By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada   New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the …

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The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices.

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.

Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome.

Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.

Junshi Biosciences, a China-based biopharmaceutical company, and Eli Lilly and Company (LLY) have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi SARS-CoV-2 Antibodies, or JS016, is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.

Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.

Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging.

Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel.

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

Today's Daily Dose brings you news about the revised FDA decision date for Bristol Myers' CAR T cell therapy for refractory large B-cell lymphoma; Enanta Pharma's primary biliary cholangitis trial results; MacroGenics' anticipated clinical data read-outs and regulatory event for this year and Trovagene's name change.

Shares of Krystal Biotech Inc. (KRYS) have now more than doubled in value since touching a 52-week low of $22.02 on June 14, 2019.

Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail

The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.

Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name.

Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

Life sciences company LabCorp (LH) announced Tuesday that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 at-home test kit.

So far this year, 16 novel drugs have received FDA approval compared to 9 which were greenlighted during the same period last year. Now, let's take a look at the biotech stocks that are awaiting a regulatory decision in May 2020.

Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37.

Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results.

Today's Daily Dose brings you news about aTyr Pharma joining the COVID-19 battle; Cara's pivotal KALM-2 trial; LabCorp's at-home collection kit for COVID-19 testing securing Emergency Use Authorization from the FDA, and Myovant's much-awaited clinical trial catalyst.

Let's take a look at the biotech/pharma companies that are slated to report clinical trial results this quarter.

Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial.

The following are some of the stocks in the healthcare sector that touched a high yesterday. Will the rally continue?

As of December 2019, approximately 41 new antibiotics with the potential to treat serious bacterial infections were in clinical development, and four were approved since the previous update in June 2019. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be...

The COVID-19 pandemic is providing a grim reminder of an unfortunate truism: Public health often does not receive the attention it deserves until a disaster hits.

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.

The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.

Communities and policymakers working to meet the challenges of a global pandemic may need to take a range of targeted actions, such as building awareness, launching preventive measures, boosting health care infrastructure, or allocating emergency funding. These decisions, which can influence health outcomes significantly, highlight the importance of having the information needed to evaluate...

Individuals with opioid use disorder (OUD) struggle to get effective care: Of 2 million Americans with the illness, only 26% receive treatment. Now, as the coronavirus pandemic presents an added strain on the U.S. health care system, it is creating greater hardships for those seeking OUD treatment.

At least 95 percent of individuals in state prisons will eventually return to communities. In fact, in a typical year more than half a million people do so, with many more coming from jails. A disproportionate share of these individuals have one or more chronic illnesses.

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...

In the span of just a few short months, the ramifications and impact of COVID-19 have been vast. Virtually every aspect of public health has been affected by this pandemic, and the fight against antibiotic-resistant bacteria is no exception.

Pew’s substance use prevention and treatment initiative sent a letter to the Drug Enforcement Administration (DEA) on April 27 encouraging the agency to expedite a final rule that will help opioid treatment programs (OTPs)—federally regulated facilities where patients take medications for opioid use disorder under the supervision of medical staff and receive counseling and other care services—...

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

More than 2 million Americans suffer from opioid use disorder, but only about 25% of people receive any sort of care. For many, inpatient treatment often means leaving a job and loved ones behind to seek recovery.

Testing for the novel coronavirus in the United States has not kept pace with the enormous demand despite national efforts to ramp up capacity.

The Pew Charitable Trusts sent a letter May 4 to the leaders of the Senate and House of Representatives urging them to support improved patient matching in electronic health records to help combat the COVID-19 pandemic.

In any public health or policy issue, it is important to consider the language used to discuss the people affected. The nation’s prolonged opioid crisis continues to touch many communities and families, and the way in which experts and others talk about substance use disorders, their causes, and the solutions is evolving.

Neuroscience has had a tough run of news lately. With Amgen deprioritizing neuro this year, Pfizer doing the same last year, and others like BMS, GSK, and AZ cutting back on CNS a few years earlier, it would seem dark

The post The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics appeared first on LifeSciVC.

Today Alkermes announced its acquisition of Rodin Therapeutics, a leader in the field of synaptic dysfunction and neuronal epigenetics. Alkermes extensive experience in CNS diseases made them an ideal partner for Rodin, and this acquisition helps expand Alkermes’ efforts into

The post Thinking Boldly: Alkermes Acquires Rodin Therapeutics appeared first on LifeSciVC.

The perennial drug pricing debate has reached a fever pitch, as loud as it’s ever been over the past few decades. Politicians on both sides are bashing the drug industry with the typical talking points about exorbitant prices, countered of

The post Venturing A Perspective On The Drug Pricing Debate appeared first on LifeSciVC.

It’s that time of year again when we pause to reflect on the state of the industry – and there’s more to focus on in biopharma today than just the drug pricing debate. As I described last year, we host

The post Our 2019 Year In Review: Macro, Biotech, and Atlas appeared first on LifeSciVC.