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Manufacturing and Production

Philippines' FDA halts sales of Sanofi's dengue vaccine

The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug Administration accused the French drugmaker of failing to comply with its stipulated post-marketing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

San Francisco scientists use CRISPR to develop stem cells invisible to the immune system

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.

"Game-changing" osteoarthritis drug receives £675k funding from Innovate UK

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 to establish national rare disease network

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.

Japanese researchers to trial stem cell therapy in four patients with serious spinal injuries

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.  

Beating the flu

Published on 18/02/19 at 01:12pm

On 14 January, the European Commission issued marketing approval for Flucelvax Tetra, the first cell-based, quadrivalent influenza vaccine. Pharmafocus spoke to Seqirus’ Dr Rajaram on the challenges of tackling the H3N2 influenza virus, as well as threats to vaccination in general.

What advantages does Flucelvax offer compared to similar products?

Top Ten most popular articles on Pharmafile.com this week!

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.

J&J acquires lung cancer-focused robotics firm Auris Health in potential $5.75m deal

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.

Sanofi name current CMO Dr Ameet Nathwani as new Chief Digital Officer

Published on: 12/02/19

French firm Sanofi has appointed pharma veteran Dr Ameet Nathwani to the position of Chief Digital Officer.

In his new role, which he will take on in addition to his current responsibilities as Executive Vice President, Chief Medical Officer, Dr Nathwani will be responsible for enhancing Sanofi’s digital strategy as the company integrates digital technologies and medical science in an effort to improve patient outcomes.

Gilead's CAR-T therapy Yescarta rejected for NHS use in Scotland

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.

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