Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.

The week was a quiet one from the perspective of news flow. Johnson & Johnson (NYSE: JNJ) was in the news for both right and wrong reasons. The company’s Phase 3 trial of its coronavirus vaccine was paused due to a trial participant contracting an unexplained illness. On a positive note, the company reported solid quarterly results and lifted its guidance.

Pfizer Inc. (NYSE: PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate.

Avenue Therapeutics Inc (NASDAQ: ATXI) shares fell from $11 to just under $4 after FDA rejected its opioid pain drug on safety concerns.

Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) and Cyclerion Therapeutics Inc (NASDAQ: CYCN) shelving alpha-1 antitrypsin deficiency and sickle cell disease studies, respectively.

The week witnessed Nasdaq debuts by six biopharma companies, which collectively raised about $650 million in gross proceeds.

Here are the key catalysts for the unfolding week.

Conferences

American College of Chest Physicians’ CHEST Annual Meeting 2020, being held virtually: Oct. 18-21

The Prostate Cancer Foundation’s 27th Annual Scientific Retreat: Oct. 20-23

IDWeek 2020: Oct. 20-25

American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25 (early programs scheduled for Oct. 19-21)

32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium: Oct. 24-25

PDUFA Dates

Zosano Pharma Corp’s (NASDAQ: ZSAN) NDA for its migraine drug Qtrypta has a PDUFA action date of Oct. 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision by the d-day seems unlikely.

The FDA is set to rule on Spectrum Pharmaceuticals, Inc.’s (NASDAQ: SPPI) BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.

Clinical Readouts

Pfizer Inc. (NYSE: PFE) is scheduled to present at the ID Week 2020 full results of the pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) will present at the ASN meeting results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.

Omeros Corporation (NASDAQ: OMER) is due to present final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation, in the form of a webcast, is scheduled for Oct. 22.

Mustang Bio Inc (NASDAQ: MBIO), founded by Fortress Biotech (NASDAQ: FBIO), is scheduled to present at the Prostate Cancer Foundation’s annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for Oct. 23.

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How Does Complementary and Alternative Medicine Benefit Autism Spectrum Disorder?

Autism is a disorder that responds best to treatment that is holistic and addresses all aspects of the condition. Recent research has shown a benefit for what is considered complementary and alternative medicine (CAM) or integrative medicine that focuses on pairing natural treatment approaches with behavioral therapies and treatments. This approach facilitates a more balanced treatment plan as it allows families, like yours, to treat the child with autism as just that – a child affected by autism.

Autism is diagnosed based on criteria from a diagnostic manual of mental disorders however, it is precisely clear that many of these symptoms are medical – not psychological.

Common medical problems in children on the autism spectrum can include:
• Digestive problems: reflux, diarrhea, constipation, irritable bowel syndrome, chronic pain, bloated abdomen
• Seizures
• Allergies, asthma, and eczema
• Food reactions
• Sleep problems
• Infections
• Poor nutrition
• Poor growth

Children with autistic-spectrum disorder have health issues that are very complex. This is the reason that the approach to help these children requires a wide variety of diagnostic tests to scientifically assess the cause of their health issues.

No two individuals experience autism in the same way, and individuals do not respond to the same treatments. This is the reason it is of utmost importance that each child with autism spectrum disorder be evaluated individually.

This is the reason that the approach to help these children requires a wide variety of diagnostic tests to scientifically assess the cause of their health issues. Tests that involve gastrointestinal functioning, allergens: both food and environmental, nutritional needs and toxin levels are paramount to identifying the causes of their symptoms and embarking on a plan to improve health. A plan may involve some or all of the following: dietary changes, use of herbal, homeopathic and nutritional supplements, as well as natural and complimentary medicines as needed to support healing and improve their health and functioning.

Much of this information is not well recognized by most of the medical community and so what is available is found in books or online. This can leave parents feeling frustrated as knowing what to do first, how to prioritize therapies, dietary changes and what supplements to use is subjective without the proper testing.

Diet is an important component for children on the Autism spectrum.

The "Autism Diet" has been around for many years and has helped many children with autism spectrum disorders (ASD) improve their health, and functioning. Research shows that 91% of autistic children improved when following the autism diet. According to the Autism Research Institute, nutritional treatments show great success in autism treatment. They suggest an autism diet of avoiding yeast, glutens, casein, and any allergens.

Since 91% of children with autism spectrum disorder improve on the autism diet, this is something that parents can implement without the consult of a doctor or health care professional.

To help implement this diet here is a list of the top 10 foods to eat or avoid according …

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