Press review

 - 

Covid-19 vaccine developers in EU talks over compensation programmes if side-effects occur

MADRID, Aug 14 (APM) - Developers of Covid-19 vaccine candidates are engaged in talks with European countries to guarantee that, "in the remote but possible" event of side effects, the governments will pay for compensations, financial newspaper Cinco Días reported on Sunday.
Representatives of the Spanish ministry of health are already discussing the terms of compensation. However, they are seeking a coordinated response to the issue at the EU level, the financial said.
When a drug or vaccine causes side effects, patients can seek compensation, usually provided by the manufacturer of the product. Due to the exceptional situation created by the Covid-19 pandemic, the terms of such compensations are subject to change, which is exactly what pharma is trying to achieve, the newspaper said.
"Pharma’s goal is obtaining a reliable legal framework amid a race to develop vaccines at a much faster pace than the usual, with the surveillance of healthcare authorities", Cinco Días said.
No details of the talks at the ministry have been disclosed so far, but official sources told the financial that any decision will be made at the EU level.

India’s Cadila launches generic version of Gilead’s remdesivir

Cadila Healthcare has announced the launch of a cheaper generic version of Gilead’s remdesivir, approved to treat severe Covid-19, daily newspaper La Vanguardia reports on Friday.
The drug, sold under the branded name Remdac in India, will cost approximately $36 per 100 mg injection, according to a company statement quoted by the newspaper.
This would make Remdac the cheapest generic version of remdesivir, with a price below that of Cipla’s and Hetero’s generics, which cost from $50 to $60.
La Vanguardia quotes Cadila Healthcare managing director Sharvil Patel as saying: "Remdac is the most affordable drug as we would like to enable patients to have access to this critical drug in the treatment of Covid-19."
The medicine will be available starting today across the country’s public and private hospitals. India is the third country with a higher number of Covid-19 cases, the newspaper notes.

Antibodies gain momentum in fight against Covid-19

The number trials of monoclonal antibodies being developed as potential Covid-19 treatments are gaining momentum, with companies including Lilly, AstraZeneca, GlaxoSmithKline, Amgen and Regeneron all working on candidates, financial newspaper Cinco Días reported on Wednesday.
The story quoted a report by Evaluate Pharma including a list of the companies which are currently assessing monoclonal antibodies as potential Covid-19 treatments, including smaller biotech firms Celltrion, Sab Biotherapeutics, Sorrento, Brill Bio, Yumab, Molecular Partners, Systinmune, Xencor, Atreca, Ossianix, Fusion Antibodies and Virna.
Roche’s MabThera (rituximab) and Herceptin (trastuzumab) were mentioned as pioneer biological cancer drugs. AbbVie’s blockbuster Humira (adalimumab) got mentioned as one of the first biological medicines for autoimmune conditions.
The most advanced of these studies is Regeneron’s. The company’s double antibody cocktail Covid-19 treatment is currently in Phase III trials with 2,000 asymptomatic individuals. This clinical programme is supported with $237 million by the U.S. government via the Operation Warp Speed scheme, aimed to obtain treatments and prevention strategies against Covid-19 fast, the financial reported. (APMHE 68059)
Lilly’s Phase I and II trials with Abcellera and Junshi were labelled "outstanding advances" in the story.

FDA grants Biogen/Eisai’s aducanumab priority review in Alzheimer’s

The U.S. Food and Drug Administration (FDA) has granted Biogen and Eisai’s Alzheimer's disease (AD) drug candidate aducanumab priority review, daily newspaper ABC reported on Monday.
This will be the first filing of an AD drug in 17 years. If approved, it would be the first therapy developed to delay disease progression in patients with this condition, the newspaper noted.
A decision is expected by 7 March, it added. (APMHE 68486)

PharmaMar signs licensing agreement to sell Yondelis in Turkey

Spain’s PharmaMar has announced a licensing agreement with Onko to commercialise its marine-derived anticancer drug Yondelis (trabectedin) in Turkey, financial newspapers Expansión, Cinco Días and El Economista reported on Tuesday.
PharmaMar will receive a non-disclosed upfront payment and is eligible for additional remunerations, including regulatory milestone payments, Expansión reported.
Last year PharmaMar recovered the commercialisation rights to the compound in the countries previously licensed by Janssen, Cinco Días reported. (APMHE 64160)

List of ‘essential’ Covid-19 medicines updated

Spanish drug regulator AEMPS has updated the list of drugs considered "essential" in the fight against Covid-19, now including Gilead’s remdesivir, daily newspapers ABC and 20 Minutos reported on Sunday.
Medical journal Diario Médico and a number of regional newspapers also carried the story on Monday. (APMHE 68497)

Dizziness drug assessed in Covid-19

Algernon Pharmaceuticals’ chief executive Christopher Moreau has announced a clinical trial to assess the efficacy of ifenprodil to reduce hospital stays, mortality and lung damage caused by Covid-19, daily newspaper ABC reported on Thursday.
The drug was first developed 50 years ago and is used to alleviate dizziness.
A number of regional newspapers also carried the story on Thursday.
bd/nm

[BD0QF0WCV]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.