Fresenius Medical Care Sale Not Yet Decided: CEO

 Stephan Sturm, chief executive officer of Fresenius SE & Co. KGaA, said in an interview published on the company's website on Tuesday that a sale of Fresenius Medical Care hasn't been decided.

Mr. Sturm said the business's outlook remains positive despite being hit hard by the pandemic. Concerning the company as a whole, management continues to expect healthy growth in sales and earnings this year despite continuing challenges from the pandemic, supply-chain issues and the war in Ukraine, he said.

"We do not have to divest FMC to finance growth in other business segments," the executive said.

Regarding Fresenius' presence in Russia, the executive added that a complete pullout from the country isn't an option as the company is standing by its effort to provide medical care to all people.

https://www.marketscreener.com/quote/stock/FRESENIUS-SE-CO-KGAA-436083/news/Fresenius-Medical-Care-Sale-Not-Yet-Decided-CEO-Says-40663270/

FTC to Study Pharmacy Benefit Manager Practices

 The Federal Trade Commission on Tuesday said it will launch an inquiry into the prescription drug middleman industry to weigh the impact that vertically-integrated pharmacy benefit managers have on the accessibility and affordability of prescription drugs.

The FTC said it is requiring the six largest pharmacy benefit managers, which negotiate rebates and fees with drug manufacturers, provide records and information related to their business practices. The compulsory orders are being sent to CVS Caremark, Express Scripts Inc., OptumRx Inc., Humana Inc., Prime Therapeutics LLC and MedImpact Healthcare Systems Inc., the FTC said

Pharmacy benefit managers also reimburse pharmacies for patients' prescriptions and create drug formularies--a list of prescription drugs that are paid for by a health plan--and other policies, the FTC said. The largest pharmacy benefit managers are vertically-integrated with health insurance companies and wholly-owned mail order and specialty pharmacies, which the FTC said gives the managers a large influence on what patients pay for their prescriptions and where they purchase them.

"Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system," FTC Chairwoman Lina Khan said. "This study will shine a light on these companies' practices and their impact on pharmacies, payers, doctors, and patients."

The inquiry will also look into the use of specialty drug lists and related specialty drug policies. The FTC said it has received more than 24,000 public comments about pharmacy benefit managers.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/FTC-to-Study-Pharmacy-Benefit-Manager-Practices-40663680/

Roche Says EU Approves Lymphoma Treatment Lunsumio

 Roche Holding AG said Wednesday that the European Commission has granted conditional marketing authorization for its cancer immunotherapy drug, Lunsumio, which was studied for use in patients with relapsed or refractory follicular lymphoma.

The Swiss pharma company said the drug is a new type of treatment which is chemotherapy-free and has a fixed duration. The treatment is off-the-shelf and readily available, which means that people don't have to wait to start treatment, the company said.

The European Union's approval is based on data from a Phase 1-2 trial. Conditional approval is granted to a drug that fulfils an unmet medical need, meaning the benefit of immediate availability outweighs the risk of having less comprehensive data, Roche said.

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-Says-EU-Approves-Lymphoma-Treatment-Lunsumio-40666923/

Novavax says COVID vaccine for U.S. to be manufactured by India's Serum

 

Novavax Inc said on Tuesday that its COVID-19 vaccine initially available in the United States, if authorized, will be manufactured by the Serum Institute of India.

"So all vaccines that are being distributed globally commercially are being made in a single facility by our partners (the Serum Institute in India) that includes the vaccines which are being deployed around the world as well as the ones that will be initially deployed in the U.S.," said Chief Medical Officer Filip Dubovsky.

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-says-COVID-vaccine-for-U-S-to-be-manufactured-by-India-s-Serum-40663717/

Bavarian Nordic eyes more monkeypox vaccine orders amid global 'wake-up call'

 Biotechnology company Bavarian Nordic expects to sign more contracts for its vaccine against monkeypox after "overwhelming" interest from governments around the world, its management told investors on Tuesday.

The Danish company, which produces the only vaccine approved in the United States and Canada against monkeypox, has become the focus of a global rush from governments around the world hoping to bolster their preparedness against the virus.

The company's CEO said many countries, which did not already have a stock of the vaccine - mostly likely kept because it also acts against the eradicated but devastating smallpox disease - might have had a "wake-up call" after the monkeypox virus started to spread in countries where it is not endemic.

"Because what has been shown to all countries, is that those countries that had a stockpile, and there are few, are much better prepared than those that did not," Chief Executive Paul Chaplin told investors during a briefing on Tuesday.

Around 30 countries where monkeypox is not endemic have reported outbreaks of the viral disease since May, with more than 911 confirmed or suspected cases mostly in Europe.

"It's clear that many of these countries are very concerned about the availability short-term but we are also talking to governments about improving their preparedness on the longer-term as well," Chief Financial Officer Henrik Juuel said.

"The interest has been overwhelming," Juuel added.

Over the last weeks, Bavarian has announced several deals with undisclosed countries for the supply of its Imvanex vaccine, prompting two upgrades to its financial guidance for this year.

The smallpox vaccine is approved for monkeypox in the United States and Canada. In the European Union, doctors can prescribe it off-label, but the company is working with the bloc's drug regulator to have the approval extended to include monkeypox.

Asked whether Bavarian Nordic expected some of these new orders to become renewable contracts, Chaplin said "time will tell".

"We'll have to see whether that really translates into longer-term orders or whether it's going to be one-offs," Chaplin said. "There's indication that several of them already will," he added.

Both Britain and Germany have said they had put down orders for Bavarian's vaccine. Earlier on Tuesday, Bavarian said it had entered a five-year contract worth around $56 million with Canada's government for the supply of its monkeypox vaccine.

https://www.marketscreener.com/quote/stock/BAVARIAN-NORDIC-A-S-1412846/news/Bavarian-Nordic-eyes-more-monkeypox-vaccine-orders-amid-global-wake-up-call-40662721/

DBV: Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut

 

• 67.0% of subjects treated with Viaskin Peanut 250 µg met response criteria at 12 months, compared with 33.5% of subjects in the placebo arm

• Pivotal trial met primary endpoint: lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 22.4%, exceeding the pre-specified threshold of 15%

• Safety results were generally consistent with safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years and older in prior clinical trials

• High treatment compliance rate observed over trial duration, with low rate of discontinuation due to adverse events

• DBV will hold a conference call today at 5:00 p.m. ET to discuss the results

DBV will host a conference call and live audio webcast on Tuesday, June 7, 2022, at 5:00 p.m. ET to discuss the results. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 23143278#

• United States: 866 374 5140

• Canada: 866 455 3403

• United Kingdom: 808 238 9813

• France: 805 102 712

A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.

https://finance.yahoo.com/news/dbv-technologies-announces-positive-topline-203000138.html

AstraZeneca Reports Positive Trial Data Of Evusheld In Outpatient Treatment Of COVID

 British drug major AstraZeneca PLC (AZN.L, AZN) announced positive results of COVID-19 treatment Evusheld in TACKLE Phase III treatment trial. Evusheld significantly prevented COVID-19 disease progression or death in the outpatient treatment of mild-to-moderate COVID-19.

In the morning trading in London, AstraZeneca shares were gaining more than 1 percent.

The company said the detailed results from the TACKLE Phase III outpatient treatment trial showed AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442) provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo.

Treatment with Evusheld earlier in the disease course leads to more favourable outcomes, the company noted.

The data have been published in The Lancet Respiratory Medicine.

TACKLE was conducted in non-hospitalised adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less. In the trial, 90% of participants were at high risk of progression to severe COVID-19 due to co-morbidities or age.

The company said it is discussing the TACKLE data with regulatory authorities and continue to progress submissions in both treatment and prophylaxis indications to help combat COVID-19 on all fronts. AstraZeneca previously announced positive high-level results from the TACKLE Phase III trial in the treatment of mild-to-moderate COVID-19.

Evusheld is being developed with support from the US government. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

https://www.nasdaq.com/articles/astrazeneca-reports-positive-trial-data-of-evusheld-in-outpatient-treatment-of-covid-19