This week, the FDA approved Novartis’ (NVS - Free Report) potential blockbuster eye drug, Beovu. J&J (JNJ - Free Report) submitted a regulatory application seeking label expansion approval of its plaque psoriasis drug, Stelara for pediatric patients. Pfizer (PFE - Free Report) , Novo Nordisk (NVO - Free Report) and Glaxo (GSK - Free Report) announced licensing deals.
Recap of the Week’s Most Important Stories
FDA Approves Novartis’ New Eye Drug: The FDA granted approval to Novartis’ ophthalmology drug, Beovu (brolucizumab) injection to treat wet age-related macular degeneration (AMD). Novartis claims that this anti-VEGF therapy offers greater fluid resolution as compared to Regeneron/Bayer’s market-leading drug Eylea. The FDA approval was based on data from the phase III HAWK and HARRIER studies, in which Beovu demonstrated significant advantages over Eylea.
Meanwhile, Novartis announced data from the phase IIb dose-finding study, which showed that more patients treated with its investigational monoclonal antibody, ligelizumab, were completely symptom-free from chronic spontaneous urticaria compared to Xolair (300 mg), which Novartis markets together with Roche.
J&J Files sBLA for Stelara in Adolescent Patients: J&J submitted a supplemental Biologics License Application (sBLA) to the FDA, seeking approval of Stelara for the treatment of pediatric patients (6 to 11 years of age) with moderate-to-severe plaque psoriasis. Stelara is already marked for adolescents and adults with moderate-to-severe plaque psoriasis. Stelara is also marketed to treat adults with active psoriatic arthritis and moderate-to-severe Crohn's disease.
Meanwhile, a Philadelphia jury ordered J&J to pay punitive damages of $8 billion to a man who claimed that the use of its antipsychotic drug, Risperdal caused him to develop breasts. The lawsuit filed by Nicholas Murray claimed that J&J did not warn of the risk that young men using Risperdal can develop enlarged breasts. J&J responded by saying that the award was “grossly disproportionate" and was confident that the jury verdict will be overturned in the court.
Pfizer, Glaxo and Novo Nordisk Sign New Deals: Pfizer in-licensed global rights to Akcea Therapeutics’ investigational antisense therapy AKCEA-ANGPTL3-LRx which is being evaluated in a phase II study as a treatment for patients with type II diabetes, hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD). AKCEA-ANGPTL3-LRx is designed to reduce the production of a protein in liver. Akcea is an affiliate of Ionis Pharmaceuticals and the companies will receive an upfront payment of $250 million from Pfizer, which will be split equally between the two companies. This apart, they will be entitled to milestone payments of up to $1.3 billion as well as royalties.
Novo Nordisk signed a three-year research deal with bluebird bio to develop in vivo genome editing candidates for hemophilia and other severe genetic diseases. Per the deal, bluebird bio’s new platform technology — mRNA-based megaTAL technology — will be utilized to create a highly differentiated approach to treat severe genetic diseases. No financial terms of the deal were disclosed.
Glaxo also announced a five-year collaboration with small biotech Lyell Immunopharma to develop next generation cancer cell therapies.
The NYSE ARCA Pharmaceutical Index rose 0.4% in the last five trading sessions.
Last week, all stocks were in the green, except J&J and Lilly (LLY - Free Report) . Bristol-Myers (BMY - Free Report) was the biggest gainer (2.5%) while J&J declined the most (1.6%).
In the past six months, Bristol-Myers has risen the most (11.4%) while Pfizer lost the most (14.2%).
(See the last pharma stock roundup here: JNJ’s Opioid Settlement, FDA Updates for AZN, GSK, MRK, RHHBY)
What's Next in the Pharma World?
Watch out for J&J’s third-quarter results and regular pipeline and regulatory updates next week.
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