Data integrity issues at Synchron Research Services spurred the European Medicines Agency to recommend the suspension of 100 drugs. Synchron, an India-based CRO, runs quality control tests for generics from several manufacturers. The firm has faced similar critiques from the US Food and Drug […]
Top Pharma Companies Form Coalition to Increase Access to Cancer Therapies in Developing Countries
Less than half of the cancer therapies deemed essential by the World Health Organization are available in low- and lower-middle-income countries (LLMICs). The newly formed Access to Oncology Medicines (ATOM) Coalition seeks to address this issue. The coalition, led by the Union for International […]
Voluntary Recall Guidance Released by FDA
The US Food and Drug Administration (FDA) issued its final guidance in April on initiating voluntary recalls for drugs, biologics, and medical devices. Although largely in line with the previous draft guidance issued in April 2019, the agency made changes based on public comments. The non-binding […]
Gilead Places Restrictions on 340B Drug Pricing for Hepatitis C Treatments
The drugmaker Gilead cut off 340B discounts for certain hepatitis C drugs to some hospitals if they do not provide claims data to their specifications. The drugs, which include Epclusa, Solvadi, Vosevi, and Harvoni, previously qualified for 340B pricing discounts, but the manufacturer accuses […]
Martin Shkreli Released Early; Transferred to Halfway House
Martin Shkreli, known as “Pharma Bro,” has been released from federal prison early. Shkreli, known for his smug demeanor, was convicted of securities fraud after becoming a target of near-universal scorn for price-gouging the life-saving HIV drug, daraprim, by over %4,000. Shkreli’s early release […]
Bridging the Innovation Gap with Biopharma Partnerships
With impending patent expirations and increased drug development times, the biopharma industry faces an innovation gap. Bridging this gap and maintaining or increasing the pipeline replenishment rate is essential for revenue growth. However, this rate is also falling, with the 25 top biopharma […]
Learning from Big Pharma to Optimize Psychedelic Drug Development
During a post-earnings conference call yesterday, May 17th, executives Atai Live Sciences N.V. explained what they’ve learned from Johnson & Johnson’s Spravato launch. The launch of Spravato, an esketamine treatment, was marred by its high price, inpatient delivery, and addiction potential, […]
Roche and Bluebird Bio Reach Sickle Cell Gene Therapy Trademark Settlement
The trademark infringement lawsuit between Roche and Bluebird Bio has been settled. The case surrounded Bluebird’s “Be the Spark,” advertising campaign for its sickle cell gene therapy. Roche claimed this name was similar to its own gene therapy division, Spark Therapeutics, and therefore infringed […]
Survey: Pharma Drives Innovation in Digital Health but Doesn’t Always Stick the Landing
A recent survey of 450 healthcare executives found that 92% agreed that pharma-sponsored digital health solutions can add value to patients and providers. However, only 4% of respondents believed that digital project launches are usually successful. This doubt was paired with a deprioritization of […]
UCB’s Psoriasis Drug’s FDA Application on Pause Due to Facility Inspection Issues
The US Food and Drug Administration (FDA) has temporarily halted the approval process for UCB’s psoriasis drug bimekizumab on concerns with facility inspections. This is the second delay UCB has faced thus far related to inspections, with the agency postponing the company’s application last October […]
