CRO Parexel International has acquired all of the outstanding equity securities of privately-owned and UK-based ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services.
Including explosion protection in initial facility plans can save money in the long-term, according to Rembe, especially as drugmakers continue to work with more volatile ingredients.
Flexible inkjet printing and personalized medicine will grow the market for orodispersible delivery technologies according to experts at a conference in Germany this week.
Campaigning group Alltrials has reiterated its call for the EMA to prevent "excessive redaction" and to let researchers print clinical trial data without fear of litigation ahead of the Agency’s vote on its access policy later today.
Boehringer Ingelheim is investing more than €100m ($126m) at its Dortmund, Germany site to expand production capacity for its Respimat inhaler, which is the third time in the past four years that the company has made a capacity-expanding investment at...
China-based WuXi PharmaTech has acquired CRO XenoBiotic Laboratories (XBL) to bolster its bioanalytical and DMPK (Drug Metabolism and Pharmacokinetics)/ADME (absorption, distribution, metabolism, and excretion) services. Financial terms were not disclosed....
Catalent has urged industry and academia to share knowledge about delivery technologies to help improve drug efficacy as it signs a deal to develop ADHD treatments for Cingulate.
The world is getting larger, at least it is in terms of the pharmaceutical industry, according to execs who cite security concerns when shipping to new markets as the top logistics worry.
Evotec has announced positive milestone news this week, revealing that efforts to develop an endometriosis drug with Bayer have moved into preclinical testing.
An ex RPS employee who claimed he was sacked after discovering the CRO was unlawfully storing potential employees’ personal data has settled his lawsuit and withdrawn allegations of wrongdoing.
The acquisition of Shasun Pharmaceuticals will add API production and contracting services to Strides Arcolab, and according to Shasun’s CEO no jobs will be lost.
Indian generic manufacturer Marck Biosciences has received a warning letter from the US FDA for failing to pay its annual facility fees for the past two years, which for foreign fixed-dose formulation facilities in 2014 was $235,152.
Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.
In a sign of further industry consolidation, CRO Chiltern has acquired Pacific Clinical Research, a pan-Asian CRO based in Singapore. Financial terms of the deal were not announced.
Hampered by manufacturing issues, Impax Laboratories has decided to settle a lawsuit over allegations related to the issues in order “to eliminate the uncertainty, distraction, burden and expense of further litigation,” the company said in a SEC filing.
As more than half a dozen companies are now vying to help treat and vaccinate Ebola victims in West Africa, where nearly 3,000 people have died from the illness, GlaxoSmithKline is taking the lead in getting product manufactured.
The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”
The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.
Merck KGaA’s acquisition of Sigma-Aldrich is testament to Big Pharma’s growing interest in personalized medicine says Horizon Discovery, which has bought Sage Labs for $48m (€38m).
Fraudsters who hoodwinked Medidata Solutions into transferring $4.8m to an "overseas" account this month did not access customer data says the clinical trial IT firm.
CRO PPD has exercised its option to acquire the remaining minority ownership interest of X-Chem for an undisclosed sum. X-Chem will continue to operate as a small molecule discovery company with its entire existing staff and management team.
At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated.
The opening of a global IT centre in India will bring services back in-house, but AstraZeneca says it is not changing its outsourcing strategy for R&D and manufacturing.
Acorda has gained a pulmonary delivery technology and a GMP manufacturing site in Massachusetts along with a Parkinson’s disease candidate in its $525m (€410m) acquisition of Civitas.
The rarity of medical research reanalysis and the extent to which reanalysis changes the original findings has two physicians calling for more transparency in an editorial in this month’s JAMA (Journal of the American Medical Association).
The Medicines Manufacturing Industry Partnership (MMIP) between the ABPI (Association of the British Pharmaceutical Industry), BIA (BioIndustry Association) and a number of companies aims to make the UK a more attractive destination for pharma manufacturing.
Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...
Newly public Horizon Discovery Group says it is looking for more acquisitions to become a fully integrated products, services and research provider as revenues soars 35%.
The market opportunity for each Indian drugmakers granted a license to manufacture Gilead’s hepatitis C drug Sovaldi could be worth over $600m, an analyst has calculated.
The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.
Hundreds of workers brought in to help fix manufacturing issues at a Boehringer Ingelheim facility will not be affected despite the firm looking to shave 600 jobs in a €450m ($580m) cost-cutting initiative.
Life science sector consolidation is a concern for some biomanufacturers, who say mega mergers like Merck KGaA’s $17bn acquisition of Sigma-Aldrich will limit their ability to negotiate on prices.
As the US Drug Supply Chain Security Act (DSCSA) traceability requirements become mandatory in 2015, standards group GS1 is offering a 137-page guideline to help manufacturers follow the new stipulations.
More commentary on the US FDA’s informed consent draft guidance is trickling out, this time with ACRO (Association of Clinical Research Organizations) and the Dana Farber Cancer Institute offering their take on what should be included in the final guidance.
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a third organization in Mexico.
CRO Covance and Fresenius subsidiary Frenova Renal Research are collaborating to find more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).
