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APIs (active pharmaceutical ingredients)

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Anti-fungal shows promise for cancer breakthrough in preclinical tests

21-Apr-2015 - An anti-fungal drug shows potential to treat a range of cancers, according to research from the Repurposing Drugs in Oncology (ReDO) project, but the drugmakers will need a financial incentive to pursue a licence for new indications.

Concerns climate change will see tick-borne diseases spread to the UK are legitimate, says PHE

15-Apr-2015 - Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.

Recipharm invests in metal-linked API delivery tech in Synthonics deal

15-Apr-2015 - Recipharm has invested $2m (EUR1.8m) in metal co-ordinated chemistry (MCC) specialist Synthonics in a deal that will also see it help develop the US firm’s range of targeted drug products.

Dispatches from BPI 2015

Pfizer's vetting process sorts the strategic CMOs from the casual flings

15-Apr-2015 - Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.

Abivax's ARV action could herald functional HIV cure, says firm

14-Apr-2015 - A drug candidate which prevents the export of viral RNA in infected cells could lead the way in developing a functional cure for HIV, according to Abivax.

International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines

13-Apr-2015 - In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and more.

API quality concerns prompt fines and drug recall orders in Taiwan

13-Apr-2015 - Thirteen Taiwanese drugmakers have been fined and ordered to recall products by regulators concerned the APIs they contain are food rather than pharma grade.

My oh Mylan! $29bn Perrigo deal would create 'unrivalled' manufacturing network

09-Apr-2015 - Mylan has bid $29bn (€27bn) to buy Perrigo in what the firm says will create a company with “unrivalled” manufacturing and supply chain capabilities across OTCs, generics and APIs.

Update

Pfizer, Amgen’s Form 483s listed among more than 100 issued by US FDA already in 2015

08-Apr-2015 - Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information Act) via the FDA.

Hospira cited for sterility issues in warning letter for Italian plant

08-Apr-2015 - Following a May 2014 inspection, US FDA officials have issued a warning letter with multiple cGMP (current good manufacturing practice) deficiencies for Hospira’s manufacturing facility in Liscate, Italy.

Biocon's Syngene in silent period but lays plans for API plant in India

07-Apr-2015 - Biocon subsidiary Syngene says it intends to build a commercial manufacturing plant for APIs and intermediates in Mangalore, India.

What's in a name? The results of our banned sex supplement quiz

01-Apr-2015 -   Learn more about pharmaceutical fakes at in-Pharmatechnologist.com's Anti-Counterfeiting Forum on April 16, 2016.

Onyx Scientific expands API facility on Phase I/II demand

01-Apr-2015 - A rise in demand for small scale APIs has driven Onyx Scientific to expand its GMP operations in North-East England.

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 - Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

‘Game changer’: latest GDP rules spell full traceability for APIs

26-Mar-2015 - Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.

AstraZeneca teams with Harvard to make human beta cells for drug screening

25-Mar-2015 - Sourcing human beta cells may soon no longer be a challenge for AstraZeneca diabetes researchers thanks to a new partnership with stem cell scientists at Harvard University.

update

Novasep joins Lonza as Mydicar API producer in deal with Celladon

25-Mar-2015 - Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

AbbVie bucks Puerto Rico departure trend with $30m expansion

25-Mar-2015 - AbbVie is investing $30m (€27m) in contract manufacturing facilities in Puerto Rico and plans to create 100 jobs over the next two years.

FDA plans new approach to manufacturer inspections in India

24-Mar-2015 - Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.

US diabetics pay most for drugs, but world’s poorest bear the biggest economic burden

23-Mar-2015 - Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month in a study assessing the diseases’ economic impact.

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