Skip to NavigationSkip to content

Sandoz

Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection

The FDA has authorised the availability of Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar version of Amgen’s Neulasta, it has emerged.

The approval covers the same approved indications as its reference product: decrease the incidence of infection caused by febrile neutropenia – a condition responsible for over 60,000 hospitalisations in the US each year – in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Sandoz acquires global commercialisation rights to Polpharma's multiple sclerosis biosimilar

Sandoz has revealed that it has sealed a deal with Polpharma Biologics to commercialise the latter’s proposed biosimilar version of natalizumab around the world. The biosimilar product is currently undergoing clinical testing at Phase 3 in the treatment of relapsing-remitting multiple sclerosis (RRMS). 

Under the agreement, Polpharma will handle development, manufacturing and supply responsibilities. Following approval from regulatory agencies, Sandoz will handle marketing and distribution duties across all markets exclusively.

Novartis aims to solve EpiPen shortage with generic launch of Symjepi to US pharmacies

Novartis has announced the immediate availability of its generic epinephrine auto-injector in pharmacies throughout the US, as it moves to remedy the nation’s shortage of the potentially life-saving drug.

The shortage, which has now gone on for an entire year, hinges on the availability of Mylan’s EpiPen, the most common and well-known version of the drug, in what the FDA has characterised as “manufacturing delays”. The problem, according to Mylan, lies at the feet of Meridian Medical Technologies, a Pfizer subsidiary that manufactures the devices.

Top Ten most popular articles on Pharmafile.com this week

On the day that UK Prime Minister Theresa May announces her resignation, we look back on the week's biggest stories in the pharmaceutical industry.

Sandoz is first multinational to secure generic approval under new Chinese guidelines

Sandoz has revealed that its generic statin rosuvastatin, known in its branded incarnation as Crestor, has been given approval in China from the country’s National Medical Products Administration (NMPA).

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

The Institute for Cancer Research (ICR) called for new measures to increase the speed with which patients in the UK access innovative cancer drugs, this week. The institute suggested a new approach to funding models was necessary in order to encourage innovation.

The call came as Pfizer’s head of immune-oncology joined cancer focused firm Aduro Biotech as the company’s new CMO. The move may lead to new and innovative immunotherapies. Meanwhile GSK exec Richard Saynor was named as Novartis subsidiary Sandoz’ new CEO.

Senior GSK exec Richard Saynor revealed as new Sandoz CEO

Novartis has seen a major leadership change within its business, as the company announced that senior GlaxoSmithKline exec Richard Saynor would be stepping up to lead Sandoz, its biosimilars and generics division, as CEO from no later than 1 August.  

He will step into the position which was originally vacated by ex-CEO Richard Francis at the end of March. The role has been filled on an interim basis since then.

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

This week was a bad week for clinical trials. While the FDA put Roche and AbbVie’s multiple myeloma trial on hold after a number of patient deaths; Biogen and Eisai pulled a study of an Alzheimer’s drug after forecasts showed it wasn’t likely to succeed. Pfizer and Merck then discontinued a Phase 3 trial of avelumab as a treatment for advanced ovarian cancer in combination with chemotherapy.

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

The US Department of Justice has launched an investigation into the sales and marketing practices of San Diego firm Acadia Pharmaceuticals in relation to Nuplazid, a psychosis drug for those with Parkinson’s disease.

Personal genomics company 23andMe, this week announced they would offer reports on customer’s likelihood they would develop type 2 diabetes. Meanwhile researchers published results showing a new class of drugs offered similar efficacy to statins.

Sandoz CEO Richard Francis to step down

Richard Francis is set to step down his role as Chief Executive of Novartis’ generics arm Sandoz after five years’ in the role, citing “personal reasons” for his departure, its parent company announced in a statement.

Francis arrived in the role in 2014, following a 13-year tenure at Biogen, where he most recently served as Senior Vice President of its US commercial organisation. Francesco Balestrieri, the current Region Head Europe at Sandoz, will take over the reins at the company on an interim basis, it was also confirmed.

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches