J& J ( JNJ Quick Quote JNJ - Free Report) announced plans to buy back $5 billion worth of shares and reaffirmed its profit outlook for 2022. Pfizer ( PFE Quick Quote PFE - Free Report) and its partner BioNTech ( BNTX Quick Quote BNTX - Free Report) received a positive recommendation from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) for authorizing their Omicron BA.4 and BA.5-adapted COVID booster vaccine. The CHMP also recommended granting marketing approval to two of AstraZeneca’s ( AZN Quick Quote AZN - Free Report) products, COVID-19 antibody cocktail drug, Evusheld and its investigational RSV vaccine, Beyfortus (nirsevimab) Recap of the Week’s Most Important Stories The CHMP CHMP Nod to Pfizer’s Omicron BA.4/BA.5 Booster: recommended granting conditional marketing authorization to Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine. The recommendation is for use in individuals aged 12 years and older. The European Commission is expected to give its decision in a few days’ time. Pfizer/BioNTech expect the Omicron BA.4/BA.5 booster to be available before winter sets in. The FDA authorized the Omicron BA.4/BA.5-adapted booster on Aug 31.
The FDA accepted and granted standard review to Pfizer’s new drug application, seeking approval of ritlecitinib, its investigational JAK3 inhibitor for severe alopecia areata. The
FDA’s decision is expected in the second quarter of 2023. The European Medicines Agency (EMA) also accepted ritlecitinib’s marketing authorization application. The EMA’s decision is expected in the fourth quarter of 2023. The regulatory applications were based on data from the phase IIb/III ALLEGRO study on ritlecitinib for severe alopecia areata, which showed that treatment with ritlecitinib led to significant scalp hair regrowth versus placebo.
Pfizer announced that the
first participants have been dosed in a phase III efficacy study to evaluate a single dose quadrivalent mRNA-based influenza vaccine in healthy adults. The study will enroll 25,000 U.S. adults 18 years and older.
Pfizer’s phase III study, evaluating its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age, met all primary and secondary endpoints. In the study, the vaccine candidate was well tolerated with an acceptable safety profile. The protection provided by two doses of MenABCWY was non-inferior to licensed vaccines (two doses of Trumenba + one dose of Menveo) for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y.
Based on this data, Pfizer plans to submit a regulatory application seeking approval for the pentavalent vaccine candidate in the fourth quarter. A pentavalent vaccine, if approved, can simplify what is currently a complex meningococcal vaccination schedule in the country
J&J’s board of directors J&J’s New $5B Stock Buyback Plan: authorized a new share buyback plan worth $5 billion. The buyback program has no time limit and may be suspended or discontinued at any time.
The company also reaffirmed its full-year sales and profit targets. Adjusted earnings per share are expected to be in the range of $10.15-$10.35. Operational constant-currency sales are expected to increase in the range of 6.5%-7.5%.
AstraZeneca announced that the CHMP recommended marketing authorization of its COVID-19 antibody cocktail drug, Evusheld in the European Union (EU). The recommendation was based on the TACKLE phase III treatment data, showing reduced risk of severe COVID-19 or death. CHMP Recommends AstraZeneca’s Evusheld and Nirsevimab:
The CHMP also gave a positive opinion recommending marketing authorization of nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. The vaccine is expected to be marketed by the trade name of Beyfortus. The CHMP’s positive opinion was based on data from the MELODY and other phase IIb studies.
AstraZeneca announced that a phase III study called ALPHA, evaluating danicopan (ALXN2040) for treating patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience clinically significant extravascular haemolysis, met the primary endpoint and key secondary endpoints. Danicopan is an investigational, oral factor D inhibitor as an add-on therapy to AstraZeneca’s C5 inhibitors Ultomiris (ravulizumab) or Soliris.
The study’s primary endpoint was change in hemoglobin from baseline at 12 weeks while the key secondary endpoints included transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score. The interim data showed that danicopan plus Ultomiris or Soliris led to statistically significant and clinically meaningful improvements in hemoglobin levels, transfusion avoidance and FACIT Fatigue scores from baseline compared to placebo plus Ultomiris or Soliris for this specific patient population.
The NYSE ARCA Pharmaceutical Index declined 0.8% in the last five trading sessions.