Industry coalition questions USP comments on elemental impurities harmonisation

29-Nov-2012 - The industry group that prompted the USP to delay new elemental impurities standards says even when completed, ICH Q3D will take time to implement.

Exemed buys UCB plant and wins supply contract

29-Nov-2012 - Belgian biopharmaceutical company UCB has agreed to sell its manufacturing plant in Vapi, India to API maker Exemed Pharmaceuticals. 

SGS and blue inspection body to be excipact trained

29-Nov-2012 - The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

FTC says suppressing generics by ‘product hopping’ is illegal

28-Nov-2012 - The US Federal Trade Commission (FTC) says making insignificant reformulations to drugs to block generic competition violates antitrust laws.

Hovione and Solvias form industry's latest bioavailability-focused accord

28-Nov-2012 - Hovione and Solvias have become the latest suppliers to team on drug solubility and bioavailability services in a new deal announced today.

People on the move: jobs in pharma

28-Nov-2012 - in-PharmaTechnologist.com presents its latest round-up of movers and shakers in the world of pharmaceuticals, including news from Cipla, Dr. Reddy’s and Immunogen.

Pfizer could re-launch virtual trial programme as soon as 2013

27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.

Merck Millipore to open new bioavailability lab in 2013

27-Nov-2012 - The bioavailability market lacks a leader that can offer comprehensive solutions according to Merck Millipore, which has set its sights on filling the gap through investments and a new lab....

News in brief

China clamps down on illegal drug adverts

27-Nov-2012 - "Church brand Chihpen Tianyun capsule”,“wind pain Kang membrane ball” and “brain Xuesaitong pill” are just three of the ‘drug’ products named and shamed by China’s SFDA in a clampdown on...

USP delays new elemental impurities standards after industry appeals

27-Nov-2012 - The USP has delayed new elemental impurities standards but is still confident they can be harmonized with ICH Q3D even if May 2014 implementation target is kept.

Rhenovia says multi-drug patch tech has big (pharma) potential

27-Nov-2012 - Rhenovia Pharma says the multi-drug delivery capabilities of its transdermal-patch could have wider application.

Equateq, Cognis and Pronova: “Each are complementary”, says BASF

26-Nov-2012 - BASF’s ever-expanding nutrition unit says its €644m bid last week bid for Norwegian omega-3 firm, Pronova Biopharma, is as important for its food supplements business as its pharmaceutical operations.

EC makes Switzerland exempt from API ‘written confirmation’ requirement

26-Nov-2012 - APIs made in Switzerland won’t need ‘written confirmation’ of quality after the EC deemed the country's manufacturing standards meet its requirements.

News in brief

Indian plans for EU API import compliance still being discussed

26-Nov-2012 - Indian Plans to hand quality oversight of APIs shipped to Europe to ‘competent authority’ are still being discussed according to Pharmexcil.

Euticals suspends production after high levels of explosive chemical found at UK site

26-Nov-2012 - Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.

FDA stresses importance of IRB role in new draft guidelines

22-Nov-2012 - The US FDA wants IRBs to remember it is their responsibility to check investigator qualifications, make sure sites are up to code and say if an IND is necessary for...

In-Pharmatechnologist.com joins BASF and Dow at CPhI India

22-Nov-2012 - in-Pharmatechnologist.com is in Mumbai this week for CPhI India to report news from BASF, Dow Wolff Cellulosics and Bend Research.

Update - comments from EFPIA

EC asks pharmas how long to add 'black symbol' to risky drugs

22-Nov-2012 - The European Commission (EC) has asked the industry how long it will take to change labels of drugs marked for additional post-market monitoring.

Johnson Matthey's API biz on the up whilst catalyst profits dip

22-Nov-2012 - Johnson Matthey saw an uptick in its API business thanks to demand for “higher margin” products.

News in brief

Anvisa holds seminar or drug disposal

22-Nov-2012 - Brazilian drug regulator Anvisa wants to engage with the pharmaceutical industry on the disposal of unused drugs.

BASF bids $823m for GSK omega-3 supplier Pronova Biopharma

21-Nov-2012 - BASF has made a bid for Pronova Biopharma ASA, underlining its intention to become the dominant player in the pharmaceutical grade omega-3 API market.  

News in brief

Obamacare tweaked, good news for pharmas

21-Nov-2012 - US insurers will cover more medicines under Obamacare according to a document published by the Department of Health and Human Services (DHSS) in the Federal Register earlier this week.

Fujifilm seeks pharma collaborators to develop new dissolvable microneedles

21-Nov-2012 - Fujifilm has developed a new “pain-free” alternative to hypodermic needles which delivers drugs through a sheet of material covered in tiny dissolvable needles.

Irresponsible antibiotic promotion may speed Superbug spread, says WHO

21-Nov-2012 - Improper antibiotic use is driving the ‘Superbug’ epidemic but irresponsible promotional may be exacerbating the problem according to the WHO.

US FDA adopts ICH Q11 on drug substance manufacturing

20-Nov-2012 - The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.

NMR culture anlaysis complies with ICH Q2A and B, says Spinnovation

20-Nov-2012 - CRO Spinnovation Biologics says its cell culture optimization technique complies with analytical methods detailed in ICH Q2A and Q2B guidelines.

News in brief

Brazil wants to buy Pharma tech from the Ukraine

20-Nov-2012 - Brazil wants to buy pharmaceutical manufacturing technology from the Ukraine as part of a $4.5bn investment plan.

News from CPhI

India will back pharma SMEs in $500m finance scheme

20-Nov-2012 - The Indian Government plans to offer financial assistance to small and medium pharma enterprises (SMEs) in a bid to drive the industry.

Marinomed granted Chinese patent for cold virus fighting polymer

20-Nov-2012 - Marinomed Biotechnologies is set to take on the ‘common cold’ in China with a new patent for an anti-viral polymer technology that prevents rhinovirus infection.

Could new nanotech be the first to treat MS without affecting immune system?

19-Nov-2012 - Researchers believe a new nanoparticle could provide the first MS therapy that does not suppress the immune system.

Micromacinazione to get bigger through Neo-Micro deal

19-Nov-2012 - Micromacinazione has bought the micronization arm of Switzerland’s Neo-Micro AG, citing growth in the API sector as the key driver for the move.

People on the move: jobs in pharma

19-Nov-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Dendreon, Shire and Targacept.

Gelatine price increases continue at Rousselot

16-Nov-2012 - Rousselot has said it plans to increase gelatine prices 7% up to low double digit levels for 2013 as continued growth in demand has not been met by raw material supply.

Indian regulations will hike costs but market will remain competitive, Government tells IPT

15-Nov-2012 - Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.

Anvisa stresses importance of pharmacovigilance and international collaboration

15-Nov-2012 - Brazilian drug regulator Anvisa has called for increased pharmacovigilance and more effective reporting of adverse reactions by authorities worldwide.

Xi Jinping wants to improve medical care in China

15-Nov-2012 - New Communist Party General Secretary Xi Jinping wants to improve medical care and says China needs to “learn more about the world.”

Lack of harmonization on impurities a concern, says industry group

14-Nov-2012 - An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs....

EXCLUSIVE - update

Source bovine materials from BSE-free Australia or NZ: CEO's plea to regulators

14-Nov-2012 - Regulators should force pharmaceutical firms to source from BSE-safe countries according to Rocky Mountain Biologicals' CEO.

News in brief

SAFC expands PharmaGrade raw material portfolio to meet demands

14-Nov-2012 - SAFC has added 25 new raw materials to its portfolio of PharmaGrade products, expanding its early phase material offering.

New targeting tech makes for better vaccines says Vaccibody

14-Nov-2012 - A new vaccine targeting technology offers both therapeutic efficacy and manufacturing advantages according to developer Vaccibody.

India's CDSCO wants quicker drug recalls

13-Nov-2012 - The Indian CDSCO wants drug companies to withdraw defective drugs faster and to practice for such recalls.

Elder Pharma wants to make pile from EU Diosmin API sales

13-Nov-2012 - Elder Pharma hopes to increase sales to European drugmakers after receiving a certificate of suitability (CEP) for the API Diosmin.

ICH working to clarify Q7 for regulators

13-Nov-2012 - The ICH says regulator uncertainty over Q7 for ingredient supply chains, contractor management and quality management systems must be resolved.

EFCG says EU API import laws ineffective and calls for mandatory inspection

12-Nov-2012 - A European industry group says EU efforts to ensure the quality of API imports are inadequate and that mandatory inspections of overseas plants are a must.

News in brief

Orchid pulls out of China JV to focus on India

12-Nov-2012 - Orchid Chemicals has pulled out of its joint venture with North China Pharmaceutical Corporation (NCPC) to focus efforts on India.

People on the move: jobs in pharma

12-Nov-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest new appoitnments within the world of pharma and biopharma including news from J&J, Teva and Amarantus.

Italy’s AIFA lifts ban on Novartis flu vaccines

12-Nov-2012 - Italian regulators have lifted a temporary ban on two Novartis flu vaccines in which high levels of protein aggregates were detected.

Boehringer withdraws Pradaxa lot after packaging line problems

12-Nov-2012 - Boehringer Ingelheim has withdrawn one lot of its anticoagulant Pradaxa in the US over concerns about defective packaging.

NPPA to inspect Indian drug plants as part of pricing role

08-Nov-2012 - Drugmakers in India face the prospect of more inspections under new guidance from the country’s price setting agency, the NPPA.

Bayer forms manufacturing partnership to access Russian market

08-Nov-2012 - Bayer Healthcare has partnered with Medsintez in a deal designed to allow the German firm to make and sell drugs in Russia. 

News in brief

DSM says acqusition of formulator Fortitech has no Pharma implications

08-Nov-2012 - DSM says acquisition of food formulation technology firm wont impact its pharmaceutical business.

MonoSol Rx partners on film flu vaccine development

08-Nov-2012 - MonoSol Rx says oral film vaccine collaboration could deliver product with compliance and storage benefits.

Comment

What Obama means for Pharma this time

07-Nov-2012 - Barack Obama’s re-election will mean millions more US citizens have health insurance, which has significant implications for the pharmaceutical industry.

Aesica ramps up HPAPI capacity to meet industry demand

07-Nov-2012 - The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is still underserved, according to Aesica.

Pharma production down in Ireland in September

07-Nov-2012 - Production by Ireland’s pharmaceutical sector fell sharply in September but it is too early to say if it was part of a longer term decline, says the CSO

GSK pulls vaccine batch in Canada over contamination concerns

06-Nov-2012 - GSK has withdrawn another lot of its Infanrix Hexa vaccine over concerns about potential microbial contamination.

News in brief

USP revises heparin labelling guide

06-Nov-2012 - The US Pharmacopeial Convention (USP) has changed its labelling rules for heparin in a mid to reduce the number of medication errors.

BASF shake-up wont impact pharma business; China expansion

06-Nov-2012 - The organisational changes BASF announced yesterday will not impact drug ingredients or excipients but intermediates will be rejigged.

News in brief

Novartis to build biotech facility in Singapore

05-Nov-2012 - Novartis will spend $500m on a new cell-culture based manufacturing facility in Singapore.

Wacker adds half-life boosting tech to biologics offering

05-Nov-2012 - Wacker Biotech has added a low cost PEGytlation alternative to its biopharmaceutical manufacturing offering in a deal with developer XL-protein.

Merck Millipore and Sistemic to use miRNA for cell culture QC

05-Nov-2012 - Merck Millipore and microRNA detection firm Sistemic have teamed up to develop QC kits for stem cell production. 

Lilly’s in-house trend continues with $140m insulin investment

05-Nov-2012 - Eli Lilly plans to boost its in-house insulin production capabilities will a $140m investment for its Indianapolis site.

People on the move: jobs in pharma

05-Nov-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Watson, OvaScience and Sirona.