China approves AstraZeneca’s Imfinzi for small-cell lung cancer
20 July | approvals
The National Medical Products Administration in China has approved AstraZeneca’s Imfinzi (durvalumab) as the first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC) in adults.
Imfinzi is indicated for use with standard of care (SOC) platinum chemotherapy of etoposide in combination with carboplatin or cisplatin.
A human monoclonal antibody, Imfinzi attaches to and hinders PD-L1 interaction with PD-1 and CD80. This mechanism addresses the tumour’s immune-evading methods and releases immune response inhibition.
In March last year, the US Food and Drug Administration approved Imfinzi for ES-SCLC in adults.
Apart from approvals for ES-SCLC and unresectable, Stage III non-small cell lung cancer, Imfinzi is authorised in various countries for treating advanced bladder cancer in people who have already received therapies.
The latest approval in China is supported by positive data from the Phase III CASPIAN trial of the drug.
The randomised, open-label, multi-centre, international trial enrolled 805 ES-SCLC patients at more than 200 sites in 23 countries.
Data from the trial showed that Imfinzi plus SOC provided statistically significant and clinically meaningful improvement in overall survival as against SOC alone.
20 july | clinical trials
NRX’S ZYESAMI PREVENTS CYTOKINE STORM IN PHASE IIB/III COVID-19 TRIAL
NRx Pharmaceuticals has reported that its investigational drug, Zyesami (aviptadil), statistically significantly prevented a steep surge in cytokines or cytokine storm in Covid-19 patients in a Phase IIb/III trial.
The trial’s prespecified goal was to analyse the change in cytokine level, as cytokines are linked to mortality in Covid-19 patients, NRx noted.
A rapid surge in interleukin 6, an inflammatory cytokine, may also cause lethal conditions such as acute respiratory distress syndrome.
The Phase IIb/III trial analysed Zyesami against placebo in critically ill Covid-19 patients with respiratory failure.
The drug’s effect was observed in a broad set of subjects with varying levels of disease severity and treated in tertiary care as well as community hospitals.
19 july | drug development
UK TO LAUNCH RESEARCH STUDIES TO DEVELOP LONG COVID THERAPIES
The UK Government has announced plans to commence a research programme comprising of 15 new studies to develop new therapies for long Covid and enhance diagnosis.
As per the National Institute for Health and Care Excellence guidance, long Covid is a condition in which signs and symptoms continue or develop after acute Covid-19.
The UK Government will provide funds worth $27.54m (£19.6m) through the National Institute for Health Research to aid researchers to assess long Covid in people with long-term effects.
The new programme will focus on understanding long Covid, assessing the efficacy of various care services and developing effective therapies such as drugs, rehabilitation and recovery to treat chronic symptoms.
19 july | innovation
GSK TO BUILD $549M BIOTECH HUB IN STEVENAGE, UK
GlaxoSmithKline (GSK) has plans to open an $549m (£400m) biotechnology campus in Stevenage, UK, which would possibly create up to 5,000 skilled jobs in the coming five to ten years.
The plan for the new hub was developed in collaboration with Stevenage Bioscience Catalyst, the UK Government, Stevenage Borough Council and the Local Enterprise Partnership.
GSK intends to convert land within its current 92-acre research and development (R&D) site in Stevenage into a large cluster for biotechnology and early-stage life sciences companies in Europe.
For this purpose, the company will sell 33 acres of land to obtain up to £400m in new investment from a private sector developer to establish the new hub.
The hub, adjacent to the company’s plant at Stevenage, could offer floor space of 100,000m² for life sciences research and development purposes.
16 july | manufacturing
REGENERON TO INVEST $1.8BN TO EXPAND FACILITIES IN NEW YORK
Regeneron Pharmaceuticals has plans to invest nearly $1.8bn to boost research, preclinical production and support sites at its Westchester County campus in Tarrytown, New York, US.
New York State Governor Andrew Cuomo announced the company’s strategies, which will create 1,000 full-time jobs in the Mid-Hudson Region in the coming five years.
To support Regeneron’s expansion in the state, Empire State Development has proposed tax credits of up to $100m under Excelsior Jobs Program if the company meets hiring targets.
Regeneron chose to expand in the Mid-Hudson region after analysing various potential locations in the tri-state area.
Cuomo said: “The continued growth of Regeneron here in New York is yet another indication that we are leading the way in the life sciences and attracting the jobs of tomorrow.
“Not only will this expansion further drive economic growth in the Mid-Hudson Region, but fuel lifesaving innovation and development that benefits the entire world.”
16 july | regulation
OCUGEN COMMENCES ROLLING SUBMISSION OF COVAXIN TO HEALTH CANADA
Ocugen has commenced the rolling submission to Health Canada for its Covid-19 vaccine candidate, COVAXIN, which is being jointly developed with Bharat Biotech International for use in the US and Canada.
COVAXIN is a purified and inactivated vaccine. Bharat Biotech developed the vaccine in partnership with the Indian Council of Medical Research’s National Institute of Virology.
The latest submission comes after Bharat Biotech reported positive data from Phase III clinical trial, which showed vaccine efficacy and safety in approximately 25,800 adult subjects.
The vaccine demonstrated an efficacy of 77.8% against mild, moderate and severe Covid-19 and offered increased protection against emerging B.1.617.2 (Delta) and B.1.351 (Beta) variants of SARS-CoV-2.
Under the Minister of Health’s interim order, the rolling submission process was suggested and accepted by Health Canada. This submission was changed to a new drug submission for Covid-19, which allows companies to provide safety and efficacy data and information when they are available.
SFDA approves Moderna’s Covid-19 vaccine for use in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) has granted approval for the registration of Moderna’s Covid-19 vaccine, mRNA-1273, in the Kingdom of Saudi Arabia.
The move comes after Moderna sought approval for registering the vaccine to facilitate its import and usage in the country, the state news agency reported.
Contraceptive mini pill to be made available over the counter in the UK
The contraceptive pill will be available to buy over the counter at UK pharmacies for the first time after a landmark ruling from the Medicines and Healthcare products Regulatory Agency.
Lilly and Verge Genomics partner to use AI for drug development
Eli Lilly has entered a three-year partnership with biotech company Verge Genomics to research and create new drugs for the treatment of amyotrophic lateral sclerosis.
Verge developed an all-in-human, artificial-intelligence (AI)-driven drug discovery and development platform to develop treatments for serious genetic diseases.
KAIST and Institut Pasteur researchers find repurposed drugs for Covid-19
A research team from the Korea Advanced Institute of Science and Technology (KAIST) and Institut Pasteur Korea has detected repurposed therapies for the treatment of Covid-19 via virtual screening and cell-based tests.
Vaxart and Altesa enter licencing deal for antiviral drug Vapendavir
Altesa Biosciences has entered an exclusive global licensing agreement with Vaxart to develop, produce and market the latter’s patented formulation of a clinical-stage antiviral drug, Vapendavir.
14 july | vaccines
RDIF AND SERUM INSTITUTE PARTNER TO PRODUCE SPUTNIK VACCINE IN INDIA
The Russian Direct Investment Fund (RDIF) and Serum Institute of India (SII) have collaborated to manufacture the Russian Covid-19 vaccine, Sputnik, at the latter’s plant in India.
The manufacturing of the first batch of Sputnik doses is anticipated to begin in September, with plans to make more than 300 million doses of the vaccine in India annually.
SII has obtained cell and vector samples from the Gamaleya Center as part of the technology transfer and the cultivation process has commenced on receiving import approval from the Drug Controller General of India.
13 july | vaccines
SINOPHARM AND SINOVAC TO DELIVER 550 MILLION VACCINE DOSES TO GAVI
Gavi, the Vaccine Alliance has signed advance purchase agreements (APAs) for a total of up to 550 million doses of Covid-19 vaccines from Sinopharm and Sinovac for supply through the COVAX facility.
As per the agreements, Sinopharm will provide a total of 170 million doses of its inactivated virus vaccine, BBIBP-CorV.
Sinopharm will deliver 60 million shots from July to October. Gavi also holds an option to buy additional 60 and 50 million doses in the fourth quarter of this year and the first half of next year, respectively.
As per the APA with Sinovac, the company will supply 50 million doses of its inactivated virus vaccine, CoronaVac, to Gavi from July to September.
Gavi also has an option to acquire another 150 million doses of CoronaVac in the fourth quarter of this year, as well as 180 million doses in the first half of next year.
This would take the number of doses to be supplied by Sinovac to a total of up to 380 million.
MCureX and Samyang sign MoU for mRNA vaccine development
OliX Pharmaceuticals’ subsidiary mCureX has entered a memorandum of understanding (MoU) with Samyang Holdings to develop a messenger ribonucleic acid (mRNA) vaccine for Covid-19.
The companies are co-developing a vaccine that could potentially target Covid-19 viral variants.
Argenx to regain rights to cusatuzumab from Janssen’s Cilag
Janssen Pharmaceutical subsidiary Cilag International has decided to discontinue its partnership and licence agreement with argenx for an investigational CD70-targeting antibody, cusatuzumab.
The development comes after Janssen reviewed all available data linked to cusatuzumab and considered the transforming standard of care for AML treatment.
Serum Institute obtains DCGI nod to produce Sputnik V vaccine in India
The Drug Controller General of India (DCGI) has granted approval to the Serum Institute of India to produce Russia’s Covid-19 vaccine, Sputnik V, in the country.
Based on an adenovirus vector, the vaccine is given in two doses with a gap of 21 days.
FDA updates Regeneron’s Covid-19 antibody EUA to lower dose
The US FDA has updated the EUA for Regeneron Pharmaceuticals’ Covid-19 antibody cocktail, REGEN-COV, reducing the dose to 1,200mg from 2,400mg.
Bristol Myers faces $6.4bn lawsuit over cancer drug delay
UMB Bank, a trustee for Celgene’s former shareholders, has filed a lawsuit against Bristol Myers Squibb for allegedly delaying the development and manufacturing of cancer drug lisocabtagene maraleucel (Liso-cel) to avoid contingent value right payments worth $6.4bn.