Integration of the Mapi Group has been initiated, Icon CEO Steve Cutler says, as the company looks to support customers facing increased pressure to demonstrate product value and safety.
Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July.
Boehringer Ingelheim and Philogen have signed a multi-target research agreement to discover and optimize new small molecule therapeutics for unmet medical needs.
A lyophilisation expansion announced in 2013 at an aseptic facility in Wasserburg, Germany has been delayed due to lengthy approval processes, says Recipharm.
API operations hit by the Petya cyberattack have not been restored according to Merck & Co Inc, which expects difficulties fulfilling some product orders and lower 2017 profits partly due to the hack.
Takeda has agreed to pay $100m (€85m) upfront for rights to make and sell to Tesaro Inc’s drug Zejula in Japan, South Korea, Taiwan, Russia and Australia.
The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.
A researcher at South Africa’s Stellenbosch University (SU) says biosurfactants made by bugs in municipal wastewater could help drug makers develop new antibiotics.
BASF SE has selected the Icertis Contract Management (ICM) platform to automate its contracting processes and improve visibility into contractual obligations and deviations.
Patient iP has been growing its Connected Site Network over the past two years – as it aims to curate one of the largest patient-centric, longitudinal clinical data sets in the world, says CEO.
Lonza Group AG has predicted it will generate annual revenue of CHF7.5bn ($7.9bn) by 2022, citing recent acquisition Capsugel and its new Visp-based Ibex manufacturing service as drivers.
Science Exchange has been certified under the EU-US Privacy Shield Framework after completing a seven-step process to demonstrate compliance with various data protection requirements.
An Israel-based contract research organization (CRO) is conducting a Ph II clinical trial for Axim’s cannabidiol (CBD) and Gabapentin chewing gum product.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
Tesaro Inc has hired STA Pharmaceutical Co. Ltd to supply intermediates for its recently approved, $117k-a-year, ovarian cancer drug Zejula (niraparib).
French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.
Takeda Pharmaceutical Company Limited and Schrödinger Inc. have formed a multi-target research collaboration that leverages Schrödinger’s in silico platform-driven drug discovery capabilities.
TPI Enterprises has bought Vistin Pharma ASA’s opiates and tabletting division for A$25.4m ($201.m) in a deal designed to expand the firm beyond its narcotic raw materials business.
The Switzerland-based biotech company has selected Verify Brand as its serialization software provider to meet the FDA’s – recently extended – DSCSA deadline.
Bioclinica has announced that the safety software company AB Cube has joined its eHealth App xChange – and is touting its platform as “the future of pharmacovigilance.”
Worldwide Clinical Trials is developing a pre-IND plan and designing pilot studies for evaluating the effectiveness of GB Sciences’ proprietary cannabis-based therapeutic, says CMSO.
The US Food and Drug Administration’s (FDA) decision to delay serialisation regulations shows drug companies and contract manufacturers are still unprepared, say industry representatives.
GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.
SQI Diagnostics Inc. has signed an agreement to commercialize a custom multiplexed assay for a Waltham, MA-based global biotechnology company's blood disorder drug program.
The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.
The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.
