Cassiopea gets FDA approval for Winlevi, the first novel acne med in decades

It’s been decades since a novel acne treatment hit the scene, but that’s set to change with Cassiopea’s approval for Winlevi.  

The FDA on Thursday approved the new prescription acne medication, set for use in people 12 and older.

Acne affects around 50 million people in the U.S., but there hasn’t been a new mechanism of action in the field in nearly 40 years, Cassiopea CEO Diana Harbort said ahead of the approval. Winlevi is a “first-in-class topical treatment” to treat acne at the “hormonal level for both males and females,” she added. 

The company expects dermatologists will use Winlevi in combination with existing treatments to address multiple facets of the condition, such as clogged hair follicles and inflammation. Doctors have indicated they’re enthusiastic about the new option, Harbort said, and the company expects “widespread acceptance and use.” 

They’ll still have to wait a while, though; Cassiopea isn’t expecting to launch its new medication until next March. In the meantime, the company is meeting with payers and incorporating lessons from other companies that have launched during the pandemic to prep for its own rollout. 

For its commercial debut, the company is planning to balance in-person physician education with a digital component, the CEO said. The field force could comprise around 70 staffers, but Cassiopea expects to refine its plans over the next few months.  

When Cassiopea launches Winlevi, the new drug will face off against branded options from Galderma, Bausch & Lomb and Menlo. 

Behind Winlevi, the company is also advancing pipeline candidates against hair loss and genital warts, as well as an antibiotic against acne. Cassiopea is a 2015 spinoff of Cosmo Pharmaceuticals.

https://www.fiercepharma.com/pharma/cassiopea-scores-fda-approval-for-winlevi-first-novel-acne-med-decades

Sanofi plans to start human testing of COVID-19 vaccine

“Sanofi (NASDAQ:SNY) expects to move to a large late-stage trial with an experimental coronavirus vaccine toward the end of the year,” said CEO Paul Hudson at a conference in France.

If proved to be effective, the Company will ship the vaccine to U.S., Europe and France.

Sanofi has teamed up with GlaxoSmithKline (NYSE:GSK) to develop a COVID-19 vaccine. A Phase 1/2 clinical trial is expected in September, followed by a Phase 3 by year-end.

If all goes well, SNY will file a marketing application in H1 2021.

Selected tickers: Pfizer (PFE -0.4%); Merck (MRK -0.3%); Johnson & Johnson (JNJ -0.1%); Moderna (MRNA -3.7%); Novavax (NVAX -1.7%); Dynavax (DVAX -0.8%); BioNTech SE (BNTX +0.6%); AstraZeneca (AZN -0.8%); Inovio Pharmaceuticals (INO -3.7%); iBio (IBIO -3.6%); Vaxart (VXRT -3.2%); VBI Vaccines (VBIV +48.9%)

https://seekingalpha.com/news/3609402-sanofi-plans-to-start-human-testing-of-covidminus-19-vaccine-bloomberg

Novavax CEO expects filing for COVID-19 vaccine approval in December

Novavax Inc expects filing for approval of its COVID-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny, released on Thursday.

The company plans to produce part of the vaccine at its Czech plant, which will give the country access to the product once it is approved, the paper cited Erck as saying.

Novavax said on Monday it had begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.

https://www.reuters.com/article/us-health-coronavirus-novavax/novavax-ceo-expects-filing-for-covid-19-vaccine-approval-in-december-paper-idUSKBN25N0O7

Glaxo Gets Approval for Myeloma Treatment in EU

GlaxoSmithKline PLC said late Wednesday that the European Commission has given conditional marketing authorization to its anti-B-cell maturation antigen therapy belantamab mafodotin.

The British pharmaceuticals giant said belantamab mafodotin has been approved as a monotherapy for the treatment of multiple myeloma in adult patient, in whom the disease was unresponsive to previous treatment.

Earlier this month, the U.S. Food and Drug Administration approved the use of belantamab mafodotin as a monotherapy in the U.S. too.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GlaxoSmithKline-Gets-Approval-for-Myeloma-Treatment-in-EU-31185739/

Novacyt launches test to differentiate COVID-19 and flu

Clinical diagnostics company Novacyt, one of many healthcare companies whose shares have surged during the pandemic, launched a test on Thursday to differentiate between COVID-19 and common winter diseases.

Novacyt said its “Winterplex” test panel included two gene targets specific to COVID-19, as well as gene targets for influenza A&B and respiratory syncytial virus (RSV).

“We believe Winterplex(TM) is one of the world’s first approved respiratory test panels that can differentiate between COVID-19 and other common respiratory diseases,” Novacyt CEO Graham Mullis said.

Novacyt said the new product was expected to drive major revenue growth, and Novacyt’s Paris-listed shares rose by around 6% in early trading, with the stock price having already surged by around 1,900% since the start of 2020.

Novacyt’s new polymerase chain reaction (PCR) respiratory test panel is one of many such ‘PCR’ type products already on the market, aimed at diagnosing the presence of COVID-19.

The PCR test is the preferred COVID-19 testing method in many countries. It detects the presence of the disease by amplifying its genetic material to a point where it can be spotted by scientists (tinyurl.com/y7rno7pf).

https://www.marketscreener.com/quote/stock/NOVACYT-11681992/news/Novacyt-launches-test-to-differentiate-COVID-19-and-flu-31186156/

Amazon launches fitness band, app

Amazon.com Inc on Thursday launched a fitness band and app, “Halo”, that will track user activity such as sleep and heart rate.

Customers in the United States can request early access to Halo starting Thursday, with the band and 6 months membership priced at $64.99, the e-commerce giant said in a statement.

https://www.marketscreener.com/news/Amazon-launches-fitness-band-app–31188556/

BeiGene in licensing deal for neutralizing COVID-19 antibodies

BeiGene (NASDAQ:BGNE) and Singlomics (Beijing DanXu) Biopharmaceuticals have executed an exclusive license agreement for BeiGene to develop, manufacture and commercialize globally ex-China, the latter’s investigational anti-COVID-19 antibodies, including DXP-593 and DXP-604.

Under the terms of the agreement, Singlomics will receive an upfront payment and be eligible to receive milestone payments and tiered royalties, up to double digits, on future product sales.

Phase 1 and Phase 1/2 clinical trials are expected to begin enrollment of healthy subjects and patients with mild to moderate COVID-19 in September and early October, respectively.

https://seekingalpha.com/news/3609306-beigene-inks-licensing-deal-for-neutralizing-covidminus-19-antibodies