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Renaissance in neuroscience drug development; states get $2B for opioid crisis

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IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

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Renaissance in neuroscience drug development; states get $2B for opioid crisis

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Many large-cap pharmaceutical companies have backed out of the high-risk, high-reward area of central nervous system drug development, leaving smaller biotechs to step up with their own novel approaches to difficult-to-treat CNS disorders.

Big pharma has kept a foot in the door by partnering with innovative biotechs and academic institutions, especially as regulatory bodies look to address the void in effective CNS drugs.

Several new therapies that take a different approach to treating neurological conditions will face their reckoning in 2019, and investors are becoming increasingly interested after the U.S. Food and Drug Administration approved Sage Therapeutics Inc.'s first-ever postpartum depression therapy Zulresso and Johnson & Johnson's Spravato for treatment-resistant depression. GW Pharmaceuticals PLC also received U.S. approvals for its cannabis-based epilepsy medication Epidiolex in June 2018.

"We have been witnessing an explosion of new scientific knowledge about the nervous system," the FDA said in April 2018.

Leerink analysts Marc Goodman and Mani Foroohar also commented, "There really is a renaissance in neuroscience."

Investors seek 'mega blockbuster' drugs as neuroscience undergoes renaissance

Chart of the week

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Amgen, Zoetis lead gains for healthcare in S&P 500 during August

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HHS Secretary Alex Azar told reporters Sept. 4 that different states have different needs for combating the opioid crisis effectively.
Source: The Associated Press

Nearly $2B in taxpayer funds headed to US communities to combat opioid epidemic

The federal government is sending nearly $2 billion in taxpayer funds to U.S. states and communities to combat the opioid crisis — an epidemic largely being fueled by the powerful synthetic drug fentanyl.

Former US FDA chiefs, health groups back Sharpless as permanent commissioner

Ned Sharpless, acting commissioner of the U.S. Food and Drug Administration, has won the support of five previous agency chiefs — Republican and Democratic appointees — and nearly 60 healthcare organizations to remain in the job permanently.

Drug industry overtakes federal government as worst US sector in public's view

A new Gallup poll showed that 58% of Americans viewed the biopharmaceutical industry negatively versus 27% positively — a net rating of negative 31%.

US may spend $2B on Emergent's smallpox vaccine to replenish biothreat stockpile

The U.S. government is buying $170 million worth of Emergent BioSolutions Inc.'s smallpox vaccine, known as ACAM2000, and has an option for nine more years of the product under the agreement.

Of Mice Not Men: Genes, scorpions show promise in opioid fight; spotting cancer with urine color

In this week's "Of Mice Not Men," researchers are exploring ways to combat drug addiction by genetically engineering scorpion toxins to learn about the painkiller pathway. Scientists are also examining a compound to diagnose cancer using urine color.

PhRMA, Trump officials parley on foreign pricing; Florida submits import plan

Drug industry lobbyists argued the burden of proof is on the Trump administration for demonstrating its plan to reference foreign prices is better than market-oriented, flexible approaches to reduce costs; and Florida submitted its importation plan.

In other news

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Merck-Pfizer's Keytruda/Inlyta combo approved in EU for advanced kidney cancer

The European Commission approved Merck & Co. Inc.'s blockbuster drug Keytruda in combination with Pfizer Inc.'s Inlyta to treat patients with advanced renal cell carcinoma, the most common type of kidney cancer.

Ohio judge orders opioid makers to face October trial

A U.S. District Court judge in Ohio has ordered that opioid-makers must face an October trial to determine whether the companies' marketing practices contributed to the painkiller addiction crisis.

Stryker to acquire medical tech companies Mobius Imaging, Cardan Robotics

Stryker Corp. agreed to acquire Mobius Imaging LLC and its sister company GYS Tech LLC, which does business as Cardan Robotics, for up to $500 million in cash.

Mylan's insulin application halted over issues at production facility

Mylan NV must wait for certain issues at Biocon's production facilities in Malaysia to be resolved before the U.S. Food and Drug Administration decides to approve its application for insulin glargine, the U.S. regulator said.

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Essential Healthcare is a weekly collection of critical developments across the pharmaceutical, biotechnology, healthcare provider, healthcare technology and medical equipment industries that draws on exclusive analysis and value-added content from the Healthcare News team at S&P Global Market Intelligence. Subscribe now to get Essential Healthcare delivered to your inbox every week.