News

Health Canada signs off on GSK's plans to improve its flu vaccine plant

GlaxoSmithKline has submitted its plans to whip its troubled Quebec flu vaccine plant into shape to Health Canada, and the regulator says the action outline is up to snuff.

Researchers retract narcolepsy study linked to Glaxo's Pandemrix

Scientists thought they may have been on to something as far as deciphering the link between GlaxoSmithKline's pandemic swine flu vaccine and narcolepsy. But now, unable to replicate their findings, they've retracted the study.

Dendreon's debt plans could leave stockholders in the lurch

Shareholders knew Dendreon had debt problems. What they did not know until Monday was that the cancer vaccine maker is considering moves that could leave them empty-handed.

EMA accepts Pfizer app to expand Prevenar in adults

Sales of Pfizer's best-selling vaccine may soon be getting bigger. The European Medicines Agency (EMA) has accepted the company's application to expand the label on Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains.

Bavarian Nordic the only bidder for Canada's smallpox vax supply

Canada has invited Danish company Bavarian Nordic--and only Bavarian Nordic--to bid for a tender to supply it with smallpox vaccines

NIH: Ebola vaccine trial could begin as early as September

The U.S. National Institutes of Health is set to begin an early-stage clinical trial for an Ebola vaccine in September, according to reports.

Affiris clears Phase I with Parkinson's vaccine candidate

Austria-based vaccinemaker Affiris announced that its Parkinson's disease vaccine has met its primary endpoint in a small Phase I safety trial of patients receiving two different doses of the jab.

U.K. and Novartis begin price negotiations on Bexsero

Let the negotiations begin. After pushing back on the price of Novartis' meningitis B vaccine, Bexsero, the U.K. is coming to the table with the Swiss drugmaker to see if it can haggle down the cost to its health system.

Sanofi dengue vaccine filings could come as soon as next year's Q1, CEO says

Sanofi's in line to rack up blockbuster sales after hitting a wide-open market with its dengue vaccine, analysts predict. And company CEO Chris Viehbacher thinks those sales could start rolling in before next year is out.

Kenya study reveals new malaria vaccine targets

Although GlaxoSmithKline has submitted its malaria vaccine to the European Medicines Agency for approval, the jab hasn't shown as much promise as hoped, underscoring the need for a better understanding of the malaria parasite and how it affects the human immune system.

PaxVax joins the marketed vaccines club with Crucell typhoid buy

PaxVax isn't just a vaccine developer anymore. The company is moving into the vaccines market with the pickup of a typhoid vaccine from Johnson & Johnson subsidiary Crucell, locking up $62 million in financing in the process.

Flu season should return Sanofi to double-digit vaccines growth, CEO says

Thanks to supply limitations in the U.S. that spurred a near-30% drop in adult booster vaccines, Sanofi reported Q2 vaccines sales down 0.4% overall. But its flu business posted big gains, ballooning 18.9% to €59 million ($78.9 million)--and CEO Chris Viehbacher says he expects that trend to continue.

Merck aims to boost HPV vaccination rates amid lagging numbers

Though Merck's Gardasil tops the company's best-selling vaccines list and has already achieved blockbuster sales, the drug giant has a long way to go if it wants to boost U.S. immunization rates against human papillomavirus.

Novartis reports high Bexsero uptake as it pushes ahead in open market

With Novartis and Pfizer racing for approval in a wide-open U.S. market, the Swiss pharma is taking the opportunity to expand its lead elsewhere, where its vaccine, Bexsero, has an expansive patient pool all to itself. And so far, it's going well, Novartis says.

Pfizer finally lands vaccines bulk-up with $635M Baxter buy

Prevnar's lonely days are over. Pfizer is finally beefing up beyond its best-selling franchise--a long-stated objective of CEO Ian Read's--nabbing Baxter's marketed vaccines portfolio in a $635 million deal.

Aduro nabs FDA 'breakthrough' nod for pancreatic cancer vaccine combo

Aduro BioTech's GVAX, a previously failed cancer vaccine, is finding new life in a combination treatment that the Berkeley-based company is testing in patients with pancreatic cancer.

AstraZeneca inks deal with Advaxis for immunotherapy-vaccine combo trial

AstraZeneca's MedImmune has joined up with immunotherapy maker Advaxis to evaluate the Big Pharma's antibody MEDI4736 in conjunction with the Princeton, NJ-based biotech's lead cancer vaccine in patients with HPV-related cancers.

SEC charges CytoGenix CEO, 'serial con artist' with fraud

According to the SEC, vaccine company CytoGenix was foundering financially when two men hatched a plan to convince investors otherwise. And now, the pair is facing charges.

Fluviral, FluLaval Tetra production on hold at Glaxo's troubled Quebec plant

GlaxoSmithKline is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec, vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.

GSK submits world's first malaria vaccine for EMA approval

It's taken 30 years, but GlaxoSmithKline's experimental malaria vaccine is finally ready for regulatory review. Looking to bring the world's first shot for the mosquito-borne disease to market, the pharma giant said Thursday that it has submitted its candidate for approval.