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Headlines > November 2012

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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.

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