News

Amgen's T-Vec wins FDA nod, EU committee recommendation

In the last week, Amgen received regulatory endorsements on each side of the Atlantic for its first-in-class oncolytic viral therapy talimogene laherparepvec, known as T-Vec.

SciVac Therapeutics agrees to acquire VBI Vaccines

Rehovot, Israel-based SciVac Therapeutics announced Monday that it will acquire VBI Vaccines to form a commercial-stage company with a licensed hepatitis B vaccine and a pipeline of preventative and therapeutic vaccine candidates.

GSK reports PhIII success for shingles jab, will file for approval in late 2016

Merck's Zostavax is the only shingles vaccine approved in the U.S. and EU, but it may not be for long. Based on results from two Phase III trials involving more than 16,000 older adults, GlaxoSmithKline plans to submit a regulatory filing for its shingles candidate, dubbed Shingrix, in North America, Japan and the EU in the second half of 2016.

GSK's malaria vaccine hits roadblock as WHO recommends pilot projects

The World Health Organization is throwing a roadblock in GlaxoSmithKline's plans to roll out its malaria vaccine, dubbed RTS,S or Mosquirix, by calling for the vaccine to be used in pilot projects before a widespread campaign. Such pilot projects can take up to 5 years to complete.

Pfizer continues vaccines hot streak with 43% Q3 growth

After a strong first half, Pfizer's vaccine unit didn't let up in the third quarter, continuing on an upward trajectory as growing Prevnar 13 sales continued to propel the unit forward.

Astellas, ClearPath launch vaccines firm aimed at healthcare-associated infections

As healthcare-associated infections continue to burden the medical system and grab headlines, Astellas and ClearPath Development are forming a vaccines company looking to help tackle the issue.

NantWorks buys control of cancer vaccines with $50M Precision Biologics investment

Placing a bet in a field that has swelled with attention in the last year, biotech billionaire Patrick Soon-Shiong and his NantWorks umbrella organization are dropping $50 million into Dallas-based Precision Biologics and its lineup of proprietary cancer vaccines.

CSL to buy back $723M of its shares

Australia's CSL, which completed its acquisition of Novartis' flu vaccines business this year, has launched a AU$1 million share buyback.

Inovio's MERS vaccine could hit PhI before year's end

In the three years since Middle East respiratory syndrome (MERS) was discovered in Saudi Arabia, more than 1,500 cases of the disease have been reported and more than 600 people have died from MERS. This year's outbreak in South Korea infected 186 and killed 36. There is no vaccine for MERS, but Inovio's candidate could enter Phase I in the next couple of months.

Cancer vaccines field sees new player emerge with Gritstone's $102M Series A

Following a wave of recent activity in the cancer vaccines space, Gritstone Oncology burst onto the scene this week, bringing with it financial backing, scientific expertise and new energy to the field that has for years experienced mostly disappointment.

Sanofi, Gates Foundation and IDRI team up to improve vaccine development process

In recent months, experts have raised concerns about the time and costs involved in developing lifesaving vaccines. Now, Sanofi Pasteur, the Bill & Melinda Gates Foundation and the Infectious Disease Research Institute (IDRI) are joining together to do their part to improve things.

Genocea puts pneumococcal vaccine on back burner following PhII failure

On the heels of successful Phase II data for its genital herpes candidate, Genocea reported that its pneumococcal vaccine missed the mark in Phase II.

MedImmune joins GSK, Vanderbilt U in Human Vaccines Project

AstraZeneca's MedImmune is joining the likes of Vanderbilt University and GlaxoSmithKline as a member of the Human Vaccines Project, the company announced Tuesday. The public-private partnership, incubated at the International AIDS Vaccine Initiative (IAVI), aims to accelerate the development of vaccines and immunotherapies against major infectious diseases and cancers "by decoding the human immune system."

Reports: Chinese firm to spend $315M on Ebola vaccine manufacturing plant

Despite the West Africa Ebola epidemic's tapering off, a Chinese firm says it will invest $315 million into a facility in Tianjin to mass produce an Ebola vaccine developed by a group out of China's Academy of Military Medical Sciences, Reuters

University of Maryland HIV vaccine candidate enters human trials

Working at the direction of esteemed HIV researcher Dr. Robert Gallo, a University of Maryland team is taking its HIV vaccine candidate to human trials. In doing so, it's joining a race that has seen no shortage of attention of late as organizations near and far have worked to battle the virus' challenging characteristics.

Immunomic licenses allergy vaccine tech to Astellas for $300M

Astellas first joined forces with Immunomic Therapeutics in February, contributing $15 million up front for a vaccine against allergies caused by Japanese red cedar. Now, the duo is entering another partnership, with Astellas handing over $300 million up front for the exclusive license to Immunomic's LAMP-vax technology to develop vaccines for human allergies.

Pfizer touts Trumenba immunogenicity when administered with Menactra, Adacel

In a potential boost to uptake and adherence, Pfizer reported promising data this week on its meningitis B vaccine Trumenba administered along with Menactra and Adacel from Sanofi Pasteur.

J&J brings Ebola vaccine to trial in Sierra Leone

Just three weeks after it struck up a $28.5 million government partnership to advance its Ebola vaccine, Johnson & Johnson announced on Friday that it is starting a safety and immunogenicity trial in Sierra Leone for its Ebola candidate.

Cipla, Serum partner to provide vaccines in S. Africa

Building on an existing relationship, Indian generics giant Cipla and vaccines outfit Serum Institute of India on Thursday announced a collaboration to bring Serum's vaccines to South Africa.

Pfizer completes acquisition of two GSK meningitis vaccines

In a move to ease antitrust concerns ahead of its multibillion-dollar asset swap with Novartis, GlaxoSmithKline announced in June that it would sell two of its mature meningitis jabs to Pfizer.