The US FDA has issued a warning letter to CDMO Ei LLC stating that topical drugs and pesticides are being made in the same building and with shared equipment.
Regulatory agencies are doubling down on compliance – and withholding funds – as the clinical research industry enters an era of accountability and transparency, say NIH officials.
Marken has expanded its cryogenic services to support demand driven by an increasing amount of global cell and gene therapy clinical trials – a market projected to reach $363m by 2022.
Inadequate temperature control and a lack of ‘appropriately’ designed manufacturing equipment are among the GMP violations that landed Goran Pharma a warning letter.
The US FDA has issued a policy that provides the proper definition of an outsourcing facility in an effort to ensure compounded drugs are made under appropriate quality standards.
In a deal worth up to $538m, AstraZeneca has entered into an agreement with Luye Pharma Group for the sale and license of the rights to Seroquel and Seroquel XR in several markets.
Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.
The UK-based CRO RxCelerate continues to expand with its recent acquisition of The Cambridge Partnership for £1.45m ($1.96m) as it aims to carry out its vision of supporting virtual biotech companies.
To distance itself from its troubled past, Valeant Pharmaceuticals is set to change its name to Bausch Health Companies, marking an important point in the "turnaround process," says CEO.
AuroMedics Pharma LLC is voluntarily recalling two lots of injectable antibiotics following customer complaints of “red particulate matter” in the product.
WuXi STA has passed its first FDA inspection at its active pharmaceutical ingredient (API) development and manufacturing facility located in Changzhou, China.
The US FDA has issued Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. a warning letter, in which it says the API maker admitted to deleting test data by accident.
The US FDA has issued a warning letter to Mexican drugmaker Degasa SA. de C.V for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.
Johnson & Johnson has reported plans to cut costs across its supply chain as it looks to shifts focus from “older parts” of its portfolio to newer technologies and capabilities, such as in biologics, says CFO.
Regulators have published results from a six-year international active pharmaceutical ingredient inspection programme that Johnson Matthey says benefits companies and authorities.
Dr. Bertalan Mesko discusses the role of artificial intelligence in the future of health care, how patients are driving adoption – and the seemingly thin line between “healing” and “upgrading.”
The acquisition of Analytica Laser adds real-world effectiveness prediction and value assessment to Certara's service portfolio – as it aims to “tackle trial to real-world value translation,” says exec.
China is becoming a fundamental player and is expected to reach market parity with the combined top five European countries by 2022, though the US still dominates, says industry expert.
Pharma must look outward to innovate and find new areas of growth, as research and development productivity and returns on innovation continue to decline, says industry expert.
The US FDA has sent a warning letter to Tris Pharma, a New Jersey-based manufacturer that makes ADHD drug Quillivant XR (methylphenidate HCl) for Pfizer.
Regulations are changing across the globe as patients, the scientific community, and other stakeholders call for increased clinical trial data transparency.
The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.
With less than a year until the full implications of Brexit set in, Parexel consultants urge the industry to not wait – assess potential risks, such as to the clinical supply chain, and take actions to mitigate them.
The US Patent and Trademark Office has granted a notice of allowance for ‘shelf life’ timer technology used to protect time-sensitive biologic materials in transit.
Ubiquitous M&A activity in the pharmaceutical industry raises several concerns – with many scholars arguing that 70 to 80% of acquisitions end up destroying value.
Parexel’s new medical writing solutions offering will provide communications services throughout the drug development and commercialization process to help sponsors meet higher documentation quality standards, says VP.
Worldwide Clinical Trials has acquired the Continuum Clinical’s Late Stage research practice following a dramatic increase in demand for real-world evidence, says CRO.
The industry is set up to accelerate the availability of new patient options in a “new era of medicine”– though robust intellectual property protection is critical to continued innovation.
The R&D playbook is evolving as the industry looks to break down the silos between clinical and commercial operations – bringing commercial voices to the earliest phases of asset development.
World Courier has created personalized supply chain teams to support direct-to-patient, cell and gene therapy, and clinical trials execution as the company experiences double-digit growth.
The European Medicines Agency (EMA) has recommended the immediate suspension and recall of AbbVie and Biogen’s multiple sclerosis drug Zinbryta (daclizumab).
The Czech Republic, Greece, Hungary, and Romania have joined the EU-US Mutual Recognition Agreement, a deal which aims to simplify cross-Atlantic site inspections.
Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.
Dutch authorities say the EMA’s permanent headquarters will be completed by November 15, 2019 – more than seven months after the agency’s relocation deadline.
Amulet Capital Partners – owner of SynteractHCR – is expanding its presence in the outsourced pharmaceutical services industry, with a recent investment in the medical communications provider Peloton Advantage.
Tax policy reforms have made the US and UK attractive locations for drugmaker investment, says PwC’s Jean Delaney, but argued Ireland is “still well positioned on the tax front.”
