Med Prep Consulting execs committed fraud and violated the Federal Food, Drug and Cosmetic Act (FDCA) according to the US DoJ, which has accused the New Jersey compounder of knowingly selling drugs produced in unsanitary conditions.
As pipelines dwindle in a post-blockbuster world, pharma and biotech R&D operations are looking for new ways to take on non-traditional product development strategies that allow for less internal resources and increased efficiency while reducing costs,...
The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make the data transparent.
Sens. Tom Carper (D-Del.) and Pat Toomey (R-Penn.) reintroduced a bill that would permanently allow CROs (contract research organizations) to capture a share of the R&D tax credit.
XstalBio, a private biopharma services company, has patented the use of stabilisers in the manufacture of dry powders for biopharmaceuticals – an alternative to freeze-drying or spray-drying techniques.
Novartis’s Japanese unit has been ordered to temporarily halt production of drugs by Japan’s health Ministry as punishment for delayed reporting of side effects.
Fluctuations in regulations over the past few years have reduced the number of clinical trials run on the subcontinent, but now governing bodies are looking at new ways to attract trials and further control the industry.
The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from the WHO and ICH, academics contend in the British Medical Journal.
Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...
A new California bill introduced earlier this week would, for the first time, require pharma companies to unveil a number of unique operational costs as a way to better understand drug pricing.
Dublin-based CRO Icon saw its quarterly net revenue, backlog and income rise over the same quarter last year, all of which helped to boost its stock by about 10% on Wednesday.
Between May 2013, when Quintiles went public, and this week, newly public companies’ stocks in the biopharma outsourcing space have all seen their prices rise by more than 35%.
Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.
Shire has acquired privately-held Meritage for an upfront fee of $70m and additional contingent payments based on the achievement of development and regulatory milestones.
Following its recent IPO, INC Research delivered double-digit net service revenue growth for the year and further diversified its customer base when compared with previous years.
Huntingdon Life Sciences has announced it will change its name this year, but has not disclosed what its new moniker will be. So Outsourcing-pharma.com would welcome readers’ suggestions.
A register of clinical investigators can help eliminate bias according to Big Pharma Group Transcelerate, which has teamed with DrugDev to develop such a database.
The HIV drug API efaverinz could be made faster and more cheaply using continuous manufacturing according to the German team behind a new ‘assembly line’ production method.
The integration of Covance and LabCorp is beginning with the announcement that LabCorp will operate under two distinct segments: LabCorp Diagnostics and Covance Drug Development, LabCorp CEO Dave King said in a conference call last week.
In order to close Novartis’ $16bn purchase of GlaxoSmithKline’s portfolio of cancer treatments, the FTC (Federal Trade Commission) is requiring Novartis to divest all assets related to its potential BRAF and MEK inhibitor drugs to settle anticompetitive...
Synexus has been bought by its management in a private equity backed deal that sees Lyceum Capital relinquish control of the trial recruitment specialist.
‘Smart’ syringes that can’t be reused should be the drug and vaccine delivery technology of choice for healthcare programmes according to the WHO, which says needle reuse is spreading deadly infectious diseases.
An API and intermediates plant set up by Granules India and Ajinomoto Omnichem is a step closer to opening after an offical inauguration ceremony last week.
The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
MedImmune, the biologics R&D arm of AstraZeneca, and the US National Institute of Standards and Technology (NIST) have signed a five-year agreement to support research that will help advance drug discovery and biomanufacturing.
A potential Type 2 diabetes drug from Novo Nordisk has met the primary endpoint of a Phase II trial and shares of Emisphere Technology, which helped to formulate the oral version of semaglutide, jumped by as much as 70% on Friday.
In another sign that mobile health technology is beginning to take off, cloud-based solution provider Medidata is collaborating with Garmin to integrate its vívofit activity tracker with the Medidata Clinical Cloud.
The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part of efforts to further protect study subjects, experts say.
In its first earnings call since launching its IPO (initial public offering) in November, PRA Health Sciences reported consistent growth over last year.
CRO Covance's stockholders voted Wednesday to adopt the previously announced $6.1bn merger agreement providing for the acquisition of Covance by LabCorp at the special meeting of Covance stockholders.
The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
Swiss CMO Lonza and clinical-stage biopharma company arGEN-X have entered into a multi-product commercial license agreement for making arGEN-X’s therapeutic antibodies.
The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.
CRO Parexel on Wednesday announced the expansion of its clinical trial site alliance network, which includes investigator sites and Site Management Organizations (SMOs) that help the company quickly access and enroll patient populations for clients’ clinical...
Lupin will co-develop a rival to GSK’s Advair in the US and has licensed rights to an inhaled drug delivery tech competitor for Forest Labs’s Aerochamber.
SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.
Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.
China-based CRO WuXi PharmaTech has entered into a syndicated loan facility to borrow up to $165m from a consortium of banks in Asia to seek out new acquisitions.
CRO Theorem Clinical Research and service provider Biomedical Systems have formed a strategic partnership to expand the type of services available to their clients worldwide.
Fresenius Kabi has sold its cancer drug pharmacy network CFL GmbH to NewCo Pharma GmbH five years after spending €42m to buy compounding capacity in Germany.
Preclinical CRO Crown is acquiring all of Molecular Response’s existing PDX (patient-derived xenograft) models as well as 8,000 viable human tumors for model development.
