SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulations

News headlines

EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.

Xellia and US FDA agree to modified consent decree at ex-Ben Venue site

02-May-2016 - The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.

French regulators lift manufacturing ban at Catalent softgel plant

02-May-2016 - Full production at Catalent’s Beinheim softgel plant has begun five months after the discovery of out-of-place capsules led to French regulators suspending operations.

Manufacturers concede on price as drug spending increases

02-May-2016 - Specialty medicine innovation is driving growth, yet advances are being offset by price concessions from manufacturers, according to IMS Health.

Uninvestigated complaints of APIs containing 'filth' land Polydrug with FDA warning

28-Apr-2016 - Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.

Biotrinity 2016

Biopharma 'future is better in Europe,' says UK life science minister

27-Apr-2016 - Britain’s minister for life sciences has called on the country’s £60bn pharma sector to rally together in support of remaining in the European Union.

Controlled substances: fewer CMOs, more regulations

26-Apr-2016 - The manufacture of controlled substances has faced increased scrutiny over the years, and as such, fewer CMOs are in the market.

George Freeman: New meds and delivery methods a regulatory challenge

26-Apr-2016 -   [View the story "Live from #Biotrinity2016" on Storify]

Exclusive Q&A

Breaking barriers: Can continuous manufacturing prevail despite hurdles?

26-Apr-2016 - Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.

WHO says Semler Research manipulated data and warns repeat studies may needed

25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.

Exco InTouch partners with Regulatory Strategies to meet data regulations

21-Apr-2016 - Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.

US FDA hits another Indian drugmaker over data integrity issues

21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.

WHO removes TB and malaria drug APIs made by Anuh Pharma from approved list

21-Apr-2016 - The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.

Rutgers leading continuous manufacturing guidance efforts

J&J success will spur pharma's shift to continuous manufacturing, Rutgers

21-Apr-2016 - Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.

update

US National Cancer Institute stops making cell therapy in light of contamination risk

20-Apr-2016 - Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.

Single-use and Stainless steel: Hybrid technologies the future of drug production says expert

20-Apr-2016 - Single-use is the future but stainless steel bioreactors will always play a role in drug production says an expert, who thinks firms could do worse than consult a CMO before deciding in which technology to invest.

Use of a comparability protocol will aid post-approval CMC changes, US FDA

20-Apr-2016 - The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.

Continuous or not? Janssen cites inventory benefits of new Prezista process

19-Apr-2016 - Janssen says the new US FDA-approved production method for its HIV drug Prezista is more efficient and will help it better control inventory.

News in brief

Alembic Indian plant hit with US FDA Form 483 and four observations

19-Apr-2016 - The US FDA has hit an Indian formulation facility run by Alembic Pharmaceuticals with a Form 483 with four observations.

Building a better biomedical knowledgebase

18-Apr-2016 - Researchers as The Scripps Research Institute (TSRI) are working to create a public database where researchers can easily access biomedical knowledge.

Related News

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...

Product Innovation