Middle East and Africa

Hikma Adds Sesen’s Vicineum To MENA Brands

 
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Hikma and Sesen Bio have struck a deal that will see Hikma distribute the Vicineum brand in the MENA region.

Global Pharma Guidance Tracker – Test sabbah

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: September 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – August 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: August 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

People On The Move: Appointments At Nestlé, Ascendis Health, Be-sup

 
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A round-up of the latest global health and wellness moves: Nestlé and Dr Reddy's name JV head; Be-sup hires comms and regulatory director; Ascendis Health appoints interim CFO.

WHO Urges Countries To Curb Spread Of Mpox With Vaccines, Therapeutics & Other Actions

 
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The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

Gavi Moves To Boost African Mpox Vaccine Supplies As Health Emergency Goes Global

 
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The vaccines alliance says its First Response Fund could be used to cover the cost of doses and has outlined plans for a vaccine stockpile. Some experts have criticized the slow rate of response to mpox and called for more solidarity on vaccine provision at global level.

Check Contract Manufacturers' GMP Compliance, US FDA Warns Eye Drop Firm, Lip Balm Provider

 

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

EU To Donate Mpox Vaccines To Africa As Public Health Emergency Is Declared

 
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The Africa CDC says the donation of more than 215,000 doses of mpox vaccine is a “crucial step” in tackling the latest outbreak.

WHO Invites Vaccine Manufacturers to Join Fight Against Growing Mpox Outbreak

 
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An emergency use listing means the vaccines can be approved for use in lower-income countries where they are not licensed, and will allow international organizations like Gavi and UNICEF to procure them for wider distribution.

Global Pharma Guidance Tracker – July 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: July 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.

EMA Awards Funding For Pan-African Drug Review Pilot

 
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A regulatory initiative underway in Africa is testing out continental-level assessments of new drug applications that its sponsors say could provide the foundations for a “robust and well-founded” African Medicines Agency.

Tackling The Challenge Of Malaria Clinical Trials In Africa

 
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Novartis leads the fight against malaria, pioneering innovative studies in sub-Saharan Africa to combat parasite resistance to current antimalarials.

Global Pharma Guidance Tracker – June 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

South Africa Drops J&J Bedaquiline Scrutiny After Generic Market Opens Up

 
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Johnson & Johnson’s actions to promote generic competition and lower the price for its crucial tuberculosis treatment, Sirturo (bedaquiline), have satisfied an investigation launched by South Africa’s Competition Commission.

Global Medtech Guidance Tracker: June 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Teva Agrees $750m Deal To Draw A Line Under Israeli Tax Tussle

 
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Teva enjoyed a favorable tax status for years in its domestic Israel. However, after the firm battled in court against challenges to its historic tax payments, Teva has now agreed a three-quarters-of-a-billion dollar settlement agreement with the Israel Tax Authority.

TVM Capital Boosts Boston Oncology Arabia’s Capacities With $35m Injection

 
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Following on from the recently announced closing of a Saudi Arabia-focused fund, TVM Capital has doubled down on its local efforts with a further $35m investment into Boston Oncology Arabia’s efforts.

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