Breaking News on Global Pharmaceutical Technology & Manufacturing

Feature

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

22-Jul-2014 - Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.

PhRMA supports Customs drug destruction, responds to critics of law

21-Jul-2014 - PhRMA (Pharmaceutical Research and Manufacturers of America) has warned that illegal medicines rejected at the US border will continue to be resubmitted for importation unless a proposed law allows their destruction.

People on the Move

Role changes for AbbVie and Shire CEOs after merger

21-Jul-2014 - It has been a hectic few days for the chief executives of AbbVie and Shire since their companies agreed a £32bn ($53bn) merger on Friday.

US FDA looks to increase cooperation with Latin American counterparts

21-Jul-2014 - The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014 - Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

India's CDSCO to pay people who report fake drugs

17-Jul-2014 - The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.

Dispute over FDA bid to destroy personally imported drugs

17-Jul-2014 - Pharma groups and patients have objected to US Food and Drug Administration (FDA) plans to destroy prescription medicines personally imported into the US by patients.

Italian API manufacturer hit with FDA warning letter over data control

16-Jul-2014 - Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.

Mylan buys Abbott’s generics business for $5.3bn

15-Jul-2014 - Abbott has sold its generics business to Mylan in a deal worth approximately $5.3bn (€3.9bn).

News in brief

India’s Cipla to invest £100m in UK R&D

10-Jul-2014 - Mumbai-based drugmaker Cipla has announced it will invest “up to £100m” ($171m) in drug development in the UK.

David and Goliath can coexist says group accusing US Pharma of anti-Indian tactics

10-Jul-2014 - The Indian industry group that accused US Big Pharma of anti-Indian tactics last week has said there is room for both generics firms and innovators. 

Waters to open laboratory with Chinese Pharmacopoeia

10-Jul-2014 - Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

GRAS always greener? FDA considers overhauling OTC monograph system

09-Jul-2014 - The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances. 

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

09-Jul-2014 - Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Ease regulations to cure drug industry antibiotic resistance, says RPS

08-Jul-2014 - The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College, London, who told in-Pharmatechnologist.com the key to encouraging antibiotics manufacture is lightening companies’ regulatory burden.

Kemwell's oral solid dose plant approved following joint European inspection

07-Jul-2014 - An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the next three years.

People on the Move

Who's going places?

07-Jul-2014 - This week's pharmaceutical changes begin with the election of Reuters' head to the Board of Pfizer.

European Commission outlines priorities for pharma sector in new report

07-Jul-2014 - In a sweeping report on the industry as a whole, the European Commission says that with an annual output of €220bn, and nearly 800,000 employees, the pharma industry is vital for the EU economy, though more needs to be done to meet its full potential.

update

Pfizer and Protalix’s Gaucher’s drug gets kosher status

03-Jul-2014 - Elelyso has been certified as kosher by a US Jewish group, which says the process used to make the lysosomal storage disease drug means it conforms to religious dietary laws.

News in brief

Sun Pharma pulls chemotherapy made at Gujarat plant

03-Jul-2014 - Indian drugmaker Sun Pharmaceutical has recalled 200 vials of the cancer drug gemcitabine in the US over concerns about its sterility.

Bulk ingredient prices skyrocket in US as payers clamp down

03-Jul-2014 - Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.

US venture capital investors continue to back biotech

02-Jul-2014 - Biopharma firms continued to attract US venture capital investment in Q1 according to new analysis by PricewaterhouseCoopers (PwC), which says the number of firms that received backing is encouraging.

B-MS recalls CMO made injectable blood thinner after finding "visible particles"

02-Jul-2014 - Bristol Myers Squibb (B-MS) has recalled several batches of the injectable version of the blood thinner Coumadin made by its CMO, Pharmalucence.

US FDA issues draft strategic priorities document

02-Jul-2014 - The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.

Spotlight

Exporters rush to meet Chinese FDA serialisation requirements

Exporters rush to meet Chinese FDA serialisation requirements

Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for...

GSK confident despite endotoxin problems at Canadian vaccine plant

GSK confident despite ongoing endotoxin problems at Canadian flu vaccine plant

GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing...

Marketing agency targets poor interns for GSK paid trials

Marketing agency targets poor interns for GSK paid trials

Representatives for GSK have targeted struggling graduates and unpaid interns as volunteers for clinical trials, saying the...

Roche: ‘If suppliers don’t open up their books, then we are done’

Roche: ‘If suppliers don’t open up their books, then we are done’

Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which...

Teva's 70+ manufacturing sites could be halved in efficiency drive

Teva's 70+ manufacturing sites could be halved in efficiency drive

Teva could halve its manufacturing network as part of its $2bn-a-year efficiency programme says CFO Eyal Desheh,...

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