Psilocybin therapy shows promise for treating anorexia and depression in small studies

Compass Pathways (Nasdaq:CMPS) announced positive data from two early studies focused on using psilocybin therapy for anorexia nervosa and severe treatment-resistant depression.

The London-based company presented the results at the Society of Biological Psychiatry Annual Meeting in New Orleans.

In the anorexia nervosa study, 10 patients received a single 25 mg of the company’s COMP360 synthetic formulation of psilocybin. Almost one-third (30%) of the patients had clinically significant reductions in eating disorder psychopathology after one month. That figure rose to 40% at three months.

A total of 90% of study volunteers reported that the clinical trial was meaningful and therapeutic.

Participants reported no serious adverse events.

Dr. Walter Kaye at the University of California San Diego School of Medicine oversaw the study.

The second treatment recruited 12 individuals with severe treatment-resistant depression who had not respon…

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Biogen CEO Michel Vounatsos to step aside as Aduhelm sales continue to sputter

With the blockbuster dreams of the Alzheimer’s drug Aduhelm (aducanumab) dashed for the foreseeable future, Biogen has announced that its CEO Michel Vounatsos will depart.

Vounatsos began his tenure as CEO in 2017.

Vounatsos’ plans to exit the company came out on the same day that Biogen reported Q1 adjusted earnings per share of $3.62, 76¢ behind the $4.38 that analysts expected. The 76¢ amount was equal to the negative impact that Biogen reported to Aduhelm inventory write-offs.

Revenue was $2.532 billion for the quarter ended March 31, 2022, down 6% from Q1 2021.

The company’s decision to pursue the FDA approval of Aduhelm after two Phase 3 trials failed to show a clear benefit proved controversial.

Michel Vounatsos [Image courtesy of Biogen]

Although the company would eventually win approval of Aduhelm in June 2021 under the accelerated approval program, the drug…
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Pfizer ticks up on Street-beating Q1, lessens full-year guidance

Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast.

The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%.

Adjusted to exclude one-time items, earnings per share were $1.62, 15¢ ahead of Wall Street, where analysts were looking for sales of $23.9 billion.

Pfizer reported 82% operational growth overall, while the company registered operational growth of 2% when excluding its Comirnaty COVID-19 vaccine and Paxlovid oral COVID-19 treatment. Comirnaty sales grew by $10.2 billion to $13.2 billion in the quarter, while Paxlovid contributed $1.5 billion to global sales, driven by the U.S. launch of the treatment in December 2021 and following international launches.

“I am very proud of our performance this quarter, both from a fina…

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Sage Therapeutics and Biogen formally pursue FDA approval for zuranolone for depression

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD).

The two companies plan on submitting additional clinical data for the NDA in the second half of the year.

Biogen entered into a $1.5 billion licensing agreement with Sage Therapeutics to commercialize zuranolone (SAGE-217) and SAGE-324 in late 2020.

Zuranolone is an oral neuroactive steroid GABA-A receptor positive allosteric modulator (PAM).

In Phase 3 clinical trials, zuranolone 50 mg is administered daily for 14 days.

In addition to MDD, Sage and Biogen plan on pursuing approval for zuranolone in PPD starting next year.

The drug candidate won Fast Track Designation from the FDA in 2017 in MDD and Breakthrough Therapy Designation a year later.

Data were positive from the LANDSCAPE and NEST clinical trial programs.

“Zuranolone has the p…

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FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…

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Why Janssen’s nipocalimab could represent a ‘pipeline in a pathway’

At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases.

One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from rheumatoid arthritis and lupus and rare diseases such as myasthenia gravis. In all, Janssen is testing the drug in ten rare diseases as well as in rheumatoid arthritis and systemic lupus erythematosus.

When taken as a whole, rare diseases are not altogether rare, said Dr. Neely Mozaffarian, vice president and autoantibody pathway area leader at Janssen Immunology.

According to an analysis in the European Journal of Human Genetics, anywhere from 3.5% to 5.9% of the world’s population suffers from a rare disease, affecting 263–446 million people globally.

Rare autoant…

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SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea 

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate.

The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant.

SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.

In the study, the vaccine candidate performed better in terms of neutralizing antibody levels than AstraZeneca’s Vaxzevria COVID-19 vaccine. SKYCovione also had a good safety profile in the study. In particular, it generated neutralizing antibody titers almost three times more than the control vaccine two weeks after administering the second dose.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 gl…

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FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis

AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine.

The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis.

The ankylosing spondylitis indication is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 respons…

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First Wave BioPharma stock tanks after announcing COVID-19 trial data

The clinical-stage company First Wave BioPharma (Nasdaq:FWBI) saw its share price fall by more than 40% to $0.37 in after-hours trading today after releasing new clinical trial data.

To save money, the company will initiate austerity measures, cutting headcount by about 20% and closing a West Coast office and facility in Langlade, France. “We also intend to defer certain obligations, including payment obligations related to our acquisition of First Wave Bio, Inc. (“FWB”), in order to conserve capital,” said James Sapirstein, CEO of First Wave BioPharma, in a letter to shareholders.

The study in question relates to FW-COV (niclosamide), a potential treatment for COVID-19-related gastrointestinal infections, which failed on efficacy in a Phase 2 RESERVOIR study.

The efficacy endpoint of the study was to remove the SARS-CoV-2 virus from the digestive tract as confirmed in patients’ stool.

The drug, however, appeared to be safe, with no serious advers…

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FDA approves first drug for chronic yeast infection

The small biopharma Mycovia Pharmaceuticals has notched its first FDA approval with Vivjoa (oteseconazole), a novel drug for treating recurrent vulvovaginal candidiasis (yeast infections).

The Durham, North Carolina-based company plans to launch the drug in the U.S. in the second quarter of the year. Vivjoa is an azole antifungal indicated for females with recurrent vulvovaginal candidiasis (RVVC) who are post-menopausal or otherwise infertile.

Specifically, the indication covers women with at least three symptomatic acute episodes of yeast infection within 12 months.

Before the approval of Vivjoya, there was no FDA-approved option for specifically treating RVVC.

Anywhere from 29% to 49% of women have had a healthcare provider-diagnosed vaginal yeast infection in their lifetime, according to an analysis in the Journal of Lower Genital Tract Disease. According to the study, at least one-fifth of the subjects suffered from recurring infections withi…

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CRO Syneos Health hires new CEO

The contract research organization (CRO) Syneos Health has promoted Michelle Keefe to be its CEO and a member of its board.

Keefe was previously the president, medical affairs and commercial solutions at Morrisville, North Carolina-based Syneos.

The company’s departing CEO, Alistair Macdonald, is retiring after working at the company for two decades.

Macdonald will serve as an advisor to the company until March 2023.

Michelle Keefe

Keefe has more than three decades of experience working in the life sciences, including two decades at Pfizer.

“I am incredibly honored to take on this role and lead our talented colleagues around the globe,” Keefe wrote in a LinkedIn post. “I look forward to leveraging my decades of life sciences industry experience to help usher Syneos Health into its next chapter as a data- and insights-driven organization, addressing market opportunities with a prod…

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Lilly’s tirzepatide gives Novo Nordisk’s semaglutide a run for the money in Phase 3 trial

Eli Lilly and Co. (NYSE: LLY) has announced that tirzepatide enabled trial participants to lose up to 22.5% of their body weight in the SURMOUNT-1 study.

Study volunteers receiving tirzepatide lost up to 52 lb. (24 kg) in the 72-week Phase 3 trial. A total of 55% of those receiving a 10 mg dose lost at least 20% of their body weight while 63% of those on a 15 mg dose hit the same benchmark. Only 1.3% of those taking placebo had the same level of weight loss.

Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor antagonist.

It is thus broadly similar to Novo Nordisk’s semaglutide, a glucagon-like peptide 1 (GLP-1) receptor antagonist that has achieved strong growth in diabetes as Rybelsus. Demand appeared to be strong for Wegovy, an injectable semaglutide formulation that won FDA approval for supporting weight management in June 2021, but the drug has faced supply challenges in the U.S. Read more

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