AstraZeneca: Alexion To Discontinue Phase 3 Trial Of Ultomiris In ALS

 British drug major AstraZeneca (AZN.L, AZN) Friday announced that its unit focused on rare diseases, Alexion Pharmaceuticals, Inc., is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis or ALS.

The decision is based on the recommendation of the Independent Data Monitoring Committee or IDMC, following their review of data from a pre-specified interim analysis.

The IDMC recommended that the trial be discontinued due to lack of efficacy. No new safety findings were observed and the data were consistent with the established safety profile of Ultomiris.

ALS is a rare, fatal neurodegenerative disease that affects motor neurons, a type of nerve cell that controls voluntary movements, in the brain and spinal cord.

The CHAMPION-ALS Phase III trial was a randomised, double-blind, placebo-controlled multicentre global trial designed to evaluate the efficacy and safety of Ultomiris across a broad ALS population.

The company noted that patients who enrolled in the trial will discontinue study medication and complete any necessary follow-up evaluations. Data from the trial will be provided to inform ongoing research.

Gianluca Pirozzi, Senior Vice President, Head of Development and Safety, Alexion, said, "We are disappointed by this outcome and what it means for patients with this devastating disease.... We continue to be confident in the potential of targeting C5 for complement-driven diseases and remain fully committed to our efforts to serve the rare disease community."

https://www.nasdaq.com/articles/astrazeneca%3A-alexion-to-discontinue-champion-als-phase-3-trial-of-ultomiris-in-als-2021-08

Illumina in EU antitrust sights over premature $8 billion Grail deal

 U.S. life sciences company Illumina could face a hefty fine for jumping the gun by completing its $8 billion cash-and-stock takeover of cancer detection test maker Grail without first securing EU antitrust approval.

Illumina closed the Grail takeover on Wednesday and said it would hold the company separate while waiting for the European Commission to decide whether to clear or block the deal.

But the EU executive said on Friday it would investigate if Illumina has breached its standstill obligation, which requires companies to secure EU antitrust approval before closing any merger deals.

“We deeply regret Illumina’s decision to complete its acquisition of Grail while our investigation into the transaction is still ongoing,” Commission Vice President Margrethe Vestager said in a statement.

“This obligation, that we call standstill obligation, is at the heart of our merger control system and we take its possible breaches very seriously,” Vestager said.

Illumina did not immediately respond to a request for comment.

Violations can lead to fines of as much as 10% of the aggregate turnover of the companies. French telecoms group Altice for instance was hit with a 125 million euro ($146 million) fine three years ago for closing its 2015 takeover of PT Portugal before gaining regulatory approval.

EU antitrust regulators had warned on July 22 that Illumina’s bid could curb innovation and competition as they opened a full-scale investigation into the matter.

Illumina’s decision to close the Grail deal came ahead of an Aug. 24 trial by the U.S. Federal Trade Commission, which has also voiced concerns about the impact of the deal.

Grail makes a non-invasive, early detection biopsy test to screen for many kinds of cancers using DNA sequencing.

https://wsau.com/2021/08/20/illumina-in-eu-antitrust-sights-over-premature-8-billion-grail-deal/

Booster Review Delayed by CDC as Debate Swirls Over 3rd Shot

 The U.S. Centers for Disease Control and Prevention has pushed back by one week a meeting by a group of outside advisers who were set to review Covid booster shots as debate swells about the need for a third dose.

The Advisory Committee for Immunization Practices, originally scheduled to meet and possibly make a recommendation about the need for boosters on Aug. 24, is now set to convene the following week. The delay was posted on the CDC website and confirmed by multiple committee members. The Biden administration announced on Wednesday that it plans to allow most fully vaccinated adults to get a third shot of vaccines from Pfizer Inc. and Moderna Inc. eight months after their second dose, starting Sept. 20. 

The plan is surrounded by controversy as the medical community remains divided about whether the data support a need for boosters and the World Health Organization has called for richer countries to hold off on distributing third doses until less-vaccinated countries catch up. 

Now, with a month until the proposed launch date, the Biden administration still needs the CDC’s recommendation and approval from the Food and Drug Administration to distribute boosters.

“The data are coming in rapidly, and we want to make sure we follow our process for review and to ensure we can have a robust deliberation at the next open meeting,” Grace Lee, chair of the committee, wrote in an email. She said she expects that meeting to happen “soon.” 

Typically the FDA and CDC would give their thumbs-up before the White House would consider announcing such a plan, and the administration’s decision to push forward without such approval has raised concerns among public health officials. Before the ACIP meeting was delayed, committee member Camille Kotton said on Wednesday that the panel has been discussing the potential for boosters for months, and that the data are sufficient for the Biden administration to recommend them.

With such a tight deadline before the rollout is set to begin in late September, even a one-week delay adds more pressure on the White House to meet its ambitious goal. 

https://www.bloomberg.com/news/articles/2021-08-19/booster-review-postponed-by-cdc-as-debate-swirls-over-third-shot

Thailand to Explore Injecting Covid-19 Vaccines Under Skin to Stretch Limited Supply

 Thailand is studying the possibility of injecting coronavirus vaccines under the skin to try to stretch its limited supply, a health official said on Thursday, as the country races to inoculate the public faster amid a worsening epidemic.

"Our previous experience shows that intradermal injections uses 25% of a muscular injection, but triggers the same level of immunity," head of the medical science department, Supakit Sirilak told reporters.

Thailand has been reporting record deaths in recent weeks among nearly 1 million cases overall.

It has inoculated 8.3% of its population of over 66 million in a mass vaccination campaign that started in June in the midst of a battle against virulent Alpha and Delta COVID-19 variants.

But despite manufacturing vaccines for AstraZeneca and ordering enough doses of different brands to cover its population, Thailand is struggling to get supplies fast enough.

It has even sought to borrow vaccines from the Himalayan kingdom Bhutan and last month became the first country in the world to mix a Chinese coronavirus vaccine and a Western shot.

It has been using the Pfizer and BioNTech vaccine as a booster for its medical personnel.

If its research confirms intradermal injections are effective, regardless of brand, Thailand could vaccinate four to five times the number of people with the same amount of vaccine, Supakit said.

AstraZeneca and Pfizer did not immediately respond to Reuters requests for comment about intradermal injections.

https://www.news18.com/news/world/thailand-to-explore-injecting-coronavirus-vaccines-under-skin-4104767.html

Britain's mass rollout of COVID booster vaccines for all over-50s may be shelved

 The mass rollout of COVID-19 booster vaccines in Britain to residents over 50 this autumn could be shelved, with government scientists considering limiting third doses only to the most vulnerable, The Telegraph reported on Thursday.

Britain's National Health Service (NHS) had drawn up plans to roll out a booster programme from September, based on interim advice from the Joint Committee on Vaccination and Immunisation, the newspaper said https://bit.ly/3swD2U4.

However, sources close to the committee told The Telegraph there is limited evidence to support such an approach and a "far more restricted" group, focused on those most in need, may be targeted.

"Any booster programme will be based on the final advice of the independent Joint Committee on Vaccination and Immunisation. Until we receive the independent JCVI advice, no decisions can be made on wider requirements for those who receive booster jabs", a government spokesman was quoted as saying by the newspaper.

Oxford vaccine chief Andrew Pollard said earlier this month that booster shots for COVID-19 vaccines were not currently needed by Britain and the doses should be given to other countries.

Britain had been planning for a COVID-19 vaccine booster programme, and health minister Sajid Javid said he expected the programme to begin in early September, pending final advice from officials.

A total of 47.41 million people in the country had received a first dose of a vaccine against coronavirus through Aug. 17 and 40.99 million people had received a second dose.

https://www.yahoo.com/news/britains-mass-rollout-covid-booster-215600543.html

U.S. probing Moderna vaccine for higher heart inflammation risk

 U.S. health officials are investigating reports that Moderna Inc's COVID-19 vaccine may be linked to a higher risk of a rare heart condition in younger adults than previously thought, the Washington Post reported late on Thursday, citing people familiar with the review.

The report quoted a source saying it was too early for the regulators to reach a conclusion, and that additional work was needed before any recommendation was made.

Health regulators in June had added a warning to the literature that accompanies the mRNA vaccines produced by Moderna and Pfizer to flag the rare risk of heart inflammation seen primarily in young males. However, they said the benefit of the shots in preventing COVID-19 continued to outweigh the risks.

There might be a 2.5 times higher incidence of myocarditis in those who get the Moderna vaccine compared with Pfizer's vaccine, the Post quoted a source as saying.

The investigation that is focused on Canadian data suggests that risks of myocarditis might especially be higher for males below the age of 30 or so, according to the report.

Moderna and the U.S. Food and Drug Administration (FDA) did not immediately respond to Reuters' requests for comment.

https://www.yahoo.com/news/u-probing-moderna-vaccine-increased-025906068.html

Acting FDA Chief Janet Woodcock ruled out as permanent nominee

 U.S. President Joe Biden’s administration has ruled out nominating Janet Woodcock as the permanent head of the Food and Drug Administration (FDA), Bloomberg News reported https://bloom.bg/2WdjOqJ on Thursday, citing people familiar with the matter.

Woodcock, who has served as acting commissioner since Biden took office, has faced firm opposition on Capitol Hill for the job from lawmakers including Democrat Senator Joe Manchin, a key swing vote in the evenly divided chamber, the report said.

Manchin had criticized the agency over the controversial accelerated approval this year of Biogen Inc’s Alzheimer’s drug, Aduhelm, according to the report.

When contacted for comment, an FDA spokesperson referred questions to the White House.

A White House official said no one had been ruled in or out until the nomination was announced.

https://whbl.com/2021/08/19/acting-fda-chief-janet-woodcock-ruled-out-as-permanent-nominee-bloomberg-news/