FDA OKs Samsung Bioepis, Biogen BYOOVIZ™ (SB11), LUCENTIS® Biosimilar

 

• BYOOVIZ™ becomes the first ophthalmology biosimilar to gain FDA approval in the United States

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i, for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the United States (US).ii,iii,iv,v

BYOOVIZ™ is the first ophthalmology biosimilar approved in the United States. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer cost savings and promote sustainable access to therapies.vi Savings in the United States over the next five years from 2020 to 2024 as a result of biosimilars are projected to exceed $100 billion.vii

https://finance.yahoo.com/news/fda-approves-samsung-bioepis-biogen-113000322.html

CVS Health to hire 25,000 ahead of flu season, COVID-19 boosters

 CVS Health Corp said on Monday it would fill as many as 25,000 clinical and retail jobs ahead of the flu season and as the United States prepares to administer booster COVID-19 vaccine shots.

The company said most of the available jobs were for full-time, part-time, and temporary licensed pharmacists, pharmacy technicians and nurses, adding that it was also looking for employees to help manage its retail stores.

CVS recently raised minimum hourly wages for its staff as retailers across the United States scramble to retain and lure more people back to work amid a nationwide labor shortage due to the COVID-19 pandemic.

CVS, rival Walgreens Boots Alliance and other pharmacies that plan to administer boosters are likely to see more traffic between November and January, putting them under increasing pressure to hire and retain employees.

CVS said on Monday the virtual hiring campaign on Sept. 24 would help it administer the extra shots, pending regulatory approval, as it continues to offer COVID-19 tests as well as vaccines to those who have not yet been immunized.

The Biden administration had planned to make booster shots widely available in the week of Sept. 20, but advisers to the U.S. Food and Drug Administration last week rejected broader approval of the shots, recommending their use in Americans 65 and older and those at high risk of severe illness.

CVS, which has administered more than 34 million COVID-19 vaccines and over 32 million tests, said in March last year it would hire 50,000 employees to assist patients and customers during the coronavirus outbreak. It hired 15,000 more people in the fourth quarter of 2020.

https://finance.yahoo.com/news/cvs-health-hire-25-000-110949452.html

Adagio Therapeutics Updates on COVID-19 Antibody Program

 New Data Supporting Potential of ADG20 for Both the Treatment and Prevention of COVID-19 to be Presented at IDWeek 2021

Patient Population in Global EVADE Phase 2/3 Clinical Trial of ADG20 Expanded following IDMC Assessment

$355.8 Million IPO Completed to Fund Continued Advancement of Portfolio of Antibody-based Solutions for Infectious Diseases with Pandemic Potential

https://finance.yahoo.com/news/adagio-therapeutics-provides-covid-19-103000746.html

Boston Sci Microspheres Improves Progression-Free Survival in Colorectal Cancer-ESMO

 Boston Scientific Corporation (NYSE: BSX) announced the EPOCH clinical trial of the TheraSphere™ Y-90 Glass Microspheres (TheraSphere treatment) successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) of patients with metastatic colorectal cancer (mCRC) of the liver. In the trial, TheraSphere treatment – a selective internal radiation therapy (SIRT) comprised of microscopic glass beads containing radioactive yttrium (Y-90) that are specifically delivered to target tumors – was used as a second-line treatment in combination with standard of care systemic chemotherapy (SOC) for patients who had disease progression during or after first-line chemotherapy. The clinical findings were presented today as late-breaking data at the European Society for Medical Oncology (ESMO) Congress 2021 and will be published in the Journal of Clinical Oncology.

Boston Scientific TheraSphere™ Y-90 Glass Microspheres

https://finance.yahoo.com/news/breaking-data-demonstrate-improved-progression-113600089.html

BeyondSpring hits endpoints in Phase 3 lung cancer trial

 

• Study met the primary endpoint showing statistically significant improvement in overall survival (OS) for the combination (DP) vs. docetaxel (D).
  

• Study met key secondary endpoints showing statistically significant improvement for DP vs. D in ORR, PFS, and 24- and 36-month OS rates, significant reduction in incidence of Grade 4 neutropenia and clinically meaningful relative improvement in Q-TWiST of 18.4%.

• In PD-1/PD-L1 exposed patients, DP had longer OS benefit vs. D (HR = 0.68); and the 24 M OS rate in the combination was triple that of docetaxel (p=0.0026).

• BeyondSpring plans to seek U.S. FDA and China NMPA approval for plinabulin in combination with docetaxel in 2nd/3rd line NSCLC based on the demonstrated clinical benefit and safety profile, with an anticipated NDA filing in 1H 2022.

• More detailed data will be presented live at 8:10 a.m. ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m. ET today. Dial-in: 877-451-6152, conference ID#: 13723041

https://finance.yahoo.com/news/beyondspring-pharmaceuticals-announces-positive-final-113000754.html

Aveo gets FDA fast track for cancer therapy

 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

https://finance.yahoo.com/news/aveo-oncology-announces-ficlatuzumab-granted-110000615.html

Pfizer says COVID-19 vaccine safe, effective for kids ages 5 to 11

 Data shows the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, the companies announced Monday morning.

"We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children," Pfizer chairman and CEO Albert Bourla said in a statement. "Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. -- underscoring the public health need for vaccination."

There were 2,268 participants ages 5 to 11 in the trial, which, while it still followed a two-dose regimen, used a lesser dose than the amount given to people ages 12 and older, for the "safety, tolerability and immunogenicity" of younger children.

"In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralizing antibody responses," the companies said in a news release.

Pfizer and BioNTech plan to share their data with the U.S. Food and Drug Administration, the European Medicines Agency and other regulators soon and will submit a request for emergency use authorization in the United States.

The FDA approved the Pfizer vaccine, which is marketed as Comirnaty, for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.

"These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," Bourla said.

Results from two other ongoing trials -- one of children ages 2 to 5 and one of children 6 months to 2 years old -- are expected as soon as later this year, the companies said.

Pfizer has also received emergency use authorization from the FDA to give a third dose of vaccine to those 12 years of age and older who have been determined to have certain kinds of immunocompromise.

However, a panel advising the federal government on vaccines recently rejected President Joe Biden's suggestion to roll out booster shots for all Americans, recommending that for now, a third dose should only be given to those 65 and older or those at high risk of severe COVID-19.

https://abcnews.go.com/Health/pfizer-covid-19-vaccine-safe-effective-kids-ages/story