mRNA licensing agreements surge 800% amid GSK lawsuits
Pharmaceutical Technology
OCTOBER 18, 2024
An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.
Licensing Vaccination Vaccine 
CureVac cuts jobs, licenses out vaccines to GSK
Bio Pharma Dive
JULY 3, 2024
The mRNA specialist plans to eliminate 30% of its workforce as part of a restructuring that will prioritize “high-value” projects like its cancer vaccines.
Vaccination 
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Sanofi signs $1.2bn licensing agreement for Novavax’s Covid-19 vaccine
Pharmaceutical Technology
MAY 10, 2024
Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine.
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LakeShore commences BLA submission to DRAP for rabies vaccine
Pharmaceutical Technology
NOVEMBER 8, 2024
LakeShore Biopharma has commenced the submission of its biologics license application (BLA) to the Drug Regulatory Authority of Pakistan (DRAP) seeking conditional approval for its PIKA Rabies Vaccine for post-exposure prophylaxis (PEP).
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Merck pays $250M to license Moderna cancer vaccine
Bio Pharma Dive
OCTOBER 12, 2022
The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release.
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Takeda nabs option to license Alzheimer’s immunotherapies from AC Immune
Bio Pharma Dive
MAY 13, 2024
The deal — worth $100 million up front and potentially billions more later on — gives Takeda an exclusive option to license an Alzheimer’s vaccine and other “active immunotherapies.”
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GSK and CureVac restructure mRNA vaccine development deal
Pharmaceutical Technology
JULY 3, 2024
GSK and CureVac have announced the restructuring of their existing partnership into a new licensing agreement for mRNA vaccine candidates.
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BARDA awards contract for Sabin’s Ebola Sudan and Marburg virus vaccines
Pharmaceutical Technology
JANUARY 13, 2023
The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.
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Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa
Pharmaceutical Technology
APRIL 13, 2023
The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.
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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license
Fierce Pharma
FEBRUARY 24, 2023
Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18
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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19
Pharmaceutical Technology
DECEMBER 2, 2022
India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.
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Meningitis vaccine comes to the forefront with impressive study results
Pharmaceutical Technology
MAY 25, 2023
A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. percentage points (96% CI, −0.3
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Valneva, LimmaTech ally on quest for first Shigella vaccine
pharmaphorum
AUGUST 1, 2024
Valneva has bolstered its vaccines pipeline with a shot designed to protect against shigellosis – a major global health threat – licensed from LimmaTech Biologics.The French pharma company – best known for its COVID-19 jab and recent approval for the world's first chikungunya vaccine Ixchiq – is paying €10 million upfront for a stake in LimmaTech's (..)
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Swiss startup LimmaTech licenses GSK vaccine, hires ex-CureVac chief as CEO
Bio Pharma Dive
JULY 20, 2023
The startup will take on development of a shigellosis vaccine GSK inherited when it acquired LimmaTech’s predecessor, GlycoVaxyn, in 2015.
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GreenLight and US NIH partner to develop Covid-19 vaccine for variants
Pharmaceutical Technology
AUGUST 1, 2022
GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.
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Moderna’s COVID-Flu Combo Shot Beats Separate Vaccines in Phase III Study
BioSpace
JUNE 10, 2024
Moderna’s combination vaccine candidate for COVID-19 and influenza outperformed licensed vaccines in older adults, according to late-stage results reported on Monday.
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Bavarian Nordic completes travel vaccine deal with Emergent
Pharmaceutical Technology
MAY 16, 2023
Bavarian Nordic has completed the acquisition of Emergent BioSolutions ’ travel vaccine portfolio for an upfront payment of $274m, with the potential for the total value to rise to $384m. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.
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Sanofi forges $1.2bn alliance with vaccines firm Novavax
pharmaphorum
MAY 10, 2024
Sanofi has licensed joint commercial rights to Novavax’s COVID-19 vaccine and will work with the biotech on the development of combined flu/COVID shots in a deal worth up to $1.2
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mRNA licensing agreements double with million-dollar deals
Pharmaceutical Technology
OCTOBER 7, 2024
mRNA-based vaccines, which instruct cells to produce proteins that can prevent or treat disease, show great promise in precision medicine.
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Mandating vaccinations is the right decision
World of DTC Marketing
SEPTEMBER 10, 2021
The government has the latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” We, as a nation, can not allow ignorance and stupidity to endanger us all. It is reckless at this point for the government not to mandate vaccination.
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South Korea authorises Novavax Covid-19 vaccine as booster dose
Pharmaceutical Technology
JANUARY 19, 2023
The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.
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Evaxion and ExpreS²ion partner to develop new CMV vaccine
Pharmaceutical Technology
DECEMBER 6, 2022
Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. Until 2025, the companies will equally share the research and intellectual property licensing expenses under the partnership.
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Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech
pharmaphorum
JANUARY 12, 2021
ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. One of the primary advantages of this approach is that the oral vaccine capsules are stable at room temperature, which means they do not require cold chain storage.
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Opinion: Will low-dose vaccination stretch the monkeypox vaccine supply, or backfire?
STAT News
AUGUST 9, 2022
heath secretary recently declared monkeypox as a public health emergency , paving the way for emergency use authorizations of additional vaccines or vaccine regimens to fight the disease. The same day, Food and Drug Administration Commissioner Robert Califf said that the U.S. — by changing the way it is given.
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Biologics License Application for 21-Valent Pneumococcal Vaccine Granted FDA Priority Review
Pharmaceutical Commerce
DECEMBER 19, 2023
Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.
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Novavax’s Covid-19 vaccine gets approval in South Korea for adolescents
Pharmaceutical Technology
AUGUST 14, 2022
Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.
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India's role in coronavirus vaccine manufacturing grows with new deals
Bio Pharma Dive
AUGUST 6, 2020
The Serum Institute, one of the world's largest vaccine producers, licensed Novavax's experimental shot, while Wockhardt signed on with the U.K. to help make AstraZeneca's candidate.
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FDA decision on Pfizer’s maternal RSV vaccine expected by August
BioPharma Reporter
FEBRUARY 21, 2023
The US Food and Drug Administration (FDA) has accepted Pfizerâs Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV in infants.
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CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III
XTalks
FEBRUARY 19, 2024
Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.
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AstraZeneca's self-administered nasal flu vaccine gets one step closer to FDA approval
Fierce Pharma
OCTOBER 24, 2023
On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.
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Monkeypox vaccine: First EUA for Bavarian Nordic amid worldwide shortages
Pharmaceutical Technology
AUGUST 26, 2022
Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.
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Experimental NIH Sudan virus vaccine protects macaques
Medical Xpress
FEBRUARY 3, 2023
A National Institutes of Health research group with extensive experience studying ebolavirus countermeasures has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. The new vaccine, VSV-SUDV, completely protected cynomolgus macaques against a lethal SUDV challenge.
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Pfizer and BioNTech seek FDA EUA for Omicron-based Covid-19 vaccine
Pharmaceutical Technology
AUGUST 23, 2022
5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.
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STAT+: Merck pays $250 million to license a Moderna skin-cancer vaccine candidate
STAT News
OCTOBER 12, 2022
Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer. Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157.
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F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday
NY Times
AUGUST 20, 2021
Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.
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Opinion: How small vaccine stockpiles can stop outbreaks of infectious disease from becoming big
STAT News
APRIL 24, 2023
Marburg could soon become the second virus in the past year to have experimental vaccine candidates ready for testing under an emergency use listing. Until this point, no licensed vaccines or treatments are available for Marburg. Read the rest…
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Moderna Q1 reveals COVID-19 vaccine sales stats: Biologics License Application to be submitted this month
BioPharma Reporter
MAY 6, 2021
The next step will be to start a rolling submission for a Biologics License Application (BLA) for its COVID-19 vaccine with the FDA this month. Moderna has reported the first profitable quarter in the companyâs history: after 10 years of research and several billion dollars of investment in its mRNA platform.
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Moderna, Pfizer Hit with New COVID Vaccine Patent Lawsuits
BioSpace
JUNE 7, 2023
Promosome filed lawsuits Tuesday against Moderna and Pfizer/BioNTech, alleging that the vaccine developers used patent-protected mRNA technology without a license.
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FDA expected to make decision on Pfizer RSV vaccine in May
BioPharma Reporter
DECEMBER 8, 2022
The US Food and Drug Administration (FDA) has accepted Pfizerâs RSV vaccine Biologics License Application (BLA) for priority review: with a decision expected in May.
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Cyfendus Anthrax Vaccine Wins FDA Approval
XTalks
JULY 25, 2023
Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.
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Blue Water Vaccines to develop oral chlamydia vaccine
BioPharma Reporter
NOVEMBER 22, 2022
Blue Water Vaccines has signed an exclusive, global license agreement for the development of a live attenuated, oral Chlamydia vaccine candidate from The University of Texas Health San Antonio.
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Takeda Withdraws Dengue Vaccine Application After FDA Request for More Data
BioSpace
JULY 12, 2023
Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
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CanSinoBIO developed a highly effective COVID vaccine with an inhalant version
pharmaphorum
JULY 18, 2022
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works. Regarding the BA.4
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Pfizer, BioNTech’s mRNA flu vaccine starts phase 3 testing
pharmaphorum
SEPTEMBER 15, 2022
The first patients have been dosed in a phase 3 trial of an mRNA-based seasonal influenza vaccine developed by Pfizer and BioNTech, which may offer quicker production and greater efficacy than shots made using traditional cell culture or recombinant techniques. It will compare the shot against a licensed inactivated vaccine.
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