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Waco hopeful for possible Allergan expansion

08-Feb-2016 - On the heels of a new study , which found that Allergan's Waco operations generated an economic impact of $263m on the area’s income, the city is hoping for new expansion.

Increased scrutiny requires digging deeper into the supply chain

04-Feb-2016 - As threats to the pharmaceutical supply chain prevail, the industry is seeing increased regulatory scrutiny as well as more inspection requirements, says industry panel.

Update

'Clear statistical reservations' surround Bial's fatal clinical trial

02-Feb-2016 - The Royal Statistical Society has questioned the design of the trial of Bial's candidate painkiller BIA-102474-101 in which one person died and others were hospitalised last month .

Ipca not surprised by US FDA warning at three Indian API plants

01-Feb-2016 - Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.

Regulatory reforms to reshape drug manufacturing in China says expert

28-Jan-2016 - More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.

Increased US FDA oversight driving recent China plant warnings

27-Jan-2016 - The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.

Sandoz welcomes US FDA promise to publish interchangeability guide in 2016

26-Jan-2016 - The US FDA plans to release long-awaited biosimilar ‘interchangeability’ guidelines in 2016 according to a publishing plan announced this week.

No Zika vaccine in sight, but modified yellow fever virus vector could speed development

25-Jan-2016 - A Zika vaccine is a long way off according to a UK academic who suggested vaccines for related viruses could be used as delivery vectors to accelerate development.

Pharma fallout: Biotrial details emerge

25-Jan-2016 - New information, including Bial’s clinical protocol document have emerged over the past week, providing new insight into the Biotrial tragedy.

Drugmakers: Government purchasing commitments would encourge antibiotics R&D

21-Jan-2016 - Government purchasing commitments would discourage industry antibiotic marketing and help developers overcome reluctance to invest in new antimicrobials say drugmakers in Davos.

Mylan: GMP issues and production halt at Agila aseptic plant 'not material'

20-Jan-2016 - Mylan has stopped production at a sterile injectables plant after Polish regulators observed 29 major violations of GMP, an EU statement of non-compliance reveals.

FAAH inhibitor safety under microscope after Bial drug trial death

19-Jan-2016 - FAAH inhibitors will be looked at closely after a volunteer died in a trial of BIA 10-2474 last week, but it is too early to say drugs of this class are unsafe according to a leading expert.

SAEs the only similarity between the BIA 10-2474 trial and 'elephant man' study, says MHRA

18-Jan-2016 - A study halted  in France after one volunteer died and others were injured differs markedly from the disastrous “elephant man” trial that hospitalized six in the UK in 2006 according to the MHRA.

US FDA and French regs hit separate Chinese API makers with warnings

14-Jan-2016 - Systemic data manipulation has landed Chinese API maker Zhejiang Hisun Pharmaceutical with a US FDA warning letter.

Pfizer and Allergan to mull splitting up again in 2018 say CEOs

13-Jan-2016 - The Pfizer-Allergan $160bn merger will create the world’s largest pharma company but potentially not for long, as the two CEOs discuss breaking the entity up in 2018.

Survey: M&A drivers, inhibitors in 2016

13-Jan-2016 - As the industry faces new challenges in 2016, the pharmaceutical industry is expected to be the second busiest sector for consolidation with large cash reserves driving deals, according to experts.

One by one: Continuous manufacturing gets broad support

12-Jan-2016 - Continuous manufacturing (CM) offers several benefits over traditional pharma manufacturing, including real-time monitoring, says expert.

Focused R&D is key to productivity according to Deloitte

12-Jan-2016 - As annual projected pharmaceutical R&D returns continue to decline and companies are under increasing pressure, focus may be the defining factor.

UK pharma manufacturing output to grow in 2016 says EEF

12-Jan-2016 - UK pharma manufacturing output increased last year according to EEF, which says lower costs and a legacy of R&D investment will drive further growth in 2016.

Paragon launches manufacturing compliance service for drug firms

05-Jan-2016 - Paragon Solutions has rolled out a new service to help drugmakers make sure their manufacturing operations comply with US FDA regulations.

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