Small Molecules Lead in Recent New Drug Approvals

DCAT Value Chain Insights | February 05, 2020

Small Molecules Lead in Recent New Drug Approvals
Small molecules still lead over biologics in recent drug approvals, accounting for nearly three-fourths of drug approvals over the past several years, but will small molecules' dominance continue? DCAT Value Chain Insights takes an inside look. One measure to evaluate the role of small molecules versus biologics is to look how they have fared in recent approvals of new molecular entities (NMEs) by the US Food and Drug Administration’s Center for Drug Evaluation and Research. Between 2015 and 2019, small molecules have accounted for nearly three-fourths of NME approvals by the FDA’s

Spotlight

Why is big pharma paying billions to take over small companies? Arash Massoudi, the FT's corporate finance and deals editor, explains that as patents expire and the pressure to cut R&D costs rises, large pharmaceutical companies are being forced to make risky bets in search of the next blockbuster drug.

Related News

PHARMA TECH

WinHealth and Immedica enter into an agreement that gives WinHealth the rights to Ravicti® in China and several other Asia-Pacific countries

WinHealth | January 04, 2021

Hong Kong WinHealth Pharma Group Co., Ltd. furthermore, Immedica Pharma AB, today declared that they have gone into an understanding under which WinHealth has the restrictive business rights to Ravicti® (Glycerol Phenylbutyrate) for Greater China, South Korea, Singapore, Vietnam , Indonesia, Malaysia , the Philippines and Thailand gets. Ravicti® is shown for the treatment of urea cycle issue (UCD) in Europe and North America, and as a feature of the reported association, WinHealth is authorized to enlist and popularize the item against UCD in the nations demonstrated. "We are satisfied to report this association with WinHealth, with which we can make Ravicti® accessible to UCD patients in this piece of the world too. The arrangement additionally fortifies Immedica's geographic presence, as it empowers us to grow our organization to incorporate another coordinated effort for uncommon infections, " says Anders Edvell, CEO of Immedica . Jack Wang , Chairman and CEO of WinHealth , remarked, "Urea cycle problem is a seriously underserved clinical need in China that, whenever left untreated, will bring about extreme neurocognitive decay, trance like state, or even passing. We anticipate banding together with Immedica and anticipate making Ravicti®, an inventive medication affirmed in both Europe and the US , accessible to patients with UCD in China and neighboring nations. "

Read More

PHARMA TECH

FDA Grants Breakthrough Device Designation to JelikaLite

JelikaLite Corp | January 07, 2022

JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age. The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition. Data from a pilot study suggests that Cognilum, a wearable medical device, can significantly improve the symptoms of children living with autism. If approved, it will offer families access to a home-based, easy-to-use, and cost-effective treatment for children with autism not available anywhere else. Autism is a serious developmental disorder that impacts families around the globe. JelikaLite Corp. believes that it can provide relief to patients and families by reducing children's autism symptoms. Children will be able to better integrate into the society and have more fulfilling lives. Their caregivers can lead less stressful lives and both insurance companies and the government will be able to spend less money on effective intervention, special education and lifelong residential care. The Breakthrough Device Designation for Cognilum was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism. The trial showed both safety and efficacy of this technology. By combining non-invasive brain stimulation with near-infrared light, EEG sensors, and AI personalization platform, Cognilum demonstrated improvements in autism symptoms through gains in communication and daily living skills. "We are thrilled that the FDA recognizes that we are developing a novel technology with a potential to change the landscape in the current approach to Autism. For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over. We recognize that Autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalized approach to every child based on their unique needs and challenges.” Dr. Eugenia Steingold, Chief Science Officer of JelikaLite JelikaLite’s vision is to bring Cognilum into the homes of families raising children with autism around the globe. This device is truly unique as it seeks to offer a personalized treatment for each child with an integrated feedback loop for both caregivers and doctors. About JelikaLite Based in New York, JelikaLite was launched in 2019 to develop Cognilum™, an innovative solution to permanently reduce children's autism symptoms, enabling better integration into society and reducing lifelong costs. Cognilum™ is a data-device integrated system, where a wearable non-invasive therapeutic medical device that provides neurostimulation treatment is combined with an AI personalization platform. JelikaLite has been founded and run by a multidisciplinary team, with experts in autism clinical therapy, transcranial photobiomodulation, commercialization of medical devices, artificial intelligence, product management, and finance.

Read More

Innovation Pharmaceuticals grants intellectual property and commercialization rights to Fox Chase Chemical Diversity for antifungal technology

Innovation Pharmaceuticals, Fox Chase Chemical Diversity Center | July 23, 2020

Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, announces today that the Company and Fox Chase Chemical Diversity Center, Inc. have amended an earlier collaborative research agreement related to antifungal drug discovery work. Under the amended terms, and in exchange for a six (6) percent fee tied to all potential future proceeds—including upfront payments, milestone payments and royalties—the Company is granting FCCDC all discovery, intellectual property and commercialization rights related to its share of their joint antifungal drug program. Both parties believe the new agreement is favorable to each, with FCCDC continuing to advance discovery and drug development, and Innovation Pharmaceuticals benefiting from potential future commercialization. Over $5 million in government grants have helped fund antifungal work conducted to date.

Read More

Spotlight

Why is big pharma paying billions to take over small companies? Arash Massoudi, the FT's corporate finance and deals editor, explains that as patents expire and the pressure to cut R&D costs rises, large pharmaceutical companies are being forced to make risky bets in search of the next blockbuster drug.