Pharmaceutical Technology Editors

NewAge Industries, a plastic and rubber tubing manufacturer, announced on March 31, 2021 that it has achieved B Corp certification from B Lab, a nonprofit organization that creates standards, policies, and tools for businesses.

According to a NewAge press release, the B Corp certification, which measures companies on their environmental performance, transparency, and accountability, was awarded after B lab took note of NewAge’s charitable contributions; its support of company employees and their physical, mental, and financial well-beings; retirement and bonus plans; and the introduction of a wellness committee to promote healthy lifestyles.

“We’re audited for financials and quality, but no one had examined us for how we operate or for our environmental practices,” said said Ken Baker, NewAge’s CEO, in the press release. “Being certified as a B Corp differentiates us from other suppliers, especially those in the biopharm and pharmaceutical industries. NewAge isn’t a big conglomerate that was formed by buying a bunch of other companies, and we do not have investors who look only at the bottom line. We’re independent, employee owned, and dedicated to staying that way.”

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NewAge Industries received B Corp certification from B Lab, a nonprofit organization that creates standards, policies, and tools for businesses. 

NewAge Industries Achieves B Corp Certification

Sanofi announced on March 31, 2021 that it has invested more than €600 million (US$704 million) into a new vaccine manufacturing facility at its existing site in Toronto, Canada.

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s Fluzone High-Dose Quadrivalent influenza vaccine, increasing its availability in Canada, the United States, and Europe, Sanofi said in a company press release.

“As a leading vaccines Company, we continuously look ahead to address the fast-growing demand for those influenza vaccines that have demonstrated clinical superiority against standard-dose vaccines. Fluzone High-Dose provides a long-term competitive advantage, and this new investment will ensure more seniors around the world are better protected against influenza and its complications. In addition, it will be a key resource to assist against future pandemics,” said Paul Hudson, CEO, Sanofi, in the press release. “We welcome the ongoing partnership with the Canadian authorities, who supported us to make today’s great news a reality; this will make the country, which has a strong legacy in vaccines research and development, one of our key hubs in our effort to protect and improve human health across the globe.”

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

Sanofi to Invest More than $700 million into New Canadian Vaccine Manufacturing Facility

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an adeno-associated viral serotype 8 (AAV8) vector capsid containing no transgene with ImmTOR. The company announced the news in a March 30, 2021 press release.

The first-in-human trial will be conducted at the SGS Clinical Pharmacology Unit (CPU) in Antwerp, Belgium, and SGS will provide a full scope of services, including regulatory support, healthy participant recruitment, project management, pharmacovigilance, and handling of unblinding data. A unique set of qualifications must be managed for the study, for instance, to accommodate for the requirement of all study subjects being AAV8 antibody negative, SGS CPU will create a specific database to enable accelerated recruitment of study participants.

In the trial, Selecta and AskBio are seeking to determine whether the administration of ImmTOR will prevent the generation of antibodies to the AAV8 vector. If it does prevent AAV8 antibody generation then it will enable redosing of the gene therapy in a patient, which could help overcome a common obstacle with gene therapies.

“Here at SGS, we are delighted to be conducting this Phase I trial. The study medication that we are testing is incredibly innovative and may have important implications in the treatment of genetic disorders,” said Jonathan van Gucht, clinical research physician at SGS, in the press release.

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

SGS Facilitates Phase I Study of ImmTOR in Gene Therapy

According to data from the UK BioIndustry Association (BIA) and Clarivate, biotech companies in the United Kingdom are set to experience another strong year for fundraising in 2021. The news was announced in a March 29, 2021 press release.

So far, the data have shown that over £830 million (US $1.14 billion) in fresh capital was raised in the three months to the end of February 2021. Other highlights from the data were an increase in £123 million (US $169 million) of venture capital raised in the period between December 2020 and February 2021 compared with the same period in the previous year, initial public offerings were up with £215 million (US $296 million) raised, and follow-on financings were up to £279 million (US $385 million).

“This strong start to 2021, with investments outpacing the record setting year of 2020, shows the incredible appetite amongst international and some domestic investors for the UK’s world leading biotech and life sciences companies,” said Steve Bates, CEO of BIA, in the press release. “This has been reinforced by the recent announcement that £1 billion [US $1.4 billion] will be invested in the sector through a UAE-UK Sovereign Investment Partnership. This quarter has also seen significant private sector investments into UK medicine manufacturing capability and clinical development pipelines, which has fueled increased confidence in the sectors outlook for 2021.”

“In the three months to 28 February [2021], the global biotech sector has maintained the momentum of last year’s record-breaking financial activity,” added Mike Ward, global head of Thought Leadership at Clarivate, in the press release. “According to data collected and curated by BioWorld, biotechs across the world raised almost £26.7 billion [US $36.8 billion], more than double the amount raised in the same period a year earlier. It is clear that investor appetite for the sector has not been satiated.”

BIA and Clarivate have released data showing that UK biotech companies are set to experience another strong year for fundraising in 2021.

UK Biotech Experiences Strong Start to 2021 Fundraising

The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

In a March 31, 2021 press release, Kineret drug company, Sobi, revealed the recommendation, which also covers systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s Disease (AOSD). Still’s disease is a rare, serious inflammatory disorder that can present in adults as AOSD or children up to 16 years old as sJIA.

“We are pleased to receive this positive news for anakinra,” said Michael Oliver, vice-president and general manager, Sobi UK and Republic of Ireland, in the press release. “As a company we are committed to improving the lives of people with rare diseases and this recommendation will provide earlier access to anakinra in patients with Still’s disease and help to enhance their quality of life.”

“I welcome this positive recommendation for anakinra in relation to sJIA, as it offers an effective, therapeutic option for a disease which can be associated with significant morbidity among patients,” commented Professor A Ramanan, consultant pediatric rheumatologist, Bristol Royal Hospital for Children, in the press release.

“This final NICE guidance endorses that clinicians have the flexibility to use anakinra earlier in the patient pathway, as a first-line biologic therapy, which is something specialists in this area welcome and brings us closer to quicker disease control that would prevent progressive joint and systemic damage,” added Paul Brogan, professor of vasculitis and speciality lead, Paediatric Rheumatology, Great Ormond Street Hospital Institute for Child Health, in the press release.

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

NICE Issues Positive Recommendation for Use of Kineret to Treat Still’s Disease

Diurnal Group has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for its second product in Europe, Chronocort (Efmody).

Efmody—hydrocortisone modified-release hard capsules—has been granted the recommendation as a treatment of adult and adolescent patients (12 years and older) with congenital adrenal hyperplasia (CAH). CAH is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.

“We are delighted that the CHMP endorses Efmody as a treatment option for adult and adolescent patients suffering from CAH,” said Martin Whitaker, CEO of Diurnal, in a March 26, 2021 press release. “We look forward to expanding our commercial portfolio with the planned launch of Efmody across Europe alongside our first product Alkindi, to provide life-long treatment for patients with CAH, enabling Diurnal to continue to drive towards becoming a world-leading specialty endocrinology business.”

A formal approval of marketing authorization by the European Commission is expected to be received in June 2021.

EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.