FDA Requires Additional Trials For Catalyst Pharmaceuticals’ Rare Disease Drug

| May 20, 2016

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On www.xtalks.com - Just two months after Catalyst Pharmaceuticals received a rarely-issued Refuse to File letter from the US Food and Drug Administration (FDA), the biotech has faced more hurdles with the regulatory agency.

Spotlight

NovaBay Pharmaceuticals

NovaBay Pharmaceuticals $NBY is a biopharmaceutical company focusing, commercializing and developing its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global eye care market. NovaBay has two distinct product categories: the NEUTROX™ family of products, led by AVENOVA™ for the eye care market, NEUTROPHASE® for wound care, and CELLERX™ for the dermatology market; and AGANOCIDE® compounds, led by AURICLOSENE™. NovaBay is commercializing AVENOVA, a prescription lid and lash hygiene product for the management of the chronic eye conditions of blepharitis and meibomian gland dysfunction – also known as dry eye syndrome. These difficult-to-manage conditions affect approximately 30 million Americans, with an annual market potential that NovaBay estimates at $500 million.

OTHER ARTICLES

As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | April 17, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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Global Antiviral Drugs Market Growth: Is Antiviral Drug the Best Coronavirus Treatment?

Article | April 9, 2020

The global antiviral drugs market has witnessed a rapid surge in demand due to the ongoing Covid-19 pandemic worldwide. So is antiviral drug the best coronavirus treatment? It is still too early to have that conclusion as many medical research and clinical trials are still trying to find the effectiveness and potential side effects of using antiviral drugs to treat coronavirus. But experts believe that antiviral drug might be the best hope for reduce the coronavirus transmission around the world at this stage. However, due to the current difficult situation of the supply chain in many lockdown countries and regions, there is a global shortage on the antiviral drugs supply. With researchers and manufacturers working hard to find and provide effective coronavirus treatment, it is expected that the global antiviral drugs market will have a significant growth over the near future. Antiviral drugs are a type of medication used specifically for treating viral infections, such as human immunodeficiency virus (HIV), hepatitis, and influenza.

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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Pricing of drugs – at what cost?

Article | February 27, 2020

We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.

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Spotlight

NovaBay Pharmaceuticals

NovaBay Pharmaceuticals $NBY is a biopharmaceutical company focusing, commercializing and developing its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global eye care market. NovaBay has two distinct product categories: the NEUTROX™ family of products, led by AVENOVA™ for the eye care market, NEUTROPHASE® for wound care, and CELLERX™ for the dermatology market; and AGANOCIDE® compounds, led by AURICLOSENE™. NovaBay is commercializing AVENOVA, a prescription lid and lash hygiene product for the management of the chronic eye conditions of blepharitis and meibomian gland dysfunction – also known as dry eye syndrome. These difficult-to-manage conditions affect approximately 30 million Americans, with an annual market potential that NovaBay estimates at $500 million.

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