18 October 2021
- Covid-19: Covid-19 testing suspended at private UK lab over potentially inaccurate results – Financial Times
- Covid-19: Second J&J Covid-19 shot gets expert backing; US FDA is looking at lowering age for Pfizer booster – Reuters
- Covid-19: Valneva says Covid-19 shot beat Astra’s in trial, prepares EU file – Bloomberg
- Covid-19: Pfizer and Moderna forecast to almost double vaccine sales in 2022 – Financial Times
- Biogen trial of ALS drug fails main goal, but company says data are encouraging – Reuters
- Philips cuts guidance after supply-chain snarls hit sales – Bloomberg
- Oxford Nanopore tapped Liam Fox to raise money from Bahrain prince – The Sunday Times
- US FDA declines to approve Revance’s frown-line treatment – Reuters
- Immodulon announced Notice of Allowance for US patent application
- Qiming-backed Abbisko makes $200m+ Hong Kong debut, as a SPAC and Agenus spinout also price on Nasdaq – Endpoints
- Hologic dreams bigger for Bolder Surgical with $160m acquisition deal – FierceBiotech
- Covid-19: NIH deals out $77.7m to develop 12 new rapid Covid-19 diagnostics from BD, Quidel and more – FierceMedTech
|Oliver Barnes and Sebastian Payne of the Financial Times report that Covid-19 testing operations at a private laboratory in central England have been suspended after tens of thousands of people were handed potentially faulty negative PCR test results. An estimated 43,000 people were given incorrect negative test results between 8 September and 12 October, the UK Health Security Agency said. It said those affected, who were mainly based in south-west England, would be contacted by NHS Test and Trace and asked to take another test.|
Financial Times >>
Julie Steenhuysen and Michael Erman of Reuters report that outside advisers to the US FDA have unanimously recommended the agency authorise a second shot of Johnson & Johnson‘s Covid-19 vaccine for all recipients of the one-dose inoculation. The agency is also considering lowering the recommended age for booster shots of the Pfizer / BioNTech vaccine to people as young as 40, US FDA official Dr Peter Marks told the advisory panel.
Thomas Mulier of Bloomberg reports that Valneva is preparing to seek regulatory approval for its experimental Covid-19 vaccine after showing it elicits better immunity than AstraZeneca’s shot. Patients injected with two doses of the product had more antibodies – a proxy for protection against the coronavirus – and fewer side effects than those who got the AstraZeneca shot in a study of about 4,000 adults, Valneva said. Both groups had the same number of Covid-19 cases and no patient got severely ill, the company said.
Jamie Smyth of the Financial Times reports that BioNTech / Pfizer and Moderna will dominate the Covid-19 vaccine market next year, generating a massive $93.2bn in combined sales, almost double the amount in 2021, according to new forecasts. The bullish projections by Airfinity, a health data analytics firm, suggest the two messenger RNA jab producers will control three-quarters of the non-Chinese Covid-19 vaccine market in 2022. Rivals AstraZeneca, Johnson & Johnson, Russia’s Sputnik V and new entrants such as Novavax make up the remainder of the market, which is forecast to double in value to $124bn next year.
Financial Times >>
Deena Beasley of Reuters reports that a late-stage trial of Biogen‘s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) failed to reach its main goal, but secondary measures and biomarkers showed favourable trends. Biogen will engage with regulators and other stakeholders “to understand the meaningfulness of this data and potential paths forward,” Toby Ferguson, head of the neuromuscular development unit at Biogen, told Reuters. The company is treating trial patients in a follow-on study and recently launched a phase 3 trial of the drug, tofersen, in patients who are not yet experiencing ALS symptoms.
William Wilkes of Bloomberg reports that Philips has reduced its growth and earnings guidance after global supply-chain disruptions weighed on sales in the third quarter. Philips now expects to deliver low single-digit sales growth for 2021, down from the low-to-mid-single digit increase it forecast previously. The company sees just a “modest” increase in its profit margin, compared to the 60-basis-point improvement it anticipated previously. “Supply chain volatility has intensified globally,” CEO Frans van Houten said, citing a shortage in electronic components. “We expect this headwind to continue in the fourth quarter.”
Katie Tarrant and Sam Chambers of The Sunday Times report that former international trade secretary Liam Fox was approached by the gene-sequencing pioneer Oxford Nanopore to raise funds via his contacts in Bahrain. The MP for North Somerset, who once resigned from cabinet for allowing friend and lobbyist Adam Werritty into defence meetings, applied to parliamentary watchdog the Advisory Committee on Business Appointments (Acoba) to complete a “short piece of work” with Oxford Nanopore.
The Sunday Times >>
Amruta Khandekar of Reuters reports that Revance Therapeutics said the US FDA had declined to approve its long-acting injectable drug to treat moderate to severe frown lines, sending its shares plunging 29%. The company said the US FDA pointed to “deficiencies” related to the regulator’s inspection of Revance’s manufacturing site. Revance’s DaxibotulinumtoxinA for Injection, a potential rival for AbbVie‘s Botox anti-wrinkle injection, was successful in reducing moderate to severe frown lines in a late-stage study in December 2018.
Immodulon announced that it has received a Notice of Allowance for the patent application relating to IMM-101 for the treatment of all cancer types. Cellia Habita, CEO said: “These allowed, broad claims cover treatment of all cancer types with IMM-101 in combination with the most commonly prescribed classes of immune checkpoint inhibitors. We continue to pursue robust intellectual property protection for IMM-101, with a growing patent estate covering the treatment of cancers with high unmet medical need.”
Max Gelman of Endpoints reports that three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index. Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226m in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150m raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40m raise.
Conor Hale of FierceBiotech reports that consistent with the tuck-in acquisition strategy it’s pursued since the beginning of this year, Hologic is taking intrepid steps to build out its surgical franchise with a $160m deal for Bolder Surgical. The Colorado-based company offers a series of laparoscopic devices that allow surgeons to dissect their way through tissue, seal off blood vessels and accurately divide them all with one device, skipping the need to pause and exchange instruments during a procedure.
Andrea Park of FierceMedTech reports that as of this week, more than 400 diagnostic tests for Covid-19 have been authorised by the US FDA. Nearly three dozen of those were developed with backing from the National Institutes of Health’s Rapid Acceleration of Diagnostics. The initiative doled out another $77.7m to 10 medtech makers currently developing a dozen new testing technologies designed to rapidly detect the coronavirus and, in many cases, other viral infections like respiratory syncytial virus and influenza A and B.
- JP Morgan Global Healthcare Conference, Shanghai Virtual Forum – China (12 – 19 October)
- Jefferies Virtual Next Generation IBD Therapeutics Summit (19 October)
- Needham & Co Virtual Biotech Private Company 1×1 Forum (19 – 20 October)
- Annual BIO Emerging Biotechnology Virtual Investor Conference – US (19 – 20 October)