BRIEFING

News in Numbers

-£71.6m

UK retailer Marks & Spencer has reported its first ever loss as a publicly-listed company after coronavirus lockdowns led to a slump in clothing sales. The company swung to a net loss of GBP71.6m (US$92.8m) in the six months to 26 September, from earnings of GBP122.4m a year earlier. One-off costs during the period included GBP92.1m related to its restructuring.

$45m

US start-up MycoWorks has secured US$45m in funding to scale production of its Reishi mushroom leather. The material is based on its patented Fine Mycelium technology, and is said to perform like cowhide leather.

20,000

An investigation into organic cotton fraud in India has revealed 20,000 metric tonnes of cotton were incorrectly certified as organic through a scam abusing the Indian government certification system

6m

Around 6m tonnes of viscose are used to produce garments annually, according to sustainable fashion innovation platform Fashion for Good, which is leading a pilot project using blockchain technology to trace the fibre along the fashion supply chain.

€5m

Material Exchange has secured EUR5m (US$6m) in funding to accelerate its growth plans. Its platform enables brands, fabric suppliers and manufacturers to source digital samples, which reduces the reliance on physical samples, and cuts material wastage.

2.3m

The Better Cotton Initiative (BCI) trained more than 2.3m cotton farmers on more sustainable farming practices in the 2018-19 cotton season. Participants achieved a reduction in water and pesticide use while increasing yields and profits.

£19.5m

UK mother and baby goods retailer Mothercare has secured a GBP19.5m (US$26m) loan to repay its debts on the back of half-year results in which it booked a loss of GBP14.1m resulting from lower sales and higher costs.

133

US footwear company Caleres is to close all but two of its Naturalizer stores in North America by the end of fiscal 2020 to focus on its high-growth digital channels. The firm, which operates the Famous Footwear, Allen Edmonds and Sam Edelman brands, will close 133 of its 135 locations.

$256.5m

Bangladesh has been granted US$256.5m from the Green Climate Fund (GCF) to help finance energy efficiency projects in the textile and garment industry. Ready-made garment production accounts for 38% of total energy consumption in the industrial sector.

£5.4m

A Royal College of Art-led consortium has been awarded GBP5.4m (US$7.1m) to establish a Textiles Circularity Centre that will explore methods to turn post-consumer textiles into renewable feedstocks and develop new supply chains.

Approvals

Sesquient (fosphenytoin sodium) for Injection

The US Food and Drug Administration (FDA) has approved Sedor Pharmaceuticals’ Sesquient (fosphenytoin sodium for injection), a Captisol-enabled, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.

Source: Business Wire

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets

Sebela Pharmaceuticals has received US FDA approval for sodium sulfate, magnesium sulfate and potassium chloride tablets (Sutab) for colonoscopy preparation, as an alternative to liquid-based colonoscopy solutions.

Source: Pharmacy Times

Tacrolimus Capsules

Glenmark Pharmaceuticals Inc has been granted final approval by the US FDA for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US.

Source: Glenmark Pharma

Bronchitol (mannitol) Inhalation Powder

Chiesi USA, Inc has received US FDA approval for Bronchitol (mannitol) inhalation powder, which is an inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis patients 18 years of age and older.

Source: Global Newswire

Clinical Trials

Personalised cancer vaccine clinical trial to expand following promising early results

A recent trial to study safety and effectiveness of a personalised cancer vaccine combined with immunotherapy drug Pembrolizumab will expand after promising preliminary data was presented. Researchers reported data on the first ten patients with head and neck cancer.

Source: ScienceDaily

Novartis’ Ilaris fails in late-stage Covid-19 trial

Novartis’ Ilaris (canakinumab) has failed to produce results in a phase III trial, which tested whether it could improve Covid-19 patients’ survival chances without need for mechanical ventilation. The company is trying to repurpose the drug used in rare inflammatory diseases such as juvenile arthritis for Covid-19, to see if it could relieve the extreme immune reaction that can prove fatal after infection with coronavirus.

Source: Pharmaphorum

Pfizer’s abrocitinib scores another phase III win in atopic dermatitis

Pfizer’s investigational oral Janus kinase 1 inhibitor abrocitinib has scored positive top-line results in a phase III atopic dermatitis trial. The 52-week phase III JADE REGIMEN study investigated abrocitinib in patients aged 12 and older with moderate to severe atopic dermatitis following response to initial open label induction with abrocitinib 200mg.

Source: Pharma Times

AstraZeneca posts positive late-stage trial results for asthma treatment

AstraZeneca has announced positive late-stage trial results for its drug candidate, tezepelumab, for patients with severe, uncontrolled asthma. The FTSE 100 group said phase III trials met the primary endpoint, which is the main result the pharma company was seeking, by combining tezepelumab to the standard of care.

Source: Proactive Investors

Sanofi/Alnylam’s haemophilia drug hits another safety speed-bump

Sanofi’s attempt to take on Roche with a ground-breaking approach to treating haemophilia has hit a setback after the company voluntarily placed its late-stage trials of fitusiran on hold because of safety issues. The news that phase III development has been put on hold was not announced by the French pharma, but in a joint statement from three haemophilia patient groups.

Source: Pharmaphorum

SinoVac gets authorisation to restart Covid-19 vaccine trial in Brazil

Chinese biopharmaceutical firm Sinovac is set to resume the Phase III trial of the Inactivated Covid-19 vaccine, CoronaVaC, after the Brazil National Health Surveillance Agency (Anvisa) authorised its resumption. The move comes after Anvisa suspended the large-scale trial of the Covid-19 vaccine owing to a severe adverse event.

Source: Pharmaceutical Technology