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WHO asked to probe vaccine prices and competitive landscape

01-Jun-2015 - The WHO has yet to decide how to investigate if barriers to competition are preventing vaccine price cuts after World Health Assembly members committed to probe the jabs industry.

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]

Draft guidance stresses need for quality in development of gene therapies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.

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 to make illegal narcotics is vital.

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.

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.

EMA drug reviews must be independent of pharma influence as an example to others, says AMF

18-May-2015 - The EMA's assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)

Hospira approval puts Pfizer on track to close $17bn deal by year's end

18-May-2015 - Pfizer is set to close its $17bn (€15bn) acquisition by the end of the year after receiving the thumbs up from Hospira shareholders.

Lack of talent will hamper continuous manufacturing adoption, says MIT Prof

13-May-2015 - A lack of scientific talent will hold pharma back from adopting continuous manufacturing despite the imminent opening of regulatory pathways, says an MIT Professor.

EMA: clinical data may not be needed for topical comparisons

13-May-2015 - The EMA (European Medicines Agency) is changing the way it assesses quality of topical drugs for marketing authorisations.

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office of the Inspector General (OIG).

Three-way collaboration to offer packaging serialisation ahead of EU Directive

06-May-2015 - Schott, Heuft and GEA have teamed up to offer drugmakers a serialisation service for primary packaging to help with EU anti-counterfeiting requirements.

IPEC says confusion around FDA review of excipients could delay ANDA review cycles

05-May-2015 - Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient Database (IID), as well as other agency policies and guidance on the review of inactive ingredients in ANDAs (Abbreviated New Drug Applications) “continue to create confusion for the pharmaceutical industry,” according to a position paper from IPEC-Americas (International Pharmaceutical Excipients Council). 

FDA calls on manufacturers to begin switch from batch to continuous production

01-May-2015 - Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s CDER Director Janet Woodcock told congressmen in a hearing Thursday. 

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