SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Headlines > June 2016

« Previous month Next month »

Silk rockets and 3D printing: Researchers looks to transform drug delivery

30-Jun-2016 - Engineers from the University of Sheffield have developed 3D-printed silk 'micro-rockets' they say could be used to improve drug delivery.

Advaxis: Manufacturing, safety and efficiency key to developing cancer drugs

30-Jun-2016 - In-house manufacturing investments have been key to the clinical development of Advaxis’ oncology candidates, the firm says.

Moonshot and independence… A week in the life of the US FDA

30-Jun-2016 - An oncology centre to support the Moonshot Initiative, conflict-of-interest guidance and calls to become independent. Welcome to in-Pharmatechnologist’s US FDA round-up.

“There are units that are doing first-in-human studies that frankly have no business doing them”

DIA: Calls for set standards in Phase I studies following Bial trial tragedy

29-Jun-2016 - Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.

US FDA slams two Chinese API makers for quality systems and data issues

29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

Yellow fever outbreak: Sanofi looks to double vaccine production

29-Jun-2016 - A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa....

Swissmedic ramps up ad hoc inspections in 2015

28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.

Brexit: Indian firms worried but Big Pharma and EMA remain positive for now

Worried and bewildered: Brexit sparks uncertainty for Indian pharma in Europe

28-Jun-2016 - Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.

Also: Qiagen completes tender offer for Exiqon

Agilent Technologies to acquire assets of iLab Solutions

28-Jun-2016 - Agilent Technologies has acquired the assets of a cloud-based laboratory management software firm.

Serialisation regulations to impact all corners of pharma, says Recipharm

27-Jun-2016 - The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.

Magnetically controlled drug dissolves blood clots with fewer side effects

27-Jun-2016 - Researchers have developed a new magnetically controlled drug that can dissolve clots up to 4,000 times more efficiently than ordinary enzyme-based drugs.

Pfizer takes axe to Hospira network, exiting 'under-utilised' Colorado plant

27-Jun-2016 - Over 100 Colorado jobs could be lost following Pfizer’s decision to exit a former Hospira API plant by 2019.

DIA 2016

'Now is the time to include Japan' says Parexel

24-Jun-2016 - Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.

UK Biopharma looks to remain strong as Brexit leads to uncharted waters

24-Jun-2016 - The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.

Biogen in negotiations to sell 2,000L stainless steel plant in MA

23-Jun-2016 - Biogen will shutter a bioproduction facility in Massachusetts by the end of the year if it fails to find a buyer.

BIO 2016

Commissioner Califf commits to tackling staffing issues at US FDA

23-Jun-2016 - Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.

India to rewrite 75-year old drug laws with an eye on business, biologics and devices

23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.

update

Three drug wholesalers have failed GDP checks according to Czech regulator

22-Jun-2016 - Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.

Opko extended-release kidney disease drug approved after Catalent 483 delay

22-Jun-2016 - The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

AMRI licenses Teewinot's cannabinoid analytical standard production tech

22-Jun-2016 - AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.

Juniper invests in tablet technology for UK site

22-Jun-2016 - Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.

Novacap subsidiary starts work on pharma-grade sodium bicarbonate plant in Singapore

21-Jun-2016 - Novacap has started building a sodium bicarbonate production facility in Singapore, citing Asian drug and food manufacturers as target customers.

Scancell stops dosing in long-term trial of cancer vaccine SCIB1

21-Jun-2016 - Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.

Collegium's OxyContin rival is first drug using Deterx anti-abuse tech launched in US

21-Jun-2016 - Collegium Pharmaceutical has launched the first product formulated using its Deterx anti-abuse technology in the US.

Comparing ClinicalTrials.gov and FDA review for accuracy and completeness

20-Jun-2016 - Clinical trial sponsors are required by law to report results to ClinicalTrials.gov; however it’s not clear if these posts are complete and accurate.

« Previous month Next month »

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...