FDA places full clinical hold on CytoDyn’s Covid-19 programme
31 March | FDA
The US Food and Drug Administration (FDA) has placed a complete clinical hold on CytoDyn’s Covid-19 programme in the country. With the full clinical hold in place, the company will not launch any new clinical trials until the regulatory agency lifts the hold. At present, CytoDyn is not carrying out any Covid-19 trials in the US, as the company is analysing the most ideal programmes to invest its resources and focus. A clinical stage biotechnology company, CytoDyn is analysing its leronlimab, an investigational humanised IgG4 monoclonal antibody, for its potential in various treatment areas, including infectious disease, cancer and autoimmune conditions. The FDA has also placed a partial hold on CytoDyn’s HIV programme, which will affect the subjects who are presently enrolled in extension trials.
7 April | DEALS
EVEREST AND CR PHARMA SIGN MOU TO LAUNCH COMPANY FOR MRNA VACCINE
Everest Medicines has signed a memorandum of understanding (MoU) for a collaboration with China Resources Pharmaceutical Group (CR Pharma) to set up an independent company focused on messenger ribonucleic acid (mRNA) vaccine development. Named ‘the mRNA’, the new company will advance its possibly best-in-class mRNA vaccine candidates through regulatory pathways in China and into marketing. CR Pharma plans to make a strategic equity investment for the mRNA technology platform of Everest. In September last year, Everest had signed a strategic collaboration with Providence Therapeutics to develop mRNA vaccines and therapies. Everest will become the mRNA’s largest and controlling shareholder.
4 April | COVID-19
ROCHE OBTAINS US FDA PRIORITY REVIEW FOR COVID-19 TREATMENT
Roche has obtained the US FDA priority review for its supplemental Biologics License Application (sBLA) for intravenous Actemra/RoActemra (tocilizumab) to treat Covid-19. A humanised interleukin-6 (IL-6) receptor antagonist, Actemra/RoActemra is currently approved to treat moderately to severely active rheumatoid arthritis (RA) in adults. The treatment is intended for hospitalised Covid-19 adult patients who are taking systemic corticosteroids and need supplemental oxygen. Roche anticipates a decision on approval from the regulatory agency in the second half of this year. In June last year, the FDA granted Emergency Use Authorization for Actemra/RoActemra, which is also approved in 16 countries globally for severe or critical Covid-19 patients in the hospital.
6 April | COVID-19
FDA SUSPENDS USE OF GSK-VIR’S SOTROVIMAB FOR COVID-19 TREATMENT IN US
The US FDA has updated the emergency use authorization (EUA) for GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab and suspended its use to treat Covid-19. Sotrovimab is an investigational monoclonal antibody that binds to the epitope of the SARS-CoV-2 virus to neutralise it. The regulatory authority noted that the antibody is unlikely to be effective against the Omicron BA.2 sub-variant, which is causing a rise in the number of Covid-19 cases in the region. In March this year, the regulatory agency updated the EUA Fact Sheet to limit the use of sotrovimab for Covid-19, due to the sub-variant. Sotrovimab had obtained FDA EUA to treat mild-to-moderate Covid-19 in adult and paediatric patients of the age 12 years or above, in May last year.
31 March | LITIGATION
TEVA AGREES TO PAY $177M TO SETTLE OPIOID CLAIMS IN FLORIDA
Teva Pharmaceuticals signed an agreement with the Attorney General of Florida to pay $177m to settle opioid-linked claims. Under the agreement, the company will pay the amount over a course of 15 years. It will also deliver a life-saving generic medicine, named Narcan (naloxone hydrochloride nasal spray), an opioid reversal treatment, at a wholesale acquisition price of $84m for over ten years. This treatment can temporarily reverse the effects of opioids in cases of overdose. A portion of the funds under the deal will be sent directly to cities and counties in Florida for opioid abatement activities, such as prevention, treatment or recovery.
11 April | COVID-19
MODERNA AND ROVI PHARMA RECALL COVID-19 VACCINE DOSES
Moderna and Rovi Pharma have recalled a batch of 764,900 doses of the Moderna Covid-19 vaccine, Spikevax. The move comes after a foreign body was detected in one of the vials from the batch produced at Rovi’s contract manufacturing site in Spain. The company noted that the contaminated vial was punctured and was not used for administration to people. The vaccines from the lot were supplied in Norway, Poland, Portugal, Spain and Sweden from 13 to 14 January this year. Moderna carried out a collective search of its global safety database and no safety issues were reported in people who took the vaccine from this lot.
Be Bio raises $130m to develop engineered B cell medicines
Be Biopharma (Be Bio) has raised $130m in a Series B funding round led by ARCH Venture Partners to progress its autologous and allogeneic Engineered B Cell Medicines (BeCM) platforms across various therapeutic areas. The company works on discovering and developing BeCM and has a wider pipeline with an initial focus on rare diseases and cancer.
Halozyme signs agreement to acquire Antares Pharma for $960m
Halozyme Therapeutics has signed a definitive agreement for the acquisition of all of the outstanding shares of Antares Pharma in a deal valued at nearly $960m or $5.60 for each share, in cash. Halozyme plans to fund the deal through cash on hand as well as new debt sources.
Engitix and Takeda extend partnership for anti-fibrotic therapy development
Engitix and Takeda have signed an agreement for the expansion of a current partnership to include the discovery and development of new therapies for fibrostenotic inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease (CD). On meeting preclinical, development, regulatory and commercial milestones, Engitix will receive payments of up to $300m.
Kite’s CAR T-cell therapy obtains FDA approval for large B-cell lymphoma
Gilead Sciences’ subsidiary Kite has secured approval from US FDA for Yescarta (axicabtagene ciloleucel) CAR T-cell therapy to treat adult individuals with large B-cell lymphoma (LBCL). Yescarta is a genetically modified autologous T cell immunotherapy directed at CD19.
Novavax seeks CMA expansion for Covid-19 vaccine in EU for adolescents
Novavax has sought an expansion for the conditional marketing authorization (CMA) from the European Commission (EC) for its recombinant, adjuvanted Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents of the age 12 to 17 years. In December last year, the vaccine obtained CMA from the EC for active immunisation to prevent Covid-19 in people aged 18 years and above.
8 April | DEALS
PFIZER AGREES TO ACQUIRE BIOPHARMA COMPANY REVIRAL FOR $525M
Pfizer has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical company ReViral and its respiratory syncytial virus (RSV) treatment candidates in a deal value totalling up to $525m. As per the deal, the total consideration comprises upfront and development milestone payments. ReViral focuses on the discovery, development and marketing of new antiviral therapies for RSV. It has a portfolio of therapeutic candidates, including sisunatovir, an oral inhibitor that can hinder the fusion of the RSV virus to the host cell. At present, sisunatovir is being assessed in an international Phase II REVIRAL1 clinical trial in paediatric subjects. ReViral also has another RSV N-protein replication inhibitor programme with the lead candidate being analysed in the Phase I trial. In March this year, Pfizer acquired clinical-stage firm Arena Pharmaceuticals for an equity value of nearly $6.7bn in cash.
3 February | Regulatory
FDA GRANTS ORPHAN DRUG STATUS TO SYROS’ MYELODYSPLASTIC SYNDROME THERAPY
The FDA has granted orphan drug designation to Inhibrx’s INBRX-101 to treat alpha-1 antitrypsin deficiency (AATD).
INBRX-101 is a recombinant human AAT-Fc fusion protein.
It can safely attain and preserve AAT levels observed in healthy people with a favourable safety profile and the possibility of dosing once a month.
ICR researchers find drug combination to treat brain cancer in children
Researchers from the Institute of Cancer Research, UK, have identified a new combination of two approved cancer drugs that can be used to treat children suffering from incurable brain cancer.
Ocugen seeks FDA EUA for Covid-19 vaccine use in children
Ocugen has sought EUA from the US FDA for its Covid-19 vaccine candidate, BBV152, for use in children in the age group of two to 18 years.
Developed by Ocugen’s partner, India-based Bharat Biotech, and the Indian Council of Medical Research – National Institute of Virology, the whole-virion, inactivated vaccine is called Covaxin.
FDA declines to grant EUA for NRx’s Zyesami to treat Covid-19 patients
The US FDA has declined to grant an EUA for NRx Pharmaceuticals’ therapy, Zyesami (aviptadil), to treat critical Covid-19 patients who have respiratory failure.
In a letter to the company, the agency noted that its decision comes due to inadequate evidence on the known and possible benefits of the treatment and its risks in critical Covid-19 patients with respiratory failure.
Novartis and Dunad sign deal to develop protein degrader drugs
Novartis and UK-based company Dunad Therapeutics have signed a strategic partnership and licence agreement to develop oral targeted protein degrader small molecule therapies.
EMA stops rolling review of Lilly’s antibodies for Covid-19
The EMA has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.