26 January 2021

Summary

  • Covid-19: BioNTech/Pfizer start clinical trial of Omicron vaccine – Financial Times
  • Scancell: Interim results for the six months ended 31 October 2021
  • Medica Group: Trading and business update for the year ended 31 December 2021
  • Diurnal: Trading update
  • Covid-19: J&J expects jump in Covid-19 vaccine sales in 2022, eyes device deals – Reuters
  • In a setback, FDA orders Gilead to hit the brakes on their late-stage, $5bn cancer play – Endpoints
  • Sierra builds approval Momentum with phase 3MF data – BioWorld
  • Smith & Nephew scores new indications for Pico wound therapy systems – BioWorld
  • Medtronic lines up FDA approval for spinal cord stimulators to treat painful diabetic neuropathy – FierceBiotech
Jamie Smyth of the Financial Times reports that Pfizer and BioNTech have enrolled the first participants in a clinical trial of a vaccine tailored to the Omicron coronavirus variant as the companies weigh whether they need to replace their existing Covid-19 jab. It is the first human trial of an Omicron-specific vaccine by a big western drugmaker and will play a pivotal role in determining whether Pfizer and BioNTech adjust a plan to manufacture 4bn doses of their existing jab in 2022.Financial Times >>
Scancell announced its interim results for the six months ended 31 October 2021. Lindy Durrant, CEO said: “we are pleased to report a period of strong operational progress for Scancell with two vaccine candidates now in the clinic. In October 2021, we initiated our COVIDITY programme in South Africa with data due during H1 2022. Post-period, we successfully dosed our first patient in the SCIB1 phase 2 clinical trial and look forward to recruitment accelerating once the impact of Covid-19 on the NHS is reduced.”Scancell >>
Medica Group has announced a trading update for the year ended 31 December 2021, as well as a business update. Dr. Stuart Quin, Chief Executive Officer of Medica, commented: “We are pleased to deliver a positive set of results whilst integrating acquisitions and executing our growth strategy. Medica continues to focus on driving reporter capacity and to look at opportunities to internationalise and further diversify its services going forward.”  Medica Group >>
Diurnal announced a half year trading update. Martin Whitaker, CEO said: “We are pleased that Alkindi revenues have shown good growth, despite continued challenges in access to hospitals due to Covid-19 restrictions. We are also pleased with the continued progress of our commercialisation partners for Alkindi® and look forward to an increased contribution from outside of our core markets in 2022. We are now focused on the commercial roll-out of Efmody® and expect to initiate commercial launch in key European markets in 2022.”Diurnal >>
Manas Mishra and Carl O’Donnell of Reuters report that Johnson & Johnson has forecast as much as $3.5bn in sales of its Covid-19 vaccine in 2022, a 46% jump for the shot that has fared poorly compared to rivals, and said it would take a more aggressive stance on deals for its medical device unit. New Chief Executive Officer Joaquin Duato said his priority now was to be “more on the acquisitive side” for the medical devices unit, its second-largest business by revenue. Reuters >>
John Carroll of Endpoints reports that Gilead’s $5bn drug magrolimab has run into a serious setback, as the Federal Drug Administration (FDA) ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms.Endpoints >>
Randy Osborne of BioWorld reports that Sierra Oncology plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase 3 study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra closed at $22.68, up $7.17, or 46% on Tuesday.BioWorld >>
Catherine Longworth of BioWorld reports that Smith & Nephew added new indications for use of its Pico 7 and Pico 14 single-use negative pressure wound therapy (sNPWT) systems. The FDA cleared the device maker’s systems for reducing the incidence of both deep and superficial incisional surgical sites and dehiscence. The Pico 7Y system, which treats two wounds simultaneously, was also cleared to aid in the reduction of the incidence of superficial incisional SSIs for high-risk patients in class I wounds, post-operative seroma and dehiscence.BioWorld >>
Andrea Park of FierceBiotech reports that Medtronic’s neurostimulation technology, a treatment for diabetic peripheral neuropathy, has received FDA approval and will soon be available to the estimated 800,000 US patients experiencing moderate to severe pain from the condition, for whom standard treatments haven’t been successful. The new approach involves implanting small devices in the epidural space between the vertebral canal and the spinal cord, which emit electrical pulses to intercept and block pain signals in the nervous system.FierceBiotech >>

Upcoming Events

  • Precision Medicine World Congress, Silicon Valley (26-28 January)
  • Stifel Biopharma Ski Summit, Park City (7-9 February)
  • Annual BIO CEO & Investor Digital Conference, hybrid (14-15 February)
  • Sachs European Healthtech CEO Forum, Zurich (15 February)

Register to receive up-to-date information and advice on tax developments within your industry.