GSK to invest $1.2bn in infectious diseases R&D in lower-income countries
24 June | R&D
GSK has announced plans to invest $1.2bn (£1bn) over a decade to expedite research and development (R&D) for infectious diseases in lower-income countries. New vaccines and therapies for the prevention and treatment of malaria, tuberculosis, human immunodeficiency virus (HIV), neglected tropical diseases (NTDs) and anti-microbial resistance (AMR) will be the focus of this research. These ailments are said to account for over 60% of the disease burden in several lower-income countries. This investment in Global Health R&D will support the company’s efforts for bringing next-generation vaccines and therapies for malaria and tuberculosis, offering shorter therapy options for patients. These options include R&D on long-acting injectables that could protect against P. falciparum malaria.The company has established a non-commercial Global Health Unit to meet the goals.
22 June | MANUFACTURING
Moderna to establish mRNA vaccine manufacturing centre in UK
Moderna has entered an agreement in principle with the UK government to set up a new messenger ribonucleic acid (mRNA) vaccine manufacturing facility in the country. The mRNA Innovation and Technology Center is anticipated to offer access to quick pandemic response expertise and respiratory virus vaccine candidates of the company. In partnership with the UK government, Moderna plans to produce mRNA vaccines domestically, including those against Covid-19, respiratory syncytial virus, seasonal influenza and other vaccines at the manufacturing site. Construction of the centre is anticipated to begin this year with the first mRNA vaccine expected to be produced in 2025.
23 Jun | COVID-19
Pfizer and BioNTech enter $3.2bn deal with US Government for Covid-19 shots
Pfizer and BioNTech have entered a new $3.2bn vaccine supply agreement with the US Government to supply further doses of their Covid-19 vaccine. This deal might comprise Omicron-adapted Covid-19 vaccines for use in adults, contingent on obtaining the US FDA authorisation. The companies anticipate supplying these vaccine doses by September and will continue into the fourth quarter of this year. On receiving the initial 105 million vaccine doses, the US government will make the agreed payment to Pfizer and BioNTech. Additionally, the government holds an option to procure up to 195 million further doses of the vaccine taking the total to 300 million.
27 June | DEALS
Ipsen to buy biopharmaceutical company Epizyme for $247m
Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. The transaction is focused on Epizyme’s lead asset, Tazverik (tazemetostat), a chemotherapy-free EZH2a inhibitor. Currently, the drug is indicated to treat metastatic or locally advanced epithelioid sarcoma in adults and paediatric patients aged 16 years and above who are not eligible for complete resection and adult patients with relapsed or refractory follicular lymphoma (FL) without any alternative treatment options. The transaction, which is subject to the satisfaction of all closing conditions, is expected to conclude by the end of Q3 this year.
22 June | DEALS
Galapagos to buy CellPoint, AboundBio to boost access to cell therapies
Galapagos has signed agreements to acquire all outstanding shares of CellPoint and AboundBio to boost access to next-generation cell therapies, in an all-cash deal totalling $251m. Under the definitive agreements signed between the companies, Galapagos will pay $132m (€125m) upfront to CellPoint while a milestone payment of an additional $105m (€100m) to be made is contingent on meeting certain goals.
1 July | DEALS
Blueprint Medicines announces financing partnerships for $1.25bn
Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. The company noted that the deal will bring substantial non-dilutive, low-cost capital to boost innovation and growth. The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects.
Japan’s MHLW accepts GSK’s submission for shingles vaccine in adults
The Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted GlaxoSmithKline’s (GSK) regulatory application for recombinant, adjuvanted Zoster vaccine, Shingrix, for preventing shingles (herpes zoster) in at-risk adults of the age 18 years and above.
EMA CHMP recommends AstraZeneca-Merck’s Lynparza for breast cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval for AstraZeneca and Merck’s (MSD outside the US and Canada) Lynparza (olaparib) as adjuvant therapy for high-risk early breast cancer patients.
Covid-19 induced immune response may damage brain, NINDS study finds
Scientists at the National Institutes of Health (NIH) unit National Institute of Neurological Disorders and Stroke (NINDS) have found that Covid-19-induced immune response could damage the blood vessels of the brain and may lead to short and long-term neurological symptoms.
FDA revises Emergency Use Authorization for Pfizer’s Paxlovid
The US FDA updated the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir), permitting pharmacists to prescribe the therapy to eligible patients. The revised EUA has certain limitations to guarantee suitable assessment of the patient and prescribing.
13 July | DEALS
Merck and Orion enter partnership to develop ODM-208 for prostate cancer
Merck (MSD outside North America) and Orion have entered an agreement to develop and market the latter’s investigational candidate ODM-208 to treat metastatic castration-resistant prostate cancer (mCRPC). The companies will also develop various other drugs that act on cytochrome P450 11A1 (CYP11A1), an enzyme vital for steroid production.
14 July | REGULATORY
Avrobio receives orphan drug designation for Hunter syndrome gene therapy
Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US FDA to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. The rare and seriously debilitating lysosomal disorder, Hunter syndrome primarily affects young boys and is caused by a deficiency in the lysosomal enzyme iduronate-2-sulfatase (IDS).
Integral Molecular and Optimeos partner to develop gene therapies
Integral Molecular has entered a collaboration with Optimeos Life Sciences for developing next-generation messenger ribonucleic acid (mRNA) and deoxyribonucleic acid (DNA)-based gene therapies. The mRNA and DNA therapeutics will leverage antibody-based molecular targeting to direct vaccines and gene therapies to appropriate tissues in the body of the patient.
Mineralys raises $118m to advance hypertension therapy development
Mineralys Therapeutics has raised $118m in a Series B funding round to advance the development of MLS-101, a new targeted treatment for hypertension. RA Capital Management and Andera Partners led the financing round with participation from new investors RTW Investments, Rock Springs Capital, SR One Capital Management and Sectoral Asset Management among others.
FDA approves Novartis’ cell therapy for follicular lymphoma in adults
Novartis obtained accelerated approval from the US FDA for its CAR-T cell therapy Kymriah (tisagenlecleucel) to treat adults with relapsed or refractory (r/r) follicular lymphoma (FL), following two or more lines of systemic therapy. With the latest approval, Kymriah is currently approved for three indications and is the only CAR-T cell therapy to obtain approval in adult and paediatric settings.
University of Oxford team discovers gene linked to chronic pain
Researchers at the University of Oxford in the UK have identified a gene that regulates pain sensitisation by augmenting pain signals within the spinal cord. This offers an insight into the key mechanism underlying chronic pain in humans. Researchers found a substantial difference in variants of one specific gene, the protein Sodium Calcium exchanger type-3, NCX3.