‘self-identify’ under new GDUFA laws.

EMA warns Pacira about manufacturing deficiencies

27-Aug-2012 - The EMA has warned Pacira Pharmaceuticals about a number of manufacturing deficiencies following an inspection of the firm’s plant in the US.

News in brief

MHRA mulls allowing physicians to prescribe drugs unlicensed drugs

27-Aug-2012 - The MHRA wants industry feedback on proposals to make drugs available before they are licensed.

CSL gets US FDA closeout letter and reports positive results for FY2012

23-Aug-2012 - CSL Group has resolved the manufacturing problems it faced over the last 12 months to finish fiscal 2012 with higher revenue and profits.

Anvisa extends comment deadline on excipient GMP after strikes

23-Aug-2012 - Brazilian regulator Anvisa has extended the deadline for public comment on plans to require excipient manufacturers to be GMP compliant after a month of industrial action by government workers.

News in brief

Universal flu vaccine in reach, says NIH

23-Aug-2012 - The first universal flu vaccine for all ages is in reach thanks to a DNA vaccine prime, according to the US National Institute of Health (NIH).

People on the move: jobs in pharma

23-Aug-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest chops and changes in the pharmaceutical development and manufacturing industry, including news from Pfizer, Cresset, and Avantor.

US FDA pulls 27 ANDAs for drugs made at banned Ranbaxy plants

22-Aug-2012 - Ranbaxy has asked the US FDA to withdraw 27 ANDAs for products previously made at Indian manufacturing facilities hit with consent decree earlier this year.

First universal HIV vaccine could be on its way, say researchers

22-Aug-2012 - The first effective universal HIV vaccine may soon be on its way thanks to a family of highly potent (HP) antibodies which neutralise the virus, according to new findings.

News in brief

Albumin sales key to Novozymes biopharma biz gains in H1

22-Aug-2012 - Higher revenue from recombinant albumin hyaluronic acid helped Novozymes’ biopharmaceutical business in the first half of 2012, but the firm expects growth to slow in the second half of the...

Capsugel wants to standardise lipid formulation tests

22-Aug-2012 - Capsugel has launched a non-profit consortium in a bid to establish a lipid formulation classification system.

Feature

WADA discusses drug industry role in catching Olympic cheats

21-Aug-2012 - From Usain Bolt’s lightspeed sprint double to Russell Brand’s brave but distinctly off-key mauling of the Beatles classic ‘I am the Walrus’ during the closing ceremony, the performances at the...

Regulatory staff wages going up despite cost cutting pharma biz, says RAPS

21-Aug-2012 - Regulatory professionals’ pay packets are going up despite a general industry preference for cost cutting, according to a new report by RAPS.

AstraZeneca and Actavis provide excipients for Danish regulators quality testing

21-Aug-2012 - Danish regulators say glycerol excipients tested as part of its drug monitoring activities all complied with appropriate quality standards.

News in brief

Diversion of drugs by Illegal internet pharmacies a big problem says INCB

21-Aug-2012 - The UN International Narcotics Control Board (INCB) says the diversion of pharmaceuticals at the national level has become one of the major sources of narcotics around the world.

US FDA updates guidance on treatment-emergent suicide risk in trials

20-Aug-2012 - The US FDA has revised its draft guidance on suicide risk in trials with updated terminology and expanded assessment criteria and has called for drug industry feedback.

GSK to close Indian API plant and turn to third-party contractors

20-Aug-2012 - GSK tells in-Pharmatechnologist.com that decision to close Indian API plant was prompted by rising cost of manufacture and availability of third party contractors.

SFDA to keep a public blacklist of pharma manufacturing offenders

20-Aug-2012 - The SFDA will name and shame companies and individuals responsible for violations of drug and medical device laws in a public blacklist.

New sustained release hydrogel could mean twice-yearly injections for diabetes sufferers

16-Aug-2012 - A new hydrogel which can provide a sustained drug release of up to six months could cut diabetes dosage down from 365 injection per year to just two, according to researchers.

Theorem and Gallus team up to help drugsmakers in emerging markets go State side

16-Aug-2012 - Theorem and Gallus say their new biologics manufacturing partnership is aimed at giving a “leg up” to drugsmakers in emerging markets looking to market products in the US.

EMD Millipore partners with UK firms Ark and Plasticell

16-Aug-2012 - EMD Millipore has announced two new collaborations this week focused on vaccine bioengineering and stem cell media.

News in brief

Sanofi gets US FDA OK for talking injection device

14-Aug-2012 - Sanofi has received US FDA approval for an auto-injector that gives audio and visual cues to assist in the injection process.

US Government must 'get a handle' on biosecurity, say experts

14-Aug-2012 - US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.

UK overhauls drug laws with new Human Medicines Regulations

14-Aug-2012 - New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.

FDA and EMA set out efforts to mitigate GMP-related shortages

14-Aug-2012 - Regulators on both sides of the Atlantic address the shortages that occur when drugmakers fail to comply with GMP in documents published this week.

Low demand for ‘Lipitor’ intermediate hits Codexis in Q2; job cuts expected

14-Aug-2012 - A drop in atorvastatin–related orders hurt Codexis in Q2 but the firm's pharma business is unlikely to face cuts.

People on the move: jobs in pharma

13-Aug-2012 - in-PharmaTechnologist.com presents its latest low down of the new faces and changing places in the world of pharmaceuticals, including news from Horizon, Conatus and Akorn.

FDA backs USP and AAMI on endotoxin testing and sets out own view

13-Aug-2012 - The US Food and Drug Administration backs pyrogen and endotoxin testing recommendations developed by the USP and AAMI, but has issued a Q&A to set out the regulatory perspective...

Goa is all go for Bosch with new pharma and food packaging tech plant

13-Aug-2012 - Bosch Packaging Technology says India is becoming one of its key markets, citing the growing pharma sector as a key driver for the development of its new Goa facility 

Accu-Break and Alembic join in tablet-splitting tech accord

09-Aug-2012 - Tablet technology firm Accu-Break Pharmaceuticals has signed a product development and licensing agreement with Indian generic drugmaker Alembic Pharmaceuticals.

CDSCO can inspect trial sites and seize docs unannounced under new guidelines

09-Aug-2012 - Inspectors will be able to visit clinical trial sites unannounced and seize records under new draft guidelines issued by the Indian Central Drugs Standard Control Organisation (CDSCO).

New Herceptin formulation allows delivery via injection

09-Aug-2012 - A new formulation of Genetech’s breast cancer drug Herceptin means patients could soon receive treatment via injection, rather than time consuming intravenous drip.

News in brief

IPEC Americas backs new SFDA excipient regs; English translation available

09-Aug-2012 - The International Pharmaceutical Excipients Council (IPEC) Americas has welcomed new SFDA excipient quality and supervision regulations, which it says are largely consistent with its own guidelines.

Pharmexcil: wants input on tax laws; and says Sri Lanka is an opportunity for Pharma

08-Aug-2012 - The Pharmaceuticals Export Promotion Council of India (Pharmexcil) wants members to suggest changes to tax laws governing pharmaceutical exports ahead of India’s next budget.

UCF team accidentally discovers "game changing" nanoparticle mass production method

08-Aug-2012 - Scientists at UCF (University of Central Florida) believe they have found a simpler and more efficient way to mass produce the structured nanoparticles used for drug delivery and production.

News in brief

Merck Millipore expands sampling tech range for biomanufacturers

08-Aug-2012 - Merck Millipore – known as EMD Millipore in the US - has launched new sampling bottles and is targeting the biomanufacturing sector.

Aurobindo sets eyes on API CRAMS biz

08-Aug-2012 - Aurobindo has announced long term plans to steer away from its generics making business in a bid to focus on long term API manufacturing partnerships.

DSM to continue Phama cuts beyond recent Percivia reorganisation

07-Aug-2012 - DSM will conduct further cost cutting at its Pharma business as part of a wider ‘profit improvement initiative’ that will see it cut 1,000 jobs over the next 18 months.

BD hunting "plug in" acquisitions

07-Aug-2012 - BD is on the lookout for more acquisitions with firms it can easily “plug in” to its business.

News in brief

Cipla to invest in three new API plants in India

07-Aug-2012 - Indian pharma firm Cipla will invest INR5bn ($90.5m) in three new API manufacturing plants.

Lack of emergency response systems put biopharma supply chain in danger: study

07-Aug-2012 - Biopharma manufacturers are putting their supply chains at risk by failing to prepare for emergencies, according to a new study by Best Practices, LLC.

SFDA publishes final excipient guidelines in wake of chromium-tainted gelatin scandal

06-Aug-2012 - The Chinese Food and Drug Administration (SFDA) has confirmed that drugmakers and suppliers will take on more responsibility for ensuring excipient quality under new provisions.

West Pharmaceutical continues balancing act despite CMO uptick

06-Aug-2012 - West Pharmaceutical Services is sticking with plans to lessen CMO (contract manufacturing organisation) activities and boost proprietary products despite a hefty uptick in contract production in Q2.

News in brief

Shasun sees big Q1 wins thanks to API CMO biz

06-Aug-2012 - Shasun’s Pharma more than doubled its net profits in Q1 thanks to its thriving API (active pharmaceutical ingredient) contract manufacturing business.

People on the move: results season special

06-Aug-2012 - Results season is well under way and in-PharmaTechnologist.com is here to bring you the latest as companies announce their chops, changes and plans for the coming quarters.

Dr. Reddy's is big enough to bear the brunt of closed Mexico plant, says Barclays

02-Aug-2012 - Dr. Reddy’s may not have as big a hill to climb as some observers suggest to regain customers lost as a result of the closure of its Mexican API plant,...

Western Europe is growth hub for pharma business says GEA

02-Aug-2012 - Drug industry customers in Western Europe drove the modest gains achieved by GEA pharmaceutical business in Q2 2012.

Impurities and starting material issues topped list of deficiencies in CEP applications says EDQM

02-Aug-2012 - Failure to discuss impurities and unacceptable starting materials topped the list of deficiencies in CEP applications in 2011 according to the EDQM.

WADA wants drugmakers to help in fight against sports cheats

02-Aug-2012 - The World Anti-doping Authority (WADA) wants pharmaceutical manufacturers to identify drug candidates in their pipelines that could be used to cheat in sport.

GE and iBio designing plant-cell based vaccine facility

01-Aug-2012 - GE Healthcare has started designing a vaccine manufacturing facility for an unnamed drug company, just days after expanding its collaboration with plant-cell production technology firm iBio.

Unilife's investments will pay off in next 6 months, says CEO

01-Aug-2012 - Unilife has reported a net loss of $52.3m at the end of its fiscal year, up from $40.7m in 2011.

Lonza calls in former SGS man to oversee ‘Visp challenge’

01-Aug-2012 - Lonza has brought in a new exec to oversee cost reduction and efficiency efforts at its largest custom API manufacturing plant in what CEO Richard Ridinger calls the Visp challenge....