Manufacturing and Production

The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug Administration accused the French drugmaker of failing to comply with its stipulated post-marketing requirements.

The decision means that all sales, distribution and marketing of Sanofi’s product in the country are currently on hold. The drugmaker is being reprimanded for what FDA Director General Nela Charade Puno called a “brazen defiance” of his organisation’s directives.

Scientists at UC San Francisco have used the gene editing tool CRISPR Cas9 to manufacture pluripotent stem cells (stem cells that can be generated directly from adult cells) that are functionally invisible to the immune system.

Pluripotent stem cells are particularly promising due to the fact that they can  be manufactured more efficiently. The 'universal stem cells' thus bring the promise of regenerative medicine one step closer to becoming a reality.

A novel and potentially “game-changing” oral therapy for the treatment of osteoarthritis (OA) has received a £675,000 cash injection from Innovate UK.

The funding will help support the enactment of a clinical of study to evaluate the drug’s safety and efficacy, undertaken by a partnership of AKL Research and Development (AKLRD) and the University of Liverpool’s Clinical Trials Unit.

China is set to establish a national collaborative network of hospitals for rare disease diagnosis and treatment to promote early detection and effective treatment of rare diseases.

The initiative, announced by the National Health Commission, will see 324 hospitals, chosen for their capacity and experience in treating patients with rare disease, participate in the network.

The network will facilitate the timely transfer of difficult and complicated cases between hospitals and the allocation of quality medical resources for patients.

The Japanese health ministry has approved a study testing the use of induced pluripotent stem (iPS) cells to treat four patients with serious spinal cord injuries, according to researchers at Keio University.

The “unprecedented, world-first clinical trial” is scheduled to begin later this year. The study will enrol four adults who have lost all motor and sensory function as a result of sports or traffic incidents.

The initial four patients will have suffered their injuries within 14 and 28 days of enrolment.  

News that the FDA’s advisory panel had recommended Janssen’s intranasal esketamine spray Spravato as a treatment for treatment resistant depression, took the top spot this week. The therapy, based on party drug ketamine, may act as a significant breakthrough in the neglected area of mental health.

Other news saw England’s chief medical officer Dame Sally Davies, who is leaving her current role to become Master of trinity College Cambridge, suggest that as many as one third of antibiotics may be prescribed inappropriately.

In a bid to bolster its footing in providing surgical treatments, Johnson & Johnson has announced it will acquire robotics specialist Auris Health via its subsidiary Ethicon in a deal worth potentially $5.75 million in cash.

This total value breaks down into an upfront cash payment of $3.4 billion and $2.35 billion in milestone payments.

It’s bad news for Scottish patients living with aggressive forms of non-Hodgkin lymphoma (NHL) as it emerges that the Scottish Medicines Consortium has chosen to reject Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel).

The decision means that patients who may have exhausted all other avenues of treatment will not be able to receive the treatment on the NHS in Scotland, with many not expected to survive longer than six months in these cases.