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Headlines > May 2015

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3D printed scaffold could free diabetic cell transplant recipients from immunosupressive meds

28-May-2015 - Dutch scientists have 3D printed a protective scaffold that could make cell transplant-based diabetes treatment more successful and eliminate the need for immunosupressive drugs.

$100m API investment a boost to Gilead's in-house capacity

28-May-2015 - Sovaldi maker Gilead Sciences has opened a new laboratory and is investing a further $100m (€91m) for API manufacturing at its site in Canada.

EC competition concerns will not stop $17bn Sigma-Aldrich deal, says Merck

28-May-2015 - Merck KGaA is confident it will close the $17bn acquisition of Sigma-Aldrich in mid-2015 despite competition concerns from the European Commission (EC).

Live: European Infrastructure for Translational Medicine conference in Amsterdam

28-May-2015 - [View the story "Many languages, same goal: World's translational medicines experts meet in Amsterdam" on Storify]

Novartis to assess biologics with micro-sugar-needle delivery tech

27-May-2015 - Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.

April US chemical output for pharma down says ACC; SOCMA welcomes R&D tax credit move

27-May-2015 - US production of chemicals for the drug industry fell in April according to data released days after renewed calls for permanent tax breaks to help American manufacturers compete globally.

Lonza set to get commercial Adva-27a contract if cancer drug is approved

27-May-2015 - Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says...

Grace: silica gel plant certification will cut customer audit burden

26-May-2015 - WR Grace says certification for its excipient plant in Germany will reduce the audit burden faced by drug industry customers.

Intertek opens new drug stability testing facility citing demand and bigger med devices

26-May-2015 - Intertek has opened a new stability facility citing demand for bespoke drug and device services like abuse potential assessments and stress testing.

Draft guidance stresses need for quality in development of gene therapies

25-May-2015 - The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.

PEOPLE ON THE MOVE

Pfizer research veteran moves to UK biotech

25-May-2015 -

EMA re-confirms drug suspensions due to faulty trial data from GVK Biosciences

25-May-2015 - Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical...

US scientists vow to answer CRISPR’s sticky moral questions

22-May-2015 - Top science academics have launched an initiative to consider emerging human gene-editing tools such as CRISPR-Cas9.

US Senator dubs Sovaldi price ‘abuse of power’ and calls to defy patent

21-May-2015 - US Senator Bernie Sanders has called on the Secretary of Veteran Affairs to invoke a law which would break Gilead’s patent on Hepatitis C drug Sovaldi and allow cheaper generics....

Industry calls for global alignment of qualification and validation guidelines

21-May-2015 - EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.

Home-brew morphine: Is opiate production about to get way too easy?

21-May-2015 - Access to yeast strains modified to produce opiates for cheaper, more effective pain meds must be strictly controlled according to researchers who warn that stopping criminals using such API manufacturing routes...

Inhalable biologics: Serendex formulates with Novozymes’ Recombumin

20-May-2015 - Serendex Pharmaceutical is a step closer to developing an inhalable biopharmaceutical for lung disease after adopting stabilising tech from Novozymes.

EMA: show clinical justification for combination drugs

20-May-2015 - The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).

Janssen and Rutgers expand R&D as continuous manufacturing picks up steam

20-May-2015 - Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realised, says Rutgers University which has received an R&D grant from J&J.

Two sterile compounders hit by FDA warning letters for violating cGMP

20-May-2015 - The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.

Cancer-hunting shark proteins are the future of drug conjugation, says Almac

19-May-2015 - Almac is coupling tiny shark proteins to a cancer-killing warhead to develop an oncology drug, saying their small size makes for easy conjugation. 

European freeze-drying market heats up: Symbiosis invests citing high demand

19-May-2015 - Symbiosis Pharmaceutical Services has launched a bulk freeze drying offering for APIs and intermediates, citing new contracts as a driver for the investment.

PEOPLE ON THE MOVE

Top lawyer moves to Amgen

19-May-2015 -

Endo buys Par, Lupin enters Brazil... it's been a busy week in generics

19-May-2015 - Endo’s $8bn takeover of Par Pharmaceutical is expected to shake-up the generics sector, while Lupin is expanding its South American network – welcome to In-Pharmatechnologist’s M&A round-up.

News in brief

US FDA investigates AZ, J&J and B-I's type 2 diabetes drugs after adverse events

18-May-2015 - Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.

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