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Breaking News on Global Pharmaceutical Technology & Manufacturing

Kitov saves time and money by filing combo pill through 505(b)(2) pathway

11-Feb-2016 - Kitov Pharma says filing combo therapy for US FDA review will take less than three years and cost less than $12m thanks to 505(b)(2) pathway. 

US FDA halts CTI BioPharma's Ph III cancer drug trial after patient deaths

11-Feb-2016 - The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”

President's US FDA budget a 'barren request'

11-Feb-2016 - Under the President’s FY 17 proposed budget request, the FDA would receive $2.743bn in budget authority appropriations – and many are frustrated with the lack of funding.

Recipharm to invest €40m in serialization tech ahead of EU and US track and trace rules

10-Feb-2016 - Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.

AstraZeneca: China formulated anaemia drug on fast-track, but timeframes vague

09-Feb-2016 - AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.

Janssen averse to extrapolation as FDA sits to review Remicade biosimilar

09-Feb-2016 - Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.

Pfizer announces executive leadership team for Allergan merger

09-Feb-2016 - Pfizer has announced the executive leadership team for the combined Pfizer and Allergan business, which will be the world’s largest pharma company. 

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

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

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.

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.

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