News

Deal in Russia could cause Pfizer, GSK to lose contracts

A unit of Rostec, Russia's state corporation, has inked a pact with the Serum Institute of India to locally produce several vaccines in Russia, the Pharma Letter reports, a development that could bring about "significant losses" for Pfizer and GlaxoSmithKline in the country.

WHO seeks to ease cholera vaccine shortage with EuBiologics approval

In a move aimed at doubling the world's cholera vaccine supply, the World Health Organization has given its nod to South Korean's EuBiologics to provide vaccines under its prequalification program.

Aimmune takes peanut allergy vaccine into PhIII

Brisbane, CA-based Aimmune Therapeutics is making strides toward a peanut allergy vaccine, announcing on Monday that it enrolled the first patient in the Phase III trial of its therapeutic vaccine, AR101.

Nearly a year into Novartis integration, GSK CEO won't discount vaccines spinoff

Since the completion of its massive asset swap with Novartis, GlaxoSmithKline has been working to integrate the Swiss drugmaker's vaccines stall into its own operations. Now, at the J.P. Morgan Healthcare Conference, GSK CEO Andrew Witty cited "optionality" for the unit in the future, saying the drugmaker wouldn't discount a future spinoff.

New HIV vaccine player Aelix Therapeutics hits the scene with $12.7M Series A

Joining a wave of companies racing in the HIV vaccines space, Aelix Therapeutics announced a $12.7 million Series A round this week--and funding from Johnson & Johnson Innovation--to support work on its therapeutic HIV vaccine candidate.

Dynavax's hep B vaccine outperforms Glaxo's jab in top-line PhIII results

The FDA has already rejected Dynavax's hepatitis B vaccine once, but the Berkeley, CA-based biotech is planning to resubmit its licensing application for the jab as it serves up promising top-line data from the third Phase III trial of Heplisav-B.

Neovacs gets public funding help for therapeutic lupus vaccine

In late 2014, Paris, France-based Neovacs reported a midstage clinical trial failure and took a big share price hit. Following that, it shifted its focus to a separate candidate--IFNα-Kinoid for the treatment of lupus--and this week entered a public funding agreement that may assist it in commercializing that vaccine.

Norway's Bionor tests drug-vaccine combo against HIV

Antiretroviral treatments sometimes fail to work in people with HIV because of the virus' ability to "hide" in cells and then reemerge once therapy stops. Norway's Bionor tested anticancer drug romidepsin and a vaccine, Vacc-4x, in 17 HIV-positive patients in the hopes that the combo would force the virus out of hiding and then kill it.

Emergex to use Midatech nanoparticle tech for vaccines against infectious diseases

Oxfordshire, U.K.-based Midatech has licensed its gold nanoparticle technology to fellow U.K. biotech Emergex Vaccines in an exclusive deal. Emergex will apply the technology to developing and commercializing vaccines against infectious diseases.

Bavarian Nordic files for Nasdaq IPO

Looking to raise more than $86 million, Danish vaccinemaker Bavarian Nordic filed for a Nasdaq IPO this week on the heels of a busy 2015.

Study finds some docs are not strongly recommending HPV vaccines for preteens

Merck and GlaxoSmithKline have spent years working to build the market for their HPV vaccines, and a new study may demonstrate one factor that has hindered their efforts.

China approves Sinovac's vaccine for hand, foot and mouth disease

In December 2015, the China FDA approved the first vaccine against the virus that causes hand, foot and mouth disease, a common infectious disease often found in children. But competition was not far behind: the agency approved a second vaccine against the virus on Monday, this one developed by Sinovac.

European MERS vaccine effective in camels

South Korea's GeneOne Life Science and San Diego, CA-based Inovio teamed up to develop a vaccine for Middle East respiratory syndrome (MERS), which has infected 1,650 and killed nearly 600 since its emergence. The candidate has entered Phase I trials in the U.S., but a rising competitor, developed by European scientists, is hot on its trail.

Vaxart initiates PhI trial of oral influenza B vaccine

South San Francisco-based Vaxart said it has enrolled the first patient in a Phase I trial of the company's oral influenza B vaccine candidate. According to a statement, the vaccine represents the last monovalent component the company needs before it can advance with the development of its quadrivalent influenza vaccine tablet.

Sanofi's dengue vaccine gets first Asian approval with more discussions underway

The Philippines' FDA approved Sanofi's first-of-its-kind dengue fever vaccine, Dengvaxia, on Tuesday. And on the same day, India's Economic Times reported that the government there is exploring opportunities to accelerate marketing authorization for the vaccine, considering exempting it from large local clinical trials.

In $171M deal, Bavarian Nordic and J&J's Janssen extend efforts to HPV

Building on a relationship struck last fall, Bavarian Nordic and Johnson & Johnson's Janssen unit inked a deal on Friday potentially worth $171 million plus milestones aimed at the development of a therapeutic HPV vaccine.

GlaxoSmithKline launched new e-commerce platform for vaccines, pharma products

In March, GlaxoSmithKline and Novartis completed their $7.1 billion asset swap that was nearly a year in the making. The deal saw the British pharma bolster its vaccine business as it traded away its oncology unit for Novartis' vaccines business. Now, Glaxo is officially announcing the launch of GSKDirect, a new e-commerce platform that simplifies the way customers order vaccines and pharmaceutical products from the company.

After 2 months, FDA lifts clinical hold on Advaxis' cervical cancer vaccine

Back in October, the FDA slammed the brakes on four studies involving Advaxis' cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. The Princeton, NJ-based company announced on Wednesday that the FDA has lifted the clinical hold, allowing it to carry on with its clinical trials and sending its shares up 38%.

FDA expands male age indication for Merck's Gardasil 9

One month after a European safety review raised no issues with the blockbuster-to-be HPV vaccine Gardasil 9, Merck received another boost for its jab this week.

FDA accepts PaxVax's BLA for cholera vaccine, grants it priority review

Just a week after announcing a $105 million investment by Cerberus Capital, PaxVax is inching closer to getting its second vaccine--and potentially the first FDA-approved cholera vaccine--to market. The Redwood City, CA-based company announced Wednesday that the FDA accepted for filing and review the Biologics License Application (BLA) for Vaxchora, its cholera candidate.