Poolbeg Pharma plc has been granted a patent by the US Patent and Trademark Office (USPTO) for ways of treating hypercytokinaemia using a small molecule immunomodulator.
Roche agrees for Sanofi to be responsible for the OTC marketing and distribution of Tamiflu in the US market, as it works on approval for its Xofluza competitor product.
The EMA issues advice on the composition of season flu vaccines for the 2019/2020 season for manufacturers.
Aviragen Therapeutics has called on shareholders to back its proposed merger with oral vaccine delivery firm Vaxart.
SGS has completed a Phase I clinical trial of a new influenza virus strain in healthy volunteers and has increased capacity at its Mississauga, Canada-based laboratory.
BPI Europe 2017
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
ABL, Inc. will provide fill/finish services for live virus-based medical countermeasures (MCM) as part of the five-year contract worth up to $50m.
Natco Pharma and partner Alvogen have launched the “first generic equivalent” of Roche’s Tamiflu (oseltamivir phosphate) in the US.
This year at Interphex, BARDA will discuss various strategies and innovations to reduce drug shortages and improve medicines availability.
An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst.
Drug industry efforts to develop a Zika vaccine are accelerating but it will be at least 18 months until the first candidates are ready for trials according to the WHO.
Cilian has teamed up with Glide Technologies to develop a solid dose influenza vaccine to be delivered via a needle-free injector.
The US CDC has recommended that doctors give people Tamiflu (oseltamivir) after detecting that this year's vaccines a less effective than in previous years.
Researchers claiming Tamiflu cuts flu symptom duration and hospitalisations analysed less than half as many studies as were included in the 2014 Cochrane Collaboration review.
Southern California-based CRO WCCT Global is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) on influenza research.
Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.
The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.
A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.
AstraZeneca’s biologics wing MedIummune has been granted a US patent for an optimised cell line used to make infleunza vaccine.
For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.
New EU laws safeguarding national ownership of ‘genetic resources’ may delay production of seasonal influenza vaccines according to EFPIA, which wants stakeholders to discuss the issue.
Scientists developing vaccines for potentially deadly diseases like influenza, SARS and HIV struggle to find a CRO with the right capabilities according to contractor TNO Triskelion.
Roche has asked Tamiflu distributors to prioritize US regions hardest hit by flu as it works to address packaging delays expected to limit supplies of the oral suspension version of the antiviral for the rest of the month.
AstraZeneca has received positive opinion from the EU for use of its nasal spray vaccine Fluenz Tetra in children.
NanoViricides' nanotech drug delivery platform has the potential to eliminate viruses, the firm says as construction began on a manufacturing facility to support upcoming clinical trials.
Vaccine manufacturer Sinovac has updated its GMP accreditation to international standards, short of the deadline set by the CFDA.
Novartis, the J. Craig Venter Institute, Synthetic Genomics Vaccines and the US CDC are racing to develop a vaccine for the H7N9 influenza virus sweeping through China.
Protein Sciences says it will license the novel manufacturing technology behind recently approved influenza vaccine, Flublok, to other producers.
Marinomed Biotechnologies is set to take on the ‘common cold’ in China with a new patent for an anti-viral polymer technology that prevents rhinovirus infection.
Novartis says two seasonal influenza vaccines temporarily banned by several European countries on quality concerns are safe.
HHS is investing $400m (€318m) to create centres to speed development and production of medical countermeasures.
Medicago has finalised a research collaboration agreement with Mitsubishi Tanabe Pharma Corporation for the development of new VLP vaccines.
Novavax leasing cGMP plant to meet expected vaccine demand
Novavax is leasing a cGMP plant in Maryland under ‘very favourable terms’ to meet anticipated demand for its VLP vaccines.
Influenza pandemic prompts EMA vaccine quality rethink
The EMA is developing new vaccine quality guidelines in response to shortcomings seen during the influenza pandemic.
Vaccine adverse events linked to virus disrupting ingredient
Use of deoxycholate to chemically disrupt influenza viruses during vaccine manufacture could be linked to adverse reactions in children, a journal reports.
Vial to prefilled syringe shift on in US ahead of flu season
More-and-more US biopharm companies are moving from vials to prefilled syringes ahead of the upcoming flu season, according to BD.
WHO agreement improves global pandemic preparedness
The IFPMA has welcomed a WHO proposal to fund creation of extra vaccine production capacity to cope with global influenza epidemics.
None hurt in fire at Catalent UK packaging facility
US contract manufacturing organisation (CMO) Catalent has reported that no employees were injured in the fire that occurred at its packaging facility in the UK last week.
Lower clinical trial spend helps Novavax halve operating loss
Novavax halved its operating loss in the fourth quarter as a result of lower clinical trial spending.
HHS national vaccine plan calls for quick, flexible production
The US HHS has published a national vaccine plan that stresses the need for rapid and flexible manufacturing methods.
Takeda & Baxter aim to set up cell culture site in Japan
Takeda is collaborating with Baxter to establish a Vero cell-based influenza manufacturing facility in Japan and launch vaccines in the country.
Novartis and Synthetics Genomics Vaccines to co-develop synthetic flu vaccines
Novartis will use technology from Synthetics Genomics Vaccines to speed up the development of influenza vaccines for seasonal and pandemic flu outbreaks.
US gov support needed for overhaul of vacc production
Cell culture, LAIV vaccines and recombinant DNA technology should be supported by the US government as part of a long-term overhaul of pandemic response capabilities, according to PCAST.
Pandemic vaccine production time could be halved in 3 years
A review of US capabilities has concluded that the time to produce a pandemic vaccine could be halved through adoption of short-term policies.
BARDA funding vaccine capacity creation in developing world
BARDA is providing the WHO with $6.4m (€5.0m) to cooperatively develop influenza vaccine production capacity in under-resourced nations.
Abbott exploring sale of vaccines unit
Abbott Laboratories has confirmed it is considering the sale of the vaccines unit it gained with the €4.5bn ($6.2bn) acquisition of Solvay Pharmaceuticals in February.
Xcellerex’ tech key to US rapid vacc production project
Xcellerex’ development and bioprocess manufacturing technology plays key role in creation of rapid, low-cost vaccine production system.