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Breaking News on Global Pharmaceutical Technology & Manufacturing

Needle in a haystack? Anti-vaxx pins may have adverse consequences

15-Feb-2016 - Persuasive anti-vaxx posts on social media may stop parents vaccinating their kids say researchers.

Mafia behind most EU pharma cargo theft: €30m worth of drugs stolen each year says expert

04-Feb-2016 - The Mafia is responsible for most pharmaceutical cargo thefts in Europe according to a researcher who says €30m ($33.5m) worth of drugs are stolen while in transit across the continent each year.

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.

Pharma, US Gov’t pushing for Zika vaccine

03-Feb-2016 - Sanofi Pasteur has launched a Zika vaccine project, levering its experience in developing vaccines for similar viruses, as the US government pushes for “intensified research.”

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 .

No Zika vaccine before Rio Olympics: Grant funded-development at early stage says US NIAID

28-Jan-2016 - The US NIAID is supporting development of several experimental Zika vaccines but none will be ready before Brazil, the country at the centre of the current outbreak, hosts the Olympic Games this summer.

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.

GSK biopharmaceutical trade secrets defendant still "at large"

26-Jan-2016 - Yan Mei, a defendant charged with stealing GlaxoSmithKline (GSK) trade secrets including biopharmaceutical manufacturing processes, remains at large, a spokesperson for the US Attourney's office told us yesterday.

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.

US NIAID awards $5m to researchers developing non-traditional therapeutics for bacterial infections

20-Jan-2016 - $5m in funding has been awarded to various research projects in order to help develop non-traditional therapeutics for bacterial infections.

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.

Pharma in emerging economies: risks, concerns, and considerations

20-Jan-2016 - Emerging markets in BRIC nations are gaining traction and will be a key revenue driver for multinational pharma companies – but not without risk.

Rx-to-OTC switching: the heart of OTC market, says GBI Research

19-Jan-2016 - Drug manufacturers, regulators, and consumers are increasing pressure on pharma companies to make the Rx-to-OTC switch, as non-prescription medications are cheaper and easier to access.

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.

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.

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.

Out with the old, in with the new… CEOs. Pharma's top-level rejigs

11-Jan-2016 - Valeant, Rentschler, Celgene, MannKind, and Syngene are among those welcoming new leaders for 2016. Oh, and Turing waves goodbye to Martin Shkreli… welcome to a New Year’s CEO special.

FDA's bioequivalence rules are out of date and need to be modernised

05-Jan-2016 - Many generic drugs are not truly bioequivalent to the original medicines they copy and switching to them can lead to worse patient outcomes, according to US researchers.

Rx, drugs and rock & roll: when pharma and music share the same stage

23-Dec-2015 - If ‘Love is the drug’ should Roxy Music be subject to regulatory scrutiny? Can The Verve say ‘The drugs don’t Work’ without conducting a clinical trial? We explore the harmonious worlds of pharma and music.

US FDA carries on criticizing wayward Sun plant in Halol

22-Dec-2015 - The US FDA has warned Sun Pharmaceutical Industries about its facility in Halol, India just months after it withdrew approval for an epilepsy drug made at the site.

New bill provides $2.7bn to FDA, $32bn to NIH

17-Dec-2015 - Under new legislation, the FDA and NIH will receive discretionary funding to combat antibiotic resistant bacteria and advance prevision medicine initiatives.

FDA updates definitions: what constitutes a manufacturing site change?

16-Dec-2015 - The FDA is seeking comment on a draft guidance which outlines the administration’s thoughts on what constitutes a manufacturing site change.

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