HMRC Latest R&D Processing Times

As of 9 May 2022, HMRC are dealing with SME R&D claims received on or before 31 March 2022 and RDEC claims received on or before 25 March 2022.

19 February 2024

  • US FDA approves AstraZeneca’s Tagrisso-chemo combo – Reuters
  • Almirall FY earnings meets estimates – Bloomberg
  • FDA approves Roche, Novartis’ Xolair to prevent severe outcomes from common food allergies – FierceBiotech
  • Eight femtech startups to watch, according to investors – Sifted
  • Anti-psychotic drug linked to 400 deaths faces medical review – The Sunday Times
  • US FDA approves Iovance’s cell therapy for melanoma, the first treatment based on tumour-infiltrating lymphocytes – Endpoints
  • US FDA sets June decision deadline for potential full approval, label expansion of Sarepta’s Duchenne gene therapy – Endpoints

Workshops: Qualifying Overseas Expenditure for UK R&D Tax Incentives

As you will be aware, restrictions on R&D tax incentives for activities undertaken overseas will apply for financial years beginning on or after 1 April 2024. The application and interpretation of the necessary conditions remain unclear, with only limited high-level and draft guidance having been released by HMRC. However, many companies are entering into contractual arrangements with suppliers that will extend beyond the commencement of these new rules and which will not sufficiently address the requirements to support compliance. 
 
Our Life Sciences Tax team are running workshops over the next few weeks to cover:

  • What we know so far: The legislation and HMRC guidance
  • Guiding principles and a framework for application
  • Discussion of case studies and other areas open to interpretation
  • Data management, evidence and documentation
  • Recommendations for engaging with CROs and CMOs/CDMO

Please email Emma McCormack to register your interest >> 

Summary

Reuters reports that a combination of AstraZeneca‘s blockbuster cancer drug Tagrisso with chemotherapy to treat a type of lung cancer has been approved by the US FDA. The drug would be used to treat adults with a type of advanced lung cancer. The FDA’s approval was based on trials which extended median progression-free survival by nearly nine months. The phase 3 trials  showed that when adding chemotherapy to Tagrisso, the risk of disease progression or death was reduced by 38% when compared to Tagrisso alone. 

Reuters >>

Thomas Gualtieri of Bloomberg reports that Almirall reported earnings for the full year that met the average analyst estimate, driven by progress in the European dermatology business. Net sales reached €894.5. The Company also announced a licensing agreement of an anti-IL-21 monoclonal antibody with fist-in-class dermatology potential from Novo Nordisk. Carlos Gallardo, Chairman and CEO said: “2023 was an important year for Almirall, further establishing us as a leader in Dermatology in Europe. Looking ahead to 2024, we are confident that Almirall’s assets and expertise will further drive growth”

Bloomberg >>

Sadia Nowshin of Sifted reports that femtechs have historically struggled to garner investor backing, with male femtech founders raising more money than their female counterparts. However, overall funding seems to be moving in the right direction for the sector. Last year, Europe’s femtechs raised $170m from investors. The UK is a hotbed for the sector; more than a third (36%) of 2023’s funding went to startups based in the UK. Investment manager’s from Calm/Storm and Speedinvest highlighted some of the companies on their watchlist for 2024, including UK companies FlutterThyia and SheSpot
Sifted >>
Kevin Dunleavy of FierceBiotech reports that people with food allergies finally have a medicine that can help prevent severe outcomes. The US FDA has blessed Roche and Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. The drug is approved for people ages one year and older with IgE-mediated food allergies, the most common of which are peanuts, milk, eggs, wheat, soy and tree nuts. Xolair helps people avoid severe reactions when they accidently eat these foods, including anaphylaxis. 
FierceBiotech >>
Sean O’Neill of The Sunday Times reports that a controversial prescription drug linked to hundreds of deaths each year is to be reviewed by the medicines watchdog. The Royal College of Psychiatrists has also called for a new approach to the anti-psychotic clozapine, saying it had contributed to deaths which could have been prevented. Clozapine is supposed to be one of the most tightly controlled drugs available on the NHS and is used in difficult cases of paranoid schizophrenia and psychosis in Parkinson’s disease.

The Sunday Times >>

Ryan Cross of Endpoints reports that an experimental approach to treating cancer finally has a long-sought and repeatedly delayed green light from the US FDA. Iovance Biotherapeutics won accelerated approval for Amtagvi, a cell therapy for patients with advanced melanoma. It’s the first modern cell therapy for a solid tumour, and the first approved treatment based on tumour-infiltrating lymphocytes, or TILs. “Because of the delay, there is pent-up demand,” interim CEO Frederick Vogt said, “we believe this will be the largest launch in cell therapy ever.”

Endpoints >>

Lei Lei Wu of Endpoints reports that Sarepta Therapeutics could soon notch another regulatory win. Despite the company and its Duchenne gene therapy getting dogged by debate, and then a failed confirmatory study, the treatment appears headed for a label expansion. Sarepta announced that the US FDA set a 21 June ’24 deadline to make decisions on expanding Elevidys’ label and converting its accelerated approval into a full one. And Sarepta won’t have to face an FDA advisory committee for the treatment.
Endpoints >>

Upcoming events

  • BIO CEO & Investor Conference, New York (26-27 February)
  • ESMO Targeted Anticancer Therapies Congress (26-28 February)
  • UBS European Healthcare Conference (27 February)
  • Sachs Annual European Life Sciences CEO Forum, Zurich (28-29 February)

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