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October 5, 2019updated 07 Oct 2019 3:16pm

September’s top news stories

Gavi Vaccine Alliance seeks $7. 4bn to immunise 300 million people and Researchers find new drug with promise for malaria treatment. Pharmaceutical-technology.com wraps up key headlines from September 2019.

Gavi Vaccine Alliance seeks $7. 4bn to immunise 300 million people

Gavi, the Vaccine Alliance initiated a $7.4bn fundraising drive to support the immunisation of 300 million children against 18 diseases, which could save up to eight million lives from 2021-25.

During the same period, governments of developing countries will invest $3.6bn into their vaccine programmes, which is an increase from $1.6bn in 2016-20.

Gavi’s first phase, starting in 2000, supported six vaccines. The support will increase to 18, including inactivated polio vaccine (IPV), rabies and multivalent meningococcal vaccines, by 2025.


Researchers find new drug with promise for malaria treatment

An international research team led by the University of Glasgow discovered a new drug that could kill the malaria-causing parasite, offering hope for the treatment of the disease.

The drug stops the activity of PfCLK3, an essential protein that controls the production and activity of other proteins required for the parasite’s survival.

According to researchers, this mechanism could help to prevent the spread of malaria.


Sumitomo Dainippon and Roivant form $3bn alliance

Japan-based Sumitomo Dainippon Pharma signed a memorandum of understanding (MoU) with healthcare technology company Roivant Sciences in a bid to provide new medicines to patients.

The partners will form the Sumitomo Dainippon-Roivant Alliance, which will be owned by the Japanese pharmaceutical company.

Sumitomo Dainippon will pay $3bn in an upfront payment to Roivant to ally. This payment includes the acquisition of an equity interest of more than 10% in Roivant.


Roche secures two EC approvals for Tecentriq in lung cancer

Roche received European Commission (EC) approval for Tecentriq (atezolizumab) in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (NSCLC).

Tecentriq is a monoclonal antibody that binds to PD-L1 and inhibits its interaction with PD-1 and B7.1 receptors to potentially facilitate T-cell activation.

EC approval is for the use of the drug with carboplatin and nab-paclitaxel in adults that have metastatic non-squamous NSCLC without EGFR mutant or ALK-positive NSCLC.


FDA approves Boehringer’s Ofev for rare lung disease

The US Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Ofev (nintedanib) medicine to slow the rate of pulmonary function decline in systemic sclerosis-associated interstitial lung disease (SSc-ILD) patients.

Systemic sclerosis is a rare autoimmune condition that results in thickening and scarring of connective tissue. It is known to affect approximately 100,000 people in the US and 2.5 million people worldwide.

Fibrosis associated with the disease impacts skin and internal organs, such as the lungs. Interstitial lung disease is a common manifestation that can be fatal and is known to be the primary cause of death in SSc patients.


UK initiates £200m genome project to address fatal diseases

The UK Government launched a £200m whole-genome sequencing project in alliance with pharmaceutical companies and health experts to tackle life-threatening diseases.

Building on genomics research’s potential to allow predictive and individualised healthcare, the UK aims to perform five million DNA analyses by 2024.

The project will sequence the genetic code of 500,000 volunteers at the UK Biobank to support better prevention, diagnosis and treatment of multiple fatal conditions such as cancer, diabetes, arthritis and heart diseases.


FDA to review ranitidine after detecting cancer-causing contamination

The US Food and Drug Administration (FDA) issued a statement regarding the safety of the drug ranitidine after the detection of N-nitrosodimethylamine (NDMA) in some samples.

Ranitidine is a histamine-2 blocker sold as a prescription and over the counter (OTC) drug. It reduces acid secreted by the stomach.

OTC ranitidine is used for prevention and relieving of heartburn caused by acid indigestion.


Lundbeck signs $1.95bn deal to buy Alder BioPharmaceuticals

Danish pharmaceutical company Lundbeck signed a definitive agreement to acquire all outstanding shares of US-based Alder BioPharmaceuticals for a maximum consideration of $1.95bn.

Lundbeck will make an upfront payment of $18 per share in cash, followed by $2 per share upon the European regulatory approval of Alder’s migraine drug eptinezumab.

Alder BioPharmaceuticals is working to discover, develop and commercialise therapeutic antibodies for the treatment of migraine. The company is developing eptinezumab as a preventive therapy for migraine in adults.


CHMP recommends AstraZeneca’s Qtrilmet for type 2 diabetes

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the marketing authorisation of AstraZeneca’s Qtrilmet to treat type 2 diabetes in adults.

Qtrilmet is a once-daily, oral therapeutic that comprises a combination of Forxiga (dapagliflozin), Onglyza (saxagliptin) and metformin hydrochloride extended-release.

Forxiga is a selective inhibitor of sodium‑glucose co-transporter 2 (SGLT2), while Onglyza blocks dipeptidyl peptidase‑4 (DPP‑4).


FDA approves first monkeypox vaccine Jynneos

The US Food and Drug Administration (FDA) approved Bavarian Nordic’s live, non-replicating Jynneos vaccine to prevent monkeypox and smallpox in adults who are at high risk of the infections.

Jynneos is said to be the first vaccine approved to prevent monkeypox worldwide. It is the only non-replicating vaccine to receive FDA approval for smallpox.

Made with attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), the vaccine is for subcutaneous administration. The virus cannot replicate in the body but can trigger an immune response.

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