Novartis cancer drug falls short of primary endpoints at Phase 3 trial

SWITZERLAND – Novartis has announced that the primary endpoints of a Phase 3 trial evaluating canakinumab drug failed in its second attempt, missing targets to improve overall survival rates for lung cancer patients and arrest the progression of free-survival of people with the condition. According to the Swiss pharmaceutical company, the CANOPY-1 trial did not show statistical significance in overall survival or progression-free survival, which is the amount of time a patient can live without the disease progressing. Canakinumab failed to meet its primary endpoints in the CANOPY-1 Phase III…

Read More

Merck’s phase 3 trials of fixed dose HIV-1 therapy achieve primary endpoint

USA – Merck has announced a positive top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens. The drugmaker has announced that the trials met their safety and efficacy endpoints at 48 weeks in adults with HIV-1 infection who are currently receiving antiretroviral therapy. According to the company, the endpoint is defined as a percentage of participants with HIV-1 RNA levels greater than 50 copies per…

Read More

Wonder drug Dupixent approved for treating severe asthma in children 6-11 years

FRANCE – Regeneron Pharmaceuticals, Inc. and Sanofi have announced in a joint that the FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by high levels of eosinophils or with oral corticosteroid-dependent asthma. Dupixent has been shown to reduce severe asthma attacks and improve lung function in children aged 6 to 11 years.  It was approved in 2017 for the treatment of moderate-to-severe atopic dermatitis. The versatile injectable monoclonal antibody drug reduces severe asthma attacks and improves lung…

Read More

Genentech’s new continuous release eye treatment gains FDA approval

USA – The FDA has approved ranibizumab 100 mg/mL injection for wet age-related macular degeneration in patients who have previously responded to at least two anti-VEGF injections, according to Genentech. The new therapy (Susvimo), formerly known as the Port Delivery System (PDS) with ranibizumab, is designed for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, Age-Related Macular Degeneration (AMD). This is the only FDA-approved wet AMD therapy that allows for as few as two treatments per year. The availability of Susvimo will decrease the…

Read More

111, Inc. partners with Chugai Pharma China Ltd to fast-track innovations in chronic disease management

CHINA – 111, Inc., a leading tech-enabled healthcare platform company dedicated to digitally connecting patients with medicine and healthcare services in China, has announced a strategic cooperation agreement with Chugai Pharma China Co., Ltd., to accelerate innovations in chronic disease management. Chronic disease has become an epidemic. The vast majority of annual health-care spending is spent on treating diseases such as heart disease, cancer, diabetes, and obesity. Nonetheless, despite trillions of dollars spent on management, chronic diseases persist. The agreement will enable 111 and Chugai Pharma China to collaborate in…

Read More

Click Therapeutic secures US$52 million in Series B funding to expand prescription portfolio

USA – Click Therapeutic, a prescription digital therapeutic company, has bagged US$52 million Series B funding round led by Health Catalyst Capital, Revelation Partners, Sanofi, K2 HealthVentures, Hima Ventures, and RidgetopHealth. Other participants included Health Catalyst Capital, Revelation Partners, Sanofi, K2 HealthVentures, Hima Ventures, and RidgetopHealth. This announcement comes more than a year after the company signed a US$500 million-plus deal with pharmaceutical company Boehringer Ingelheim to jointly commercialize a digital treatment for schizophrenia patients. Click’s pipeline of innovative digital therapeutics covers a wide range of therapeutic areas, including psychiatry…

Read More

Rare nervous system syndrome linked to AZ’s Covid -19 jab

UNITED KINGDOM – The Medicines and Healthcare products Regulatory Agency (MHRA) has added Guillain-Barré syndrome, a rare nervous system syndrome, as a possible side effect of the AstraZeneca COVID vaccine. Guillain-Barré syndrome (GBS) is a rare autoimmune disorder in which a person’s own immune system attacks their nerves, causing weakness and, in severe cases, paralysis. According to the NHS, the disease primarily affects nerves in the feet, hands, and limbs, and symptoms can last from a few weeks to several years. Most people recover completely, but some may suffer permanent…

Read More

AstraZeneca cancer drug improves survival rate in liver cancer patients

UNITED KINGDOM – AstraZeneca PLC has reported its trial of the cancer drug Imfinzi (Durvalumab) showed a “statistically significant and clinically meaningful overall survival benefit” when compared to chemotherapy alone. The positive results of the Topaz-1 Phase III trial demonstrated that Imfinzi was effective as a treatment for patients with advanced biliary tract cancer when combined with standard-of-care chemotherapy. According to Astra, the trial met the primary endpoint by demonstrating an improvement in overall survival as well as improvements in progression-free survival and overall response rate, which are key secondary…

Read More

WHO’s advisory group to deliberate on Covaxin EUL approval

SWITZERLAND – The World Health Organization (WHO) has announced that experts will meet on October 26 to decide whether to grant emergency use status to Bharat Biotech’s Covid-19 vaccine Covaxin. Harsh Vardhan Shringla, India’s foreign secretary, expressed optimism that the WHO will soon approve Hyderabad-based Bharat Biotech’s Covid vaccine Covaxin. “It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come…

Read More

Sanofi scores sixth win for its versatile monoclonal antibody drug

FRANCE – Regeneron Pharmaceuticals and French major, Sanofi, have announced positive pivotal Phase 3 results from a trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease characterized by severe itching and skin lesions. The trial of the blockbuster met its primary and all key secondary endpoints, demonstrating that Dupixent significantly reduced itch and skin lesions in this investigational setting when compared to placebo. Uncontrolled prurigo nodularis has the highest impact on quality of life of any inflammatory skin disease with intense, chronic…

Read More