The pharma industry briefing

The latest news, approvals and clinical trials you need to know about this month

Data:
News
in Numbers

 $300,000  

The controversial new yearly price of Catalyst Pharmaceuticals’ life-sustaining rare disease drug Firdapse

17

The number of companies that the FDA has taken action against for illegally selling products claiming to treat Alzheimer’s disease

£10m 

The sum raised by Grey Wolf Therapeutics to develop therapies that increase tumour visibility

60%

The percentage that Sanofi and Regeneron have cut the price of the anti-cholesterol drug Praluent

763,000 

The estimated number of tablets covered by the recall of the valsartan-containing blood pressure drug Amvalo in Japan

Data:
News
in Numbers

 $300,000 

The controversial new yearly price of Catalyst Pharmaceuticals’ life-sustaining rare disease drug Firdapse

17  

The number of companies that the FDA has taken action against for illegally selling products claiming to treat Alzheimer’s disease

£10m 

The sum raised by Grey Wolf Therapeutics to develop therapies that increase tumour visibility

60%

The percentage that Sanofi and Regeneron have cut the price of the anti-cholesterol drug Praluent

763,000 

The estimated number of tablets covered by the recall of the valsartan-containing blood pressure drug Amvalo in Japan

 Johnson & Johnson to provide price of popular drug in TV ads

Johnson & Johnson will become the first drug maker to include the price of a prescription drug in TV ads.

The pharmaceutical titan will provide both the list price and potential patient costs for its most frequently prescribed medicine, Xarelto, a blood thinner, starting in March.

Source: CNN

Samsung Bioepis forms new alliance to expand in China

Samsung Bioepis has signed a licensing deal with healthcare-focused private equity firm C-Bridge Capital to accelerate expansion in China.

The agreement involves the biopharmaceutical company’s SB11, SB12 and SB3 biosimilar candidates, which reference Lucentis (ranibizumab), Soliris (eculizumab) and Herceptin (trastuzumab) respectively.

Source: Samsung Bioepis

 ‘Trojan horse’ cancer drug shows promise in multiple tumour types

A new type of cancer drug that acts as a ‘Trojan horse’ to get inside tumour cells has shown promise in patients with six different cancer types.

In patients with advanced, drug-resistant cancers, over a quarter with cervical and bladder tumours, and nearly 15% with ovarian and lung tumours, responded to the new treatment.

Source: Pharmaphorum

 Call for retraction of 400 scientific papers amid fears organs came from Chinese prisoners

A world-first study has called for the mass retraction of more than 400 scientific papers on organ transplantation, amid fears the organs were obtained unethically from Chinese prisoners.

The Australian-led study exposes a mass failure of English language medical journals to comply with international ethical standards in place to ensure organ donors provide consent for transplantation.

Source: The Guardian

Approvals

 Cablivi (caplacizumab-yhdp)  

The US Food and Drug Administration has approved Sanofi’s Cablivi (caplacizumab-yhdp) to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood clotting disorder.

Source: Sanofi

Wixela Inhub

The US Food and Drug Administration (FDA) has approved Mylan’s generic version of GlaxoSmithKline’s (GSK) asthma treatment Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

Dubbed Wixela Inhub, Mylan’s treatment is the first generic of Advair. The FDA approved three dosages of the generic inhaler for twice-daily asthma therapy in patients aged four years and older.

Source: Mylan

Ajovy (fremanezumab) 

Teva Pharmaceutical Industries has secured positive recommendation from the European Medicines Agency panel to grant a marketing authorisation for its drug Ajovy as a prophylaxis of migraine.

Ajovy is a humanised monoclonal antibody designed to bind to the calcitonin gene-related peptide ligand and prevent its binding to the receptor.

Source: The Pharma Times

 Vizimpro® (dacomitinib) 

Pfizer has received positive opinion for Vizimpro® (dacomitinib) from the European Union’s Committee for Medicinal Products for Human Use for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations.

Source: Pfizer

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